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VAERS ID: 518564 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-19
Onset:2013-11-23
   Days after vaccination:4
Submitted: 2014-01-07
   Days after onset:45
Entered: 2014-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010759 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Borrelia test negative, Incomplete course of vaccination, Paresis, Swelling face, Upper respiratory tract infection, VIIth nerve paralysis
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Aphthous stomatitis
Diagnostic Lab Data: Borrelia serology done on 24-Nov-2013 (Ig G and Ig M) was negative.
CDC Split Type: WAES1401CHE001576

Write-up: Information has been received from SPMSD (MFR#2013-11419) on 30-DEC-2013. Case initially reported by a physician and received from the Health Authorities on 30-Dec-2013 under the reference number 2013-06154. Case medically confirmed. A 13-year-old female patient (weight: 29kg, height not reported) with no known allergies, no medication, no pregnancy and recurrent oral aphtose, had received on 19-Nov-2013 an initial vaccination with a GARDASIL (batch number J010759) via intramuscular route (site of administration not reported). On 23-Nov-2013, 4 days after the patient received the vaccine, she developed a left facial paralysis, which led to an emergency consultation in the hospital. The symptoms of incomplete eyes closing, incomplete frowning, incomplete laughing and left swelling cheek were diagnosed as a left isolated peripheral facial palsy. Borrelia serology done on 24-Nov-2013 (Ig G and Ig M) was negative. The requested emergency report showed that the patient presented at the time of symptoms onset an infection of the upper airways. A differential diagnosis of HSV infection was taking into consideration. The patient was severely affected by paresis. The patient had not yet recovered from the event at the time of reporting (30-Nov-2013). Follow-up from 18-Dec-2013: the regular follow-up showed, without further therapy, a continuous regression of the facial nerve, the lid closure was complete, only trumpet playing was not yet possible. The mother refused re-vaccination with GARDASIL. Further investigations (including HSV tests) were not yet done. At time of reporting, the event was assessed as not recovered. According to the Health Authorities, the reaction was possibly related to the vaccination. The Health Authorities assessed the case as serious (medically significant).


VAERS ID: 518568 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-03
Onset:2013-12-03
   Days after vaccination:0
Submitted: 2014-01-07
   Days after onset:35
Entered: 2014-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007399 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient, Deafness transitory, Dizziness
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401GBR001587

Write-up: Information has been received from SPMSD (MFR#E2013-11489) on 31-DEC-2013. This case was received from health authority in the foreign country on 31-Dec-2013. GB-MHRA ADR 22362700. The case is medically confirmed. A 12 year old female patient, with no medical history reported, received an injection of GARDASIL (batch number J007399) by intramuscular route, dose in series and site of administration not reported on 03-Dec-2013 and on the same day, the patient experienced dizzy, loss of hearing and loss of sight briefly. At the time of reporting, the patient had recovered from all adverse events. The MHRA considered that case serious due to be medically significant.


VAERS ID: 518673 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-01
Onset:0000-00-00
Submitted: 2014-01-08
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-SS-A antibody positive, Anti-SS-B antibody positive, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Arthralgia, Asthenia, Blood count normal, Blood test abnormal, DNA antibody negative, Joint effusion, Polyarthritis, Rheumatoid factor positive, Synovitis, Systemic lupus erythematosus, Ultrasound joint, Ultrasound scan abnormal
SMQs:, Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Parotitis; 07/2013, GARDASIL, Drug Reaction: Parotitis
Diagnostic Lab Data: Anti-cyclic citrullinated peptide antibody, Negative; Antinuclear antibody, $g1280 not provided; Autoantibody test, SSA, SSB positive; Blood count, Normal; 12/17/2013, Blood pressure, 11/8 not provided; Blood test, Moderate inflammatory syndrome; DNA antibody, Negative; Rheumatoid factor, Positive; Ultrasound scan, Joint effusion
CDC Split Type: WAES1401FRA002192

Write-up: Information received from Sanofi Pasteur MSD (SPM) (E2013-11458) on 30-DEC-2013. Case received from a health care professional via MSD company in a foreign country on 30-Dec-2013: A 16-year-old female patient had received the first dose of GARDASIL (batch number not reported) in Jul-2013 and the second dose of GARDASIL in Sep-2013. On 17-Dec-2013, she was seen by a physician because she had developed inflammatory polyarthralgia of hands, wrists, feet, shoulders and knees which had started two months before the consultation. It was associated with night arousals and functional disability for some gestures. There was no peripheral vascular disease and no photosensitization. She also experienced slight asthenia. Physical examination on the same day showed blood pressure at 11/8, heart and pulmonary auscultation unremarkable. Joint examination showed a synovitis aspect in metacarpophalangeal joints (MCP) of both hands, probable synovitis in wrists and patellar shock. Cutaneous mucosal examination was normal. Weight was stable. Biological examination showed blood count normal and moderate inflammatory syndrome. The clinical picture was suggestive of an inflammatory polyarthritis of probable autoimmune origin (lupus?). According to the reporter, the causal relationship with GARDASIL could not be ruled out. Treatment with PLAQUENIL bid was initiated due to the pain. The patient was seen again on 26-Dec-2013. A joint echography had been performed. The result confirmed joint effusion of metacarpophalangeal joint thumb, left and right interphalangeal proximal joint and moderate bilateral knee effusion. Autoimmune work-up showed antinuclear antibodies $g1280 with positive autoantibody test for SSA and SSB, anti-DNA antibodies negative, anti-cyclic citrullinated peptide antibodies negative and rheumatoid factor positive. Inflammatory polyarthritis of probable autoimmune origin was diagnosed, with probable early stage of lupus. As the patient experienced pain, corticotherapy was introduced and progressively tapered down during one month: prednisone 30 mg per day then 20 then 10 mg day. Treatment with PLAQUENIL bid was carried on. Dietary precautions were reminded. Search for proteinuria and anticoagulant would be checked up at the next work-up. To be noted that the patient had a medical history of 3 flares-up of parotitis. She had no surgical history. Her mother and grandmother had a medical history of cervical cancer. At the time of reporting, the patient had not recovered.


VAERS ID: 518674 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-20
Onset:2013-12-23
   Days after vaccination:3
Submitted: 2014-01-08
   Days after onset:16
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Delirium, Loss of consciousness, Pyrexia, Rash
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401VNM001607

Write-up: This spontaneous report as received from a pharmacist refers to a 17 year old female patient. On 20-DEC-2013, the patient was vaccinated with GARDASIL lot number and expiry date not provided. No other concomitant medications were reported. On 22-DEC-2013 the patient experienced rash, delirium and fever. She went to hospital was prescribed and discharged. On 23-DEC-2013 the patient experienced unconsciousness (hospitalization) and was hospitalized for the same. Unspecified treatment was provided. The patient was discharged on 02-JAN-2014. The outcome of unconsciousness, delirium, fever and rash is unknown. The causality for the events was not reported. Additional information has been requested.


VAERS ID: 518708 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-06-25
Onset:2013-05-01
   Days after vaccination:310
Submitted: 2014-01-08
   Days after onset:252
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G016831 / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Ocular vasculitis, Panophthalmitis
SMQs:, Vasculitis (narrow), Ocular infections (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 04/20/2012 Historical Drug GARDASIL; Drug Indication: Immunisation
Diagnostic Lab Data:
CDC Split Type: WAES1312DEU012274

Write-up: Information has been received from a physician via SPMSD as par of a business agreement (Sender''s case report number DE-1577272925-E2013-10904) on 03-JAN-2014. Case was received from a healthcare professional on 17-Dec-2013. Case is medically confirmed. An adolescent female patient received a dose of GARDASIL, (lot-no. not reported) on an unspecified date. Unspecified time later she developed an ophthalmitis. Duration and outcome were not reported. Follow-up information received on 30-Dec-2013. Reporting from was provided. The 15-year-old female patient (weight: 63.9 kg; height: 174 cm) received a second dose of GARDASIL (lot-no G016831, exp. 30-NOV-2013) into the upper arm on 25-Jun-2012. Ten months later in May-2013 at the age of 16 years, she developed an ocular vasculitis of unknown origin. From 05-Jun-2013 to 08-Jun-2013 the patient was hospitalised. At the time of reporting the patient had not recovered. Unspecified time "later", the patient stated to take hormonal contraceptives for systemic use. First dose of GARDASIL (lot-no G016831, exp. 30-NOV-2013) was given into the upper arm on 20-Apr-2012, toleration was not reported. According to the reporter the relation between the event and the vaccine was not assessable.


VAERS ID: 518797 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-01-10
Onset:2011-08-01
   Days after vaccination:203
Submitted: 2014-01-08
   Days after onset:891
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Migraine, Speech disorder, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 07/06/2010, GARDASIL, Immunisation; 09/04/2010, GARDASIL, Immunisation
Diagnostic Lab Data:
CDC Split Type: WAES1401FRA002254

Write-up: Information has been received from SPMSD (MFR control # E2014-00021) on 06-JAN-2014. Case received from the Health Authorities on 02-Jan-2014 under the reference number LL20131770. A 17-year-old female patient had received the three doses of GARDASIL, (batch numbers not reported) on 06-Jul-2010, 04-Sep-2010 and 10-Jan-2011. On 01-Aug-2011, i.e. 6 months after the third dose, the patient developed migraines with vomiting, vertigo and speech disorder. She was hospitalized one day and one night. In Sept-2013, the patient was hospitalized again for the same symptoms. After seeing a neurologist, the patient was prescribed EPITOMAX and sumatriptan. The seizures frequency was of 5 per month including 3 during her menstrual periods. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 L1) according to the method of assessment. The Health Authorities specified that causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of court procedures for compensation.


VAERS ID: 518799 (history)  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-09
Entered: 2014-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Papilloma viral infection, Postural orthostatic tachycardia syndrome, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 2005, Supraventricular tachycardia; Pneumothorax
Diagnostic Lab Data:
CDC Split Type: WAES1401FRA002304

Write-up: Information received from Sanofi Pasteur MSD on 06-JAN-2014. Case received from the Health Authorities in a foreign country on 02-Jan-2014 under the reference number TO20132354: A 21-year-old female patient had received a dose of GARDASIL (batch number unk) in 2008. She had a medical history of pneumothorax, and of junctional tachycardia diagnosed in 2005 which required a treatment with STOLAEX. In order to stop a long-term treatment, the patient benefited from a left lateral accessory cardiac pathway ablation in August 2009. After the surgical operation, SOTALOL was stopped but tachycardia progressively recurred until occurring daily again at 190 bpm. SOTALOL was then reintroduced but remained inefficient. Then the following antiarrhythmic treatments were tried but were not efficient: -STIADYNE -TILDIEM (treatment of the flare-up of junctional tachycardia) -KARDEGIC during one month -CARDENSIEL: no duration of treatment -PROCORALAN: no duration of treatment -KERLONE: no duration of treatment -ISOPTINE: no duration of treatment -TEMERIT: no duration of treatment. In November 2012, the patient was diagnosed dysautonomia of postural orthostatic tachycardia syndrome type, which was treated with SECTRAL. Tachycardia regressed although it remained present. As reported by the patient, she developed dysautonomia subsequently to vaccination with GARDASIL in 2008. It is noteworthy that the patient was diagnosed with HPV infection in July 2013. Biological work-up was unremarkable. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful according to the Foreign method of assessment. Upon medical review the company judged relevant to code the adverse event and HPV infection which was mentioned by the competent authorities in the narrative but not coded, and to code the adverse event postural orthostatic tachycardia syndrome, which was coded by the competent authorities in the medical history as well as accessory cardiac pathway ablation.


VAERS ID: 518873 (history)  
Age: 45.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-09
Onset:2013-05-07
   Days after vaccination:59
Submitted: 2014-01-09
   Days after onset:247
Entered: 2014-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000160 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody positive, C-reactive protein increased, Computerised tomogram abnormal, Granulomatosis with polyangiitis, Sinusitis
SMQs:, Interstitial lung disease (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Antineutrophil cytoplasmci antibody, Positive; C-reactive protein, Increased; Computerised tomogram, sinusitis; Computerised tomogram, thoracic: process apically
CDC Split Type: WAES1401DNK002482

Write-up: Case of adverse event received from a health care professional via the Health Authorities in a foreign country on 07-Jan-2014 under the reference number DK-DKMA-ADR 22363735 and DK-DKMA-EFO7851. Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # DK-1577272925-E2014-00051) on 08-JAN-2014. The primary reporter was a physician. A 45 year old female patient (weight: 75 kg cm), had received the first dose of GARDASIL, (batch and lot number J000160, expiration date on 30-JUN-2015) via intramuscular route of administration in not reported site of administration on 09-Mar-2013 and later on , 07-May-2013, she developed Wegeners granulomatosis. The patient had undergone CT of the thoracic with the result: apically process. She had CT scan of the sinuses as well which showed sinusitis. Her c-reactive protein was increased and antineutrophil cytoplasmic antibody (Anca) was positive. She had no other vaccines or medications. Patient''s medical history was not reported. At the time of reporting, the patient had not recovered.


VAERS ID: 518874 (history)  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-23
Onset:2013-07-31
   Days after vaccination:8
Submitted: 2014-01-09
   Days after onset:162
Entered: 2014-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003267 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Central nervous system lesion, Dizziness, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 01/17/2013, Delivery; 05/29/2013, GARDASIL, Immunisation
Diagnostic Lab Data: 18-SEP-2013: MRI: lesions in cerbrum, cervical and thoracic medulla
CDC Split Type: WAES1401DNK002468

Write-up: Information has been received from a physician via SPMSD as part of a business agreement (Sender''s case report number DK-1577272925-E2014-00054) on 08-JAN-2014. Case of adverse event received from a health care professional via the Health Authorities on 07-Jan-2014 under the reference number DK-DKMA-ADR 22363635 and DK-DKMA-EFO7845. The primary reporter was a physician. A 24 year old female patient, had received the second injection of GARDASIL (batch and lot number J003267, exp. 30-JUN-2013) via intramuscular route of administration in not reported site of administration on 23-Jul-2013 and later on, 31-Jul-2013, she developed multiple sclerosis/disseminated sclerosis. On unspecified dates she experienced vomiting and extremely pronounced dizziness. The patient had visited the doctor due to vomiting and extremely pronounced dizziness on 02-Sep-2013. Her condition was investigated and her first known attack of multiple sclerosis was verified with MR-scanning. The patient had undergone MRI-scanning of cerebrum and medulla on 18-Sep-2013 and the test result was received on 19-Sep-2013. It showed pathological contrast enhancement on several lesions both in the cervical and thoracic medulla as well as two of the cerebrum''s lesions. According to the reporter, the medical history and MRI-scanning meets McDonalds criteria for relapsing disseminated sclerosis. The patient had no other vaccines or medications. The patient had delivered a baby She had one previous vaccination with GARDASIL (batch and lot number J002122, exp. 31-AUG-2015) on 29-May-2013. Toleration was not reported. At the time of reporting the patient had not received the third vaccination. At the time of reporting, the outcome of multiple sclerosis was not recovered and outcome of the reactions vomiting and dizziness were unknown.


VAERS ID: 518894 (history)  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-11-27
Onset:2009-12-12
   Days after vaccination:15
Submitted: 2014-01-10
   Days after onset:1490
Entered: 2014-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging, confirming multiple sclerosis
CDC Split Type: WAES1401FRA003749

Write-up: Information received from Sanofi Pasteur MSD (SPM) (manufacturer number of E2014-00060) received on 06-JAN-2014. Case received from the Health Authorities in a foreign country on 06-Jan-2014 under the reference number NC20131185: A 21-year-old female patient developed multiple sclerosis on 12-Dec-2009, ie two weeks after she had received the second or third dose of GARDASIL (batch number not reported) via intramuscular route on 27-Nov-2009. The diagnosis of multiple sclerosis was confirmed by an MRI. The patient had received the first dose of GARDASIL on 18-Nov-2008. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful according to the Foreign method of assessment. The Health Authorities specified that "causality was assessment without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation. Additional information received from the Health Authorities on 08-Jan-2014: Patient''s initials and date of birth were provided.


VAERS ID: 519032 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-13
Entered: 2014-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoacusis
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401RUS002962

Write-up: This spontaneous report as received from an employee of CSL via CSL on 08-JAN-2013 refers to his/her friend, female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, indication, route not reported). On an unknown date the patient experienced hearing has been decreased and the patient thought it could have something to do with taking GARDASIL. The outcome of the event was unknown. Upon internal review, the hearing decreased was considered as medically significant. Additional information is expected.


VAERS ID: 519182 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-07
Onset:2013-09-01
   Days after vaccination:25
Submitted: 2014-01-13
   Days after onset:134
Entered: 2014-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003184 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Formication, Headache, Muscle spasms, Stress, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401FRA002814

Write-up: Information has been received from SPMSD (manufacturer control number FR-1577272925-E2014-00022) on 02-JAN-2014. Case received from the Health Authorities in a foreign country on 02-JAN-2014 under the reference number TO20132276. The primary reporter was a consumer. A 14-year-old female patient with no relevant medical history had received the first dose of GARDASIL, (batch number J003184, Expiration Date 30-JUN-2015) on 07-AUG-2013 and after vaccination, on 01-SEP-2013, she experienced formication, cramps in the legs, stress, cephalgia and visual disturbance. She received the second dose of GARDASIL (batch number J006656, Expiration Date 31-OCT-2015) on 01-OCT-2013. No laboratory test results were available. No non-drug related aetiology was found. The Health Authorities mentioned in their narrative that events lasted for 10 weeks, up to 11-NOV-2013, but also mentioned that the patient had not recovered and coded that all events had not resolved. The Health Authorities assessed the causal relationship between the reported events and vaccination as doubtful (C2 S1 I1) according to the method of assessment. Additional information received on 06-JAN-2014:The patient was 160 cm tall and weighed 40 kg. The Health Authorities assessed the causal relationship between the reported events and vaccination as doubtful (C2 S1 B3 I1) according to the method of assessment.


VAERS ID: 519193 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-30
Onset:2013-11-07
   Days after vaccination:38
Submitted: 2014-01-14
   Days after onset:68
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J004978 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy bone marrow, Haemorrhage, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Menorrhagia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Bone marrow examination (results not reported)
CDC Split Type: WAES1401IRL004771

Write-up: Information has been received from SPMSD (manufacturer control number IE-1577272925-E2014-00110) on 10-JAN-2014. This case was received from the health authority on 07-JAN-2014. IMB REF 2013-019223. This case is medically confirmed. A 13 year old female patient, with no medical history reported, received on 30-SEP-2013 an injection of GARDASIL, (batch and lot number J004978, expiration date 31-AUG-2015), 0.5 mL intramuscularly, dose in series and site of administration not reported. Approximately one month post vaccination, on 07-NOV-2013, the patient experienced Idiopathic thrombocytopenic purpura (ITP) and bleeding which has led to excessive blood loss from menorrhagia. The patient was under review by a paediatric consultant and a bone marrow examination was carried out in view of bilineage cytopenia (results not reported). Corrective treatment included intravenous immunoglobulins. Upon medical review, the company judged relevant to add the adverse event "menorrhagia" which was mentioned in the narrative but not coded by HA. At the time of reporting, the patient has not recovered from both of the adverse events. The IMB considered that case serious due to be medically significant and due to the patient''s hospitalisation (the reporter did not report any information about patient''s hospitalisation).


VAERS ID: 519199 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-14
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Antinuclear antibody negative, Borrelia test negative, Chlamydia test negative, Double stranded DNA antibody, Dry skin, Finger deformity, Hyperhidrosis, Joint swelling, Mobility decreased, Rheumatic disorder, Rheumatoid factor negative
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Fertility disorders (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Menarche; Contraception; Hypoaesthesia; Skin discolouration; 2007, Amenorrhoea; GARDASIL, Immunisation; 2007, GARDASIL, Immunisation
Diagnostic Lab Data: Antinuclear antibody, Negative; Borrelia test, Negative; Chlamydia test, Negative; Double stranded DNA antibody, Negative; Rheumatoid factor, Negative
CDC Split Type: WAES1401DEU005429

Write-up: Information has been received from Sanofi Pasteur MSD (DE-1577272925-E2014-00057) on 13-JAN-2014 as part of a business agreement. Case received from a health care professional via a company representative on 07-Jan-2014. Case is medically confirmed. A female patient, born on 08-Mar-1998, received the third dose of GARDASIL, (lot-no. not reported) on an unspecified date in 2008. On an unspecified date, the patient developed amenorrhoea (at the age of 19, after discontinuing contraception), sweating attacks, dry skin and suspicion of rheumatoid disease due to swelling of knee, swelling of hand joints, decreased mobility of hands and starting deformity of fingers. Blood samples were taken. Rheumatoid factor, double stranded DNA, ANA, Borrelia and Chlamydia were all negative. Specific results were not provided. No polycystic ovary syndrome and no hyperandrogenism were seen. At the time of reporting, the outcome was not reported. First dose of GARDASIL was given in 2007. Toleration was not reported. No information about date and toleration of second dose. At the age of 12/13 years, the patient had the first menstruation which came regularly. The patient had developed amenorrhea in 2007. Contraception was prescribed and menstruation was regular again. The patient had developed numbness and discoloration of hands (red, purple and white). Raynaud''s disease was suspected but excluded by blood tests. At that time sugar free diet was recommended. Upon medical judgment the case was assessed as serious by the company.


VAERS ID: 519200 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-04
Onset:2009-10-01
   Days after vaccination:58
Submitted: 2014-01-14
   Days after onset:1566
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Narcolepsy
SMQs:, Convulsions (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 06/04/2009, GARDASIL, Immunisation
Diagnostic Lab Data:
CDC Split Type: WAES1311DNK009639

Write-up: Information has been received from SPMSD (mfr control # E2013-09537) on 22-NOV-2013. Case received from a healthcare professional via the Health Authorities on 15-Nov-2013 under the references DK-DKMA-ADR 22320296 and DK-DKMA-EFO7515. Case is medically confirmed. A 12-year-old female patient (weight 60 kg, height 165 cm) with no medical history had received the second injection of GARDASIL, (batch number NK05560) intramuscularly into not reported site of administration on 04-Aug-2009. Concomitant medication included PRIORIX given on 04-Jun-2009. In Oct-2009, the patient developed narcolepsy (symptoms of tiredness). The physician saw the patient first time on 28-Oct-2009. The patient had received the third injection of GARDASIL (batch number NK36120) intramuscularly into not reported site of administration on 04-Dec-2009. Investigations had been done at hospital children ward and neurophysiological clinic, results were not reported. At the time of reporting, the patient had not recovered. The patient had received D1 of GARDASIL (batch number NK05560) intramuscularly into not reported site of administration on 04-Jun-2009, toleration was not reported. Information has been received from SPMSD (mfr control # E2013-09537) on 10-JAN-2014. Follow up information received from the health authority on 07-Jan-2014. The HA has upgraded this case to serious (other medically important event) as Narcolepsy has been assessed as serious. No other new information.


VAERS ID: 519298 (history)  
Age: 25.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-01
Onset:2013-03-01
   Days after vaccination:0
Submitted: 2014-01-14
   Days after onset:319
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Blood glucose decreased, Blood test normal, Dizziness, Fatigue, Headache, Memory impairment, Muscle tightness, Myalgia, Nausea, Pigmentation disorder, Uterine pain, Visual impairment, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Cervical spine flattening; 10/2012, GARDASIL, Immunisation
Diagnostic Lab Data: Blood tests taken on a non-specified date showed nothing - she was tested for vitamin deficiency, diabetes, metabolic diseases, joint and gout disease. The patient has undergone X-ray of the shoulder and neck, but these showed a straightened cervical lordosis which she surely has had for a long time and may have been born with.
CDC Split Type: WAES1401DNK004830

Write-up: Information has been received from a consumer via SPMSD as part of a business agreement (Sender''s case report number DK-1577272925-E2014-00088) on 10-JAN-2014. Case of adverse event received from a non-health care professional via the Health Authorities on 07-Jan-2014 under the reference number DK-DKMA-ADR 22371557 and EFO7868. The primary reporter was a consumer. A 25 year old female patient (weight: 67 kg; height: 172 cm), had received a dose of GARDASIL, (batch number not reported, dose number in series not specified) via not reported route of administration in not reported site of administration on an unspecified date in Mar-2013 and later on, unspecified date in Mar-2013, she developed headache, muscle tension, myalgia, fatigue, dizziness, nausea, visual disturbance, abdominal pain, uterine pain, white pigmentation on the back, slightly too low blood sugar, joint pain and memory impaired. Treatment for the reactions: Acupuncture, physical therapy, stretching, painkillers, training, heating pad, muscle manipulation and massage. The doctor and physiotherapist do not know anymore what to do about it. She has been on sick leave for 3 months but she has been treated for over six months. She is becoming convinced that she has developed strong reactions related to HPV vaccine. The patient has not been admitted because of the reactions. The patient has other medications but no additional information was not provided. Blood tests taken on a non-specified date showed nothing - she was tested for vitamin deficiency, diabetes, metabolic diseases, joint and gout disease. The patient has undergone X-ray of the shoulder and neck, but these showed a straightened cervical lordosis which she surely has had for a long time and may have been born with. The HA has requested medical confirmation from the patient''s general practitioner, answer is pending. The patient has a medical history of cervical spine flattening but has no other health problems in general. She had the first vaccination with GARDASIL (batch number not reported) via not reported route of administration in not reported site on an unspecified date in October-2012. At the time of reporting, the outcome was not recovered for all reactions.


VAERS ID: 519447 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness unilateral, Ulcerative keratitis, Uveitis
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Corneal disorders (narrow), Retinal disorders (broad), Ocular infections (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA006193

Write-up: Information has been received from a literature article concerning a 18 year old female patient developed, uveitis, corneal ulceration and unilateral blindness, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 44 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reported multiple vaccines were administered simultaneously. There was insufficient data in the case reports to determine whether other causes of keratouveitis were excluded in case #2 and 12. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination an uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.


VAERS ID: 519504 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-27
Onset:2009-02-01
   Days after vaccination:5
Submitted: 2014-01-15
   Days after onset:1809
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test normal, Colour blindness, Diplopia, Dysaesthesia, Fatigue, Gait disturbance, Hemiparesis, Hypoaesthesia, Lumbar puncture abnormal, Multiple sclerosis, Muscle spasms, Neuralgia, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Pain, Papillitis, Paraesthesia, Polymerase chain reaction, Sensory disturbance, Sleep disorder, Urinary tract disorder, Visual acuity reduced, Visual acuity tests abnormal, White matter lesion
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular infections (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOLDORM
Current Illness: Sleep disorder; Immunisation
Preexisting Conditions: 11/18/2008, GARDASIL, Immunisation
Diagnostic Lab Data: On 25 May 2009: the visual acuity of the left eye was measured at 0.05/10. The rest of the neurologic status was without abnormality. Lumbar puncture performed on 25 May 2009: pleocytosis (62/mm3) with proteinorrachia in the standard and intrathecal synthesis of IgG oligoclonal bands. MRI brain performed on 28 May 2009: showed a decade of lesions of the white matter with right frontal lesion. PCR and blood test (date not reported): were negative for infectious agents or antinuclear antibodies. MRI performed on 01-Sep-2009: the decade of white matter lesions were still present, showed three new left frontal lesions (right frontal lesion disappeared), one right temporal lesion, and two lesions of the left anterolateral part of the spine up to
CDC Split Type: WAES1401CHE005672

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # CH-1577272925-E2014-00151) on 08-JAN-2014. Case reported by a consumer to the Health Authorities on 08-Jan-2014 under the reference number 2013-06444. Case not medically confirmed. A female patient (weight and height not reported) had received a second dose of GARDASIL (batch number not reported) on 27-Jan-2009 via intramuscular route (site of administration not reported). The patient''s medical history included medication with contraceptives (several pills prescribed, registered trademarks unknown) since 2009. The patient had no other health disorder. The patient received a first dose of GARDASIL (batch number not reported) on 18-Nov-2008. The patient''s family medical history included a case of multiple sclerosis on one of the twin sons of the maternal great aunt of the patient. The patient''s mother reported that her daughter experienced burn-like pains and numbness in arms and legs since Feb-2009, some weeks after the second dose of GARDASIL administration, which occurred intermittently within the following months and which not responded well to anti-inflammatory medications. The mother make the link between vaccination and the daughter''s symptoms after seeing a TV show related to a complaint initiated by a patient diagnosed with multiple sclerosis and who experienced the first symptoms of the disease after a vaccination with GARDASIL. On 25 May 2009, the patient was hospitalised for a left optic neuritis. The first symptoms occurred on 22 May 2009 (progressive decrease of visual acuity, disturbed vision of colors). The visual acuity of the left eye was measured at 0.05/10. The rest of the neurologic status was without abnormality. Corticotherapy IV was administered to the patient, leading to an important improvement of visual acuity. Other exams performed (brain MRI and cerebrospinal fluid analysis) were compatible with an inflammatory condition, but nothing could be concluded. A control exam (MRI, in neurologic consultation) was scheduled at 3 months. The brain MRI performed on 01-Sep-2009 was compatible with a progression of inflammatory lesions of the white matter. Diagnostic criteria for a multiple sclerosis were present. The evolution was defined by remission and relapse of the disease. A second flare occurred on 07-Sep-2009: the patient experienced legs hypoesthesia with strength loss and walking disturbances, and diplopia on 17-Sep-2009. A third flare on Dec-2009 was characterized by a right very moderate papillitis. A fourth flare probably in Jun-2010 was characterized by sensory troubles. A fifth flare occurred in Aug 2010, with crural-brachial-facial dysesthesia and hypoesthesia, urinary symptoms and fatigue. No other flare was reported since then. The details concerning the motor, sensory and visual symptoms during these years were not provided but the neurologic status performed on May-2012, far away from the last flare, showed no real strength loss or sensory troubles. There were pains like sensations of burn and "needles in the back", at the level of the lower limbs and palmar sides of the hands. These pains were described at the time of the reporting as omnipresent, with strong exacerbations episodes, and were associated with spasms, occurring during the night in arms and legs. The ophthalmologic control performed on 12-May-2010, during optic neuritis and papillitis episodes, showed a visual function on the upper limit of the normal on both sides. The patient received the following therapies: IV corticotherapy during flares, (REBIF, 44 micrograms, via subcutaneous route, 3 times per week from 14-Oct-2009 to Mar-2013), which was replaced by TYSABRI (started on 30-Mar-2013), GILENYA (started since the mid of 2013). The treatment for the pain of intermittent symptoms included SAROTEN (since Dec-2009), and NEURONTIN (since Apr-2010, due to aggravation of paroxystic symptoms like left facial hemiparesia). The patient also received for sl


VAERS ID: 519512 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-23
Onset:2013-12-25
   Days after vaccination:2
Submitted: 2014-01-16
   Days after onset:22
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006698 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood glucose normal, Coma scale abnormal, Convulsion, Dry skin, Epilepsy, Fatigue, Foaming at mouth, Headache, Mobility decreased, Nausea, Neurological examination normal, Pallor, Petechiae, Skin warm, Tremor, Unresponsive to stimuli
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 10/23/2013, GARDASIL, Immunisation, Headache; 10/23/2013, GARDASIL, Immunisation, Nausea; 10/23/2013, GARDASIL, Immunisation, Abdominal pain
Diagnostic Lab Data: 12/25/2013, Blood glucose, 5.6; 12/25/2013, Body temperature, 37; 12/25/2013, Coma scale, 8; Neurological examination, Normal
CDC Split Type: WAES1401DNK005199

Write-up: Information has been received from Sanofi Pasteur MSD (E2014-00104) on 07-Jan-2014. Case was received from the Health Authorities on 07-Jan-2014 under the references DK-DKMA-ADR 22371350 and DK-DKMA-EFO7864. HA received initial information from a consumer on 25-Dec-2013 and additional information from a physician on 03-Jan-2014. Primary source was a consumer. Case is medically confirmed. This case is linked with non serious case E2014-00196 (same patient, same vaccine, different reaction). A 12-year-old female patient (weight 43 kg, height 152 cm) who had never had any illness, allergy or suffered from any kind of disease, had received the second dose of GARDASIL, (batch number J006698, route and site of administration not reported) on 23-Dec-2013 according to the vaccination program. On 25-Dec-2013, the patient developed an epileptic seizure, subsequent tiredness, pale skin, harmless petechiae and was unresponsive. Her mother woke up at approx. 09.50 due to some strange noises coming from her daughter. It sounded like she almost could not breathe. The mother watched her lying suffering from convulsions in almost half fetal position in recovery position with slightly trembling arms and legs bent in front of her. The eyes were closed and there was no contact. There were no contractions at the mouth, but foam came from it. There was no fever. The eyes moved around when opening the eyelids. When she was shaken to wake up, nothing happened. According to the mother the seizures had lasted for a maximum of 2 minutes. Subsequently, the patient lay completely motionless and was unresponsive. Emergency was called and the patient was transferred to hospital. The patient continued being unresponsive for the first minutes, but had no further seizures. Coma score was 8, axillary temperature was 37 and glucose 5.6 (units not reported). All other tests were normal. There was no secretion or tongue biting. Anamnesis: until todays seizure, there have been no signs of disease the days before, no fever, no influenza symptoms. Patient had normal bowel movements and urination, had not taken any medicine, had eaten general Christmas food as the rest of the family. The patient did not remember anything from the day before she was in the ambulance car, she remembered the normal Christmas Even yesterday. There were no complaints about headaches, eye pain, photophobia or skin itching. No respiratory problems, no coughing. Patient was a little tired, her skin somewhat pale and hot and dry. There were harmless petechiae, pin-sized on the face, mostly on the right cheeks and slightly on the forehead. Neurological examination was normal. Cardiac examination (not specified) and blood sugar has been measured (results not provided) and after Christmas the patient will undergo a EEG. After D1 of GARDASIL (batch number unknown) given on 23-Oct-2013 the patient developed headache, abdominal pain and nausea. These reactions were not considered as related to vaccination by the consumer, as several people had been affected by the influenza during that period. The outcome of the reactions were unknown. There was no known history of epilepsy or other known disorders in the family. Patient''s grandmother had diabetes. At the time of reporting, the patient had recovered on 25-Dec-2013 from epileptic seizure/convulsions and unresponsive were possibly related to vaccination. According to the reporter (not specified whether it was the physician or consumer), it is unknown what other adverse reactions the vaccination may have caused. No further information was provided.


VAERS ID: 519659 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-02-04
Onset:0000-00-00
Submitted: 2014-01-16
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK47540 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF test abnormal, Cataplexy, Fatigue, Narcolepsy, Sleep study abnormal
SMQs:, Convulsions (broad), Guillain-Barre syndrome (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 09/02/2010, GARDASIL, Immunisation, (Batch number unknown an can not be provided) via intramuscular route of administration in not reported site of administration; 07/05/2010, GARDASIL, Immunisation, (Batch number unknown an can not be provided) via intramuscular route of administration in not reported site of administration
Diagnostic Lab Data: Unknown date: CSF test: Low hypocretin (<10) HLA-DQB*0602; Unknown date: Polysomnography: Short average sleep latency (30 seconds); Unknown date: Multiple sleep latency test: Short average sleep latency (30 seconds); Unknown date: Sleep study: SOREM (sleep onset REM) in 4 out of 5 periods.
CDC Split Type: WAES1401DNK005526

Write-up: Information has been received from a physician via SPMSD as part of a business agreement (Sender''s case report number DK-1577272925-E2014-00144) on 13-JAN-2014. Case of adverse event received from a health care professional via Health Authorities on 09-Jan-2014 under the reference number DK-DKMA-ADR 22377196 and DK-DKMA-EFO7893. The primary reporter was a physician. A 13 years-old female patient (weight: 58 kg; height: 167 cm), had received the third dose of GARDASIL (batch number NM46920, lot number NK47540, exp. 31-MAY-2012) via intramuscular route of administration in not reported site of administration on 04-Feb-2011 and later on, unspecified date in Feb-2011, she developed narcolepsy. In addition, on an unspecified date after the third vaccination, she developed persistent tiredness and three months later she experienced narcolepsy with cataplexy (hypocretin deficiency). Patient medical history is unknown. The patient had received two previous doses of GARDASIL (batch numbers are unknown and cannot be provided) via intramuscular route of administration in not reported site of administration on 05-Jul-2010 and 02-Sep-2010. It is unknown if the patient had other vaccines or medications. Test of spinal fluid showed low hypocretin (<10) HLA-DQB*0602. Polysomnography and MSLT (multiple sleep latency test) showed short average sleep latency (30 seconds). SOREM (sleep onset REM) was in 4 out of 5 periods. At the time of reporting, the outcome was unknown for persistent tiredness and narcolepsy with cataplexy. Outcome was not recovered for narcolepsy.


VAERS ID: 519660 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-16
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fatigue, Paraesthesia, Petit mal epilepsy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401SWE006365

Write-up: Case received from a health professional via the Health Authority on 08-Jan-2014 under the reference number 2014-000137. Case was medically confirmed. Primary source was a physician. The company considered the case as serious (other medically important condition) due to absence attacks, even though HA reported the case as non-serious. A 15-year-old female patient with no medical history reported, had received a dose of GARDASIL, (batch number not reported) via not reported route and site of administration on an unspecified date. On an unspecified date in 2012, the patient developed absence attacks, tiredness, paresthesia like symptoms, syncope and dizziness. At the time of reporting, the patient had not recovered from tiredness and paresthesia like symptoms. The patient recovered from all other events within an unspecified timeframe. Additional information is not expected.


VAERS ID: 519661 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2010-04-30
Onset:0000-00-00
Submitted: 2014-01-16
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1693U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abscess, Breast mass, Fatigue, Headache, Hidradenitis, Multiple sclerosis, Nodule, Nuclear magnetic resonance imaging brain normal, Pain, Skin lesion, Temperature intolerance
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ethinyl estradiol (+) levonorgestrel
Current Illness: Non-tobacco user; Immunisation
Preexisting Conditions: Menarche, at 12 year old; 11/06/2009, GARDASIL
Diagnostic Lab Data: MRI brain (15-JUL-2010): Normal
CDC Split Type: WAES1401CHE006605

Write-up: Information has been received from Sanofi Pasteur [manufacturer control # CH-1577272925-E2014-00139] on 08-JAN-2014. Case reported by a pharmacist to the Health Authorities on 08- Jan-2014 under the reference number 2013-06303. Case medically confirmed. A female patient born (weight: 63 kg; height not reported) had received a second dose of GARDASIL (batch number NH55610 and lot number 1693U) on 11-Dec-2009 and a third dose of GARDASIL (batch number NH55610 and lot number 1693U) on 30-Apr-2010, via intramuscular route (site of administratoin for both doses not reported). The patient''s medical history included menarche at 12 years old. The patient was non smoker. The first dose of GARDASIL (batch number NJ35180). The patient had no health problem until the end of 2009 and she was not taking any medications. No case of hidradenitis suppurativa was reported in the patient''s family. Since Jan-2012, the patient was taking a contraceptive pill with Ologyn (1 dosage form once daily). On an unspecified date, but at the latest in Christmas 2009, the patient developed cutaneous lesions: abcessed nodules between the breasts and on groin folds/genital area, associated with burn-like pains, whereas there was no lesions before Nov-2009. The lesions persisted and evolved into nodules in the breasts. A Verneuil disease (also called hidradenitis suppurativa or acne inversa) was diagnosed in 2012 by a dermatologist. On an unspecified date, but clearly exacerbated after the third GARDASIL injection on 30-Apr-2010, the patient developed headaches, heat intolerance and fatigue. At the time of reporting, the patient did not recover from fatigue and headaches, which partly responded to antalgic medications (paracetamol, ibuprofen). The patient did not completely recover from heat intolerance but slightly improvement occurred since 2010. Pain due to cutaneous abscesses and headaches was very pronounced and caused school absenteeism (around 3 to 5 days of absenteeism per month). The patient''s mother reported these symptoms to the pharmacist and made the link between her daughter''s symptoms and GARDASIL vaccination after seeing a TV show focused on a complaint initialized by a female patient in this country. This patient was diagnosed with multiple sclerosis which first developed after GARDASIL vaccination. Two cases of Veneuil disease were also reported on this occasion. The mother was very concerned for her daughter. A MRI brain performed on 15-Jul-2010 showed no abnormality. At time of reporting, the patient was recovering from heat intolerance and had not yet recovered from the other events. The Health Authority coded "Sweet gland disorder", "Abscess", "Headache", "Fatigue" and "Heat intolerance". The Company added "hidradenitis suppurativa" (reported diagnosis) as an additional event. According to the Health Authorities, the reactions were possibly related to the vaccination. The Health Authorities considered the case sa serious (disabling). Additional information is expected.


VAERS ID: 519908 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-07-01
Onset:2014-01-09
   Days after vaccination:557
Submitted: 2014-01-17
   Days after onset:8
Entered: 2014-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Dissociative disorder, Dizziness, Dysgeusia, Headache, Hyperventilation, Insomnia, Irritability, Malaise, Memory impairment, Nervous system disorder
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401JPN006988

Write-up: Initial information has been received from a physician via the agency concerning a 19 year old female who in July 2012, was vaccinated with GARDASIL IM injection syringe (dose not reported). No information on underlying/concomitant diseases and a past medical history, etc, was provided. There were no items to pay attention (allergy, underlying disease, growth status, history of vaccination and disease within the last 1 month, etc), and the patient''s family history is unknown. Information on other concomitant medications was not reported. In July 2012, the patient received intramuscularly the first dose of GARDASIL. On an unspecified date, the patient developed higher cerebral dysfunction. In August 2012, the patient developed general malaise, anxiety and hyperventilation attack. In September 2012, the patient received intramuscularly the second dose of GARDASIL. She developed fussy head, headache, swaying feeling, anxiety disorder, sleep loss, dissociative disorder and short-term memory impairment. In April 2013, the patient received intramuscularly the third dose of GARDASIL. Her headache got worse. In September 2013, the patient experience taste disturbance. As of the time of this report higher cerebral dysfunction was not recovered/resolved, and the outcome of general malaise, anxiety disorder, hyperventilation attack, fuzzy head, headache, swaying feeling, sleep loss, dissociative disorder, short-term memory impairment and taste disturbance was unknown. The reporting physician considered that higher cerebral dysfunction was serious as it may result in disability. The reporting physician did not assess the seriousness of general malaise, anxiety disorder, hyperventilation attack, fuzzy head, headache, swaying feeling, sleep loss, dissociative disorder, short-term memory impairment and taste disturbance. The reporting physician felt that higher cerebral dysfunction was related to the GARDASIL. The reporting physician did not assess the causal relationship of general malaise, anxiety disorder, hyperventilation attack, fuzzy head, headache, swaying feeling, sleep loss, dissociative disorder, short-term memory impairment and taste disturbance to the GARDASIL. Additional information has been requested. Information has been received for a direct report from the agency regarding a case provided by the physician.


VAERS ID: 519917 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-02
Onset:2013-07-03
   Days after vaccination:1
Submitted: 2014-01-20
   Days after onset:201
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008564 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Immunoglobulin therapy, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401ITA008014

Write-up: Information has been received from Sanofi Pasteur [manufacturer control #E2014-00244] on 13-JAN-2014. Case received after Health Authority (case n. 232810) on 13-JAN-14 through SPMSD. Case initially reported by a physician. Case medically confirmed. An 11 year old female patient was vaccinated on 02-JUL-13 with one dose of GARDASIL (batch/lot n. H008564, expiry date: 31-JAN-2015). On 03-JUL-13 she presented with thrombocytopenia purpura. She was hospitalized and treated with IG VENA I.V.. The outcome is not recovered. The case is closed.


VAERS ID: 520038 (history)  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-10-11
Submitted: 2014-01-21
   Days after onset:102
Entered: 2014-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adenocarcinoma of the cervix, Biopsy cervix abnormal, Cervical conisation, Cervical dysplasia, Colposcopy, Cytology normal, Human papilloma virus test positive, Nuclear magnetic resonance imaging normal
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 09/2005, Cytology normal
Diagnostic Lab Data: A cytology was performed on SEP-2005 with negative results, all was correct. A cytology was performed on 2012 with normal results. A cytology performed on JUL-2013 was unsatisfactory due to inflammatory smear. No relevant. A cytology performed on 19-SEP-2013 showed glandular and epithelial cells altered. HPV test was positive for type 16. On 19-SEP-2013, a first biopsy showed HSIL. Also a colposcopy was performed (results not reported). Other biopsy was performed again on 11-OCT-2013 and it showed a well defined intensely ulcerated adenocarcinoma. A resonance (MRI) was performed on an unspecified date, it didn''t show vaginal infiltration. A conization was performed 25 days before reporting in order to determine the stage and confirm the dia
CDC Split Type: WAES1401ESP008362

Write-up: Information has been received from Sanofi Pasteur MSD [E2014-00294] on 17-JAN-2014. Case received from a healthcare professional, a physician, through a company representative, on 14-JAN-2014. Case medically confirmed. A 26 years-old female patient with no medical history reported had received GARDASIL (number of doses not reported, batch number, route and site of administration not reported) when she was 20 years-old (date not reported) and on 11-OCT-2013 the patient was diagnosed with endometrial adenocarcinoma of the cervix, HPV serotype 16 positive. A cytology was performed on SEP-2005 with negative results, all was correct. HPV test was not performed. A cytology was performed on 2012 (exact date not reported) with normal results. A cytology performed on JUL-2013 was unsatisfactory due to inflammatory smear. No relevant. A cytology performed on 19-SEP-2013 showed glandular and epithelial cells altered. HPV test was positive for type 16. On 19-SEP-2013, the patient went to this physician (reporter) with HSIL. A first biopsy was performed by this physician this same day, on 19-SEP-2013, it showed HSIL. Also a colposcopy was performed (results not reported). Other biopsy was performed again on 11-OCT-2013 and it showed a well defined intensely ulcerated adenocarcinoma. A resonance (MRI) was performed on an unspecified date, it didn''t show vaginal infiltration. A conization was performed 25 days before reporting in order to determine the stage and confirm the diagnosis, an endometrial adenocarcinoma of the cervix was diagnosed. According to the physician, a surgery will be performed (date not reported). A time of reporting the patient had not recovered. Upon medical review the company considered the case as serious with other medically important condition as criteria. No further information was reported.


VAERS ID: 520127 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-21
Entered: 2014-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis, Walking disability
SMQs:, Parkinson-like events (broad), Optic nerve disorders (broad), Demyelination (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401GRC008050

Write-up: Information has been received from SPMSD (manufacturer control # GR-1577272925-E2014-00356) on 13-JAN-2014. Case received from a paediatrician on 13-Jan-2014 via the contractual partner VIANEX under the reference number SPV14002. A 16-year-old female patient had received the second dose of GARDASIL, batch number and expiry date unknown) intramuscularly in the arm on an unspecified date in 2012 and 2 or 4 months later in 2012 she experienced walking disability. She was hospitalised in a neurological ward and was diagnosed with multiple sclerosis. At the time of reporting, the patient had not recovered. The reporting paediatrician who had prescribed the vaccine, specified the patient had no relevant medical history. There was no concomitant therapy. The reporter did not know if the reaction was related to the vaccine.


VAERS ID: 520268 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-29
Onset:2013-12-30
   Days after vaccination:31
Submitted: 2014-01-22
   Days after onset:23
Entered: 2014-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005033 / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC378133BH / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Haemorrhage, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 09/26/2013, GARDASIL
Diagnostic Lab Data:
CDC Split Type: WAES1401IRL008335

Write-up: Information has been received from SPMSD (sender''s case report number IE-1577272925-E2014-00350) on 17-JAN-2014. This case was received from the health authority on 14-Jan-2013. REF 2014-019235. This is one of three cases from the same reporter, concerning the same vaccine and event and is linked with E2014-00110 and E2014-00090. This case is medically confirmed. A 12 year old female patient with no medical history or concomitant medications reported received dose two of GARDASIL (lot and batch number J005033), IM in the left deltoid, on an unreported date. On 30-Dec-2013, one month post vaccination, the patient experienced severe thrombocytopenia with a sudden onset of bleeding and bruising and idiopathic thrombocytopenic purpura. The reporter stated that it could have potentially led to a severe haemorrhage. The patient had the first dose of GARDASIL (batch number not reported) on 26-Sep-2013. The patient received a single dose of BOOSTRIX (batch number AC378133BH), 0.5mls, IM, on 29-Nov-2013. Corrective treatment included tranexamic acid, IV immunoglobulins and steroids. At the time of reporting the patient''s symptoms were persisting. The agency considered the case serious due to hospitalization and medically significant.


VAERS ID: 520289 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-23
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Peripheral artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401DEU010186

Write-up: Case was received from a healthcare professional via SPMSD (manufacturer control# DE-1577272925-E2014-00389) as part of a business agreement on 17-JAN-2014. Case is medically confirmed. A 16-year-old female patient received a dose of GARDASIL (lot-no. not reported) on an unspecified date. One day later she developed a thrombosis of interosseous artery in the left lower arm leading to hospitalisation for an unspecified time. An intravasal vaccination was not excluded, but was not suspected by the hospital physician. Concomitant medication included hormonal contraceptive for systemic use. According to the reporter, the event was rather related to the hormonal contraceptives and not to the vaccination. The final outcome was not reported.


VAERS ID: 520292 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-08
Onset:2014-01-08
   Days after vaccination:0
Submitted: 2014-01-23
   Days after onset:15
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022183 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anaphylactic reaction, Nausea, Pallor, Rash
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401PRT009829

Write-up: Information has been received from SPMSD (sender''s case report number PT-1577272925-E2014-00455) on 21-JAN-2014. Case received from the Health Authorities on 16-Jan-2014 under the reference number N201401-32 via the local site Sanofi Pasteur MSD. The primary reporter was a nurse. A 12-year-old female patient had received the first dose of GARDASIL (lot and batch number H022183) intramuscularly on 08-Jan-2014 and 1 minute post vaccination she experienced facial and extremities pallor (mucous), then 20 minutes post vaccination she experienced anaphylactic reaction with abdominal pain, nausea and rash on face and neck. The patient was given specific treatment with SOLU-MEDROL (60 mg) intramuscularly and recovered 1 hour later. There was no known prior adverse reaction to other drugs. The reporter stated that the patient had been referred for immunoallergology medical visit.


VAERS ID: 520691 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-10-01
Submitted: 2014-01-24
   Days after onset:115
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute abdomen, Dyspnoea, Erythema nodosum, Haemorrhagic ovarian cyst, Leukocytosis, Platelet count increased, Thrombocytosis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Platelet count (OCT2013) results: Increased (Thrombocytosis)
CDC Split Type: WAES1401SUR011247

Write-up: This spontaneous report as received from a physician refers to a 12 year old female patient. Medical history or concomitant conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL, 0.5 ml, (frequency reported as: day 1, 2 months after 1st dose, 6 months after 1st. dose), intramuscular (dose was not reported). Concomitant therapy was not reported. In October 2013, the patient was hospitalized due to erythema nodosum, thrombocytosis, leukocytosis and dyspnoea. It was reported that hospitalization was prolonged. On an unknown date, the patient experienced acute abdomen because of bleeding in adnexa cyst which required an emergency room (ER) visit and went to operation room. Leukocyte count was 100 x 10g/L. The outcome of erythema nodosum, thrombocytosis, leukocytosis and dyspnoea was reported as not recovered/not resolved. The outcome of acute abdomen because of bleeding in adnexa cyst was unknown. The reporting physician considered erythema nodosum, thrombocytosis, leukocytosis and dyspnoea as life-threatening and disabling events. Additional information is not expected.


VAERS ID: 520692 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-24
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401IRL007576

Write-up: Information has been received from SPMSD (sender''s case report number IE-1577272925-E2014-00090) on 17-JAN-2014. This case concerning multiple patients was reported by the HSE in a foreign country on 06-Jan-2014. This case is medically confirmed. Three female patients with unreported medical history received GARDASIL, dose, batch, route and site not reported on unreported dates. An unreported time post vaccination, on an unreported date in the last few months the patient experienced thrombocytopenia. The patient outcomes were not reported. Follow up information was received from the IMB via a hospital doctor on 14-Jan-2014 (IMB REF 2014-019231). This case is now one of three linked cases from the same reporter and concerning the same vaccine and event and is linked with E2014-00110 and E2014-00350. This case now concerns one female patient of unknown age. On an unreported date in the last few months the patient experienced thrombocytopenia and idiopathic thrombocytopenic purpura. The patient outcome was not reported.The events were considered by the IMB due to medically significant and hospitalisation.


VAERS ID: 520782 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-06
Onset:0000-00-00
Submitted: 2014-01-27
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebellar syndrome, Neuromyelitis optica, Pyrexia, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Visual impairment
Diagnostic Lab Data:
CDC Split Type: WAES1401FRA011567

Write-up: Case received from a physician in a foreign country via SPMSD (manufacturer control #FR-1577272925-E2014-00485) on 23-JAN-2014. A female patient (age unspecified) with a medical history of visual disturbances had received the first doe of GARDASIL (batch number not reported) on 06-NOV-2012. On an unspecified onset of time, she developed a cerebellar syndrome associated with visual disturbances and fever. Devic''s disease was subsequently diagnosed. According to both the parents patient and the physician, there was no causal relationship with the vaccination. At the of reporting, the patient had not recovered. To be noted that the neurologist who followed the patient was opposed to carrying on the vaccination schedule.


VAERS ID: 520793 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-27
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test normal, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Malaise; GARDASIL, Loss of consciousness
Diagnostic Lab Data:
CDC Split Type: WAES1401FRA011242

Write-up: Information has been received from SPMSD (sender''s case report number FR-1577272925-E2014-00476) on 23-JAN-2014. Case received from a gynecologist on 20-Jan-2014. The reporter was told by a patient''s father that his 14-year-old daughter had received the first and second doses of GARDASIL, (batch number not reported) on unspecified dates, and both time experienced repeated malaises with loss of consciousness one month after the injection. She was hospitalized several days for a work-up which results were normal. At the time of reporting, the patient had not recovered.


VAERS ID: 521104 (history)  
Age: 35.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-29
Entered: 2014-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Blood pressure abnormal, Exercise tolerance decreased, Impaired driving ability, Quality of life decreased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Diagnostic Lab Data:
CDC Split Type: WAES1401ESP011953

Write-up: Information has been received from a consumer via SPMSD as part of a business agreement (Sender''s case report number ES-1577272925-E2014-00473) on 24-JAN-2014. Case received from a patient from another company through SPMSD on 20-JAN-2014 and transmitted to another country. Case not medically confirmed. A 35-year-old female patient, who didn''t have any of the symptoms before the vaccine, had received the third dose of GARDASIL (batch number, route and site not reported) in 2008 and 2 years before initial receive date was diagnosed with dysautonomia. According to the patient she experienced severe difficulties to keep her blood pressure stable and a lack of life quality. She had seen her sight diminished, her capacities diminished and her resistance was very low. She had to take care not to tired herself up as if she was an old lady. She had to measure herself at work, she couldn''t get too tired. She couldn''t go out at night. She couldn''t even think about driving long distance or longer than 40 minutes, not even talk about partying. Going to the grocery store was a jeopardy. The patient had received two previous doses of GARDASIL (batch numbers and route not reported) on unspecified dates. It was not reported whether the patient presented any adverse event after these doses or not. According to the information provided the patient had not recovered. Upon medical review, the company considered the case as serious with other medically important condition and disability as criteria. No further information was reported.


VAERS ID: 521108 (history)  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-01-03
Submitted: 2014-01-29
   Days after onset:26
Entered: 2014-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Cervical dysplasia, Cytology abnormal, Histology abnormal, Human papilloma virus test positive, Papilloma viral infection
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: On 11-SEP-2013, the cytology showed low grade squamous intraepithelial lesion (LSIL). On 03-JAN-2014, cytology showed Atypical Squamous Cells Of Undetermined Significance (ASCUS), KNIPS-histology showed high grade/ Cervical intraepithelial neoplasia II (HG/CINII)/ lesion; HPV 16 was positive in basal portion of the surface epithelium and in the whole range of filling the dysplastic epithelium of some glands. 01/03/2014, Human papilloma virus test, positive, see relevant tests N/A
CDC Split Type: WAES1401CZE012296

Write-up: This spontaneous reprot as received from a physician refers to a 20 year old female patient. On 09-DEC-2008 the patient was vaccinated with the first dose of GARDASIL (dose not reported, lot# reproted as NH 37990) subcutaneously. On 06-FEB-2009 the patietn was vacainted with the second dose of GARDASIL (dose no reproted, lot# reported as NH 55890) subcutaneously. The patient had first sexualintercourse in September 2009, after all three doses of GARDASIL were administered. On 11-SEP-2013, the cytology showed low grade squamous intraepithelial lesion (LSIL). On 03-JAN-2014, cytology showed Atypical Squamous Cells of Undermined Significance (ASCUS), KNIPS-histology showed high grade/Cervical intraepithelial neooplasia II (HG/CINII)/ lesion; HPV 16 was positive in basal portion of the surface epithelium and in the whole range of filling the dysplastic epithelium of some glands. At the time of reporting, the paitent had not recovered from the event. The event was considered to be medically significant event. additioanl information ha sbeen requested.


VAERS ID: 521398 (history)  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-16
Onset:2013-01-17
   Days after vaccination:1
Submitted: 2014-01-30
   Days after onset:378
Entered: 2014-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Headache, Nuclear magnetic resonance imaging, Pain in extremity, Tenderness, Ultrasound scan, X-ray
SMQs:, Dementia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 09/15/2012, GARDASIL
Diagnostic Lab Data: 01/02/2014, Nuclear magnetic resonance imaging, No specific results provided; 11/04/2013, Ultrasound scan, No specific results provided; 11/13/2013, X-ray, No specific results provided.
CDC Split Type: WAES1401DNK012424

Write-up: Case received from the patient insurance company (reference number 14-0126) via the Health Authorities on 22-Jan-2014 under the reference DK-DKMA-ADR 22386688. Case is not medically confirmed. Primary source was a lawyer. A 27-year-old female patient (weight and height not reported) with no medical history received the second dose of GARDASIL (batch number not reported) via not reported route into not reported site of administration on 16-Jan-2013. On 17-Jan-2013, 1 day after vaccination, she developed headache, joint pain in the hips and tenderness throughout the body. She had a lot of headaches. She had a very sore arm, the one that got stung. It lasted approximately 3 weeks. Pain in the left arm started around February 2013. Pain in right arm started approximately 2 weeks after. In February, she began to exercise less because of pain in her arms. In April, it went really bad, and she could not complete a training session. Then she went to see a physiotherapist. Her physical therapist was unsure if the pain came from the back, or whether it was a tennis elbow. She suggested a chiropractor when her treatment had no effect. After various examinations the chiropractor stated that it was tennis elbow in both arms. He advised her to go to the doctor and to keep her arms at rest. When the work performance started to cause her problems because of pain, she got lighter jobs in approx. 14 days, but because of the pain she had to take sick leave from 16-May-2013. She was at the general practitioner on 21-May-2013 who also believed it was tennis elbow / golf elbow in both arms since she was in pain where the doctor had pressed. They agreed that she should keep her arms at rest and do some specific exercises. During a control 14 days after there was no improvement in her arms, so she was referred to a rheumatologist. The blockades only made it worse. Despite the fact that she has not exercised for a long time and have not worked, the pain only got worse. Investigations were performed by private doctor, physiotherapist and chiropractor. The patient also received other alternative treatment. On 31-Oct-2013, there was a consultation at Hospital. On 04-Nov-2013 an ultrasound was performed, on 13-Nov-2013 a X-ray was done and on 02-Jan-2014 she underwent a MRI scan. She has an appointment on 23-Jan-2014 at Hospital and will receive answers for MRI scanning. At the time of reporting, the patient had not recovered. Symptoms had a high extent. She was still on sick leave from her job, and could not even perform the daily chores such as washing dishes, changing bed linens, go shopping, vacuuming etc. While shampooing could hurt at times, and blow drying could not be done without severe pain afterwards. Even when she bicycled she got severe pain in both elbows. Her normal workout has also stopped long ago. The patient had received GARDASIL via not reported route into not reported site of administration on 15-Sep-2012 (D1, batch number H011751) and on 06-Jun-2013 (D3, batch number not reported). Toleration was not reported. Noteworthy: There is a discrepancy regarding start date of pain in the left arm. HA coded 17-Jan-2013 in the structured field but mentioned that pain in the left arm started around February 2013 in the narrative. There was a number missing for a date in the narrative: ''21-May-201'' (incomplete year stated by the HA, but presumably 2013). The events of pain in the left and right elbow, pain and soreness in the left arm, pain in the right arm, headache, joint pain in hips, tenderness throughout the body were considered to be medically significant by the reporter.


VAERS ID: 521404 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-18
Onset:2013-11-19
   Days after vaccination:1
Submitted: 2014-01-31
   Days after onset:73
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased appetite, Headache, Influenza like illness, Myalgia, Nausea, Pain in extremity, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 09/30/2013, GARDASIL, No adverse event
Diagnostic Lab Data:
CDC Split Type: WAES1312SWE011884

Write-up: Information was received from Sanofi Pasteur (# SE-1577272925-E2013-10901) on 26-DEC-2013, as part of business agreement. Case received from healthcare professional via Health Authorities on 17-Dec-2013 under the reference number SE-MPA-2013-000381. The primary reporter was other healthcare professional (not further specified). An 11-year-old female patient, had received an unspecified dose of GARDASIL (batch number H022294) via not reported route of administration in not reported site of administration on unspecified date and later on 30-Sep-2013 she developed vomiting, nausea, abdominal pain and muscle pain. No information on medical history reported. At the time of reporting, the patient had not yet recovered. Follow-up information was received from Sanofi Pasteur (# SE-1577272925-E2013-10901) on 28-JAN-2013, as part of a business agreement. Follow up information received from the health authority on 23-Jan-2014. The patient received the second dose of GARDASIL (batch number H022294, 0.5 ml) via intramuscular route of administration in not reported site of administration on 18-Nov-2013. After the injection the patient developed pain in arm (the HA coded onset unspecified date in Nov-2013). The day after the vaccination she had fever that lasted for one day. Furthermore she vomited for two days with influenza like symptoms. On 13-Dec-2013 she still had daily nausea with recurrent abdominal pain and loss of appetite were still continuing. Several times a week she experienced headache and diffuse muscle pain over the entire body. The patient received the first GARDASIL vaccination (batch number not reported) on 30-Sep-2013 with no adverse reactions. Note from the health authority: the reporter has assessed the reactions as not serious. In accordance with applicable guidelines for seriousness assessment the Agency has classified the reactions as serious. At the time of reporting, the outcome of all reactions were not recovered except for loss of appetite which was not reported. The health authority has assessed abdominal pain, nausea, vomiting, headache, muscle pain, influenza like symptoms, pain in arm and fever as possibly related to the vaccination. Discrepancy in HA report: The HA coded outcome for fever as not recovered but mentioned in narrative that it lasted for one day. In addition, it was mentioned in narrative that the patient vomited for 2 days nevertheless the HA has coded outcome as not recovered. Upon medical review the company judged relevant to code the following adverse event: loss of appetite (onset was not reported) which was mentioned by the HA in the narrative, but not coded.


VAERS ID: 521411 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-23
Onset:0000-00-00
Submitted: 2014-01-31
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010963 / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Colitis, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type: WAES1401IRL013956

Write-up: Information has been received from SANOFI PASTEUR MSD (MFR # E2014-00605) on 28-JAN-2014. This case was received from the health authority on 23-Jan-2014. IMB REF 2014-019311. This case is medically confirmed as it was reported by a physician. A 13 year old female patient, with a medical history of asthma, received on 23-Sep-2013 a first dose of GARDASIL (batch number H010963), route and site of administration not reported. On an unreported date, the patient developed severe diarrhoea and was diagnosed with colitis 3 weeks post vaccination. The patient was treated with immunosuppressive medications as corrective treatment. The reporter indicated that the patient was advised to delay further vaccinations with GARDASIL because of corrective treatment. At the time of reporting, the patient''s outcome was unknown for the adverse events. The IMB considered that case serious due to medically significant.


VAERS ID: 521719 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-14
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Appendicectomy, Arthralgia, Borrelia infection, Borrelia test positive, CSF test abnormal, Chest X-ray normal, Chills, Fatigue, Headache, Infectious mononucleosis, Listless, Nuclear magnetic resonance imaging brain normal, Post viral fatigue syndrome, Syncope, Ultrasound abdomen normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 06/19/2013, Borrelia test, serum IgG 1300% of cutoff; 06/19/2013, CSF test, Borrelia IgG positive; 02/20/2013, Nuclear magnetic resonance imaging, MR brain normal; 07/29/2013, Ultrasound scan, abdomen normal; 05/23/2013, X-ray, Thorax no pathological findings
CDC Split Type: WAES1401NOR001829

Write-up: Information has been received from Sanofi Pasteur (manufacturer control # NO-1577272925-E2013-11390) on 31-JAN-2014. Case received from a health professional via the Health Authorities on 27-Dec-2013 under the reference number NO-NOMAADVRE-FHI-2013-16784. Case is medically confirmed. Primary reporter was a physician. A 13-year-old female patient received a complete vaccination series with three doses of GARDASIL (batch numbers not reported) via parenteral route into not reported site of administration on 11-Nov-2010 (D1), 17-Feb-2011 (D2) and on 14-Jun-2011 (D3). On an unspecified date, the patient experienced listlessness and syncope. The patient developed tiredness between D1 and D2. After about one year, the patient developed shivering, abdominal pain and headache. At the time of reporting, the outcome of syncope was unknown and the patient had not recovered from all other events. According to the HA, the events were possibly related to all 3 vaccinations. Persisting symptoms after GARDASIL. According to the reporter, the patient was followed up in hospital. Case considered as non-serious by HA. Follow up information received from the health authority on 29-Jan-2014. The case has been upgraded by the HA to serious due to hospitalization and disabling. According to the reporter, the girl is followed up in hospital. The HA received additional information 20-Jan-2014: Discharge summary from 05-Nov-2013- 08-Nov-2013, which summarize the adverse events from autumn 2011. Girl born, vaccinated with GARDASIL 11-Nov-2010, 27-Feb-2011, 14-Jun-2011. According to mother the daughter''s symptoms started between the first and the second dose of GARDASIL. Autumn 2011 she apparently was diagnosed with mononucleosis (coded as medical history by HA). She had repeating syncope episodes in the lessons of physical education, point of time is not further described. She had to be performed from these lessons. Symptoms as listlessness, tiredness, shivering, abdominal pain, headache and pain in joints had been going on for more than one year when she was carefully examined in course of spring and summer 2013. MR brain, X-ray thorax, U/S abdomen revealed no pathology. Borrelia IgG was (19-Jun-2013) measured to 1300% of cutoff, increased from an earlier measurement of 150% (time of point not reported). There was also findings of Borrelia IgG in CSFF (19-Jun-2013) She was treated with Doxyline for 14 days. Diagnosis according to the discharge summary: Post viral fatigue syndrome. The discharge summary describes follow-up planning: Her family doctor will participate in developing a responsibility group, with a comprehensive plan for the school work the next years. The girl will also be followed up by a physiotherapist and the health care visitor. The patient''s sister got the diagnosis ME in 2006. This is the final report. All events are assessed as possible to the three doses. Upon medical review the company judged relevant to code borrelia infection, mentioned in the narrative but not coded. The company judged it relevant to code mononucleosis and appendectomy as adverse reaction and not as medical history as by the HA, since it started after vaccination. HA comment: HPV vaccine is a non-living vaccine and can not cause infections. General malaise may occur the first few days after many vaccines. The symptoms of the report are not common side effects after HPV vaccine. In a recent publication no increased risk of fatigue syndrome after HPV vaccination can be found. Agency has found no literature that supports a causal relationship between HPV vaccine and ME.


VAERS ID: 521720 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-17
Onset:2014-01-18
   Days after vaccination:1
Submitted: 2014-02-04
   Days after onset:17
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Erythema, Inadequate aseptic technique in use of product, Local swelling, Pain in extremity, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR000555

Write-up: This case was received from the health authority on 28-Jan-2014. GB-MHRA-ADR 22397644. Information has been received from Sanofi Pasteur as part of a business agreement (manufacturer control # GB-1577272925-E2014-00769) on 31-JAN-2014. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient (weight: 57.15 kg), with no medical history reported, received on 17-Jan-2014 an injection of GARDASIL (batch number not reported), dose in series, route and site of administration not reported. The following day, on 18-Jan-2014, the patient experienced bright red arm which was very hot to touch, very swollen, painful and itchy. The patient believed she suffered from cellulitis. The patient''s arm was not cleaned before the injection was given, potentially allowing an infection to enter in her body. The patient spoke to the pharmacist the day after the vaccination who told her to take histamine. Three days later, the patient was given antibiotics (no more information reported) as corrective treatment. At the time of reporting, the patient has not recovered from the adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 521869 (history)  
Age: 40.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-01-01
Onset:2013-07-01
   Days after vaccination:547
Submitted: 2014-02-04
   Days after onset:218
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Human papilloma virus test positive, Laryngeal cancer
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 2013, Cytology, HPV C16 positivity
CDC Split Type: WAES1401HUN014396

Write-up: This spontaneous report as received from a consumer wife refers to a male patient in his 40s. Consumers wife reported the case to her gynecologist first, and then the gynecologist reported the case to sales representative. Approximately on January 2012 (about 2 years ago), the patient was vaccinated with SILGARD, 0.5 ml,, in the arm. On an unknown date in July 2013 the patient was diagnosed with laryngeal cancer (medically significant)(grade not reported). On an unknown date in 2013, cytology of the lymphatic nodule showed HPV C16 positivity. As the patients wife reported to he gynecologist, the pathologist who performed the cytology explained them that her husbands reported: the pathologist told them that laryngeal cancer was caused by the SILGARD, injected in his arm because it spread up from his arm to his pharynx). The referred pathologist was contacted but did not confirm what the patient reported. The pathologist did not see any causal relationship between the event and SILGARD. The outcome of laryngeal cancer was unknown. The gynecologist had neither connection with the male patient nor confirmed the patients report and causality assessment, therefore the case was considered to be not medically confirmed. Upon internal review, laryngeal cancer was considered serious due to other important medical event. Additional information is not expected.


VAERS ID: 521879 (history)  
Age: 40.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-31
Onset:2014-01-06
   Days after vaccination:6
Submitted: 2014-02-04
   Days after onset:29
Entered: 2014-02-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood creatine normal, Blood potassium normal, Blood sodium normal, Blood urea decreased, C-reactive protein increased, Erythema, Gamma-glutamyltransferase increased, Glomerular filtration rate, Haemoglobin normal, Headache, Lip swelling, Lipase normal, Liver function test abnormal, Lymphocyte morphology abnormal, Lymphocytosis, Myalgia, Pain in extremity, Platelet count normal, Pruritus, Pyrexia, Urticaria, Visual acuity reduced
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (narrow), Malignant lymphomas (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLAGYL
Current Illness: Vaginal infection; Immunisation
Preexisting Conditions: Smear cervix; 2009, Rheumatic disorder; 2009, Panniculitis
Diagnostic Lab Data: 10-JAN-2014: Alanine aminotransferase: 358; Alkaline phosphatase: 247; Aspartate aminotransferase: 166; C-reactive protein: 110; Gamma-glutamyltransferase: 317; Hemoglobin: 8.2; Lymphocyte morphology: atypical.; 09-JAN-2014: Body temperature: 39 degrees C; 23-JAN-2014: C-reactive protein: 17; Body temperature: 38.6 degrees C; Thrombocyte count: 157; Sodium: 139; Potassium: 3.5; Creatine: 53; Glomerular filtration rate: $g90; Urea: 2.6; LDH: 197; Bilirubin: 43/46; Lipase: 18
CDC Split Type: WAES1402NLD000549

Write-up: Case was received from a health professional via the Health Authorities on 28-Jan-2014 under the reference number NL-LRB-166366. Information has been received from Sanofi Pasteur as part of a business agreement (manufacturer control # NL-1577272925-E2014-01726) on 31-JAN-2014. Case is medically confirmed. Primary source was a physician (specialist). A 40-year-old female patient (weight 85 kg and height 170 cm) with medical history of panniculitis and rheumatism received a dose of GARDASIL (batch number unknown) intramuscularly into not reported site of administration after PAP III result (PAP smear performed on unspecified date) on 31-Dec-2013 and FLAGYL 500 mg tablet, MFR other, batch number not reported) orally twice daily for vaginitis on 01-Jan-2014. On 06-Jan-2014, 6 days after the vaccination, the patient developed urticaria described as progressive dermatological deviations with occasionally localized pruritus, headache and low vision of right eye. The general practitioner prescribed clemastine, dexamethasone and prednisone. On 09-Jan-2014, 9 days after the vaccination, the patient also experienced pyrexia at night up to 39 degrees C. Another 60 mg prednisone was prescribed. Somewhat improvement of the skin deviation could be observed, but severe headache and visual loss of right eye persisted. On 10-Jan-2014, the results of liver function tests were abnormal. Physical findings were: sick looking woman, clear and adequate. No abnormalities were found except for diffuse erythema on the skin, particularly on the trunk. Body temperature was 38.6 degrees C on an unspecified date. Laboratory tests were performed on 10-Jan-2014: alanine aminotransferase 358, alkaline phosphatase 247, aspartate aminotransferase 166, C-reactive protein 110, gamma-glutamyltransferase 317 and lymphocyte morphology was atypical. On 23-Jan-2014, C-reactive protein was 17. Other laboratory tests were done on unspecified date: hemoglobin 8.2, thrombocytes 157, sodium 139, potassium 3.5, creatine 53, eGFR$g90, urea 2.6, LDH 197, bilirubin 43/36 and lipase 18. On an unspecified date, she also developed swelling of lips, but the tongue was normal. Furthermore she suffered from pain on palm of the hands and soles of the feet. She was admitted to the hospital with urticarial skin, abnormal liver function tests, atypical lymphocytosis and an increased CRP. Prednisone was continued which resulted in normalizing of skin, liver function tests and CRP. Severe headache and visual loss were still persisting for which she referred to neurologist for checking neuritis optica. On 14-Jan-2014, after 4 days, she was discharged. 9 days later she was seen at the outpatient clinic with persisting headache, myalgia and variable skin deviations. Liver function tests almost normalized. At the time of reporting, the patient had recovered from abnormal liver function test, pyrexia, increased CRP, but had not recovered from headache, urticaria and myalgia. The outcome of visual acuity reduced was unknown. The outcome of swelling of lips, pain on palm of the hands and soles of the feet, atypical lymphocytosis was not provided. According to the HA, the events were possibly related to GARDASIL and FLAGYL. Causality for reactions and metronidazole was considered possible based on latency and SmPC information. The patient''s medical history included panniculitis in 2009, possibly based on sarcoidosis. The patient also had rheumatism in 2009: sarcoidosis, DD Sweet''s syndrome or reactive arthritis. No allergies known. Noteworthy: Upon medical review the company judged relevant to code the following adverse events: swelling of lips, pain on palm of hands and soles of the feet, atypical lymphocytosis which had not been coded by HA but were mentioned in the narrative. There is a discrepancy regarding causality for events and GARDASIL. HA coded possible in the structured field but mentioned in the narrative that causality for reactions and HPV vaccination was considered unlikely, based on


VAERS ID: 521890 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-08
Onset:2013-10-08
   Days after vaccination:0
Submitted: 2014-02-05
   Days after onset:120
Entered: 2014-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Chills, Headache, Inappropriate schedule of drug administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 10/07/2008, GARDASIL, Dose 1.
Diagnostic Lab Data: Body temperature: 41.3 degrees C.
CDC Split Type: WAES1311DNK008337

Write-up: Case of misuse received from consumer via Health Authorities on 14-Nov-2013 under the reference numbers DK-DKMA-ADR 22292266 and DK-DKMA-EFO7313. Follow up information has been received from Sanofi Pasteur as part of a business agreement (manufacturer control # DK-1577272925-E2013-09342) on 03-FEB-2014. The primary reporter was a patient. This is a case of misuse, as an inappropriate schedule of vaccination was used, as the first dose was administered 5 years before dose 2. A 19-year-old female patient (weight: 72; height: 176) had received the second dose of GARDASIL (batch number unknown, 0.5 ml) via i.m. route of administration on 08-Oct-2013 and later on the same day she developed buzzing/shivering of legs, severe headache and high fever. It was reported that the patient developed high fever (41.3 degrees), buzzing/shivering legs and severe headache after injection of GARDASIL. The patient was treated for the AE. She was admitted to hospital (dates not specified) and received salt water drip in, as well as 2 pain relief pills for the headache. There were also blood samples taken (no details rep). The patient previously received first dose of GARDASIL on 07-Oct-2008 (batch number unknown). The patient was previously healthy. At the time of reporting, the outcome was recovering. Follow up information received in a newsletter from the health authority on 29-Jan-2014. The reaction high fever is assessed as possible related to the vaccination by the health authority.


VAERS ID: 522032 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-06
Onset:0000-00-00
Submitted: 2014-02-06
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007399 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Choking sensation, Dizziness, Feeling abnormal, Hypotonia, Malaise, Rash, Rash macular
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROBINUL
Current Illness: Unknown
Preexisting Conditions: Anxiety
Diagnostic Lab Data: Blood pressure diastolic, 82 mmHg; Blood pressure systolic, 135 mmHg; Heart rate, 68;
CDC Split Type: WAES1402GBR002215

Write-up: Information has been received from SPMSD (Manufacturer control # GB-1577272925-E2014-00871) on 04-FEB-2014. This case was received fro health authority in a foreign country on 30-Jan-2014. GB-MHRA ADR 22401181. The case is medically confirmed. A 12 year old female patient, received a second dose of GARDASIL (batch number JOO7399, however the format of batch number match to J007399 which usually refers to BN of GARDASIL and is more appropriate in this case, expiry date 29-FEB-2016) 0.5 mL intramuscularly, site of administration not reported, on 06-NOV-2013 and on an unreported date after the vaccination, the patient felt unwell and had to lie on the mat for approximately 1 hour. She also experienced blotchy rash, dizziness and shivery on unreported dates. The patient complained of feeling strange, went floppy and face and neck went blotchy on unreported dates. The patient was able to talk to staff whilst resting on the mat. Blood pressure systolic was 135 mmHg, blood pressure diastolic was 82 mmHg and pulse rate was 68. She then recovered following this and requested to stay in school. The patient informed her mother that she felt a choking sensation at time of vaccine although no stridor or airways problem were noted at school. The reporter advised the patient''s mother to contact the doctor to discuss and assess before the third vaccine. The doctor advised that the third vaccine was not given. The patient had a medical history of feeling anxious and hyperhidrosis which was treated with ROBINUL coded as concomitant treatment. The patient received an injection of human papillomavirus vaccine (manufacturer unknown, batch number not reported), dose in series, route and site of administration not reported, on 18-SEP-2013 and experienced blotchy and dizziness. Patient''s reaction following vaccine was slightly worse following second dose. Upon medical review, the company judged relevant to add the adverse event "feeling unwell" which was mentioned in the narrative and not coded by HA. At the time of reporting, the outcome for feeling unwell was not reported and the patient had recovered from other adverse events. The MHRA considered that case serious due to medically significant.


VAERS ID: 522035 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-23
Onset:2013-10-01
   Days after vaccination:131
Submitted: 2014-02-06
   Days after onset:128
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H018808 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402DEU002317

Write-up: Case was received from a health professional via the Health Authorities in a foreign country (reference no. PEI2014006082) via SPMSD (MF. no E2014-00787) on 04-FEB-2014. Case medically confirmed. Primary reporter was a physician (gynecologist). A 15-year-old female patient received the third dose of GARDASIL (lot-no. H018808, EXP date 31-MAR-2015, route and administration site not reported) on 23-MAY-2013. On an unspecified date in October 2013, the patient developed tachycardia leading to hospitalisation. Tachycardia occurred at irregular intervals. A cause for the event could not be found. At the time of reporting to the HA (21-JAN-2014), the patient had not recovered. The patient believed the vaccination to be the cause. According to the reporter, the causality between the event and the vaccination was not assessable. D1 and D2 of GARDASIL (lot no. not reported) given on unspecified dates were well tolerated.


VAERS ID: 522074 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-04
Onset:2013-12-12
   Days after vaccination:8
Submitted: 2014-02-06
   Days after onset:56
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pneumomediastinum, Subcutaneous emphysema
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402FRA001929

Write-up: Case received from a physician on 31-Jan-2014: Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # FR-1577372925-E2014-00916) on 04-FEB-2014. A 12-year-old female patient had received a dose of GARDASIL (batch number not reported) on 04-DEC-2013. 10 days after vaccination, she presented with pneumomediastinum, with the occurrence on 12-DEC-2013, i.e. 8 days post-vaccination, of left subcutaneous emphysema. No etiology was found. There was no viral or bacterial infection, no particular risk factor, and the patient was not asthmatic. A CT scan was planned. At the time of reporting, the outcome was not provided.


VAERS ID: 522076 (history)  
Age: 25.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2012-11-07
   Days after vaccination:0
Submitted: 2014-02-06
   Days after onset:456
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN12630 / 2 RL / UN

Administered by: Other       Purchased by: Other
Symptoms: Diplegia, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMBALTA
Current Illness: Unknown
Preexisting Conditions: Medication error; GARDASIL, Drug administered at inappropriate site; Hypoaesthesia; Depression
Diagnostic Lab Data:
CDC Split Type: WAES1402DNK001933

Write-up: Case of misuse was received from a consumer or other non health professional via the Health Authorities in a foreign country on 31-Jan-2014 under the reference DK-DKMA-ADR 22403712 and DK-DKMA-EFO8097. Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # DK-1577272925-E2014-00899) on 05-FEB-2014. Case is not medically confirmed. A 25 (also reported as 27)-year-old female patient (weight 63 kg, height 164 cm) with a medical history of depression received the third dose of GARDASIL (batch no. G007714, lot number NN12630, Exp. Date: 23-SEP-2013) via not reported route into the right hip on 07-Nov-2012. Concomitant medication included CYMBALTA for depression. on 07-Nov-2012, the patient developed legs in paralyzed state. No examinations were performed. The recovered on 10-Nov-2012. After the third vaccination, the patient''s legs were in paralyzed state for two to three days. The patient received the vaccines in the right hip. The HA received information on 30-Jan-2014 from the patient via telephone. The patient indicated that she experienced numb feeling on the skin until Oct-2013. The patient also informed vaccine batch numbers and dates. Previous doses of GARDASIL were given into the right hip on 11-May-2012 (D1, batch no. G009615, lot number NN43360, Exp. Date: 01-DEC-2013) and on 06-Jul-2012 (D2, G020674, lot number NP00860, Exp. Date: 01-NOV-2014). On an unspecified date in Aug-2012, the patient developed numbness of the skin on the face and entire body. The patient experienced numbness in the face, at first, later the numbness spreads throughout the body. The patient indicated that she had experienced the numb feeling on the skin until Oct-2013. Additional information received from the HA on 03-Feb-2014. The HA had confirmed that the patient had numbness in legs. In the description of the adverse reaction the patient send to the HA, she described paralysis with the term numbness. Hence the HA had decided in the coding to code the adverse reaction as numbness and not as the medical term paralysis. However the company judged relevant to code paralysis as it was also mentioned by the patient. Upon medical review the company considered this event to be medically important event. Discrepancy in the HA report: duration of legs in paralysis state was coded as 3 days (mentioned in narrative as 2-3 days) however the HA has coded onset date as 07-Nov-2012 and cessation as 10-Nov-2012.


VAERS ID: 522123 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-22
Onset:2014-01-23
   Days after vaccination:1
Submitted: 2014-02-07
   Days after onset:15
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Local swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Chlorpheniramine maleate
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR003104

Write-up: Case received from sanofi pasteur with manufacturer number of E2014-00934 on 05-FEB-2014. This case was received from the health authority in a foreign country on 31-Jan-2014. GB-MHRA-ADR 22401401. This case is medically confirmed as it was reported by a physician. A 15 year old female patient, with no medical history reported, received on 22-Jan-2014 an injection of GARDASIL (batch number not reported), dose one, on left arm, route of administration not reported. One day following vaccination, the patient developed swelling and itching of index finger on right hand (had injection in contralateral arm). At the time of reporting, the patient has recovering from the adverse events. Patient is concomitantly receiving Chlorphenamine (dose unspecified). The MHRA considered this case serious due to be medically significant.


VAERS ID: 522124 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-08
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Meningitis, Nausea, Photophobia, Somatoform disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Anxiety disorder; Hypertension
Preexisting Conditions: 2008, Appendicectomy; 2011, Electrocardiogram ambulatory
Diagnostic Lab Data:
CDC Split Type: WAES1402FRA002368

Write-up: Case received from the Health Authorities in a foreign country on 31-Jan-2014 under the reference number DJ201400700 and SANOFI PASTEUR MSD as business partner (FR-1577272925-E2014-00902) on 04-FEB-2014. A 14-year old female patient had received the three doses of GARDASIL (batch numbers unknown) via intramuscular route on 26-Apr-2013, 08-Jul-2013 and 08-Nov-2013. In the following days after the third injection, she presented with cephalgia and nausea associated with photophobia leading to hospitalization from 13 to 14-Nov-2013 for suspicion of meningitis. However, the work-up was reassuring and cephalgia resolved after the patient was put on rest, in calm and given an analgesic treatment with non-steroidal anti-inflammatory drugs. Meningitis was ruled out. But since that episode, the patient developed persisting cephalgia with sometimes dizziness, nausea and vomiting. The different investigations were negative, i.e. cervical, vesicular, ophthalmologic and blood pressure disorders were ruled out. From a semiologic standpoint, the patient was hospitalized again in Jan-2014. It seems that no organic cause was found. The question of a psychogenic original arouse. A visit to an internal medicine physician was planned in March 2014. To be noted that the patient was ridden to anxiety. She also had a medical history of increased blood pressure with holter monitoring in 2011 (no drug treatment) and appendicectomy in 2008. According to the Health Authorities, a causal relationship could be suspected between GARDASIL and the onset of cephalgia due to the chronology of the events. There was no other known concomitant medication (no contraception). At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the adverse events photophobia, dizziness, vomiting and psychogenic disorder which were mentioned by the competent authorities in the narrative but not coded. The health authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the method of assessment.


VAERS ID: 522127 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-05
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Convulsion, Drug screen negative, Electroencephalogram, Feeling abnormal, Lethargy, Mouth ulceration, Mydriasis, Nuclear magnetic resonance imaging, Paraesthesia
SMQs:, Severe cutaneous adverse reactions (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Drug test (27-SEP-2013): negative
CDC Split Type: WAES1401ZAF011713

Write-up: This spontaneous report as received from reporter via vaccine helpline (BP) refers to a 19 year old patient. On 13-FEB-2013, the patient was vaccinated with her first dose of GARDASIL (lot #, expiry date, dose, strength and route not reported). On 05-APR-2013, the patient was vaccinated with her second dose of GARDASIL (lot #, expiry date, dose, strength and route not reported). On 12-AUG-2013, the patient was vaccinated with her third dose of GARDASIL (lot #, expiry date, dose, strength and route not reported). On 13-SEP-2013, the patient was seen by the physician and had a mouth ulcer and tingling sensation in the face. on 27-SEP-2013, the patient was back at the doctor as she seemed "strange"-her pupils were dilated, she was lethargic and seemed ''spaced out''. A drug test was done to exclude any possibility of drugs being taken. The drug test was negative. The outcome of the events and relatedness to GARDASIL was unknown. Follow up information has been received from a physician on 28-JAN-2014. Physician reported that main issue regarding the patient was multiple, repeated, generalized seizures documented over the past 6 months since the patient had her final GARDASIL dose. She has been extensively investigated as a inpatient by 2 independent neurologist/electroencephalograms (EEG''s)/computerized tomograms (CT''s)/magnetic resonance imaging (MRI''s)/blood tests, no treatment had helped and no organic cause for the seizure was found, only the explanation was the link to GARDASIL. The outcome of multiple, repeated, generalized seizures documented over the past 6 months since the patient had her final GARDASIL was unknown. Upon internal review event multiple, repeated, generalized seizures documented over the past 6 months since the patient had her final GARDASIL was considered to be medically significant. Additional information is not expected.


VAERS ID: 522128 (history)  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-12
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Conversion disorder
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402ZAF002430

Write-up: This spontaneous report as received from a physician, via company representative, refers to a 20 year old female patient. The patient was vaccinated with three doses of GARDASIL (dose, strength, route and site of administration not reported) on 13-FEB-2013, 03-APR-2013 and 12-AUG-2013. The patient''s boyfriend reported that the patient had episodes of "absent moments" in approximately August 2013 (reported as 2 months prior to admission to hospital). On 08-OCT-2013 the patient was admitted to hospital and diagnosed with "non epileptic disorder"/"conversion disorder" - neurologist diagnosis. The outcome of the event was unknown. The relatedness between GARDASIL and event was not reported. Additional information has been requested.


VAERS ID: 522227 (history)  
Age: 25.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-18
Onset:2011-03-18
   Days after vaccination:0
Submitted: 2014-02-09
   Days after onset:1059
Entered: 2014-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0756Y / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cervical dysplasia, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Reproductive premalignant disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Uterine and fallopian tube malignant tumours (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypersensitivity, Sensitive to intramuscular injection, Continuing; Cervical dysplasia, Early stage, Continuing; 03/18/2011, Feeling abnormal, Illness at time of vaccination, Feeling upset, Continuing
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1103USA02884

Write-up: Information has been received from a physician (Local reference# KOR2011030066) concerning a 25 year old female patient with cervical intraepithelial neoplasia (CIN) early stage and sensitive to intramuscular injections who on 18-MAR-2011 was vaccinated with a 0.5ml first dose of GARDASIL (Batch #NN16840, Lot# 0756Y), IM. The physician stated that on 18-MAR-2011 the patient experienced loss of consciousness 2 minutes after vaccination. At the time of vaccination the patient was a bit upset about finding cervical intraepithelial neoplasia (CIN) early stage. The physician reported that the patient was sensitive to intramuscular injection rather than GARDASIL. The physician stated that the patient recovered a few minutes later at the clinic. No further information is available. 09-FEB-2014. This is a correction. The event of ''loss of consciousness'' was upgraded to ''medically significant''.


VAERS ID: 522229 (history)  
Age: 25.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-26
Onset:2011-05-26
   Days after vaccination:0
Submitted: 2014-02-09
   Days after onset:990
Entered: 2014-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1105USA04097

Write-up: Information has been received from a physician (local reference # KOR201105027) concerning a 25 year old female with no history or concurrent conditions who on 26-MAY-2011 was vaccinated with the first dose of GARDASIL (lot # not reported), prefilled syringe. There was no concomitant medication. On 26-MAY-2011, after the vaccination, the patient complained of dizziness and experienced loss of consciousness. Ten minutes later, the patient recovered from dizziness and loss of consciousness. This is one of several reports received from the same source. No further information is available. 09-Feb-2014. This is a correction. The event of ''loss of consciousness'' was upgraded to ''medically significant''.


VAERS ID: 522254 (history)  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-27
Onset:2011-05-27
   Days after vaccination:0
Submitted: 2014-02-09
   Days after onset:989
Entered: 2014-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Loss of consciousness
Diagnostic Lab Data:
CDC Split Type: WAES1105USA04105

Write-up: Information has been received from a physician (Local reference #: KOR-2011-05-028), concerning a 22 year old female patient with a history of loss of consciousness, who on 27-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported), prefilled syringe. THere were no concomitant medications reported. Physician reported that after vaccination, on 27-MAY-2011, patient complained of dizziness and she experienced loss of consciousness. 10 minutes later, on 27-MAY-2011, patient recovered from loss of consciousness and dizziness. The causality of GARDASIL was not provided. This is one of two reports from the same source. Additional information is not expected. 09-Feb-2014. This is a correction. The event of ''loss of consciousness'' was upgraded to ''medically significant''.


VAERS ID: 522256 (history)  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-14
Onset:2011-09-14
   Days after vaccination:0
Submitted: 2014-02-09
   Days after onset:879
Entered: 2014-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1201USA03645

Write-up: Information has been received from a patient''s guardian (local reference number KOR-2012-01-011) concerning a 21 year old female who in early July (on approximately 01-JUL-2011), was vaccinated with the first dose of GARDASIL (lot number, dose and route not reported) and on 14-SEP-2012 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot number not reported). The patient''s guardian reported that on 14-SEP-2012 immediately after her 2nd vaccination, the patient experienced vomiting, dizziness, headache and felt she seemed to go black out. The patient stayed in the clinic for an hour and the symptoms improved so the patient went home. On the way home, the vomiting and dizziness symptoms still existed. At the time of the report the patient recovered from headache and felt she seemed to go black out and was recovering from dizziness and vomiting; the patient was scared of the symptoms of her second injection, so she could not receive the third injection. It was unknown if the patient sought medical attention. Additional information is not expected. 09-Feb-2014. This is a correction. The event of ''loss of consciousness'' was upgraded to ''medically significant''.


VAERS ID: 522263 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Retinal vascular thrombosis, Visual acuity reduced, Visual acuity tests abnormal
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: In 2014, visual acuity reduced
CDC Split Type: WAES1402JPN002605

Write-up: Initial information has been received from a pharmacist concerning a female patient (age unknown) who was vaccinated with a dose of GARDASIL, IM, injection drug (date of vaccination, dose, injection site, lot number, and indication not provided). No information or concomitant medication was provided. On an unspecified date, the patient was vaccinated with GARDASIL. Around 2014, a blood clot developed in the patient''s eye, and it caused visual acuity reduced. At the time of reporting on 05-FEB-2014, the outcomes of blood clot in the eye and visual acuity reduced were unknown. Reporter''s comment: not provided. The reporting pharmacist did not assess the causal relationship of blood cot in the eye and visual acuity reduced to GARDASIL. The reporting pharmacist did not assess the seriousness of blood clot in the eye and visual acuity reduced. Upon internal review, blood clot in the eye was determined to be serious due to other important medical event. No further information is available.


VAERS ID: 522266 (history)  
Age: 31.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-22
Onset:0000-00-00
Submitted: 2014-02-09
Entered: 2014-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J001983 / 2 GM / UN

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Hypoaesthesia, Monoplegia, Pain in extremity, Paraesthesia, Tenderness, Vaccination error
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 03/21/2013, GARDASIL, Immunisation; 02/07/2013, GARDASIL, Immunisation
Diagnostic Lab Data:
CDC Split Type: WAES1402DNK002231

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control DK-1577272925-E2014-00940) on 05-FEB-2014. Case of vaccination error with adverse event received from non-health professional via Health Authority on 31-Jan-2014 under the reference number DK-DKMA ADR 22391907 and DK-DKMA-EFO7992. The primary reporter was a patient or consumer. A 31 year old female patient (weight: 67 kg; height: 179 cm) had received the third dose of GARDASIL (batch number J001983) via not reported route of administration in left buttock on 22-Aug-2013 and later on the same day, she developed pain and tenderness in the entire left leg, burning/tingling pain in the entire left leg, numbness in the entire left leg. On a non-specified date post-vaccination she developed paralysis sensation throughout the left leg (outcome not reported). The pain circulates around the buttock to the toes. The patient is very troubled by pain in general. The patient''s left leg has been examined by a physician. The patient has been checked for infection count (no results provided). The patient has no other medications. The HA received additional information on 30-Jan-2014. Telephone conversation with both the patient and the patient''s gynecologist, who informs that the patient had received all three vaccinations. After the last vaccination, the patient informed onset of adverse reactions. This is a case of vaccination error as it is unknown whether the vaccine was administered in the left buttock intentionally or not. The patient had previously received two doses of GARDASIL (batch number H017284 and J000394 respectively) on 07-Feb-2013 and 21-Mar-2013 respectively. Toleration was not reported. No other medical history was reported. At the time of reporting, the patient had not recovered for burning/tingling pain, pain and tenderness and numbness in the entire left leg. The outcome for paralysis sensation was not provided. Upon medical review the company considered this case as serious due to reported term paralysis sensation (although case was coded as non-serious by HA). Upon medical review the company judged relevant to code the following adverse event: paralysis leg which was mentioned by the HA in the narrative, but not coded.


VAERS ID: 522374 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-23
Onset:2013-03-23
   Days after vaccination:0
Submitted: 2014-02-10
   Days after onset:324
Entered: 2014-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015737 / 2 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Angioedema, Eyelid oedema, Incorrect route of drug administration, Lip oedema, Vaccination error
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Dose 2, Immunisation; GARDASIL, Dose 1, Immunisation
Diagnostic Lab Data:
CDC Split Type: WAES1402FRA003281

Write-up: Case of vaccination error received from the Health Authorities on 03-Feb-2014 under the reference number MA20140072. Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # FR-1577272925-E2014-00989) on 07-FEB-2014. A 15-year-old female patient had received the third dose of GARDASIL (batch and lot number H015737, Exp. Date: 28-FEB-2015) via subcutaneous route - instead of intramuscular as recommended - on 23-Mar-2013 in the morning, in the evening on the same day, she experienced giant urticaria characterized by lips oedema and eyelid oedema. She was hospitalized during 24 hours for monitoring and infusion. At the time of reporting, the patient had recovered. The Health Authorities specified that no other explanation was found. Upon medical review the company judged relevant to code the adverse event "inappropriate route of vaccination" and "vaccination error" which were mentioned by the competent authorities in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as possible (C2 S2 I2) according to the foreign method of assessment.


VAERS ID: 522411 (history)  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-11
Entered: 2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2007, GARDASIL; 2007, GARDASIL
Diagnostic Lab Data: In 2013 cervical Pap smear showed ASC-US. Human papillomavirus serology test positive.
CDC Split Type: WAES1402FRA004153

Write-up: Case received from the Health Authorities on 04-Feb-2014 under the reference number PO20140029 from Sanofi Pasteur MSD (reference # FR-1577272925-E2014-00990) as a part of a business agreement on 07-FEB-2014. A 20-year-old female patient had received the three doses of GARDASIL (batch number unknown) via intramuscular route in 2007, at the age of 14 years old, probably before her first sexual intercourse. In 2013 a cervical Pap smear was performed and showed ASC-US (cytologic atypical malpighian cells of undetermined significance) with HPV typing negative for 18 and 18 and positive for others. Condylomas were visible on the perineum. At the time of reporting, the outcome was unknown. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment. Upon medical review the company judged relevant to code the adverse events ASC-US and human papillomavirus serology test positive, which were mentioned by the competent authorities in the narrative but not coded.


VAERS ID: 522413 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-01-19
Submitted: 2014-02-11
   Days after onset:23
Entered: 2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Peroneal nerve palsy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR004149

Write-up: This case was received from health authority in the foreign country on 04-Feb-2014. GB-MHRA ADR 22403807, from Sanofi Pasteur MSD as a part of a business agreement (reference # GB-1577272925-E2014-01068) on 07-FEB-2014. The case is medically confirmed as it was reported by a physician. A 13 year old female patient, with medical history of asthma, received one dose of GARDASIL (batch number unknown), intramuscularly, dose in series and site of administration not reported on an unreported date. On 19-Jan-2014, the patient experienced pain and weakness in the right foot. On the same day, on 19-Jan-2014, the symptoms progressed and they developed weakness in the right ankle resulting in a foot drop. On an unreported date following the vaccination, the patient experienced tingling in right foot. The patient was transferred to a specialist centre for ongoing investigations and management. It was not known yet what the cause of the symptoms were but, according to the reporter, given the timing of the symptoms with administration of the vaccination, a reaction cannot be ruled out. At the time of reporting, the patient had not recovered from foot drop, foot pain and weakness. The outcome for tingling of right foot was unknown. The MHRA considered that case serious due to be medically significant.


VAERS ID: 522451 (history)  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-29
Onset:2012-01-05
   Days after vaccination:1071
Submitted: 2014-02-12
   Days after onset:769
Entered: 2014-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NH55880 / 2 RA / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Infertility female, Laboratory test normal
SMQs:, Fertility disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: Diagnosed with sterility of unknown origin. (Tests showed no reason for sterility).
CDC Split Type:

Write-up: Unable to conceive. Diagnosed with sterility of unknown origin. Unable to find sterility studies by Merck comparing sterility rates on vaccinated women and non-vaccinated women.


VAERS ID: 522467 (history)  
Age: 36.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-27
Onset:2014-01-28
   Days after vaccination:1
Submitted: 2014-02-11
   Days after onset:14
Entered: 2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Local swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401KOR013849

Write-up: This spontaneous report was received from a nurse via a company representative referring to a female patient of unknown age. The nurse reported that on 27-JAN-2014 the patient was vaccinated with GARDASIL injection vials [lot # not reported], (route reported as injection, dose not reported). No other concomitant therapies reported. On an unknown date the patient experienced both arm swelling. The action taken of the event with the suspect product was assessed as not applicable. The causality of the event was unspecified. The outcome of the event, both arm swelling was unknown. Follow up information was received via a company representative from a physician concerning the 36 year old female patient. Physician reported that both arm swelling occurred on 28-JAN-2014 and the patient felt difficult in office life due to the event on approximately 28-JAN-2014. Until the time of reporting both arm swelling persisted. The outcome of difficult in office life was unknown. The patient felt difficult in office life due to the both arm swelling was considered to be disabling. Additional information is not expected.


VAERS ID: 522473 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-08
Onset:2013-11-16
   Days after vaccination:8
Submitted: 2014-02-12
   Days after onset:88
Entered: 2014-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009200 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Audiogram abnormal, Borrelia test negative, C-reactive protein normal, Deafness neurosensory, Deafness unilateral, Epstein-Barr virus antibody positive, Neutrophil count decreased, Nuclear magnetic resonance imaging normal, Otoscopy normal, VIIth nerve paralysis, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 2012, Malaise, no neurological or heart etiology found after an exhaustive work-up
Diagnostic Lab Data: 12/27/2013, Audiogram, acoumetry/Weber: left-lateralised; 12/27/2013, Audiogram, right perceptive deafness, normal on the left; 11/20/2013, Borrelia test, Negative; 11/20/2013, C-reactive protein, 0.2; 11/27/2013, Ear, nose and throat examination, normal typanum, no anomalies on cranial nerves; 11/27/2013, Ear, nose and throat examination, normal bilateral otoscopy; 11/27/2013, Ear, nose and throat examination, parotid area palpation; 11/27/2013, Ear, nose and throat examination, house-brackman score for facial palsy=4; 12/04/2013, Ear, nose and throat examination, same facial palsy scoring; 12/27/2013, Ear, nose and throat exmaination, no hypoacousia, no; 12/27/2013, Ear, nose and throat examination, facial palsy scoring=4, improvement in
CDC Split Type: WAES1402FRA004675

Write-up: Information has been received from SPMSD with MFR with E2014-00995, on 07-FEB-2014. Case received from the Health Authorities in a foreign country 04-Feb-2014 under the reference number LY20140105. A 12-year-old female patient had received first dose of GARDASIL (batch number J006656, expiry date: 31-OCT-2015) on 18-Sep-2013 and the second dose of GARDASIL (batch number J009200, expiry date: 31-OCT-2015) on 08-Nov-2013, both via intramuscular route. On 12-Nov-2013, Epstein-Barr virus serology was positive for IgG anti VCA, ant EBVNA and IgM antiVCA (not considered as a cause to the event). It was unknown why this serology was performed. A notion of excessive medication was reported. On 16-Nov-2013, the patient abruptly experienced right peripheral facial palsy. There was no notion of virosis in the previous days. On 20-Nov-2013, Epstein-Barr virus serology was positive again for IgG anti VCA, anti EBVNA and IgM antiVCA. Borrelia test was negative, C-reactive protein was at 0,2, White blood cell count at 4,48, Neutrophil count at 1,35. On 27-Nov-2013 ENT examination were performed, showing right isolated peripheral facial palsy of grade (House-Brackman). Parotidea area palpation was normal. Bilateral otoscopy was normal too. Tympanum were normal, and there was no anomaly on cranial nerves. According to the patient, the symptoms were regressing. On 04-Dec-2013, the patient underwent a further ENT examination, with the same facial palsy scoring. Speech therapy was initiated. On 27-Dec-2013, facial palsy scoring was still 4. An improvement in the lower area was observed. Palpebral occlusion was impossible. There was no hypoacousia and no dizziness. An audiogram was performed, which showed a very significant right perceptive deafness. The left side was unremarkable. Acoumetry showed left-lateralised Weber. On 02-Jan-2014, an MRI was performed. The results showed a normal pontocerebellar angle and no expansive process. At the time of reporting, the patient had not recovered. It is noteworthy that the patient had a medical history of recurring episodes malaises in 2012 with noneurological or heart etiology found after an exhaustive work-up. There was no recurrence since 2012. She had no medical history of allergy and there was no trip abroad. Vaccination schedule was up-to-date. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the Foreign method of assessment.


VAERS ID: 522556 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-13
Entered: 2014-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402DEU006138

Write-up: Information has been received from business partner (manufacturer number DE-1577272925-E2014-01135) on 12-FEB-2014. Case was received from a healthcare professional on 07-Feb-2014. Case is medically confirmed and poorly documented. A female patient (age not reported) received the first dose of GARDASIL (lot-no, not reported) on an unspecified date. 10 days after the vaccination, the patient developed an autoimmune thrombocytopenia. The outcome was not reported. The event of autoimmune thrombocytopenia was considered to be medically significant event.


VAERS ID: 522636 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-23
Onset:2012-12-01
   Days after vaccination:8
Submitted: 2014-02-14
   Days after onset:440
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody increased, Antinuclear antibody positive, Arthralgia, Blood alkaline phosphatase normal, Blood calcium normal, Blood creatine phosphokinase normal, Blood phosphorus normal, Chlamydia test negative, Collagen disorder, Complement factor C3, Complement factor C4, Echocardiogram abnormal, Hepatitis C test negative, Joint swelling, Mitral valve prolapse, Musculoskeletal pain, Myoglobin blood, Nuclear magnetic resonance imaging thoracic normal, Parvovirus B19 test negative, Pericarditis, Plethysmography, Polyarthritis, Raynaud's phenomenon, Red blood cell count normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Scleroderma, Streptococcus test negative, Urine analysis normal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Systemic lupus erythematosus (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 07-Apr-2013: Thorax imaging (not specified): unobstrusive, unremarkable heart-lung findings. 15-Apr-2013: Plethysmography of the body showed no evidence of a diffusion disorder though with a borderline diffusion capacity. 15-Apr-2013: Echocardiography: Prolapse of the anterior mitral valve. No pericardial effusion and no evidence of pulmonary arterial hypertension. Unknown dates: -Increased antinuclear antibodies 91:640) with also a slight increased of anti-RNP antibody (23 U/mL). -Negative rheumatoid factors including anti-CCP antibodies and negative antistreptolysin. -Negative serology for IgM parvovirus B19 as well as Chlamydia and Hepatitis C. Complentary lab data showed a normal red and white blood cells count, BSR (erythrocyte sedimen
CDC Split Type: WAES1402CHE005506

Write-up: Information has been received from SPMSD (MFR# E2014-01090) on 10-FEB-2014. Case initial reported by a physician and received from the Health Authority in a foreign country on 05-FEB-2014 under the reference number 2013-06160. Case medically confirmed. An adult female patient born on an unspecified date in 1990 (discrepancy for age: reported as 23-year-old) (weight: not reported; height: not reported) had received a second dose of 0.5 ml for GARDASIL (batch number not reported) (route and site of administration not reported) on 23-Nov-2012 for the prevention of cervical cancer. The patient received a first dose of GARDASIL (batch number not reported) on 01-Oct-2012. No other medical history was reported. At the end of Dec-2012/beginning of Jan-2013 (about one month after the second dose of GARDASIL), the patient experienced right shoulder pain. Despite treatment with a non-steroidal anti-inflammatory drug (no further specified), no significant improvement was observed. On an unspecified date, the patient complained of pain in the left shoulder, elbows, wrists, hips, knee and ankle joints with occasionally swelling of the affected joints. The patient was treated with NOVALGIN (40 drops (1000mg)), SPEDIFEN (400 mg, in reserve), and pantoprazole 20 mg daily. On 07-Apr-2013, the patient underwent a thorax imaging (no further specified) which showed unremarkable heart-lung findings. on 15-Apr-2013, a plethysmography of the body showed no evidence of a diffusion disorder though with a borderline diffusion capacity. On 15-Apr-2013, an echocardiography showed hints of a proplapse of the anterior mitral valve. No pericardial effusion and no evidence of pulmonary arterial hypertension. On 15-Apr-2013, the patient was diagnosed with a not further specified collagenosis with arthralgias. The patient also presented with polyarthritis on the left elbow, left wrist and right knee joints. Laboratory tests performed on an unspecified date showed increased antinuclear antibodies (1:640) with also a slight increase of anti-RNP antibody (23 U/mL), negative rheumatoid factors including anti-CCP antibodies and negative antistreptolysin, negative serology for IgM parvovirus B19 as well as Chlamydia and Hepatitis C. Complementary lab data (date not specified) showed a normal red and white blood cells count, ESR (erythrocyte sedimentation rate) 17 mm/h, normal values for calcium, phosphate, AP, CK, myoglobin, complement C3 and C4, slightly elevated GPT (alanine aminotransferase, 43 U/L), significantly increased antinuclear antibodies (1:2560) with also slightly elevated anti-RNP antibodies (31 U/L, normal <10). Urine analysis performed on an unspecified date was normal. On 02-Jul-2013, a rheumatological control revealed regressive residual activity with migratory arthralgias treated with PLAQUENIL (200 mg twice daily) and SPIRICORT (10 mg daily), and CALCIMAGON D3 (one tablet in the evening). The rheumatological control on 19-Sep-2013 showed that, during the course of the disease, there was diverse and highly variable symptoms. The condition of the patient improved under treatment with PLAQUENIL and SPIRICORT in terms of less frequent and less intense occurring relapses. On an unspecified date, sclerodermiform lesions distal to the PIP joints (proximal interphalangeal joints), more transient polyarthralgia respectively intermittently transient arthritis in each joint as well as Raynaud''s symptoms were observed. Due to persistent complaints under basic treatment with PLAQUENIL, the patient received an additional treatment with AZAREK since an unspecified date at the end of Nov-2013 (no further details provided). Shortly after the start of the therapy with AZAREK, the patient developed a pericarditis. A viral infection cannot be excluded. At the time of reporting, the patient was still under treatment and had not completely recovered. Outcome for the other event was not reported. According to the Health Authority, the event collagenosis was possibly rel


VAERS ID: 522637 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-29
Onset:2013-04-26
   Days after vaccination:393
Submitted: 2014-02-14
   Days after onset:294
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Muscle spasms, Rheumatoid arthritis
SMQs:, Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, No adverse event
Diagnostic Lab Data:
CDC Split Type: WAES1402DEU006819

Write-up: Information has been received via SPMSD as part of a business agreement (manufacturer control # DE-1577272925-E2014-01148) on 12-FEB-2014. Case was received from a physician via Company representative on 07-Feb-2014. Case is medically confirmed. Case is poorly documented. A 14-year-old female patient received a third dose of GARDASIL, (lot-no. not reported) on 29-Mar-2012. One year later, on 26-Apr-2013, she developed thoracic pain (value of 8 on a pain scale up to 10) and muscle cramps. Rheumatoid arthritis was diagnosed. Treatment was carried out with MTX, ENBREL and corticosteroids. Under this treatment symptoms improved but the girl had not recovered at the time of reporting. Due to the latency, the reporter assessed the causal relation as unlikely. All previous vaccinations were well tolerated. Upon medical review the company considered the case as serious due to the adverse event: rheumatoid arthritis.


VAERS ID: 522677 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-16
Onset:2013-09-17
   Days after vaccination:1
Submitted: 2014-02-14
   Days after onset:150
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013137 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Local swelling, Periorbital oedema, Swelling face, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Coeliac disease
Diagnostic Lab Data:
CDC Split Type: WAES1402IRL006356

Write-up: This case was received from health authority in foreign country on 07-FEB-2014. REF 2014-019429 as a part of a business agreement with SANOFI PASTEUR (reference # IE-1577272925-E2014-01223) on 12-FEB-2014. This case is medically confirmed. A 18 year female, with history of coeliac disease, received a first dose of GARDASIL (batch/lot number H013137, expiration date 31-MAR-2105), 0.5 mL intramuscularly, site of administration not reported. On 16-Sep-2013 and on 17-Sep-2013, the patient experienced periorbital oedema, swelling of face and neck and blurred vision for 2 weeks. The reporter indicated that the felt it was a serious allergic reaction to GARDASIL. The patient was treated with ZYRTEC. At the time of reporting, the patient had recovered from all adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 522793 (history)  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-16
Entered: 2014-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Colposcopy abnormal, Human papilloma virus test positive, Smear cervix abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2007, GARDASIL, Second dose
Diagnostic Lab Data: Colposcopy, Abnormal
CDC Split Type: WAES1401FRA012708

Write-up: Information has been received from SPMSD, as part of a business agreement (MFR No FR-1577272925-E2014-00572) on 27-JAN-2014. Case of suspected vaccination failure received from a physician on 23-Jan-2014. A 27-year-old female patient had received the three doses of GARDASIL, (batch number not reported) in 2007. At the time of reporting, she presented with HPV test positive for 16 and 18 without clinical sign. Vaginal colposcopy was normal. A follow-up was planned within 6 months. The physician suspected a recent infection as no infection had been detected before. To be noted that the patient had recently changed partner. At the time of reporting, the patient had not recovered. Follow up information has been received from SPMSD, as part of a business agreement (MFR No FR-1577272925-E2014-00572) on 11-FEB-2014. Follow-up information received on 07-Feb-2014: Case upgraded due to medically significant event. The patient''s follow-up was to be performed within 6 months. Contrary to what was previously reported, pap smear showed unspecified anomalies confirmed by colposcopy. That is why an HPV test had been performed.


VAERS ID: 522795 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-15
Onset:2013-02-01
   Days after vaccination:109
Submitted: 2014-02-17
   Days after onset:381
Entered: 2014-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Flank pain, Headache, Palpitations, Photopsia
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Retinal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Malaise; Musculoskeletal stiffness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402JPN006908

Write-up: This spontaneous report as received from a physician concerning a 14 year old female patient with shoulder muscle stiffness and malaise (also reported as medically unexplained symptoms). On 15-OCT-2012, the patient was vaccinated with the first dose of GARDASIL (lot# expiry date and injection site was not reported), intramuscular injection drug, intramuscular, 0.5 ml. On 17-FEB-2013, the patient was vaccinated with the second dose of GARDASIL (lot#, expiry date and injection site was not reported), intramuscular injection drug 0.5 ml once a day. No information on concomitant medication was provided. Around February 2013, the patient experienced headache, chest pain, flank pain, palpitations and flash vision. On 24-APR-2013, the patient was vaccinated with the third dose of GARDASIL (lot#, expiry date and injection site was not reported), intramuscular injection drug, intramuscular, 0.5 ml. On an unspecified date, the patient experienced sinusitis. On an unspecified date, the patient recovered from sinusitis. At the time of reporting on 12-FEB-2014, headache, chest pain, flank pain, palpitations and flash vision had not resolved. Reporter''s comment: At the consultation, it was considered that sinusitis caused headache, chest pain, flank pain, palpitations and flash vision. However, as the symptoms had persisted after the absence of sinusitis, it was considered that the symptoms were related to the vaccination. The seriousness of the symptoms was considered to be other important medical event. The reporting physician felt that the causal relationship of headache, chest pain, flank pain, palpitations and flash vision to GARDASIL was related, and did not assess the causality between sinusitis and GARDASIL. The reporting physician considered that headache, chest pain, flank pain, palpitations and flash vision as serious (other medical event), and did not assess the seriousness of sinusitis. Additional information has been requested.


VAERS ID: 522797 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-23
Onset:0000-00-00
Submitted: 2014-02-17
Entered: 2014-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013132 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Dyspnoea exertional, Fatigue, Lactose intolerance, Mucosal dryness, Myalgia, Nasal dryness, Nausea, Oropharyngeal pain, Pharyngitis, Spinal disorder, Thirst, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/31/2012, GARDASIL, Immunisation, No adverse event, lot number G020676, D2; 03/29/2012, GARDASIL, Immunisation, No adverse event, lot number G014502, D1
Diagnostic Lab Data:
CDC Split Type: WAES1402DEU005431

Write-up: Information has been received from Sanofi Pasteur, with MFR number E2014-01007, on 10-FEB-2014. Case was received from the Health Authorities on 05-Feb-2014 (reference no. PEI2014007852). Case is not medically confirmed (report from the patient''s mother). A 13-year-old previously healthy female patient(weight 50 kg, height 158 cm) received the third dose of GARASIL (lot-no. H013132) on 23-Oct-2012. In the end of Oct-2012, exact date not reported, the patient developed exercise dyspnea, exhaustion, increased thirst, joint pain, mucosal dryness, muscle pain, nose dryness, throat infection, throat pain and spinal disorder ("vertebral blockade"). In Dec-2012, the patient developed abdominal pain, diarrhea, nausea and vomiting. In Apr-2013, the patient additionally developed lactose intolerance. The patient was hospitalised and presented to several physicians and specialists, examinations (not specified) did not reveal a cause for the complaints. Treatment was carried out according to academic medicine and traditional healing. At the time of reporting to the HA on 22-Jan-2014, the patient had not recovered. Previous doses of GARDASIL were given on 29-Mar-2012 (D1, lot-no. G014502) and on 31-May-2012 (D2, lot-no. G020676, expiry date 31-DEC-2013) and well tolerated.


VAERS ID: 522981 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-18
Entered: 2014-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Monoplegia, Multiple sclerosis relapse, Nuclear magnetic resonance imaging abnormal, Pain
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Multiple sclerosis
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging, increase of lesions
CDC Split Type: WAES1402FRA008245

Write-up: Information has been received from SPMSD (E2014-01266), on 14-FEB-2014. Case received from a physician on 10-Feb-2014: An 18-year-old female patient with a medical history of multiple sclerosis had received the first dose of GARDASIL, (batch number not reported) in March of an unspecified year. In the Summer following the vaccination, she experienced a flare-up of multiple sclerosis with arm paralysis and positional pain. She subsequently experienced three further relapses. A repeat MRI was performed which confirmed the relapses. Treatment with SOLU-MEDROL was initiated. The patient was hospitalized for several days. At the time of reporting, she had not recovered.


VAERS ID: 523007 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-18
Entered: 2014-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Hyperventilation, Loss of consciousness, Nuclear magnetic resonance imaging, Screaming
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402JPN007702

Write-up: This spontaneous report as received from a physician refers to a 13 year old female patient. In 2013, the patient was vaccinated with a dose of GARDASIL, injection, intramuscular (IM) (dose, injection site, lot number, expiry and indication not reported). No information on concomitant medication was provided. In 2013, the patient was vaccinated with GARDASIL. On an unspecified date, hyperventilation, screaming and loss of consciousness developed in the patient. At the time of reporting on 13-FEB-2014, the patient remained hospital at the department of psychiatry. A psychiatrist and a neurologist examined the patient, and she was under examinations of computed tomography (CT) (result unknown) and magnetic resonance imaging (MRI) (result unknown). An intelligence test was scheduled to be performed. The outcomes of hyperventilation, screaming and loss of consciousness were unknown. Reporter''s comment: causality of GARDASIL was unknown at the moment. The reporting physician considered that the causal relationship of hyperventilation, screaming and loss of consciousness to GARDASIL was unknown. The reporting physician considered that hyperventilation, screaming and loss of consciousness were serious due to hospitalization. Upon internal review, loss of consciousness was considered as medically significant. Additional information has been requested.


VAERS ID: 523013 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-05
Onset:0000-00-00
Submitted: 2014-02-19
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H0085667 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Condition aggravated, Headache, Injection site pain, Mobility decreased, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Food intolerance; Seasonal allergy
Diagnostic Lab Data:
CDC Split Type: WAES1401SWE012379

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # E2014-00478) on 17-FEB-2014. Case was received from a health professional via Health Authorities on 22-Jan-2014 under the reference number MPA-2014-000882. Case is medically confirmed. Primary source was a physician. An 11-year-old female patient (weight, height not reported) received a dose of GARDASIL, (batch number not reported) via not reported route and site of administration on an unspecified date. On 27-Dec-2013, the patient developed myalgia. At the time of reporting, the patient had not recovered. The HA assessed the seriousness criteria as disabling/incapacitating. No further information provided. Follow-up information received from HA on 11-Feb-2014. HA considered the case serious due to both disabling/incapacitating, as well as other medically important condition. It was reported that the patient received first dose GARDASIL on 03-Oct-2013 (batch number H0085667) and second dose GARDASIL on 05-Dec-2013 (batch number H0085667), both by i.m. route in left arm. The patient has birch pollen allergy and is sensitive to some food. After first vaccination the girl developed pain in left upper arm. Her mobility was decreased and she could not lift her arm above her shoulder. She started complaining of headache, sometime severe, by the end of October. After second dose GARDASIL was administrated she also developed pain in back and previous problems aggravated. The problems are still continuing by the end of January 2014. She has been examined by a physician, who prescribed naproxen (Alpoxen, dose not rep) and treatment was started on 21-Jan-2014, and ever since she also experiences tingling in left arm, between elbow and shoulder. Upon medical review the company judged relevant to code decreased mobility and tingling in left arm, which was mentioned by HA in the narrative, but not coded. At the time of reporting the outcome was not recovered. HA assessed the relation between the adverse events (myalgia, headache, pain in arm and pain in back and both doses of GARDASIL vaccine as possible.


VAERS ID: 523021 (history)  
Age: 36.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-14
Onset:2014-01-15
   Days after vaccination:1
Submitted: 2014-02-19
   Days after onset:35
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site oedema, Injection site pain, Neurological symptom, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NOVYNETTE
Current Illness: Contraception
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402CZE001026

Write-up: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of SILGARD (lot#, dose and route not reported). On an unknown date the patient experienced neurologic symptoms. The outcome of neurologic symptoms was reported as unknown. Follow up information received with updates: This report as received from a physician refers to approximately 36 year old female patient with known demographics. It was reported that on 09-FEB-2013 the patient was vaccinated with first dose of SILGARD. The patients second dose was on 10-SEP-2013 (Also reported as 10-SEP-2014). On 14-JAN-2014 the patient was vaccinated with third dose of SILGARD subcutaneously (3 dose lot # 50009125, expire December-2015) in the left arm. Concomitant therapies included NOVYNETTE for contraception. On 15-JAN-2014, in the evening the patient experienced fatigue (medically significant), afebrile, no reaction at the site of vaccination administration; during the night, she experienced pain and oedema of left arm (arm where vaccine was administered), erythema at the site of administration (5 cm in diameter). She also later experienced pain of right arm and leg (medically significant). It was reported that the patient took IBALGIN for the adverse events and fell asleep. On 18-JAN-2014, the symptoms (fatigue, pain and oedema of left arm, erythema at the site of administration, pain of right arm and leg) were reported as recovered. On 22-JAN-2014, the patient informed physician that she only has mild pain of right hip remains. It was also reported that the patient was sent to neurology department for further investigation but results are not available at the moment. The reporter considered fatigue, pain of right arm and leg (hand and leg pain) and reaction at site of the administration of vaccine (5cm in diameter) to be related to SILGARD. It was unknown causality regarding the event pain and oedema of left arm (arm where vaccine was administered), erythema at the site of administration and mild pain of right hip. The reporter considered the events fatigue, reaction at site of the administration of vaccine, hand and leg pain as medically significant. Additional information has been requested.


VAERS ID: 523023 (history)  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-01
Onset:2013-03-01
   Days after vaccination:0
Submitted: 2014-02-19
   Days after onset:355
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Blood test, Nuclear magnetic resonance imaging spinal
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 08/28/2012, GARDASIL; 10/29/2012, GARDASIL
Diagnostic Lab Data:
CDC Split Type: WAES1402DNK008555

Write-up: Information has been received from SPMSD (Sender''s case report number DK-1577272925-E2014-01352) on 18-FEB-2014. Case received from health care professional via Health Authorities in a foreign country on 13-Feb-2014 under the reference numbers DK-DKMA-ADR 22401684 and DK-DKMA-EFO8068. The primary reporter was a physician. A 22-year-old female patient (Weight: 60 kg, Height: 175 cm) with no reported medical history, had received the third dose of GARDASIL (batch and lot number H019870, exp. 31-MAY-2015) via i.m. route of administration in unspecified site of administration on 01-Mar-2013 and later on the same day, 01-Mar-2013, she developed acute severe back pain. It was reported that she experienced a sudden onset of spontaneous acute strong back pain, creating a need for strong painkillers. The woman has been investigated by back specialists without any cause found, and there is a suspicion that it may be a reaction to the third dose vaccine. The patient is continuously treated with analgesics and followed by back specialists. The patient has been examined by general blood tests and MR-scanning of spine (results not reported). According to the narrative, the patient did not receive other medication. The case is reported as serious due to hospitalization, but no details were reported. The patient previously received GARDASIL on 28-Aug-2012 (batch and lot number H003811) and 29-Oct-2012 (batch and lot number H011751). No other medical history reported. At the time of reporting, the patient had not recovered.


VAERS ID: 523039 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-11
Onset:2013-11-21
   Days after vaccination:10
Submitted: 2014-02-19
   Days after onset:90
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Decreased appetite, Fatigue, Gastritis, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR008500

Write-up: Information has been received from SPMSD (manufacturer control# E2014-01344) on 17-FEB-2014. This case was received from health authority on 12-Feb-2014. GB-MHRA ADR 22411680. The case is medically confirmed. The case is linked to the case E2014-01347 (same patient, same product, same reporter, several same adverse events). A 12 year old female patient, with no medical history reported, received a first dose of GARDASIL (batch number J005923, lot number J005923, expiration date: 28-FEB-2016) 0.5 mL intramuscularly, site of administration not reported, on 11-Nov-2013. On 21-Nov-2013, the patient experienced pyrexia, prolonged vomiting, malaise and fatigue. On unreported dates, the patient also had no appetite and vomiting caused gastritis. The patient had 2 weeks school absence due to these symptoms. The patient''s parents were very concerned about girl''s health and suspected reaction to GARDASIL. The patient was treated with paracetamol. On 05-Dec-2013, the patient had recovered from pyrexia. On 28-Jan-2014, she had recovered from fatigue. On 29-Jan-2014, she had recovered from malaise. At the time of reporting, the outcome for appetite lost and gastritis was unknown. The regulatory authority considered that case serious due to the patient''s disability.


VAERS ID: 523069 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-14
Onset:0000-00-00
Submitted: 2014-02-19
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Malaise, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 11/11/2013, GARDASIL; Drug Reaction: Gastritis; 11/11/2013, GARDASIL, Drug Reaction: Vomiting; 11/11/2013, GARDASIL, Drug Reaction: Pyrexia; 11/11/2013, GARDASIL, Drug Reaction: Malaise; 11/11/2013, GARDASIL, Drug Reaction: Fatigue; 11/11/2013, GARDASIL, Drug Reaction: Decreased appetite
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR008906

Write-up: Information was received from Sanofi Pasteur MSD (SPM) (MFR Control# E2014-01347) on 17-FEB-2014. This case was received from health authority in the foreign country on 12-Feb-2014. GB-MHRA ADR 22422253. The case is medically confirmed. The case is linked to the case E2014-01344 (same patient, same product, same reporter, several same adverse events). A 12 year old female patient, received a second dose of GARDASIL (batch number J005923, expiry-28-FEB-2016) 0.5 mL intramuscularly, site of administration not reported, on 14-Jan-2014. Nine days after the vaccine, the patient experienced headache, vomiting, fatigue and malaise. On unreported dates, the patient experienced pyrexia controlled with paracetamol, stomach pains and joints and body aching. The patient was absent from school for 7 school days. The patient''s mother stated that her daughter seemed recovered now. She consulted general practitioner who advised that symptoms were not due to human papillomavirus vaccine. The patient''s parents were very concerned about her girl''s health and suspected adverse reaction after second dose of GARDASIL, so the mother had withdrawn her consent for the third dose of human papillomavirus vaccine. The patient received a first dose of GARDASIL (batch number not reported) route and site of administration not reported, on 11-Nov-2013 and experienced appetite lost, fatigue, gastritis, malaise, pyrexia and vomiting (see case E2014-01344 for more information). At the time of reporting, the patient had recovered from all adverse events. The MHRA considered that case serious due to the patient''s disability.


VAERS ID: 523105 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2014-02-19
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Back pain, Decreased interest, Fatigue, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Headache, Memory impairment, Mental impairment, Mobility decreased, Neuropathy peripheral, Nuclear magnetic resonance imaging, Orthostatic intolerance, Parosmia, Sluggishness, Somnolence
SMQs:, Peripheral neuropathy (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CALONAL; IMIGRAN; METLIGINE
Current Illness: Orthostatic intolerance; Headache
Preexisting Conditions:
Diagnostic Lab Data: 03/19/2013, Body temperature, 36.8 degrees; 06/11/2013, Body temperature, 36.9 degrees C; 12/24/2013, Body temperature, 36.6 degrees C
CDC Split Type: WAES1402JPN008216

Write-up: Initial information has been received from a physician via Pharmaceutical and Medical Devices Agency concerning a 14 year old female patient who on 11-JUN-2013 was intramuscularly vaccinated for the second time with GARDASIL injection drug (Lot No.: 9QN08R), 0.5 ml once a day in the upper-third level of the left upper arm of cervix carcinoma. Information including underlying/concomitant diseases and past medical history was not obtained. According to the medical history interview sheet (allergy, underlying disease, status of growth, history of vaccination/disease during recent one month, etc.), the patient had no problem. She had no family history. Other concomitant medications are shown in therapy information. On 19-MAR-2013, the patient''s body temperature was 36.8 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the first time in the upper-third level of the left upper arm (Lot No.: 9QN08R). There was no concomitant from the patient. On 11-JUN-2013, the patient''s body temperature was 36.9 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the second time in the upper-third level of the left upper arm (Lot No.: 9QN08R), as stated above. After vaccination, the patient began to fall asleep during meals and also made frequent complaint of headache. The headache persisted for about 2 weeks. The patient somewhat began to lose interest quickly. She took CALONAL and IMIGRAN at times of headache. Also, she was told to have developed orthostatic dysregulation, and was prescribed with METLIGINE to be taken on awakening and at bedtime. In June 2013, the headache that developed after vaccination was diminishing. On an unspecified date (around summer), the patient became unable to walk since she felt that exhaust gases outside smelled extremely bad. On 24-DEC-2013, the patient''s body temperature was 36.6 degrees Celsius. At 4:07 p.m., she was intramuscularly vaccinated with GARDASIL for the third time in the upper-third level of the left upper arm (Lot No.: 9QN12R). At around 6:00 p.m., after returning home, the headache that had been diminishing aggravated. The patient felt pain as if she was being hit on the head with a hammer. She also cold not put strength in both hands, especially in the left hand, so that she dropped her rice bowl. Her gait was abnormal and sluggish. She could run normally and could cross the street before the crossing light changed. At the end of 2013, tears continuously flowed to the lean side when the patient lay down. The patient complained that she was rapidly forgetting what she had learned. She quickly lost interest in her favorite television program and could not watch it continuously. She could not continue taking a meal because both her hands become tired. The patient used to love reading books, but she could no longer recognize the characters. She could not open a milk bottle with her hands or open a plastic bag of bread. On an unspecified date, higher brain dysfunction and Guillain-Barre syndrome developed. On an unspecified date, the patient had MRI taken at the pediatrics department of Hospital A and also visited the department of ophthalmology. On 01-FEB-2014, the patient visited the reporting physician''s hospital with her mother. On 05-FEB-2014, at night, the patient experienced back pan and headache so severe that she could not get up. On 06-FEB-2014, the patient had severe pain in head to the extent that she could not take a painkiller, and slept for more than 18 hours. The patient woke up for a short time at night and took a small amount of meal, and then slept again. She had been absent from school. In February 2014, the patient had no headache with oral painkiller. As of the time of this report, the outcomes of higher brain dysfunction and Guillain-Barre syndrome were not recovered/resolved. The outcomes of orthostatic dysregulation, back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous


VAERS ID: 523143 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-23
Onset:2013-10-01
   Days after vaccination:8
Submitted: 2014-02-20
   Days after onset:142
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bladder catheterisation, Dizziness, Electroencephalogram normal, Lumbar puncture normal, Neurogenic bladder, Nuclear magnetic resonance imaging normal, Vasculitis, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Vasculitis (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Electroencephalogram, Normal; Lumbar puncture, No findings; Nuclear magnetic resonance imaging, No findings
CDC Split Type: WAES1402SWE009077

Write-up: Information has been received from Sanofi Pasteur (MSD) (Manufacturer Control # E2014-01366) on 19-FEB-2014. Case received from health care professional on 14-Feb-2014. The primary reporter was a physician. An 11-year-old female patient with no reported medical history, had received the first and the second dose of GARDASIL, (batch number not reported) via unspecified route of administration in unspecified site of administration on 23-Sep-2013 and 11-Nov-2013, respectively. Later around end of October 2013 the girl developed neurogenic bladder disorder. In January 2014 she had a sudden loss of vision to 60% on both eyes, and later she had a dizziness episode. The mother of the patient was suspecting vasculitis. It was reported that the patient had received two doses of GARDASIL during Fall 2013. By the end of October symptoms started for neurogenic bladder disorder. She was seeking medical attention on 01-Nov-2013 and was seeing a specialist on 05-Nov-2013. Catheterization of the bladder was necessary for emptying. In January 2014 the girl was experiencing a sudden loss of vision of 60% on both eyes. She was investigated by LP and MRI, but no connection was found. In connection to these examinations, she developed a dizziness episode. An EEG was performed after this episode, but was normal. No cause for symptoms have been found, but the girl is continually followed by physician. The mother of the patient has read about vasculitis and was suspecting this, but the physician cannot confirm any signs. A second referral of pictures will be evaluated concerning vasculitis. The patient had no medical history reported. At the time of reporting, the patient had not recovered.


VAERS ID: 523145 (history)  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-18
Onset:0000-00-00
Submitted: 2014-02-20
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Bone scan normal, Dysstasia, Gait disturbance, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Limb operation, Mobility decreased, Nerve injury, Pain, Pain in extremity, Quality of life decreased, Sensory disturbance, Ultrasound scan normal, Vaccination site nodule
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: All investigations you can imagine including ultrasound and bone scintigraphy were normal.
CDC Split Type: WAES1402DNK009110

Write-up: Information has been received from Sanofi-Pasteur MSD (ID # E2014-01353) on 18-FEB-2013. Case was received from a health professional via a lawyer and the Health Authorities on 13-Feb-2014 under the references DK-DKMA-ADR 22392231 and DK-DKMA-EFO7996. Case is medically confirmed. Primary source was a physician. A 20-year-old female patient (weight, height not reported) with no medical history reported received a complete vaccination series with three doses of GARDASIL IM into not reported site of administration on 22-Jan-2009 (D1, lot-no. not reported), on 19-Feb-2009 (D2, lot-no. not reported) and on 18-May-2009 (D3, lot-no. not reported). In Jan-2009, the patient became red where she was stung, developed a node at the vaccination site, swelled up where she was stung, became warm where she was stung and could not lift the arm for several months. On an unspecified date in 2009, the patient developed pain in both lower legs corresponding to the shin, could not stand for long periods of time, pain radiating up to the thigh/pain on movement in legs, sensory disturbances in both legs and could not walk more than few meters without pain. On an unspecified date, the patient developed hypersensitivity and nerve damage/impact. In Nov-2012 the patient underwent leg surgery. The patient has through five years had daily pain in both lower legs corresponding to the shins. The patient have tried all kinds of therapy, shoe inserts, exercise, physical therapy, surgery, pain killers both over the counter medicines and stronger, including gabapentin (other mfr) and lamotrigine (other mfr), nothing has worked. She has also received treatment with electrostimulation without effect. The patient came to the conclusion that there was a correlation between the beginning of her pain and her GARDASIL vaccinations in 2009. The patient had been vaccinated by her own doctor and the reporting hospital doctor did not know the vaccination dates and batch numbers. No other vaccines or medicines were given. On 23-Jan-2014 additional information was reported, before the case has been sent out, from the Patient Insurance Company, case number 13-8878. It was noted that it was the patient''s notification to the Patient Insurance Company, which the HA has received. Patient Insurance has not yet discussed/decided the matter: The patient has been treated in the following locations for the drug injury: general practitioner (3 different GPs), and others. The patient''s description of drug injury: She has now for 4 years had severe pain in her shins that radiated up to the thigh just above her knees also on both legs. In 2008 she got HPV vaccine for the first time. She swelled up where she was stung, it was all red, warm and she could not lift her arm for months thereafter and got a hard node at the vaccination site. Her doctor said it was a strange reaction and that they have not heard or seen it before. It also happened to vaccination 2 and 3 (2008-2009). In 2009, the patient experienced pain on movement in her legs. For starters it came primarily from physical activity, but eventually it became so bad that it was also on easy walking. The pain aggravated much in 2009/2010 that she had pain all the time also at rest and when she woke up at night with pain. The pain image was so extremely troublesome that she was disabled and her work was at risk like her quality of life was severely impaired. She could not do anything that means having to use her legs, could not walk more than few meters without being severely pain affected the entire rest of the day and most of the next day. Clinically, it would appear to be a form of shin splints, but no studies that would normally confirm this, have been able to show what was wrong with her and the doctors could not give her a substantiated diagnosis. The patient has tried every treatment for shin splints including injection of corticosteroid and a major surgery of the leg and a number of other treatment options, but nothing has hel


VAERS ID: 523195 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-21
Onset:2009-09-25
   Days after vaccination:66
Submitted: 2014-02-20
   Days after onset:1609
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Aphagia, Back pain, Blood test, Bone pain, Chest pain, Disturbance in attention, Dizziness, Dyspnoea, Ear pain, Eye inflammation, Fatigue, Headache, Herpes virus infection, Hyperhidrosis, Lymphadenopathy, Memory impairment, Myalgia, Mydriasis, Nasal congestion, Nausea, Pancreatitis, Peripheral coldness, Pharyngitis streptococcal, Pruritus generalised, Pupils unequal, Rash generalised, Vomiting, Weight gain poor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Osteonecrosis (broad), Fertility disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Blood test, Results not provided
CDC Split Type: WAES1402DNK008939

Write-up: Information received from Sanofi Pasteur (MSD) with manufacturer number of -E2014-01365 received on 18-FEB-2014. Case was received from a consumer or other non health professional via the Health Authorities on 13-Feb-2014 under the references DK-DKMA-ADR 22404918 and DK-DKMA-EFO8102. Case is not medically confirmed. Primary source was a consumer. A 16-year-old female patient (weight 47 kg, height 160 cm) with no medical history received a dose of GARDASIL, (batch no. not reported) via not reported route and site of administration on 21-Jul-2009. On 05-Sep-2009, the patient developed large pupils. On 25-Sep-2009, the patient developed absent menstruation, rash on the face and on the body, swollen glands, nausea, throwing up, poor weight gain, could not eat, was extremely tired, pain in bones, pain in muscles, cold fingers, sweating back and palms, breathing problems, chest pain, headache, ear pain, itching all over the body, concentration difficulty, poor memory, dizziness, unequal pupils and back pain especially over the lumbar. On an unspecified date, the patient also developed eye inflammation, sudden blocked nose, streptococcus in throat, inflammation in pancreas and Herpes virus 1 infection (severe attack). The patient was hospitalised. Blood tests were done at the Department of Infectious Diseases, and Department of Hematology. The patient was not treated. No other medicines were given. The HA requested the patient''s GP for medical confirmation as well as dates and batch numbers for GARDASIL vaccination(s) (only one vaccination was mentioned). At the time of reporting, the outcome for eye inflammation, sudden blocked nose, streptococcus in throat, inflammation in pancreas and Herpes virus 1 infection was unknown. The patient had not recovered from all other events.


VAERS ID: 523222 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-12
Onset:2013-12-06
   Days after vaccination:24
Submitted: 2014-02-20
   Days after onset:76
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005626 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chronic fatigue syndrome, Dysphonia, Lethargy, Oropharyngeal pain, Post viral fatigue syndrome
SMQs:, Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Food allergy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR009070

Write-up: Information has been received from SPMSD (manufacturer control number E2014-01379) on 18-FEB-2014. This case was received from health authority in a foreign country on 13-FEB-2014. GB-MHRA ADR 22414463. The case is medically confirmed. A 13 year old female patient, with medical history of allergy to nuts, received an injection of GARDASIL, (batch number J005626) 0.5 mL intramuscularly, dose in series and site of administration not reported, on 12-NOV-2013. On 06-DEC-2013, the patient developed sore throat, hoarse voice and lethargy with symptoms worsening, following vaccination. The patient was unable to attend school full time and was experiencing prolonged periods of lethargy. General practitioner has diagnosed chronic fatigue syndrome and myalgic encephalopathy which started on 06-DEC-2013, and referred to paediatricians for further investigation and management. At the time of reporting, the patient has not recovered from all the adverse events. The regulatory authority considered that case serious due to the patient''s disability.


VAERS ID: 523248 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-18
Onset:2010-03-01
   Days after vaccination:164
Submitted: 2014-02-21
   Days after onset:1453
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac stress test, Dyspnoea, Echocardiogram, Electrocardiogram, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/29/2009, GARDASIL, immunisation; 03/12/2009, GARDASIL, Immunisation
Diagnostic Lab Data: Cardiac stress test, not provided; Echocardiogram, not provided; Electrocardiogram, not provided
CDC Split Type: WAES1402DNK009464

Write-up: Information has been received from SPSMD (manufacturer control # DK1577272925-E2014-01393) in 19-FEB-2014. Case was received from a health professional via the Health Authorities on 14-Feb-2014 under the references DK-DKMA-ADR 22409359 and DK-DKMA-EFO8127. Case is medically confirmed. Primary source was a physician. Case assessed as serious. A 15-year-old female patient (weight, height not reported) with no medical history reported received the third dose of GARDASIL (batch # NJ50800, lot #: 0773X, expired date: 16-JUN-2011) via intramuscular route on 18-Sep-2009. In March 2010, the patient developed tachycardia, breathlessness and palpitations. The patient was a soccer player who did not play in winter. Upon re-start of soccer in March 2010, she cold not play due to the adverse events. Cardiac investigations including medications were given. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given via intramuscular route on 12-Mar-2009 (dose 1, batch#, NK36120, lot#: NJ33240, expired date: 30-SEP-2011) and on 29-May-2009 (dose 2, batch # NK05560, lot# 0773Z, expired date: 16-JUN-2011). Toleration was not reported.


VAERS ID: 523249 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-01-19
Onset:2010-02-10
   Days after vaccination:22
Submitted: 2014-02-21
   Days after onset:1472
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Cardiac function test normal, Dizziness postural, Dystonia, Endocrine test normal, Fatigue, Headache, Muscle twitching, Nausea, Palpitations, Syncope, Tilt table test positive, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (broad), Dystonia (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Tilt table test showed significant increase in heart rate during transition to standing but this is not enough for a certain diagnosis of POTS; Cardiac function test, Unremarkable; Endocrine test, unremarkable
CDC Split Type: WAES1402DNK009540

Write-up: Information has been received from Sanofi Pasteur MSD (SPM), manufacturer control number E2014-01398 on 19-FEB-2014. Case of adverse event received from a health care professional via Health Authorities in a foreign country on 14-Feb-2014 under the reference number DK-DKMA-ADR 22410913 and DKMA-DK-EFO8141. The primary reporter was a physician. A 13 year-old female patient (weight: 55kg; height: 164cm) with no medical history reported, had received the first dose of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on 19-Jan-2010 and later on 10-Feb-2010, she developed syncope, headache, dystonia, nausea, tiredness and fairly pronounced amnesia after severe and prolonged syncope. On not reported date she had experienced dizziness with orthostatic nature, frequent viral infection and intermittent heart palpitation. And she was suspected of POTS. As per HA report, adverse reactions: syncope, headache and dystonia. Progression around the adverse reactions: No syncope at the time of vaccination but approximately three weeks after the first vaccination the patient begins to faint, with increasing frequency to a frequency of 2-3 times a week. Severe, prolonged syncope with fairly pronounced amnesia which followed by several days of tiredness, nausea and headache. After starting a suitable treatment with FLORINEF (other MFR) now she has only syncope once every couple of months. In addition the patient has tiredness, dizziness with orthostatic nature and intermittent palpitations. No certain cardiological or endocrinological findings. Frequent "muscle twitch" in terms of involuntary muscle activity. Tilt table test showed significant increase in heart rate during transition to standing but this is not enough findings for a certain diagnosis of POTS. Exercised a lot. She is now actually able to do so again but with pauses for several days due to dizziness and frequent viral infections. A little uncertainty about the time association with the headache, however it is certain that the tendency to headache started about three weeks after vaccination. The patient had no other vaccines however it is unknown whether the patient had other medications. GARDASIL was given via intramuscular route of administration on 19-Jan-2010, 05-Nov-2010 and 15-Oct-2012 (dates are double checked by the HA). Lot numbers cannot be obtained. The reporter does not know whether the patient had taken any other test somewhere else. At the time of reporting, outcome of all reactions were not recovered. The HA has assessed seriousness criteria of this case as serious due to hospitalization (dates not reported). Upon medical review the company judged relevant to code the following adverse event: suspected postural orthostatic syndrome which was mentioned by the HA in the narrative, but not coded.


VAERS ID: 523260 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-30
Onset:2012-12-01
   Days after vaccination:32
Submitted: 2014-02-20
   Days after onset:446
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: HLA marker study positive, Uveitis
SMQs:, Ocular infections (broad), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, 2nd Dose; GARDASIL, 1st Dose
Diagnostic Lab Data: HLA-B gene status assay, Positive for HLA-B27
CDC Split Type: WAES1402FRA009531

Write-up: Information received from Sanofi Pasteur (manufacturer control # E2014-01380) on 18-FEB-2041. Case received from the Health Authorities on TS20140067 on 14-Feb-2014. A 14-year-old female patient had received the third dose of GARDASIL, (batch number unknown) via intramuscular route on 30-Oct-2012. In Dec-2012, she developed physical signs of panuveitis in the right eye. Etiological work-up was negative. HLA-B gene status assay was positive for HLA-B27. She was treated with local corticotherapy. To be noted that both the localisation and the physician signs of the panuveitis were not suggestive of a role of the genotype. It is noteworthy that in their narrative the Health Authorities reported the final outcome as favorable however outcome of panuveitis was coded as not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful (C2 S1 L1) according to the method of assessment.


VAERS ID: 523261 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-25
Onset:2010-04-01
   Days after vaccination:311
Submitted: 2014-02-21
   Days after onset:1422
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Disturbance in attention, Somnolence, Visual acuity reduced, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 01/28/2009, GARDASIL, Immunisation; 12/02/2008, GARDASIL, Immunisation
Diagnostic Lab Data:
CDC Split Type: WAES1402DNK009793

Write-up: Information has been received from Sanofi Pasteur MSD (ID # E2014-01395) on 19-FEB-2014. Case was received from a health professional via the Health Authorities on 14-Feb-2014 under the reference DK-DKMA-ADR 22403496 and DK-DKMA-EFO8094. Case is medically confirmed. Primary source was a physician. Case assessed as serious. A female patient (weight 60 kg, height 170 cm), with no medical history received the third dose of GARDASIL (batch no. unknown) via intramuscular route on 25-May-2009. On an unspecified date, the patient developed change of visual strength from -0.5 to -8.5 very rapidly, joint pain, concentration impairment and large need for sleep. On 01-Apr-2010, the patient developed decreased strength of muscles. The patient was hospitalised and examined on pediatric ward and neurology department. The patient''s brother had congenital muscular dystrophy and it was suspected that the patient may also has this, but it was not found. No other medications or vaccines were given. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given via intramuscular route on 02-Dec-2008 (D1, batch no. unknown) and on 28-Jan-2009 (D2, batch no. unknown). Toleration was not reported.


VAERS ID: 523390 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-21
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402ECU010326

Write-up: This spontaneous retrospective pregnancy report was received from a nurse concerning to a female patient of unknown age. The patient''s pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASAIL, (0.5 mL IM), Lot number and expiration date were not provided. On an unknown date the patient became pregnant. The LMP and EDD were not known. On an unknown date, the patient experienced an spontaneous abortion after GARDASIL vaccination. At the time of the report, the patient''s outcome was unknown. The relatedness between the event and suspect therapy was not provided. Upon internal review, the event of spontaneous abortion was considered to be other important medical event. Additional information has been requested.


VAERS ID: 523401 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-21
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Electroencephalogram, Grand mal convulsion, Postictal state, Pyrexia, Rash vesicular, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: Electroencephalography (EEG) (date not reported): results not reported; Body temperature (date not reported): patient had fever.
CDC Split Type: WAES1402AUS008523

Write-up: Information was obtained on a request by the Company from the agency via a public case detail (#332721) concerning male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the second GARDASIL (lot number and expiration date was not reported), 1 DF, intramuscular. Other suspect therapies included BOOSTRIX, IPOL and M-M-R II; second dose for all vaccines. On an unknown date the patient received dose of IPOL, BOOSTRIX, M-M-R II and GARDASIL unknowingly at school after already having received them at the general practice (GP) clinic. The patient developed fever and had generalised tonic-clonic seizure which lasted for 20 minutes later followed by post-ictal drowsiness. The following day he developed a vesicular rash in his hands, feet and oral cavity. Seizure lasted 20 minutes followed by post-ictal drowsiness. At the time of the report the outcome the events was reported as not recovered. Patient was taken for observation and discharge several hours later. Seen in outpatient at Hospital by neurology and had a electroencephalography (EEG) done (results were not reported). The agency considered that the events were related to GARDASIL and M-M-R II. Upon internal review the event "Grand mal convulsion" was considered as Medically significant. The original reporting source was a state/Territory health department. Additional information is not expected.


VAERS ID: 524001 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-19
Onset:2013-09-02
   Days after vaccination:14
Submitted: 2014-02-26
   Days after onset:177
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody positive, Full blood count normal, Platelet count normal, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL; 02/26/2013, GARDASIL
Diagnostic Lab Data: 01/02/2014, Antinuclear antibody, 1/200, speckled; 01/02/2014, Blood test, Except platelet normal FBC; 01/02/2014, Platelet count, 204000
CDC Split Type: WAES1402FRA011197

Write-up: Information has been received from SPMSD (sender''s case report number FR-1577272925-E2014-01483) on 21-FEB-2014. Case received from the Health Authorities on 17-Feb-2014 under the reference number NC20140147. A 17-year-old female patient had received the first dose of GARDASIL, (batch number G0005284) on 26-Feb-2013 and the second dose (lot and batch number H017056) on an unspecified date. She had received the third dose GARDASIL, (lot and batch number H022182 which is an invalid lot number for GARDASIL) via intramuscular route on 19-Aug-2013 and 14 days after vaccination she presented with thrombocytopenia purpura. It was not possible to measure platelet counts. The patient was hospitalized 8 days in September and 48 hours in November. Corticotherapy was stopped in early December. On 02-Jan-2014, platelet count was at 204000. Except for platelets, full blood count was normal. Antinuclear antibodies were at 1/200 and had a speckled aspect. At the time of reporting, the patient was recovering. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C2 S1 L1) according to the foreign method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation".


VAERS ID: 524002 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-01
Onset:2013-04-01
   Days after vaccination:243
Submitted: 2014-02-26
   Days after onset:331
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-thyroid antibody positive, Antiphospholipid syndrome, Autoimmune thyroiditis, Cor pulmonale acute, Hyperthyroidism, Hypothyroidism, Inappropriate schedule of drug administration, Lung disorder, Pulmonary embolism, Radioisotope scan, Radioisotope scan abnormal, Thyroid stimulating immunoglobulin, Ultrasound scan abnormal
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pulmonary hypertension (narrow), Hypothyroidism (narrow), Hyperthyroidism (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; 2008, Migraine
Preexisting Conditions: 11/12/2008, Facial paresis, totally resolved; 2008, hepatitis B virus vaccine (unspecified), VIIth nerve paralysis; 09/14/2010, GARDASIL; 09/25/2008, GARDASIL, VIIth nerve paralysis
Diagnostic Lab Data: Anti-TSH receptor antibody, date unknown, Negative; Anti-thyroid antibody, 350; Anti-thyroid antibody, 90; Radioisotope scan, rate quantatively reduced to 75 kg for 300 s with; Thyroid stimulating immunoglobulin, Negative; Ultrasound scan, small thyroid, no nodule, heterogenous parenchyma; Ultrasound scan, Thyroid right: 21*15*42, left: 19*16*34 mm, Parenchyma was heterogenous and with no nodule.
CDC Split Type: WAES1402FRA012305

Write-up: Information has been received from Sanofi Pasteur (MSD) (manufacturer control # E2014-01591) on 25-FEB-2014. Case received from the Health Authorities in a foreign country on 21-Feb-2014 under the reference number CN20140063. Case linked with non serious case E2014-01592 (same reporter, same patient). A 20-year-old female patient had received the first dose of GARDASIL (batch number NH38010, lot 1526U, expiry date 02-OCT-2010) on 25-Sep-2008, the second dose of GARDASIL (batch number NM15330, lot NM15330) on 14-Sep-2010 and the third dose GARDASIL (batch number not reported) in Aug-2012, all via intramuscular route. This was an inappropriate schedule of vaccination. In Apr-2013 she was hospitalized for severe bilateral pulmonary embolism with acute pulmonary heart disease. A few weeks later she also developed a pneumopathy on this pulmonary embolism. Antiphospholipid syndrome was diagnosed. The patient was also followed up for autoimmune thyroiditis diagnosed after the following symptoms: thyroglobulin antibodies positive at 350, thyroid peroxidase antibodies positive at 90 and anti-TSH antibodies negative. Furthermore, she was found to have alternation of hypothyroidism treated with LEVOTHYROX and of hyperthyroidism treated with NEOMERCAZOLE. There was nothing to suggest a connective tissue disease, in particular no cutaneous eruption, or hair fall, peripheral vascular disease or arthralgia. The patient was treated with carbimazole 15 mg oad, warfarin 7 mg oad (long-term anticoagulation with target INR between 2.5 and 3), chlormadinone 20 mg oad and levothyroxine 25 ug oad. In May 2013, scintigraphy showed a rate quantatively reduced to 75 kg for 300 s with a homogenous distribution of the radiotracer. Ultrasonography showed a small thyroid with a right lobe at 21x15x42mm and a left lobe at 19x16x34mm. Parenchyma was heterogenous and with no nodule. At the time of reporting, she had not recovered. It is noteworthy that in 2008, the patient had experienced idiopathic facial palsy on 12-Nov-2008, 15 days after receiving hepatitis B vaccine. The symptoms had spontaneously and totally resolved (see linked case E2014-01592). She had a medical history of migraine since 2008, and no surgical or obstetrical history. She was not a smoker. Upon medical review the company judged relevant to add the coding "inappropriate schedule of vaccine administered" and "vaccination error" according to the information reported by the Health Authorities in the narrative.


VAERS ID: 524007 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-10
Onset:2014-02-10
   Days after vaccination:0
Submitted: 2014-02-26
   Days after onset:16
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Allergy test positive, Allergy to vaccine, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 02/2014, Laboratory test, allergic to GARDASIL
CDC Split Type: WAES1402HKG010799

Write-up: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On 10-FEB-2014 the patient was vaccinated with GARDASIL (lot number not reported). No other concomitant medications were reported. It was reported the patient got itchiness on the same night (i.e. 10-FEB-2014) and rash on the next day (i.e. 11-FEB-2014) of taking GARDASIL. The patient was admitted to hospital and she claimed to have laboratory result showing that she was allergy to GARDASIL. It was reported that cream was prescribed by the hospital to the patient but the rash persists after patient using the cream. The reporter (doctor who prescribed GARDASIL to patient) instructed the patient to take injection of PIRITON/dexamethasone via a mobile instant messaging application, and the patient reported that the rash still persists. The outcome of itchy the events was unknown. The reporter considered the events to be related to GARDASIL because laboratory result showing that patient was allergic to GARDASIL. Follow-up consent from the reporter was received. Remarks: The date of GARDASIL injection and adverse experience onset were confirmed in year 2014 from the Sales Representative by phone on 20-Feb-2014 and staff on 21-Feb-2014 (because year was not indicated in source document). The site(s) of itchiness and rash is/are unknown. The date and duration of hospital admission of patient is unknown. As per patient''s claim, the allergy is diagnosed. The active ingredient of cream is unknown. It is not known whether the patient only got cream from the hospital for her allergy. It is not known whether the patient took PRITON (a typo in source document as PERITON, rechecked with staff) or dexamethasone, the source of the drugs were not known. It is not known whether MSD product(s) is/are used in the patient''s treatment (the PRITON or dexamethasone). Upon internal review the event of allergic to GARDASIL was made as medically significant. Additional information has been requested.


VAERS ID: 524009 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-10
Onset:0000-00-00
Submitted: 2014-02-26
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007399 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR011724

Write-up: Information has been received from SPMSD (manufacturer control # E2014-01573) on 24-FEB-2014. This case was received from the health authority on 20-Feb-2014. GB-MHRA-ADR 22425161. This case is medically confirmed. A 13 year-old female patient, with no medical history reported, received a dose of GARDASIL, batch/lot#: J007399, expiration date: 29-FEB-2016, series and site not reported, via IM route, on the 10/Feb/2014. Following vaccination the patient was short of breath, adrenaline (dose not reported) was administered and an ambulance arrived. Patient was admitted to hospital for approximately 6 hours. At the time of reporting, the patient had recovered. Patient concomitant medication was not reported.


VAERS ID: 524119 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-16
Onset:2014-01-16
   Days after vaccination:0
Submitted: 2014-02-27
   Days after onset:42
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Electromyogram normal, Hypoaesthesia, Lumbar puncture normal, Muscle spasms, Nuclear magnetic resonance imaging normal, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATROVENT; Beclomethasone dipropionate; amoxicillin
Current Illness: Asthma; Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Electromyogram normal, clear; Lumbar puncture, clear; Nuclear magnetic resonance imaging, clear
CDC Split Type: WAES1402GBR012983

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # E2014-01576) on 26-FEB-2014. This case was received from the health authority in a foreign country on 20-Feb-2014. GB-MHRA-ADR 22422742. This case is not medically confirmed. A 13 year-old female patient, with medical history of slight asthmatic, received an injection of GARDASIL, batch not reported, series site and route not reported, on the 16/Jan/2014. Following vaccination on the 16/Jan/2014 the patient experienced numbness in hands and feet leaving right foot unable to function and in pain. Patient was admitted to hospital (date not reported) where magnetic resonance imaging (MRI) scans, lumbar puncture and electromyography (EMG) were performed and all tests came back clear. Patient is now undergoing private and other physiotherapy to try to regain use of foot. Three weeks on and foot is still very painful and cramping. Patient has a hospital appointment next Thursday to discuss stronger pain killers. Patient''s concomitant medication include amoxicillin, ATROVENT, beclomethasone and dipropionate (doses not reported). At the time of reporting patient had not recovered. Upon internal review the Company judged relevant to code "foot unable to function" that was mentioned in the narrative but not coded by HA.


VAERS ID: 524247 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-01
Onset:0000-00-00
Submitted: 2014-02-28
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Asthenia, Headache, Memory impairment, Migraine with aura, Nuclear magnetic resonance imaging normal
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging, clear
CDC Split Type: WAES1402IRL011689

Write-up: Information has been received from SP MSD (manufacturer control number E2014-01584) on 25-FEB-2014. This case was received from health authority in a foreign country on 21-Feb-2014. REF 2014-019586. The case is not medically confirmed as it was reported by the patient''s mother. A 12 year old female patient, with no medical history reported, received an injection of GARDASIL (batch number not reported) dose in series, route and site of administration not reported, in early Nov-2013. On unreported dates, the patient experienced migraine like aura and weakness. Subsequently, on unreported date, the patient experienced word finding ability reduced, she confused her words and forgot what she was saying. The time to onset was unclear. On an unreported date, the patient also experienced headache that did not seem to be migraines. The patient''s mother had a medical history of migraines that started when she was 12. The patient underwent a MRI which was clear. At the time of reporting, the patient had not recovered from all the adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 524325 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-27
Onset:2014-02-28
   Days after vaccination:1
Submitted: 2014-03-01
   Days after onset:1
Entered: 2014-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 AR / SYR

Administered by: Unknown       Purchased by: Private
Symptoms: Arthralgia, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Very high fever, severe headache and joint pain.


VAERS ID: 524370 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:2013-05-01
   Days after vaccination:50
Submitted: 2014-03-02
   Days after onset:305
Entered: 2014-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN07R / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature decreased, Electroencephalogram abnormal, Epilepsy, Grand mal convulsion, Nuclear magnetic resonance imaging normal, Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 07/17/2012, Body temperature, 36.3 degrees C; 09/25/2012, Body temperature, 35.4 degrees C; 03/12/2013, Body temperature, 35.8 degrees C; 09/02/2013, Electroencephalogram, frequent spike waves dominantly in frontal area; 09/02/2013, Nuclear magnetic resonance imaging, no lesions
CDC Split Type: WAES1402JPN013388

Write-up: Initial information has been received from a physician via a regulatory authority concerning an adolescent female patient (14 or 15 years old) who on 17-JUL-2012 received GARDASIL IM (intramuscular) (also reported as parenteral) injection drug (dose not reported). No information including the parent''s underlying/concomitant diseases and past medical history was provided. There were no specific notes (underlying disease, allergy, history of vaccination and disease within the last 1 month, drugs currently being taken, adverse reaction history, growth status, etc.) in the Medical Questionnaire for Vaccination. Information on other concomitant medications was not reported. On 17-JUL-2012, at 3:00, the patient received the first dose of GARDASIL (daily dose unknown, batch# 9QN04R, lot#0108AA, expired date 26-JAN-2014) at hospital A. On 25-SEP-2012, at 5:00, the patient received the second dose of GARDASIL (daily dose unknown, lot# 9QN02R) at hospital A. On 12-MAR-2013, at 5:00, the patient received the third dose of GARDASIL (daily dose unknown, lot# 9QN07R) at hospital A. In around May 2013, the patient had occasional tonic seizures lasting 10 to 20 seconds. On an unspecified date, the seizure frequency gradually increased. On 31-AUG-2013, the patient had generalised tonic-clonic seizure. On 02-SEP-2013, the patient made the first visit to hospital B. Magnetic resonance imaging (MRI) revealed no lesions but electroencephalography showed frequent spike waves dominantly in the central region of the right frontal area. The patient was diagnosed with epilepsy and started oral medication. On an unspecified date, although sign of seizure was observed with the change of the medication, clinical seizure was suppressed. However, treatment with the oral medication would be continued. At the time of the report, epilepsy was not recovered/resolved. Reporter''s comment: It is highly likely that seizure lasts permanently without oral medication and it was considered that the patient should continue the treatment through her life. The reporting physician considered that epilepsy was serious due to other important medical event. The reporting physician felt that the causal relationship between epilepsy and GARDASIL was unknown. The reporting physician considered that congenital factor was the other cause for epilepsy. Additional information has been requested. Information had been received for a direct report from the regulatory authority regarding a case provided by the physician.


VAERS ID: 524373 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-07
Onset:2014-02-12
   Days after vaccination:5
Submitted: 2014-03-03
   Days after onset:19
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008568 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Lumbar puncture, Nuclear magnetic resonance imaging, Psychotic disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test; Lumbar puncture; Nuclear magnetic resonance imaging
CDC Split Type: WAES1403DNK000309

Write-up: Information has been received from Sanofi Pasteur MSD [MFR # E2014-01699] on 27-FEB-2014. Case was received from a health care professional via the Health Authorities in a foreign country on 25-Feb-2014 under the references DK-DKMA-ADR 22433249 and DK-DKMA-EFO8303. Case is medically confirmed. Primary source was a physician. A 12-year-old female patient (weight, height not reported) with no medical history reported received an injection of GARDASIL (batch number J008568; expiration date: 30-NOV-2015) via intramuscular route into not reported site of administration on 07-Feb-2014. On 12-Feb-2014, the patient developed psychosis. The patient was hospitalised. Lumbar puncture, MRI scan and blood tests were performed, but results were not provided. No other medicines were given. It was unknown if other vaccines were given. At the time of reporting, the patient had not recovered.


VAERS ID: 524377 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-02-24
Onset:2009-04-29
   Days after vaccination:64
Submitted: 2014-03-03
   Days after onset:1769
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Chest pain, Dizziness, Dyspnoea, Feeling abnormal, General physical health deterioration, Immune system disorder, Memory impairment, Nuclear magnetic resonance imaging, Syncope, Tremor, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403DNK000322

Write-up: Information has been received from sanofi pasteur (MSD) with manufacturer number of E2014-01636 received on 27-FEB-2014. Case of adverse event received from consumer via Health Authorities on 25-Feb-2014 under the reference number DK-DKMA-ADR 22416213 AND DK-DKMA-EFO8175. The primary reporter was a patient. A 14 year old female patient (weight: 67 kg; height: 181 kg), had received the primary dose of GARDASIL (batch number not reported) via intramuscular route of administration in not reported site of administration on 24-Feb-2009 and later on 29-Apr-2009, she developed breathing problems, visual disturbance, memory problems, fainting, dizziness, tremor, chest and abdominal pain and weakened immune system. But the adverse reactions aggravate especially in relation to chest pain, tremor and the patient cannot feel her body getting enough oxygen. The patient has not been treated for the adverse reactions. The patient has no other medications. The patient was examined by a private general practitioner, ear specialist, ophthalmologist and at a private hospital. There are considerations of asthma, orthostatic blood pressure, iron deficiency, B-vitamin deficiency, stress, tumor on the optic nerve. A MRI scan was performed on a non-specified date (results not provided). Notes from patient: She is familiar with and knows several girls who have similar symptoms over the years, who have also underwent several examinations. The actual number of affected individuals must be known (no further information provided). She has always adored sport. She does not smoke and drink. She has always had a strong immune system. She was never sick before she was vaccinated. The patient still attends school and performs her duties. But her health has weakened. Suddenly her immune system is always down, as the first in the family and also sick the longest. Everything that she was before, has turned upside down after vaccination. The patient passes out on the field. She has to stop training because she gets dizzy. The training has stopped because she cannot breathe. The patient had to stop training because of severe pain in the chest that she have experienced for up to 11 min. The patient also received the second dose of GARDASIL on a non-specified date (no further information provided). The third dose of GARDASIL (batch number not reported) was received via intramuscular route into not reported site of administration on 25-Sep-2009. There is no history of heart disease in the family. The patient has in general no other health problems. The HA has requested medical confirmation and more information on all three vaccination dates and batch numbers from the patient''s general practitioner. At the time of reporting, the patient outcome was not recovered.


VAERS ID: 524401 (history)  
Age: 34.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-17
Onset:2013-09-17
   Days after vaccination:0
Submitted: 2014-03-03
   Days after onset:167
Entered: 2014-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J001983 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood iron, Dizziness, Haemoglobin, Liver function test, Loss of consciousness, Nausea, Renal function test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Blood iron, Unknown; Haemoglobin, Unknown; Liver function test, Unknown; Renal function test, Unknown
CDC Split Type: WAES1403DNK000545

Write-up: Information has been received from Sanofi Pasteur Pharmaceutical (MSD) (E2014-01698) on 28-FEB-2014. Case was received from a health care professional via the Health Authorities on 25-Feb-2014 under the references DK-DKMA-ADR 22418405 and DK-DKMA-EFO8191. Case is medically confirmed. Primary source was a nurse. A 34-year-old female patient (weight 73 kg, height 178 cm) with no medical history received an injection of GARDASIL (lot/batch number J001983, exp. date: 31-AUG-2015, dose 0.5 ml) via intramuscular route into not reported site of administration on 17-Sep-2013. On the same day, the patient developed fainting, dizziness and nausea. On an unspecified date, the patient also experienced unconsciousness. The patient was hospitalised. Laboratory tests included hemoglobin, iron, liver function tests, kidney counts and infection test. Specified results were not provided. No other medicines were given. The patient recovered from fainting on 25-Sep-2013, and from dizziness and unconsciousness within an unspecified timeframe. The patient had not recovered from nausea.


VAERS ID: 524444 (history)  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-09-01
Submitted: 2014-03-04
   Days after onset:1645
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal hypomotility, Impaired gastric emptying
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402SWE013607

Write-up: Information has been received from the Sanofi Pasteur (SPMSD) (manufacturer control number E2014-01689) on 27-FEB-2014. Case was received from a health professional via the Health Authorities on 25-Feb-2014 under the reference MPA-2014-001510. Case is medically confirmed. Primary source was a physician. A 17-year-old female patient (weight, height not reported) with no medical history reported received a dose of GARDASIL, (batch number not reported) via not reported route and site of administration on an unspecified date. On an unspecified date in Sep-2009, the patient experienced intestinal pseudo-obstruction and gastroparesis. At the time of reporting, the patient had not recovered.


VAERS ID: 524447 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-30
Onset:2013-12-19
   Days after vaccination:50
Submitted: 2014-03-04
   Days after onset:75
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antiphospholipid antibodies negative, Cardiolipin antibody negative, Cytogenetic analysis normal, Protein C, Protein S normal, Prothrombin level, Retinal vein thrombosis, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 08/28/2013, GARDASIL
Diagnostic Lab Data: Dates and units unknown: Prothrombin test: no genetic mutation; Protein S: normal; Protein C: normal; Antiphospholipid antibodies, negative; Cardiolipin antibody, negative; Factor V Leiden mutation, none
CDC Split Type: WAES1402FRA013588

Write-up: Information has been received from Sanofi Pasteur (ID # E2014-01733) on 28-FEB-2014. Case received from the Health Authorities on 25-Feb-2014 under the reference number NC20140152: A 19-year-old (also reported 14 year-old) female patient had received the first dose of GARDASIL (batch number unknown) on 28-Aug-2013 and the second dose GARDASIL (batch number not reported) on 30-Oct-2013. On 19-Dec-2013, she was found to have retinal vein thrombosis revealed by a visual acuity decrease associated with myelodesopsy. Thrombophilia work-up was negative: antiphospholipid antibodies were negative, protein S and protein C were normal. Prothrombin test showed no genetic mutation and there was no Factor V Leiden mutation. To be noted that the patient had no relevant personal history but there was a notion of thromboembolitic accidents in her maternal family (phlebitis, pulmonary embolism). At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation".


VAERS ID: 524449 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-12-01
Onset:0000-00-00
Submitted: 2014-03-04
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Cataplexy, HLA marker study, Narcolepsy, Sleep study abnormal
SMQs:, Dementia (broad), Convulsions (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Tobacco user
Preexisting Conditions: GARDASIL
Diagnostic Lab Data: HLA marker study, ongoing for DQB10602; Sleep study, normal sleep; Sleep study, decreased diurnal sleep onset latency; Sleep study, electrical data consistent with narcolepsy
CDC Split Type: WAES1403FRA000553

Write-up: Information has been received from SPMSD as part of a business agreement (FR-1577272925-E2014-01734) on 28-FEB-2014. Case received from the Health Authorities on 25-Feb-2014 under the reference number TO20140231. A 19-year-old female patient had received the second or third dose of GARDASIL (batch number unknown) via intramuscular route in Dec-2011. Since the end of Dec-2011-early 2012, the patient presented with fits of cataplexy when having emotions, and narcolepsy. She experienced a drop in vigilance in early afternoon. Search for HLA marker study was ongoing for DQB10602. Sleep study was performed. Electrical data was consistent with narcolepsy. It showed normal sleep patterns and decreased diurnal sleep onset latency at 3 times during paradoxical sleep. At the time of reporting, the patient had not recovered. Symptomatic treatment was given with MODIOPAL 3 dosage forms and EFFEXOR 1 dosage form LP 37.5 mg. Her working hours were adapted and she was put on part-time working on health grounds. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 524473 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-08-30
Onset:2011-09-01
   Days after vaccination:2
Submitted: 2014-03-04
   Days after onset:915
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK44350 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure decreased, Chest pain, Cytomegalovirus test positive, Discomfort, Dyspnoea, Epstein-Barr virus test positive, Headache, Heart rate increased, Muscle spasms, Palpitations, Pollakiuria, Postural orthostatic tachycardia syndrome, Roseolovirus test positive, Tilt table test positive
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Coeliac disease; Immunisation
Preexisting Conditions: Roseolovirus test, Positive; Cytomegalovirus test, Positive; Epstein-Barr virus test, Positive
Diagnostic Lab Data: Cytomegalovirus test, Positive; Epstein-Barr virus test, Positive; Roseolovirus test, Positive; Tilt table test, Significant increase in heart rate
CDC Split Type: WAES1402DNK013578

Write-up: Information has been received from SPMSD (reference number E2014-01700) on 27-FEB-2014. Case was received from a health care professional via the Health Authorities on 25-Feb-2014 under the references DK-DKMA-ADR 22430204 and DK-DKMA-EFO8281. Case is medically confirmed. Primary source was a physician. A 13-year-old female patient (weight 56 kg, height 177 cm) with a medical history of positive Epstein-Barr virus test, cytomegalovirus test and human Herpes virus 6 test as well as celiac disease received an injection of GARDASIL, (batch number NN02290, lot # NK44350, expiration date 31-MAY-2012) intramuscular route into not reported site of administration on 30-Aug-2011. On 01-Sep-2011, the patient developed postural orthostatic tachycardia syndrome. On an unspecified date, the patient also developed orthostatic discomfort, heart palpitation, shortness of breath on physical exertion, chest pain on physical exertion, headache, frequent urination and muscle cramps. Tilt table test showed significant increase of heart rate ($g40 bpm) and tendency to decrease in blood pressure. The patient was also investigated for infectious diseases revealing positive tests for EBV, CMV and HH6. It was unknown if other vaccines or medicines were given. At the time of reporting, the patient had not recovered.


VAERS ID: 524944 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-20
Onset:2013-06-15
   Days after vaccination:115
Submitted: 2014-03-06
   Days after onset:264
Entered: 2014-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016967 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Arthropathy, Dizziness, Fall, Fatigue, Headache, Heart rate increased, Hypotonia, Muscular weakness, Musculoskeletal disorder, Musculoskeletal pain, Orthostatic intolerance, Pain, Pain in extremity, Pallor, Peripheral coldness, Sensory loss, Syncope, Tilt table test positive, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL: Immunisation, first dose (batch number H011751)
Diagnostic Lab Data: Tilt table test, orthostatic intolerance N/A; Tilt table test, maximum increase in heart rate of 57 (60-117 bpm) bpm
CDC Split Type: WAES1403DNK002308

Write-up: Information was received from Sanofi Pasteur MSD (MFR number E2014-01839) on 04-MAR-2014. Case of adverse event received from health care professional via Health Authorities in a foreign country on 27-Feb-2014 under the reference number DK-DKMA-ADR 22416492 and EFO8182. The primary reporter was physician. A 12 year-old female patient (weight: 62: height: 168), had received the second dose of GARDASIL (batch number H016967) via intramuscular route of administration in not reported site of administration on 20-Feb-2013 and later on, 15-May-2013, she developed muscle weakness and pain burning. And then 15-Jun-2013, she had orthostatic intolerance and headache. In Jun-2013 she had tiredness and dizziness. Later on 15-Jul-2013 she started experienced syncope. In addition, on an unspecified date she experienced nearly total loss of sensation in legs, could not walk, had to sit in a wheelchair, fell down like a timber, pain in right shoulder, pain in arms and legs and cold legs. Reported reactions: Orthostatic intolerance, syncope, headache, muscle weakness, pain burning. Pain and function reduction in right shoulder, the condition spread to both arms and both legs. The patient developed "attack" when both her legs suddenly loose tonus and become weak, and she fell down like a timber. Dizziness, tired, increasing tormented by headaches. Later on, addition of syncope. For several months the patient had syncope 2-3 times a week. She could not go to school during these months. Developed muscle weakness in both legs to the point where she could not walk and had to sit in a wheelchair. In the same period, both her legs were pale, cold and had nearly total loss of sensation. The family described that they could prick her with needles without she felt it. This subsided and she could start training walking again. Most symptoms, including weakness, syncope and dizziness had subsided by the time she had the tilt table test. She was quite uncomfortable during tilt table test and had a maximum increase in heart rate of 57 (60-117 bpm) but the heart rate does not remain increased, therefor she did not received the diagnose POTS but instead "orthostatic intolerance". It was unknown whether the patient had other tests or examinations. It was unknown if the patient had other vaccines or other medications. The patient was hospitalized (dates not provided). The patient had received the first primary dose of GARDASIL (batch number H011751) via intramuscular route in not reported site of administration on 24-Oct-2012. No medical history reported. At the time of reporting, outcome was unknown for tiredness and fell down like a timber. Outcome was recovering for dizziness, cold legs, pain in arms and legs, pain in right shoulder, pain burning, had to sit in a wheelchair, could not walk, nearly total loss of sensation in legs, muscle weakness, syncope and orthostatic intolerance. And headache was not recovered. HA considered hospitalization and disabling/incapacitating as criteria for seriousness.


VAERS ID: 525017 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-06
Entered: 2014-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Rash, Rash pruritic, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403GBR001784

Write-up: Information was received from Sanofi Pasteur MSD (SPM) (MFR Control#E2014-01820) on 03-MAR-2014. This serious adverse event case was reported by the regulatory authority on 26/Feb/2014. GB-MHRA ADR22430197. This case is medically confirmed. A 13 year-old female patient, with no medical history, received an injection of GARDASIL, batch J07399, 0.5 mL, site and series not reported via the IM route, on an unspecified date. Immediately following vaccination the patient fainted. Patient''s parent has reported that the patient is experiencing an itchy rash to all four limbs. AE is treated with PIRITON. At the time of reporting adverse events were reported as recovering. Patient concomitant medication were not reported. The regulatory authority considered that case serious due to be medically significant. Lot number J07399 is an invalid lot for GARDASIL.


VAERS ID: 525027 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-06
Entered: 2014-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cervical conisation, Cervix carcinoma stage 0, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation
Diagnostic Lab Data: Cervical conisation, PAP IV
CDC Split Type: WAES1403DEU002104

Write-up: Information has been received from Sanofi Pasteur MSD on 04-MAR-2014. Case of vaccination failure was received from a healthcare professional on 27-Feb-2014. Case is medically confirmed. Primary source was a physician. A female patient (age not reported) received a complete vaccination series with three doses of GARDASIL (lot numbers, routes, administration sites not reported) on unspecified dates in 2007/2008. "Despite these vaccination" the patient developed PAP IV. Cervical consiation had been performed on an unspecified date. Since then, the patient had been presenting to the gynaecologist every 3 months for control. The outcome was not reported. Vaccination failure was concluded by the reporter.


VAERS ID: 525196 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-05
Onset:2013-12-10
   Days after vaccination:188
Submitted: 2014-03-07
   Days after onset:87
Entered: 2014-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J001754 / 2 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Chest pain
SMQs:, Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Weakness in the body~HPV (Gardasil)~1~13.42~Patient|Pain in the chest~HPV (Gardasil)~2~13.92~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: NO
CDC Split Type:

Write-up: Chest pain with body weakness during physical activity.


VAERS ID: 525335 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-10
Entered: 2014-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403NZL002674

Write-up: This spontaneous report as received from a immunisation nurse via a company representative, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (also reported as HPV vaccine). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse stated the female patient died "last month" (approximately in February 2014), and no other patient identifiers are available. The nurse mentioned the region where this reportedly occurred was "the same place where a girl''s death after GARDASIL vaccination was previously reported in December (MARRS # 1312NZL004481). No patient identifiers or additional information was available. The reporting nurse also advised that received information from another nurse, who had heard from someone else that one of the mothers in the area had recently not consented to her daughter being vaccinated with GARDASIL because "her cousin died from HPV vaccine about a month ago". The reporting nurse is trying to contact a total of 15 patients who had not consented to their daughters'' vaccination during that time, to identify the reporter of the above information. The nurse stated that the area is not the most highly populated area and she is trying to contact physicians in the area to confirm the report. The nurse stated that if there had been a death, she and her team would know about it. The reporting nurse "suspects very strongly that this is a duplicate case" (of MARRS # 1312NZL004481) with which she had been previously involved. The causality was not reported. Additional information has been requested.


VAERS ID: 525362 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-31
Onset:2013-12-29
   Days after vaccination:59
Submitted: 2014-03-10
   Days after onset:70
Entered: 2014-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF test, Eyelid function disorder, Facial paresis, Neurological examination normal, Serology test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CSF test; Neurological examination, cranial nerves normal; Serology test, confirmed diagnosis
CDC Split Type: WAES1403DEU003081

Write-up: Information has been received from business partner SPMSD (MFR #DE-1577272925-E2014-01804) on 04-MAR-2013. This case was reported through a post-authorization study (market research study: Virtual visiting of gynaecologist practices) sponsored by SPMSD for GARDASIL on 27-Feb-2014. Case is medically confirmed. A 16-year-old female patient received a first dose of GARDASIL (lot-no. not reported) IM into the upper arm on 31-Ocr-2013. Eight weeks later, on 29-Dec-2013, she presented with idiopathic facial paresis on the right. It was possible for her to close her eyelids on both sides, but the right side was limited. She was hospitalised. Investigation of the cranial nerves was normal. Diagnosis was confirmed by examination CSF and serology test, results were not reported. Borreliosis was excluded as a diagnosis. The patient recovered on 31-Dec-2013.


VAERS ID: 525438 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-01
Onset:2013-10-01
   Days after vaccination:0
Submitted: 2014-03-11
   Days after onset:161
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Borrelia test negative, Cytomegalovirus test negative, Full blood count normal, Neurological examination normal, Tinnitus, VIIth nerve paralysis, Varicella virus test negative, Viral test negative
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Borrelia test, Negative; Cytomegalovirus test, Negative; Full blood count, Normal; 11/29/2013, Neurological examination, Ramsay Hunt area: no rash, no auditory deficiency not provided; 11/29/2013, Neurological examination, aymetrical nasolabial fold, no syncinesis not provided; Serology test, Murine sarcoma virus: negative not provided; Varicella virus test negative, Negative
CDC Split Type: WAES1403FRA004891

Write-up: Information has been received from Sanofi Pasteur MSD (Manufacturer control number E2014-01736) on 07-MAR-2014. Case received from the Health Authorities in a foreign country on 26-Feb-2014 under the reference number RE20140178: A 13-year-old female patient had received the second dose of GARDASIL (batch number unknown) in Oct-2013. Two days after vaccination, she presented with left peripheral facial paralysis, without clinical sign of virus nor exposure to cold. The onset was abrupt and followed by a few tinnitus on the left. Approximately one month after the beginning of the paralysis, she consulted at the hospital on 29-Nov-2013. No treatment was initiated. First signs of recovery appeared as the patient became able to close her left eye almost completely on exertion. Nasolabial folds were still asymmetric. There was no syncinesis, no eruption at the level of Ramsay Hunt''s zone and no auditory deficiency. The eardrums were normal. The rest of the neurological examination was strictly normal. Aetiological investigations including serologies for Borrelia test, Cytomegalovirus, Murine sarcoma virus and Varicella Zoster virus and complete blood count were normal. To be noted that a cousin of the patient had a medical history of multiple sclerosis. It was not known whether the patient was taking concomitant treatments. The first signs of recovery were encouraging but the complete recovery would require several weeks and rest. At the time of reporting, the patient was recovering. The Health Authorities assessed the causal relationship between the reported reaction (s) and vaccination as doubtful according to the method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation".


VAERS ID: 525454 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-11
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Periodontitis, Surgery
SMQs:, Oropharyngeal infections (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403HKG004975

Write-up: This spontaneous report as received via a Patient Support Program from the relative of a consumer refers to a patient of unknown age and gender with no reported medical history. On an unknown dates the patient was vaccinated with GARDASIL (route, dose and lot number unknown) dose 1 and dose 2. No other suspect therapy or concomitant medication was reported. The reporter mentioned that her relative (the patient) would like to have the third dose of GARDASIL vaccination. Simultaneously, on an unknown date, the patient also needed to perform surgery for periodontitis (the detail of surgery was not captured in system) (medically significant by company). It was not known if the periodontitis onset before or during GARDASIL vaccination. The outcome of need to have surgery for periodontitis and periodontitis is unknown. Absent of consent to follow-up with reporter. The reporters relatedness of needed surgery for periodontitis and periodontitis to GARDASIL is unknown. Additional information is not expected.


VAERS ID: 525485 (history)  
Age: 25.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-11-01
Submitted: 2014-03-11
   Days after onset:130
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test normal, Cerebral artery occlusion, Cerebral infarction, Cognitive disorder, Dyspnoea, Fall, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paralysis, Syncope, Tremor, Visual acuity reduced
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: MRI: Blood vessel which connected the left and the right brain was blocked; Brain and spinal cord test: Not multiple sclerosis; Blood test: not multiple sclerosis.
CDC Split Type: WAES1403KOR004134

Write-up: Information has been received from SK Chemicals (reference number SK20140306_02) on 07-MAR-2014. This spontaneous report was received via a business partner, SK Chemicals (reference number: SK20140306_02), from the patient''s mother concerning the 25 years old female patient who completed three doses of GARDASIL vaccinations. Approximately 2 years ago, the patient completed GARDASIL vaccination when she was 25 years old. In November 2013, the patient dropped the spoon while having dinner and experienced limbs weakness, partial muscle paralysis and tremors. The patient visited an emergency room and was told cerebral infarction was suspected, so she moved to the bigger hospital and MRI was performed. In the result, blood vessel which connected the left and the right brain was blocked, so the patient was hospitalized and examination was performed. In the result of brain and spinal cord test and blood test, the patient was not multiple sclerosis, and the cause was not found. The patient was discharged after 3 nights and 4 days. It was reported that the patient received fluid injections and the patient''s cognitive ability was improved. When the reporter was asked in the hospital whether there was any drug administered to the patient, she did not recognize the patient was vaccinated with GARDASIL and answered there was not. 1 week after the discharge, the patient experienced loss energy and paralysis symptoms, but the patient did not want to go to the hospital so the reporter massaged the patient''s arms and watched her condition. After that the patient experienced muscle weakness and paralysis symptoms twice. Due to short of breath and poor visibility, the patient had visited a clinic and after receiving fluid injection the symptoms were improved. Also the reporter had heard from the patient that the patient had experienced syncope feeling so she fell in the toilet and it was hard to breathe. Additional information is not expected.


VAERS ID: 525552 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-07
Onset:2014-01-27
   Days after vaccination:234
Submitted: 2014-03-11
   Days after onset:42
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Dyskinesia, Electroencephalogram abnormal, Epilepsy
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 01/27/2014, Electroencephalogram, Epilepsy
CDC Split Type: WAES1403JPN001447

Write-up: Initial and follow up information has been received from a physician refers to a 13 year old female patient who on 07-JUN-2013, was vaccinated with the first dose of GARDASIL intramuscular injection drug (dose, injection, site, lot number not provided) at hospital A. The patient was previously healthy and had no past medical history of febrile/afebrile convulsion and family history. No information on concomitant medication was provided. On an unspecified date, the patient experienced jerky movements or convulsive seizure of the upper limb after the vaccination. It did not appear with loss of consciousness, but her body showed jerky movements. On 27-JAN-2014, the patient experienced first afebrile convulsion and was transported to the reporting hospital. Electroencephalography were performed later on, and she had a diagnosis of epilepsy. Regular examinations had been performed at the department of pediatrics of the reporting hospital. On 25-FEB-2014, although the patient experienced convulsive seizure again, no treatment was performed and she was under observation at her urge. Electroencephalography was planned to be performed once again in August. At the time of reporting on 07-MAR-2014, the outcomes of jerky movements or convulsive seizure of the upper limb, afebrile convulsion were unknown. Reporter''s comment: The reporter was not going to confirm or deny the opinion of the patient''s family. And the reporter was also going to confirm the adverse event of the drug. The severity of afebrile convulsion was rather mild for this kind of symptom. The reporting physician considered that the causal relationship of afebrile convulsion to GARDASIL was unknown, and did not assess the causality between jerky movements or convulsive seizure of the upper limb and GARDASIL. The reporting physician felt that afebrile convulsion was non-serious, and did not assess the seriousness of jerky movements or convulsive seizure of the upper limb. Upon internal review, afebrile convulsion (diagnosis of epilepsy) was determined to be serious as an other important medical event. Additional information has been requested.


VAERS ID: 525553 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-11
Onset:2013-10-14
   Days after vaccination:3
Submitted: 2014-03-11
   Days after onset:148
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Anxiety, Confusional state, Delirium, Disorientation, Hallucination, Hypersomnia, Hypersomnia-bulimia syndrome, Nuclear magnetic resonance imaging brain normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging brain, unremarkable N/A
CDC Split Type: WAES1403FRA004779

Write-up: Information has been received from SPMSD (manufacturer control #: FR-1577272925-E2014-01963) on 07-MAR-2014. Case received from the Health Authorities in a foreign country on 04-Mar-2014 under the reference number PP20140087. A 15-year-old female patient had received an injection of GARDASIL (batch number not reported) (dose and route unknown) on 11-Oct-2013 and 3 days later on 14-Oct-2013, she presented with a hypersomnia episode lasting for 10 days including behaviour disorders (apathy, loss of interest, speech impairment) and suicidal ideation requiring immediate admission of the patient at an emergency unit. On 25-Nov-2013, she experienced another hypersomnia episode which also lasted 10 days accompanied by confusion, spacial and temporal disorientation, delirious episodes, behaviour disorders and anxiety. According to the reporter, a diagnosis of suspected Kleine-Levin syndrome was suggested. On 23-Dec-2013, the patient presented with a third hypersomnia episode including hallucinations and bahaviour disorders. The MRI brain scan performed (date not reported) was unremarkable. On 09-Feb-2014, she was admitted at hospital in a sleep laboratory in order to confirm her diagnosis and was discharged on 1--Feb-2014. At the time of the report, the patient had still not recovered. The health Authorities assessed the causal relationship between the reported reactions and GARDASIL vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 525554 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-12
Onset:2009-02-01
   Days after vaccination:20
Submitted: 2014-03-12
   Days after onset:1864
Entered: 2014-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Immunoglobulin therapy, Motor dysfunction, Plasmapheresis, Polyneuropathy, Quadriplegia, Walking aid user
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403FRA004783

Write-up: Information has been received from SPMSD (manufacturer control #: FR-1577272925-E2014-01966) on 07-MAR-2014. Case received from the Health Authorities on 04-Mar-2014 under the reference number NC20140188. An 18-year-old female patient received the third injection of GARDASIL (batch number not reported) (dose and route unknown) on 12-Jan-2009. She had previously received 2 doses of the vaccine on 11-Jul-2008 and 12-Sep-2008. The patient had no personal or family relevant medical history except notion of a bronchitis in December 2008. In February 2009, she developed a very severe subacute sensimotor polyradiculoneuritis leading to tetraplegia with major motor deficit within 6 months. Her condition required various prolonged hospitalisations in different hospitals and reeducation centers. The patient was treated with sequential transfusions of intravenous immunoglobulins followed by plasmapheresis and long-term corticotherapy and immunosuppressive therapy. She started to recover at the end of 2009 and made continuous progresses until the end of 2012, when her neurological condition seemed to stabilise at a sequelae stage: with tetraparesis and proprioceptive ataxia, walk aided with splints to prevent steppage gait. At the time of the report, the patient was still under immunosuppressive therapy with IMUREL and intravenous immunoglobulins, in the course of discontinuation. Upon medical review the company considered relevant to code hospitalisation as seriousness criterion that was mentioned in the narrative by the Health Authorities but not coded. The Health Authorities assessed the causal relationship between the reported reactions and GARDASIL vaccination as doubtful according to the foreign method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation".


VAERS ID: 525556 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-12
Entered: 2014-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Muscle rigidity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403ESP004884

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [E2014-01998] on 07-MAR-2014. Case retrieved from the literature search performed on 03-MAR-2014. Case medically confirmed. This case is linked with the mother case E2014-01980. Abstract: Introduction: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Centre after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. Material and methods: Descriptive study of SARs reported following this vaccine to the Centre between 2007 and 2011. Results: The clinical symptoms most frequently reported were dizziness, headache and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. Conclusions: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile. Descriptive study of suspect adverse reactions reported following the quadrivalent human papillomavirus vaccine reported to the Centre by healthcare professionals between SEP-2007 and DEC-2011. Female adolescents aged between 13 and 15 years of age and who had the minimum information were included in the study. During the study''s period 194 notifications were included, 33 cases were reported in 2008, 106 cases in 2009, 42 cases in 2010, and 13 cases in 2011. In 2007 (SEP-DEC) there was no notification of suspect adverse reactions. 32% of the notifications were classified as serious by the staff of the Centre. It was not reported which of the cases were considered as serious. There were 38 cases of syncope (20%). In 4 cases the syncope was accompanied with convulsions (one of these is this case), and in 32 remaining cases, 14 presented with only syncope and in the other 18 cases syncope was accompanied with other clinical manifestations (see linked cases). Six of the notifications were convulsions. Four of them were associated with syncope. Of the 6 notifications of convulsions, 5 had as start date of event the day of vaccine administration of the vaccine. Current case concerns a female patient, between 13 and 15 years, exact age not reported who received a dose of quadrivalent human papillomavirus vaccine (GARDASIL, product name was not reported in the article, but it is the only quadrivalent human papillomavirus vaccine available, batch number not reported, route and site not reported) on an unspecified date. After vaccine administration (latency not reported), between 2008 and 2011, the patient presented with syncope and muscle rigidity, and the same day of vaccination the patient presented with convulsions. Outcome was not reported. Upon medical review the company considered the case as serious. No further information reported.


VAERS ID: 525560 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-12
Entered: 2014-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Hypertonia, Myoclonus, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403ESP004848

Write-up: Information was received from Sanofi Pasteur MSD (SPM) (MFR# E2014-01999) on 07-MAR-2014. Case retrieved from the literature search performed on 03-MAR-2014. Case medically confirmed. This case is linked with the mother case E2014-01980. Abstract: Introduction: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Centre after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. Material and methods: Descriptive study of SARs reported following this vaccine to the Centre between 2007 and 2011. Results: The clinical symptoms most frequently reported were dizziness, headache and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. Conclusions: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile. Descriptive study of suspect adverse reactions reported following the quadrivalent human papillomavirus vaccine reported to the Centre by healthcare professionals between SEP-2007 and DEC-2011. Female adolescents aged between 13 and 15 years of age and who had the minimum information were included in the study. During the study''s period 194 notifications were included, 33 cases were reported in 2008, 106 cases in 2009, 42 cases in 2010, and 13 cases in 2011. In 2007 (SEP-DEC) there was no notification of suspect adverse reactions. 32% of the notifications were classified as serious by the staff of the Centre. It was not reported which of the cases were considered as serious. There were 38 cases of syncope (20%). In 4 cases the syncope was accompanied with convulsions (one of these is this case), and in 32 remaining cases, 14 presented with only syncope and in the other 18 cases syncope was accompanied with other clinical manifestations (see linked cases). Six of the notifications were convulsions. Four of them were associated with syncope. Of the 6 notifications of convulsions, 5 had as start date of event the day of vaccine administration of the vaccine. Current case concerns a female patient, between 13 and 15 years, exact age not reported who received a dose of quadrivalent human papillomavirus vaccine (GARDASIL, product name was not reported in the article, but it is the only quadrivalent human papillomavirus vaccine available, batch number not reported, route and site not reported) on an unspecified date. After vaccine administration (latency not reported), between 2008 and 2011, the patient presented with syncope, myoclonus and hypertonia, and the same day of vaccination the patient presented with convulsions. Outcome was not reported. Upon medical review the company considered the case as serious. No further information reported.


VAERS ID: 525630 (history)  
Age: 9.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-23
Onset:2012-04-23
   Days after vaccination:60
Submitted: 2014-03-12
   Days after onset:688
Entered: 2014-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Atrophy, Complex regional pain syndrome, Decreased appetite, Depression, Muscular dystrophy, Pain
SMQs:, Congenital, familial and genetic disorders (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 60 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403BRA005302

Write-up: This spontaneous report as received from a Physician, who sent an email to Global Medical Affairs, refers to his niece a 9 year old female patient. On unspecified dates the patient was vaccinated with GARDASIL dose 1 and 2, 0.5 mL, intramuscular. On 23-FEB-2012 the patient was vaccinated GARDASIL dose 3, 0.5 mL, intramuscular - UAE. On 23-APR-2012, 61 days after onset of therapy the patient begin to present several symptoms, which were diagnosed later, by a rheumatologist, as Complex Regional Pain Syndrome (hospitalization and disability). Approximately on June 2012, the patient experienced surgical procedure to insert a electrical stimulation device on patient''s spinal cord (medically significant). On an unknown date the patient experienced depression and anorexia. The outcome of complex regional pain syndrome, anorexia and depression was reported as not recovered/not resolved. The reporter considered complex regional pain syndrome, anorexia and depression to be related to GARDASIL. Additional information has been requested. Following there is a copy of the message sent by the reporter to Merck: "This is my niece''s case. She was 9 yo when received the third dose of GARDASIL in Feb 23, 2012 (she was living there on that time). Two months later the last shot, she started to have some neurological symptoms, such as allodynia and severe pain in left foot. It was initially considered as a muscle strain and treated with foot immobilization and medicines. The clinical signs did not improve and, in fact, started to get more severe. She came here, a rheumatologist has given her a diagnosis of Complex Regional Pain Syndrome (CRPS). The diagnosis was also confirmed in Hospital and some months later as well. In mid-2012 she has undergone a surgical procedure because of untreatable pain even using high doses of opioid drugs. This procedure inserted an equipment in the spinal cord in order to make an electrical stimulation. Pain was partially controlled after this procedure. A few months later, she spent two months in a specialized hospital to treat the CRPS with intensive physiotherapy. Unfortunately, the treatment was not able to stop the disease progression, and pain started to get worse again even using the electro stimulator equipment. A muscular dystrophy in the left lower limb has progressively become evident (atrophy of the left foot, which twisted internally). According to the orthopedists, this situation has low chances to be reverted. I''ve read something about this Syndrome and, when the disease is not well controlled, the dystrophy is the natural course of it. Meanwhile, she developed a severe depression and anorexia. In fact, I''m very concerned about the outcome. Currently, she has been treated with a specialized team on chronic pain and children psychiatry. Sadly we haven''t seen any significant improvement since she started the treatment in 2012. In fact, as a physician, I''m not so helpful of seeing her getting better. In spite of all efforts in defining the reasons for the CRPS, no evident etiological factor was found. Vaccine has been always refused by her physicians as the reason for her CRPS. But now, they are strongly considering this possibility since there is no reasonable explanation for the disease after a comprehensive investigation. You know better than me how enthusiastic I am in terms of HPV vaccination. We have wonderful results, those that we recently published. We had no severe adverse events in our cohort. I always refused all negative media reports about GARDASIL, such as Guillain-Barre, neurological dysfunctions, depression, CRPS, and so on. But, to be honest, I''ve started to be concerned about vaccine safety after the report of a couple of cases of CRPS supposedly related to GARDASIL. This came in the same time my own niece has been fighting against a weird disease with no evident etiological factor. So, I''m strongly considering that my niece''s disease can be a severe adverse event related to GARDASIL. I k


VAERS ID: 525638 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-13
Entered: 2014-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Echocardiogram normal, Electrocardiogram normal, Nausea, Palpitations, Pulmonary function test normal, Pyrexia, Tachycardia, Thyroid function test normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Echocardiogram, Normal; Electrocardiogram, Long term ECG: no pathological findings; Electrocardiogram, Normal; Heart rate, 140 bpm; Pulmonary function test, Normal
CDC Split Type: WAES1403DEU006353

Write-up: Information has been received from Sanofi Pasteur MSD (Manufacturer control number E2014-02027) on 11-MAR-2014. Case was received from a paediatrician on 06-Mar-2014 with additional information received on 10-Mar-2014. Case is medically confirmed. A 15-year-old female patient received a dose of GARDASIL, lot-no., injection route and site not reported) on 25-Feb-2014. Five days later, on 02-Mar-2014, she developed tachycardia with palpitations and a constant heart rate of about 140 beats/minutes, asthenia and nausea. She was hospitalised on the same day. Eight days p.v., on 05-Mar-2014 she developed one fever spike. All examinations included ECG, long term ECG, echocardiography, thyroid function and lungs were without pathological findings. No inflammatory markers were detected (not otherwise specified). Myocarditis was ruled out. No signs for orthostatic dysregulation were found. No serology testing was performed. It was reported that the patient did not receive concomitant medication. The symptoms notedly improved under unspecified infusions and the patient recovered completely. She was discharged within a few days. The reporter underlined that they did not find a cause for the tachycardia.


VAERS ID: 525647 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-13
Entered: 2014-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Blood test normal, Electrocardiogram normal, Endometriosis, Fatigue, Hypertension, Hypothyroidism, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Hypothyroidism (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Diagnostic Lab Data: Blood test, inflammatory values: normal; Electrocardiogram, normal
CDC Split Type: WAES1403DEU006601

Write-up: Information has been received from Sanofi Pasteur MSD (report number DE-1577272925-E2014-02099) on 12-MAR-2014. Case was received from a healthcare professional on 07-Mar-2014. Case is medically confirmed. An about 15 year-old female patient received a third dose of GARDASIL (lot-no., injection route and site not reported) on an unspecified date in 2009. Mid of 2012, at the age of about 18 years, she developed tachycardia, arterial hypertension, hypothyroidism and endometriosis. She also felt exhausted. ECG and inflammatory values showed normal results, myocarditis as other cardiac diseases were ruled out. She was medicated with beta-blockers (not otherwise specified), BELLA HEXAL and unspecified thyroid drugs. She also received psychotherapy. Due to exhaustion, the patient was only able to work for four hours per day. At the time of reporting she had not recovered. According to the reporter, the events were not related to vaccination. Patient received two doses of GARDASIL on unspecified dates, toleration was not reported. Upon medical judgement the company assessed the case as serious due to disability (not able to work normally) and duration of the events.


VAERS ID: 525737 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-08
Onset:0000-00-00
Submitted: 2014-03-13
Entered: 2014-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1172U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chlamydial infection, Discomfort, Lichen sclerosus, Vaginal discharge, Vaginal infection, Vulvovaginal pruritus
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Hypothyroidism; Asthma; Rhinitis allergic; 08/22/2008, GARDASIL; 06/05/2008, GARDASIL
Diagnostic Lab Data:
CDC Split Type: WAES1402DEU006229

Write-up: Information has been received from SPMSD (sender''s case report number DE-1577272925-E2014-00642) on 11-MAR-2014. Case was received from a health professional on 27-Jan-2014. Case is medically confirmed. A 15-year-old female patient received a complete vaccination series with three doses of GARDASIL (lot-no. not reported) on unspecified dates in 2008. About two years later, on 28-Jan-2011, the patient was diagnosed with mild lichen sclerosus at the introitus. The patient received cortisone leading to improvement. Routine investigation in Sep-2009 showed no pathological results. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL (D1, D2) were given on unspecified dates in 2008. Toleration was not reported. Follow up report received from the Health Authorities on 06-Mar-2014 (reference no. PEI2014010614). The patient''s initials were provided. Medical history included a general allergic disposition, rhinitis allergica, asthma bronchial and hypothyroidism. An application for the acceptance of vaccination damage was filed and submitted to the county district office. GARDASIL was given on 05-Jun-2008 (D1, lot no. BNH10940), 22-Aug-2008 (D2, lot-no. not reported) and on 08-Jan-2009 (D3, lot-no. 1172U, batch-no. NH13130). The patient reported that the symptoms of increased vaginal discharge and intermittent vaginal itching had started approximately 2 months after the HPV vaccination. Due to aggravation of symptoms and the development of porcelain-like skin changes the patient was diagnosed with lichen sclerosus on 28-Jan-2011. The patient presented twice to hospital (03-Dec-2013 and on 14-Jan-2014) to receive confirmation of the diagnosis by histological tests. However, histological confirmation was considered as not necessary by the physician and local treatment with DERMOXIN and OVESTINC ointment was started. At the first presentation the patient stated being virgo intacta but was treated for chlamydia infection at the same time. One week later she presented additionally to a dermatologist. At that time, the lichen sclerosus symptoms had resolved and the dermatologist could not confirm the diagnosis. However, enterococcus colpitis was detected which could lead to discomfort. At the time of reporting, the patient had not recovered. According to the hospital physician, the causal relationship between GARDASIL vaccination and lichen sclerosus was considered as not related. The case was judged as serious by Health Authority (other medically important condition).


VAERS ID: 525781 (history)  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-28
Onset:2014-02-27
   Days after vaccination:2131
Submitted: 2014-03-14
   Days after onset:14
Entered: 2014-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1113U / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2001, Sexually active; Cervical conisation; Cervical dysplasia; Infection; 10/23/2007, GARDASIL; 08/14/2007, GARDASIL
Diagnostic Lab Data: 02/27/2014, Biopsy cervix, portio: CIN III; Human papillomavirus test, type 16 positive; Smear cervix, Pap III D
CDC Split Type: WAES1403DEU006880

Write-up: Information has been received from SPMSD (DE-1577272925-E2014-02069) on 12-MAR-2014. Case was received from a physician (also reported as a healthcare professional) on 07-MAR-2014. Case is medically confirmed. A 32-year-old female patient, with a medical history of infection after conisation (not specified), Pap III D and first sexual intercourse in 2001, received a complete vaccination series with three doses of GARDASIL on 14-AUG-2007 (D1, lot-no. not reported), on 23-OCT-2007 (D2, batch-no. NF23330, lot# 1518F, expiry date 11-DEC-2009) and on 28-Apr-2008 (D3, batch-no. NH10080, lot# 1113U, expiry date 19-JUL-2010) IM into the upper arm, starting at the age of 25 years. On 27-FEB-2014 biopsy of portio was carried out due to Pap III D (two times) and human papillomavirus test positive for HPV type 16 (dates not specified). She was diagnosed with severe cervical intraepithelial neoplasia III (CIN III) in the degree of a squamous epithelium carcinoma in situ. Another conisation was planned. The outcome was not reported. Upon medical review the company assessed this case as serious due to "CIN III in the degree of a squamous epithelium carcinoma in situ".


VAERS ID: 525899 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-02-26
Onset:2014-02-26
   Days after vaccination:0
Submitted: 2014-03-17
   Days after onset:18
Entered: 2014-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007158 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Disorientation, Grand mal convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Syncope; GARDASIL, Immunisation, Syncope; 11/13/2013, GARDASIL, Immunisation, Syncope
Diagnostic Lab Data:
CDC Split Type: WAES1403GBR007398

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # GB-1577272925-E2014-02224) on 13-MAR-2014. This serious case was reported from the MHRA under the reference GB-MHRA ADR 22443373 on 10/Mar/2014. This case is medically confirmed. A 13-year-old female patient received an injection of GARDASIL, lot # J007158, third dose, site and IM route on 26/Feb/2014, the patient was lying when given the immunisation. Additionally, she appeared to have a small tonic-clonic seizure lasting about 30-40 seconds. The patient had no knowledge of being spoken to during the episode and initially did not know where she was for about 10-15 seconds. According to the reporter, it seems that with each administration of the immunisation the fainting episodes have become worse. The reporter is unsure if it''s related to anxiety of anticipating fainting or a reaction to immunisation. The reported informed that most other fainting episodes witnessed during immunisation sessions are immediate due to seeing the needle or having the injection, unlike this patient who faints several minutes following the injection. The patient had a medical history of fainting after injection of GARDASIL dose 1 on 13/Nov/2013, batch not reported, and dose 2 on an unreported date, batch not reported. The patient quickly recovered from fainting episodes. Concomitant medication was not reported. At the time of reporting, the patient recovered form all the events on 26/Feb/2014. The case was considered serious for other medically significant reasons.


VAERS ID: 525901 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-27
Onset:2014-01-30
   Days after vaccination:34
Submitted: 2014-03-17
   Days after onset:45
Entered: 2014-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, HLA-B gene status assay, Hypergammaglobulinaemia, Immunoglobulins increased, Joint stiffness, Laboratory test normal, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Antineutrophil cytoplasmic antibody, negative; Antinuclear antibody, negative; HLA-B gene status assay, HLA B27 negative; Immunoglobulins, hypergammaglobulinemia
CDC Split Type: WAES1403FRA007170

Write-up: Information was received from Sanofi Pasteur (FR-1577272925-E2014-02239) on 13-MAR-2014. Case received from the Heath Authorities on 11-Mar-2014 under the reference number TO20140285: An 18-year-old female patient had received a dose of GARDASIL (batch number unknown) via intramuscular route on 27-Dec-2013. On 30-Jan-2014, she developed an oedema as well as joint stiffness symmetrical in both hands. On 01-Feb-2014, she also developed a feet oedema. Biological work-up showed hypergammaglobulinemia. Non-drug induced etiology. HLA-B gene status assay showed HLA B27 negative. ANCA and antinuclear antibodies were negative. At the time of reporting, the patient had not recovered but her physical state was improving under corticotherapy (not NSAIDs). The Health Authorities assessed the causal relationship between the reported conditions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 525905 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-17
Entered: 2014-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Pain, Pyrexia, Shock, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403KOR007450

Write-up: This spontaneous report was received from a female patient of an unknown age via company representative. On an unknown date the patient was vaccinated with GARDASIL (Injection (Vials)). Dose and lot information were not provided. No concomitant medications were reported. Subsequently the patient experienced dizziness, shock symptom and syncope. Also, on the date of vaccination, the patient had fever and body ache. The outcome of syncope was reported as recovered/resolved. The outcome of shock, body ache, fever and dizziness was unknown. The causality was not reported. Upon internal review, Shock was considered as medically significant. Additional information is not expected.


VAERS ID: 525966 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-23
Onset:2014-01-23
   Days after vaccination:0
Submitted: 2014-03-17
   Days after onset:52
Entered: 2014-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012134 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Electromyogram normal, Gait disturbance, Muscular weakness, Nerve conduction studies normal, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Electromyogram, 25Jan2014, Normal; Motor nerve conduction studies (29JAN2014) - Without alteration in the speed of the nerve conduction in motor and sensitive lower limbs.
CDC Split Type: B0975509A

Write-up: This case was reported by a physician and consumer (subject''s father) via a regulatory authority (# ES-AGEMED-539945340) and described the occurrence of gait disturbance in a 11-year-old female subject who was vaccinated with TWINRIX pediatric, (GlaxoSmithKline) and GARDASIL, (non-GSK). On 23 January 2014, the subject received unspecified dose of TWINRIX pediatric (.5 ml, intramuscular, unknown injection site and batch number) and unspecified dose of GARDASIL (.5 ml, intramuscular, unknown injection site). On 23 January 2014, less than 1 day after vaccination with TWINRIX pediatric, the subject experienced dizziness. At about 30 minutes later, she was improved and was administered GARDASIL. The dizziness occurred again and resolved the same day. the subject was also suspected to have neurological infection. On 24 February 2014, the subject''s parents informed that she was on a wheel chair. On 25 January 2014, the electromyogram was performed and the results were normal, ruling out any form of neuromuscular pathology. On 27 January 2014, the subject was hospitalised for the study of the walking alteration and loss of force in the lower limbs was observed. The subject''s father reported that the events were disabling. On 29 January 2014, the motor nerve conduction test was conducted without any alterations in speed. On 6 March 2014, the subject was discharged and as per the discharge report, the neurological infection was changed to gait disturbance. At the time of reporting the gait disturbance was improved. No further information was expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. Therefore the case has been closed.


VAERS ID: 526014 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-08
Onset:2014-03-09
   Days after vaccination:1
Submitted: 2014-03-18
   Days after onset:8
Entered: 2014-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Back pain, Computerised tomogram normal, Musculoskeletal pain, Neurological examination normal, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Papilloma viral infection
Preexisting Conditions:
Diagnostic Lab Data: 03/09/2014, Computerised tomogram, Normal; 03/10/2014, Neurological examination, Normal
CDC Split Type: WAES1403ARG007355

Write-up: This spontaneous report was received from a consumer (reported as patient''s mother) refers to a 11 year old female patient. On 08-MAR-2014 the patient was vaccinated with second dose of GARDASIL (strength 0.5 millilitre(ml), total daily dose:0.5 ml, frequency was reported as day 1, 2 months after 1st dose, 6 months after 1st dose) intramuscularly for HPV infection and there was no swelling at the injection site. On 09-MAR-2014, the patient experienced arm paresthesia. On 09-MAR-2014, the patient also experienced pain in the inner side of elbow, wrist pain and 20 minutes after those events, patient lost the strength in the left hand (reported as event that lasted for 1 hour approximately). The patient was taken to the emergency room (ER) and she was recovered from strength loss in left hand. On 09-MAR-2014 the patient underwent computerized tomogram (CT) scan which resulted as normal. The patient went to her house on 09-MAR-2014 and experienced shoulder blade pain. On 10-MAR-2014, the patient underwent neurological exam which resulted normal. the pain was subsided with heat. On 12-MAR-2014, the patient recovered from pain but was still experiencing mild back pain. The outcome of wrist pain, shoulder blade pain, strength loss in left hand and pain in inner side of the elbow was reported as recovered/resolved. The outcome of arm paresthesia and mild back pain was unknown. The causality was not reported. The events were considered as serious (medically significant) by the physician. Additional information has been requested.


VAERS ID: 526117 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-01-02
Onset:2014-01-02
   Days after vaccination:0
Submitted: 2014-03-18
   Days after onset:74
Entered: 2014-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010308 / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Sensory disturbance
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 09/05/2013, GARDASIL, Dose 2. Lot number J003687; 06/04/2013, GARDASIL, Dose 1. Lot number J000282
Diagnostic Lab Data:
CDC Split Type: WAES1403DEU008406

Write-up: Case was received from a health professional on 11-Mar-2014. Information has been received from Sanofi Pasteur as part of a business agreement (manufacturer control # DE-1577272925-E2014-02205) on 17-MAR-2014. Case is medically confirmed. Primary source was a physician. A 16-year-old female patient, who was healthy and had no risk factors, received a complete vaccination series with three doses of GARDASIL on 04-Jun-2013 (D1, lot-no. J000282, Exp. Date: 30-JUN-2015), on 05-Sep-2013 (D2, lot-no. J003687, Exp. Date: 31-AUG-2015) and on 02-Jan-2014 (D3, lot-no. J010308, Exp. Date: 30-NOV-2015, vaccination site: right upper arm). On 02-Jan-2014 after the third dose, the patient developed severe oedematous swelling of the right hand of the vaccinated arm. The patient was hospitalised on the following day. Thrombosis was excluded. Swelling resolved approximately after 2 days. 3-4 weeks later, the patient developed the same symptoms on the left hand. The symptoms appeared a third time, again on the right hand. The patient also experienced intermittent sensory disturbance. At the time of reporting, the patient had not recovered.


VAERS ID: 526118 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-03-10
Submitted: 2014-03-18
   Days after onset:8
Entered: 2014-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016923 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403SWE007502

Write-up: Information has been received from a business agreement partner Sanofi Pasteur (SPM) (Mfr# SE-1577272925-E2014-02260) on 13-MAR-2014. Case was received from a health professional via the Health Authority on 12-Mar-2014 under the reference MPA-2014-001826. Case is medically confirmed. An 11-year-old female patient (weight, height not reported) with no medical history reported received a dose of GARDASIL, (batch no. H016923; lot# H016923, expire date: 31-MAR-2015) via not reported route and site of administration on an unspecified date. On 10-Mar-2014, the patient developed swelling face, numbness of tongue and hands, tiredness and dizziness. At the time of reporting, the outcome was unknown.


VAERS ID: 526121 (history)  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-19
Onset:2013-01-10
   Days after vaccination:52
Submitted: 2014-03-19
   Days after onset:432
Entered: 2014-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-neuronal antibody, Anti-neuronal antibody negative, Blood electrolytes normal, C-reactive protein normal, CSF culture negative, CSF test normal, Central nervous system lesion, Coma scale, Computerised tomogram thorax abnormal, Electrophoresis protein normal, Enophthalmos, Eyelid ptosis, Facial spasm, Full blood count normal, HIV antibody negative, Haematology test normal, Hepatitis B antibody negative, Hepatitis C antibody negative, Liver function test normal, Muscle contractions involuntary, Nuclear magnetic resonance imaging brain abnormal, Reflex test normal, Renal function test normal, VIIth nerve paralysis
SMQs:, Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 08-FEB-2014: Thorax CAT; Thorax CAT was performed on 08-Feb-2013 to search argument suggesting lymphoma or sarcoidosis in this patient who presented with lesion of the brain stem and a hypersignal in fluid attenuated inversion recovery (FLAIR), with a probable compression of the 4th ventricle. 01/25/2013, Anti-neuronal antibody, Anti-TA negative; 01/25/2013, Anti-neuronal antibody, negative; 01/25/2013, Blood electrolytes, normal; 01/25/2013, C-reactive protein, 3 mg/l; 01/25/2013, CSF test, normal; 01/25/2013, Coma scale, 15; 01/25/2013, Cryoglobulinaemia, negative; 01/26/2013, Electrophoresis protein, normal; 01/25/2013, Full blood count, normal; 01/25/2013, HIV antibody, negative; 01/25/2013, Haemostasis, normal; 01/25/2013, Hepatitis B
CDC Split Type: WAES1403FRA008407

Write-up: Information has been received from Sanofi Pasteur, manufacturer control # FR-1577272925-E2014-02284 on 17-MAR-2014. Case received from the Health Authorities on 13-Mar-2014 under the reference number AN2014220. A 18 years old female patient had received a dose of MENINGITEC (other manufacturer, batch number not reported) on 9-Oct-2012 and the first dose of GARDASIL (batch number not reported) via intramuscular route on 19-Nov-2012. On 10-Jan-2013, upon waking up, she presented with muscular contractions in her right cheek. She also presented with a facial hemispasm on the right side of her face, a narrowing and asymmetry at the palpebral fissure and a loss of her left nasolabial fold. An MRI brain scan was performed showing a lesion of the brain stem and a hypersignal in fluid attenuated inversion recovery (FLAIR). The patient did not have any noticeable personal or family medical history, nor surgical history, and was not under any treatment. She had no known allergy. On 25-Jan-2013, a clinical examination was performed on the patient. Glasgow coma scale was at 15 points, her pupils were symmetrical and reactive. She presented with a hyposthesia of her left hemiface, a right side ptosis with enophtalmos, symptoms of a Homer syndrome. Loss of her left nasolabial fold. She also presented with an asymmetric smile on the right, symptom of a right-side facial palsy. There was no sign of a cerebellous syndrome. Her plantar reflexes were normal at bending. Her tendon reflexes were active and symmetrical. Additional examinations were performed on 25-Jan-2013, including Liver function tests, ionic test and kidney test normal, C-reactive protein < 3 mg/l, normal electrophoresis protein, normal hematologic and hemostasis profiles, negative HIV antibody negative Hepatitis C antibody and negative Hepatitis B antibody, negative cryoglobulinemia. Normal CSF testing, including normal proteinorachia and glycorachia, negative culture, low cellularity with almost exclusively T lymphocytes without phenotypic abnormalities, normal quantitative immunofixation. Search for antibodies on 25-Jun-2013 showed Anti-Yo, anti-Ri antibodies, Anti-neuronal nuclear antibody-2, Anti-amphiphysin antibody, Anti-neuronal antibody negative. Thorax CAT was performed on 08-Feb-2013 to search argument suggesting lymphoma or sarcoidosis in this patient who presented with lesion of the brain stem and a hypersignal in fluid attenuated inversion recovery (FLAIR), with a probable compression of the 4th ventricle. There was no mediastinal adenomegaly, no interstitial syndrome or parenchytamal opacity of suspect or evolutive aspect. Surrenal were unremarkable. Exploration of the lesion was ongoing. An inflammatory or low-grade tumor origin was possible. The patient was seen for her last visit on 10-Dec-2013 and no evolution was put forward. MRI were performed in January, April and Jul 2013 showing no evolution of this signal anomaly, which was firstly suggestive of a demyelinating impairment. Stereotaxic biopsy was not considered due to the absence of evolution and considering the functional risks of such an act. The conclusion was the discovery of a lesion of the cerebral trunk in a patient vaccinated with MENINGITEC and GARDASIL in the previous months. The Health Authorities assessed the causal relationship between the reported reactions and both vaccination as doubtful (C1 S1 I1) according to the method of assessment.


VAERS ID: 526206 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-31
Onset:2013-11-01
   Days after vaccination:580
Submitted: 2014-03-19
   Days after onset:138
Entered: 2014-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN43340 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Fatigue, Insomnia, Middle insomnia, Myalgia, Myopia, Ophthalmological examination normal, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 11/26/2011, GARDASIL, Immunisation, Dose 2, Batch number NP23380; 09/17/2011, GARDASIL, Immunisation, Dose 1, Batch number NN53800
Diagnostic Lab Data:
CDC Split Type: WAES1403FRA008411

Write-up: Case received from the Health Authorities on 12-Mar-2014: Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # FR-1577272925-E2014-02268) on 17-MAR-2014. A 16-year-old female patient had received intramuscularly the three doses of GARDASIL (batch number NN53800, lot number NK18520, Exp. Date: 20-FEB-2012), 26-Nov-2011 (GARDASIL, batch number NP23380, lot number NK38610, Exp. Date: 30-APR-2012) and on 31-Mar-2012 (GARDASIL, batch number G00777, lot number NN43340, Exp. Date: 28-NOV-2013). On 12-Feb-2014, the patient went to see her new general practitioner (she was previously followed by a paediatrician) as she was found to have the following disorders since 3 to 4 months: joint and muscle pain in both legs and particularly in both knees; slight disorder characterized by aggravated myopia. She went to see an ophthalmologist but no particular disorder was found; sleep disorder: she found it difficult to get asleep and woke up in the middle of the night; significant fatigue (due to sleep disorder?). According to the patient, the symptoms were related to the vaccination with GARDASIL that she had received approximately two years before, although it seemed that the events appeared not long before this report. The patient mentioned that "she was not aware before". Her physician was going to prescribe different work-up in order to rule out an underlying pathology. The patient had not been seen again on 06-Mar-2014. The Health Authorities assessed the causal relationship between the reported conditions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 526207 (history)  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-19
Onset:2011-04-01
   Days after vaccination:13
Submitted: 2014-03-19
   Days after onset:1083
Entered: 2014-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Paraesthesia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403KOR004120

Write-up: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. In 2011 the patient completed three doses of GARDASIL (doses, lot # and expiration dates were not reported). One month after vaccinations (exact date unspecified) the patient experienced hand tingling and hand tremor. The patient visited hospital and heard cerebral infarction symptoms was seen, but it was not a cerebral infarction. At the time of the report, the patient still had the symptoms (also reported as: the outcome was unknown). The relatedness between the events and GARDASIL was not reported. Follow up information as received from a physician refers to the 23 year old female patient. On 19-MAR-2011 the patient was vaccinated with third dose of GARDASIL. Approximately in April 2011 ("one month after vaccination"), the patient experienced muscle weakness and was hospitalized due to the event. One month after vaccinations, in approximately April 2011, the patient experienced hand tingling and hand tremor. The patient was not recovered from muscle weakness and was in treatment for the event. The patient had not been exposed to GARDASIL prior to these vaccinations. Additional information is not expected.


VAERS ID: 526212 (history)  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-20
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cervix carcinoma stage 0, Smear cervix abnormal
SMQs:, Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: HPV, Immunisation
Diagnostic Lab Data: 2014, Smear cervix, Abnormal, Pap IVa
CDC Split Type: WAES1403DEU009422

Write-up: Information has been received from business partner SPMSD (MFC# DE-1577272925-E2014-02273) on 18-MAR-2014. Case was received from a physician on 13-Mar-2014. Case is medically confirmed. This case is linked with E2014-02178 (same reporter, same product, different reaction). A female patient had received a complete immunisation series with three doses of HPV vaccine (MFR, lot-no. injection route and site not reported) on unspecified dates. Unspecified time later in 2014 at the age of 23 years, she was diagnosed with Pap IVa. At the time of reporting she had not recovered. Upon medical judgement the company assessed this case as serious due to the AE: Pap IVa.


VAERS ID: 526213 (history)  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-12-01
Submitted: 2014-03-20
   Days after onset:839
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative, Blindness, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Borrelia test negative, Colour blindness acquired, Demyelination, Eye pain, Immunology test normal, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Optic neuritis, Papilloedema
SMQs:, Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (narrow), Retinal disorders (narrow), Ocular infections (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Myopia
Diagnostic Lab Data: Borrelia test, Negative, IgG and IgM in serum negative; Immunology test, Negative, ENA, c-ANCA, p-ANCA and SSA/RO negative; Immunology test, ANA 1:160 fine-grained; Investigation, no signs of systemic disease; 03/22/2012, Nuclear magnetic resonance imaging, regressive single R frontoparietal demyelinations; 03/22/2012, Nuclear magnetic resonance imaging, spinal: demyelinating lesion at CV3 region; Nuclear magnetic resonance imaging brain, typical demyelinating changes
CDC Split Type: WAES1403DEU009468

Write-up: Information received from SANOFI PASTEUR MSD (E2014-02252) on 18-MAR-2014. Case was received from the Health Authority on 13-Mar-2013 (ref. no. PEI2014008522). Case is medically confirmed. A 26-year-old female patient with a history of myopia, received the second dose of GARDASIL (lot-no. not reported) on an unspecified date in 2007. In Dec-2011, one week prior to hospitalisation, the patient developed visual loss as well as decrease of colorfulness and motility pain of the left eye. The patient was hospitalised from 19-Dec-2011 to 24-Dec-2011. Ophthalmologic check up revealed papilledema and she was diagnosed with retrobulbar neuritis. Cranial MRI revealed typical demyelinating changes leading to suspicion of multiple sclerosis. Prednisolone therapy was initiated and the patient''s condition improved "subjectively". However a visual improvement was not evident at the time of discharge. On 12-Apr-2012, the patient presented for a follow-up examination. The patient had no new complaints. Visual loss of the left eye had resolved quite completely. On 22-Mar-2012, cranial MRI revealed single right frontoparietal demyelinations which were regressive compared with the previous imaging. Spinal MRI showed one demyelinating lesion in the region of cervical vertebra 3. Diagnosis was "suspicion of multiple sclerosis in stage of clinical isolated syndrome (CIS). Microbiologic findings (Borrelia IgG and IgM in serum negative) as well as vasculitis screening: ANA 1:160, ENA, c-ANCA, p-ANCA and SSA/RO antibodies were negative and showed no signs of a systemic disease. At the time of reporting, the patient had not recovered. The company added the following AE which was mentioned in the hospital report but not coded by HA: retrobulbar neuritis.


VAERS ID: 526220 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-20
Onset:2013-11-20
   Days after vaccination:0
Submitted: 2014-03-20
   Days after onset:119
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000893 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fall, Jaw fracture, Syncope, Tooth injury
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, No adverse event
Diagnostic Lab Data:
CDC Split Type: WAES1403SWE009018

Write-up: Information has been received from Health Authority (MPA-2014-001765) via SPMSD (manufacturer control # E2014-02362) on 19-MAR-2014. Case was received from a health professional via the Health Authority on 14-Mar-2014 under the reference MPA-2014-001765. Case is medically confirmed. Primary source was a nurse. A 13-year-old female patient (weight, height not reported) with no medical history reported received the second dose of GARDASIL, (batch no. J000893, lot number J000893, expiration date 30-JUN-2015) via intramuscular route into not reported site of administration on 20-Nov-2013. On the same day, the patient fainted. The patient had to sit down for 5 minutes after vaccination before she could stand up. The patient was not very nervous since dose 1 had been tolerated well. When the girl was on her way out of the room she fell helplessly flat out into the door frame. She fell so badly that she had a fracture in upper jaw and her front teeth were seriously injured. The ambulance was called and she went to the hospital. At the time of reporting, the outcome was unknown. According to the HA, the event of fainted was possibly related to the vaccination. Previous dose of GARDASIL (D1, batch no. not reported) given via not reported route and site of administration on an unspecified date was well tolerated. Noteworthy: Upon medical review the company judged relevant to code the following adverse events: fall, upper jaw fracture and teeth injury which were mentioned in the narrative but not coded by the HA.


VAERS ID: 526289 (history)  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-20
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adenocarcinoma of the cervix, Laboratory test
SMQs:, Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic labortatory test (??-???-2014): Adenocarcinoma in situ was diagnosed
CDC Split Type: WAES1403ZAF008481

Write-up: This spontaneous report as received from a physician via a company representative refers to a 24 year old female patient. No medical history or concurrent conditions were provided. At the age of 20 years (approximately in 2010, also reported as 6 years ago), the patient received all three vaccinations of GARDASIL (dose, route and lot number not provided). No co-suspect or concomitant therapies were reported. In 2014 (date not specified), the patient was diagnosed with adenocarcinoma in situ (diagnostic laboratory test unspecified), confirmed as cervical adenocarcinoma. At the time of the report, the outcome of the event was unknown. The reporting physician did not do the vaccine or prescribe the medication. It was reported that Human papillomavirus (HPV) strand was not tested, and that the patient was referred to an oncologist for further testing. At the time of the report, the patient was on no other medication except contraceptive pills (not specified). It was also reported that the registration of GARDASIL in the country was on 08-FEB-2008. The physician did not report the relationship between the cervical adenocarcinoma and GARDASIL, but stated that the patient said the event was related to GARDASIL. The reporting physician wanted more information on GARDASIL and cervical adenocarcinoma. Upon internal review, cervical adenocarcinoma was considered as medically significant. Additional information has been requested.


VAERS ID: 526292 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-03-13
Submitted: 2014-03-20
   Days after onset:7
Entered: 2014-03-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Myelitis, Nuclear magnetic resonance imaging normal, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging, Normal
CDC Split Type: WAES1403FRA009120

Write-up: Case received from a physician on 13-Mar-2014: Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # FR-1577272925-E2014-02342) on 18-MAR-2014. A 14-year-old female patient had received the first or second dose of GARDASIL (batch number not reported) in March 2014. On 13-Mar-2014, ie 4 days post vaccination, the patient went to the Emergency Unit Care as she presented with left lower limbs tremor and left lower limb weakness. She was given TRANXENE as corrective treatment. The tremor regressed but not the lower limb extensions. Diagnosis of Guillain-Barre syndrome was ruled out, but myelitis was suspected. MRI was performed and was normal. At the time of reporting, the patient had not recovered.


VAERS ID: 526351 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-19
Onset:2013-12-26
   Days after vaccination:37
Submitted: 2014-03-21
   Days after onset:84
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Blood test abnormal, Cognitive disorder, Convulsion, Extrapyramidal disorder, Immunodeficiency, Mechanical ventilation, Paraplegia, Pneumonia, Pyrexia, Stomatitis, Tracheostomy, Transfusion, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature (26-DEC-2013): increased, fever. Blood test (07-JAN-2014): anemia.
CDC Split Type: WAES1403COL009549

Write-up: This spontaneous report as received from a physician refers to a 14 years old female patient. On 05-JUL-2013 the patient was vaccinated with the first unspecified dose of GARDASIL (route, lot number and expiration date not reported). On 19-NOV-2013 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot number and expiration date not reported). On 26-DEC-2013 the patient experienced vomit and fever. On 07-JAN-2014 the patient was hospitalized since she experienced a convulsive syndrome (onset date reported: 07-JAN-2014) that was treated with levetiracetam (dose unknown), extrapyramidal syndrome (onset date reported: 07-JAN-2014) with cognitive impairment that is actually resolving, gingivostomatitis (onset date reported: 07-JAN-2014) and pneumonia (onset date reported: 07-JAN-2014) already treated. The physician reported that at the time of this report the patient was immunosuppressed due to the steroid therapy (unspecified) (onset date approximately in 2014). The patient underwent 3 cycles and had been 27 days under mechanical ventilation treatment (in approximately 2014) and a tracheostomy procedure (in approximately 2014), and was paraplegic at the time of the report (reported as "currently") (onset date reported: 07-JAN-2014). The patient experienced anemia (onset date reported: 07-JAN-2014, also reported as on an unknown date) and was transfused (in approximately 2014) with unknown number of blood units. The outcomes of convulsion, tracheostomy, gingivostomatitis, pneumonia, transfusion, paraplegia, anaemia, mechanical ventilation, immunosuppressant drug therapy, fever and vomiting were unknown. At the time of this report the patient was recovering from the event of extrapyramidal syndrome with cognitive impairment. The relatedness between the events and GARDASIL was not reported. Upon internal review convulsive syndrome and tracheostomy procedure were considered to be medically significant. Additional information has been requested.


VAERS ID: 526527 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-13
Onset:2014-03-13
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:8
Entered: 2014-03-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Hyperaemia, Skin lesion
SMQs:, Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403BRA009227

Write-up: This spontaneous report as received from a other health professional who is nurse (considered as Health Care Provider) regarding to a 13 year old female patient with CATAFLAM and CELESTAMINE. On 13-MAR-2014 the patient was vaccinated during National HPV vaccination campaign with GARDASIL (lot # J012279) dose 1, intramuscular. On 13-MAR-2014, 20 min after onset of therapy the patient experienced hyperaemia (face) (medically significant) and lesion on face (unspecified). According to the reporter, the patient was admitted to Hospital, where she remained under observation and where was administered 500 mg FLEBOCORTID (intravenous injection, without saline solution) as treatment. The patient was discharged from hospital at 3:30 PM in good conditions. The outcome of hyperaemia (face) and lesion on face (unspecified) was reported as recovered/resolved. The relatedness for hyperaemia (face) and lesion on face (unspecified) is unknown for GARDASIL. Reference# IBFV2014-0027. Lot verification process was started. Additional information is not expected.


VAERS ID: 526590 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-19
Onset:2013-12-02
   Days after vaccination:13
Submitted: 2014-03-25
   Days after onset:112
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase increased, Anti-actin antibody positive, Antineutrophil cytoplasmic antibody positive, Aspartate aminotransferase increased, Asthenia, Autoimmune hepatitis, Bilirubin conjugated increased, Biopsy liver abnormal, Blood bilirubin increased, Blood thyroid stimulating hormone normal, Cytomegalovirus test negative, Epstein-Barr virus antibody positive, Gamma-glutamyltransferase increased, Gene mutation identification test positive, Haemoglobin normal, Hepatic necrosis, Hepatitis B test negative, Hepatitis C test negative, Hepatitis viral test negative, Herpes simplex serology negative, Jaundice, Mean cell volume normal, Platelet count normal, Prothrombin time shortened, Smooth muscle antibody positive, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Vasculitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DOXY
Current Illness: Immunisation; Acne
Preexisting Conditions: 03/2013, 09/01/2013, DOXY, Acne; 07/16/2013, GARDASIL; 05/14/2013, GARDASIL
Diagnostic Lab Data: Activated partial thromboplastin time, Normal; 12/03/2013, Alanine aminotransferase, 920 IU/l; 12/06/2013, Alanine aminotransferase, 904; 12/09/2013, Alanine aminotransferase, 975; 12/12/2013, Alanine aminotransferase, 959; 01/02/2014, Alanine aminotransferase, 365; 01/20/2014, Alanine aminotransferase, 119; 02/03/2014, Alanine aminotransferase, 71; 02/17/2014, Alanine aminotransferase, 70; Anti-actin antibody, Positive; Antineutrophil cytoplasmic antibody, Positive; Antineutrophil cytoplasmic antibody, Negative; 12/03/2013, Aspartate aminotransferase, 745 IU/l; 12/06/2013, Aspartate aminotransferase, 835; 12/09/2013, Aspartate aminotransferase, 837; 12/12/2013, Aspartate aminotransferase, 925; 01/02/2014, Aspartate aminotransferase, 107; 0
CDC Split Type: WAES1403FRA011179

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-02428) on 21-MAR-2014. Case received from the Health Authorities on 17-Mar-2014 under the reference number CF20140104. A 15-year-old female patient had received intramuscularly the three doses of GARDASIL (batch number unknown) on 14-May-2013, 16-Jul-2013, and 19-Nov-2013. She had no relevant medical history, no allergic diathesis, and was not taking any contraceptive pill. She was treated with DOXY 50 per os for acne since March 2013 up to 01-Sep-2013 with a stop during the summer. On 01-Sep-2013, treatment was increased to DOXY 100. On 02-Dec-2013, the patient saw her general practitioner due to asthenia. Subicterus was noticed. On 03-Dec-2013, a biological work-up put forward a major cytolysis (ASAT 745 IU/L, ALAT 920), high Gamma GT at 169, total bilirubin at 83.8 and conjugated bilirubin at 71.8, i.e. higher than normal range. The work-up was subsequently completed and was very much suggestive of a type 1 autoimmune hepatitis: ANCA positive, smoother muscle antibodies positive, anti-actin antibodies positive, myeloperoxidase antibodies positive and proteinase-3 antibodies negative. The following virus serology tests revealed negative: HAV, HBV, HCV, HEV, CMV, HSV 1+2 (IgM) and toxoplasmosis. Epstein-Barr virus test was compatible with a former serology, and TSH was normal. DOXY 100 was immediately stopped within the week, i.e. on 09-Dec-2013. On 06-Dec-2013: ASAT 835, ALAT 904 and GGT 149. On 09-Dec-2013: ASAT 837, ALAT 975 and GGT 128. On 12-Dec-2013: ASAT 925, ALAT 959 and GGT 120. On 19-Dec-2013, the patient was hospitalized so as to perform a liver biopsy. Anatomopathological analysis of the liver biopsy evidenced significant lesions of portal hepatitis with extensive periportal necrosis, and numerous porto-portal bridges. Those morphological findings were fully compatible with type 1 autoimmune hepatitis. From an hematologic standpoint, haemoglobin was at 12.3 g/dl and mean corpuscular volume at 91 fl. White cell blood count and platelets were normal. Prothrombin time was at 76%, activated partial thromboplastin time and occlusion time were normal. On 20-Dec-2013, a treatment was initiated by CORTANCYL 60 mg oad and IMUREL 100 mg oad. The patient went to see a dietician to adapt her food. Treatment with calcium, vitamin D was added to the treatment with CORTANCYL and IMUREL, as well as a proton pump inhibitor. Gene mutation identification for thiopurin S methyltransferase found the presence of 2 mutations 3B and 3C in heterozygotes form associated to a reduction of the thiopurin S methyltransferase metabolic capacity for thiopurine drugs. Action to be taken for such cases was to reduce the dosage from 0.2 to 0.3 mg/kg/day. The patient''s rate of IMUREL was of 1.7 mg/kg/day instead of 2 mg/kg/day. Consequently the dosage of IMUREL 100 mg oad was maintained for the moment with close medical supervision of the blood count. On 02-Jan-2014, liver work-up had clearly improved: ASAT 107, ALAT 365 and GGT 144. The improvement subsequently carried on. ASAT became normal, ALAT and GGT got stable at 2N in the two last available work-ups. 20-Jan-2014: ASAT 39, ALAT 119 and GGT 99. 03-Feb-2014: ASAT 36, ALAT 71 and GGT 79. 17-Feb-2014: ASAT 32, ALAT 70 and GGT 74. The Health Authorities report concluded to a serious and life-threatening adverse event. Treatment by CORTANCYL and IMUREL was initiated. The evolution was favourable with a probable future decrease of the corticosteroids considering the evolution of transaminases. According to the Health Authorities, drug induced etiology, whether GARDASIL or DOXY, was doubtful. The Health Authorities specified that causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation. The Health Authorities assessed the causal relationship between the reported reactions and vaccination, an


VAERS ID: 526593 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-19
Onset:2013-11-19
   Days after vaccination:0
Submitted: 2014-03-25
   Days after onset:125
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007741 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Bacterial test negative, Headache, Malaise, Muscular weakness, Musculoskeletal stiffness, Osteomyelitis, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Bacterial test, Negative
CDC Split Type: waes1403SWE011194

Write-up: Information received from SANOFI PASTEUR MSD (manufacturer control number E2014-02497) on 21-MAR-2014. Case received from health care professional via company representative on 18-Mar-2014. Additional information received from health care professional on 19-Mar-2014 and from Health Authorities on 20-Mar-2014, under the reference SE-MPA-2014-002038. The primary reporter was a physician (pediatrician at Hospital and school physician). An 11-year old female patient, had received the second dose of GARDASIL (lot number H007741) via intramuscular route of administration in right arm on 19-Nov-2013 and later on in the evening, she developed neck stiffness, headache and was feeling unwell. Around the same time she started to experienced pain in back and in the left leg. On a non-specified date the patient also developed weakness in the leg. HA coded osteomyelitis, with onset 19-Nov-2013. The pain in the left leg aggravated more and more and the patient underwent different examinations (lab dates and results not specified). Finally a MRI was taken a month later (exact date not specified), which showed suspected osteomyelitis in the left thigh/hip. Cultivation from this site has not produced any bacteria. According to the physician, the patient was hospitalised in December 2013 when the MRI was taken (not further specified). Since the symptoms started in temporal correlation with vaccination and the patient''s family have not received any clarity in what might have caused the osteomyelitis, and bacteria culture was negative, they are wondering whether it might be GARDASIL that have caused this. The physician did not consider that the suspected osteomyelitis was related to vaccination. However, as the throughout of correlation between vaccination and adverse event still remained in the family, the physician tried to investigate it further. The patient was previously healthy. She received her first dose of GARDASIL (lot number H001930) via not reported route of administration in not reported site of administration on 01-Oct-2013. At the time of reporting, the patient was feeling better. She was not fully recovered as she had remaining weakness in the leg. The outcome for all other events was not specified. HA coded the outcome for osteomyelitis as not recovered.


VAERS ID: 526595 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-25
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403FRA011387

Write-up: This spontaneous report was received from a physician via medical representative. The physician stated that she read a newspaper article concerning a female child who was vaccinated (date unknown) with GARDASIL (dose, frequency, Lot# and indication not reported). On an unknown date, the patient experienced multiple sclerosis. The outcome of multiple sclerosis was not reported. Relatedness between multiple sclerosis and GARDASIL was not reported. Upon internal review the event of multiple sclerosis was considered as medically significant. Additional information has been requested.


VAERS ID: 526689 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-25
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Orthostatic hypotension
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403SWE011186

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-02490) on 21-MAR-2014. Case was received from a health professional via the Health Authorities on 19-Mar-2014 under the reference MPA-2014-001995. Case is medically confirmed. Primary source was a physician. A female patient (gender, weight, height not reported) with no medical history reported received a dose of GARDASIL (batch/lot no. H022294, expiry date 30-JUN-2015) via not reported route and site of administration on an unspecified date. On an unspecified date, the patient developed orthostatic hypotension. At the time of reporting, the patient had not recovered.


VAERS ID: 526713 (history)  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-10
Onset:2014-03-10
   Days after vaccination:0
Submitted: 2014-03-26
   Days after onset:16
Entered: 2014-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Multiple allergies, Pharyngeal inflammation, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cough, cold, and flu therapies (unspecified)
Current Illness: Immunisation; Multiple allergies
Preexisting Conditions: 12/19/2013, GARDASIL, No adverse event
Diagnostic Lab Data:
CDC Split Type: WAES1403DEU011206

Write-up: Information received from Sanofi Pasteur MSD (manufacturer control # E2014-02435) on 21-MAR-2014. Case was received from a physician on 18-Mar-2014. Case is medically confirmed. An 18-year-old female patient with a medical history of multiple allergies under treatment with antihistamines (not otherwise specified) received a second dose of GARDASIL (lot-no. not reported) on 10-Mar-2014. On the same day in the evening she developed an allergic reaction with hives, itching and swelling of pharynx. The patient was treated intravenously with cortisone and recovered within an unspecified time. Allergic testing was planned. It was underlined by the reporter that on the same day of vaccination the patient had also eaten nut cake. First dose of GARDASIL was given on 19-Dec-2013 and was well tolerated.


VAERS ID: 526815 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-11
Onset:2014-03-11
   Days after vaccination:0
Submitted: 2014-03-26
   Days after onset:15
Entered: 2014-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012779 / 0 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Dyspnoea, Malaise, Psychosomatic disease, Speech disorder, Tongue disorder
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Depression
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403BRA009201

Write-up: This spontaneous report as received from a Nurse, who applied the vaccine during national HPV vaccination campaign refers to a 13 year old female patient who presents depression. On 11-MAR-2014, at the end of afternoon, the patient was vaccinated with GARDASIL lot # J012779 dose 1, intramuscular. On 11-MAR-2014, approximately 4 hours after onset of therapy the patient experienced "wrapping tongue" - speech difficulty (hospitalization), breathlessness (hospitalization) and malaise. On 11-MAR-2014 the patient was hospitalized. She stayed in the hospital overnight and was discharged on 12-MAR-2014 recovered from the events. On 13-MAR-2014 the patient sought for medical care again. The physician who accompanied the patient in both occasions, after an evaluation, concluded that the patient was presenting psychosomatic symptoms, once she was simulating breathlessness and speech difficulty. According to the reporter, this was not the first time the patient experienced familiar and school issues. The patient was forwarded to psychological counseling and the physician did not relate the events to GARDASIL. The outcome of wrapping tongue - speech difficulty, malaise and breathlessness was reported as recovered/resolved. The reporter considered wrapping tongue - speech difficulty, breathlessness and malaise to be not related to GARDASIL. Reference # IBVV2014-0033. Additional information is not expected.


VAERS ID: 526839 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2014-03-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2014-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Flushing, Immediate post-injection reaction, Malaise, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403GBR012460

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-02692) on 26-MAR-2014. This case was received from a consumer on 21-Mar-2014. This case is not medically confirmed as it was reported by a consumer. A female patient received on 11-Mar-2014 the second dose of GARDASIL (batch number not reported) route and site of administration not reported, five days later, she had immediate onset of pain on the lower left stomach with breathlessness, so much that she could not call out for help. She was attended by the ambulance and taken to accident and emergency and given a type of morphine. She had a urine test and that was clear. Blood tests were performed and results were pending. It started at about 10:00 a.m. and then they were at home by 2.00 p.m. On unreported dates after vaccination, she has subsequently had dizziness and feeling sick this week and she was feeling flushed and has slight blurred vision from time to time. She had a bit of sore arm and so she received CALPOL when she got home and then the problems began five days later. She was tested for anaemia and coeliacs disease and they were awaiting for the results. Her mother did not want her to have the vaccine, but she choose to have after reading the information about it. They were looking for all of the options and other things as an undercooked take away but the she didn''t eat much of that. She also had a burn on her arm but her mother don''t think that was related. The patient had received on 11-Dec-2013, the first dose of GARDASIL (batch number not reported) route and site of administration not reported and no adverse events were reported. At the time of reporting, the outcome was not reported for all adverse events. Upon internal review, this case was considered serious due to be medically significant.


VAERS ID: 526840 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-12
Onset:2014-03-13
   Days after vaccination:1
Submitted: 2014-03-27
   Days after onset:14
Entered: 2014-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007240 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Lip swelling, Paraesthesia, Respiratory distress, Swelling face, Swollen tongue, Tryptase, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Tryptase, awaiting mast cell tryptase result N/A
CDC Split Type: WAES1403GBR012532

Write-up: Information has been received from Sanofi Pasteur (MSD) with manufacturer number of E2014-02701 received on 26-MAR-2014. This case was received from the health authority on 21-Mar-2014. GB-MHRA ADR 22463943. This case is medically confirmed as it was reported by a physician. A 13 years old female patient (weight: 66.4 kg), with no medical history reported, received at school, on 12-Mar-2014 in the morning, an injection of GARDASIL (batch number J007240, expiry: 28-FEB-2016) intramuscularly, dose in series and site of administration not reported, and on 13-Mar-2014 she presented swelling of tongue, lips and face, tingling to arms and legs, wheezing episode and respiratory distress. She was admitted to accident and emergency department where she received intramuscular adrenaline, intravenous hydrocortisone and intravenous chlorphenamine. The reporter was unsure of the cause and this was possible true anaphylaxis. On 13-Mar-2014, the patient had fully recovered. The MHRA considered that case serious due to hospitalisation.


VAERS ID: 526931 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-26
Entered: 2014-03-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403RUS011092

Write-up: This spontaneous report as received from a physician via a company representative from social media refers to a several patients of unknown age and gender. On an unknown date, the several patients were vaccinated with GARDASIL (strength, dose, frequency, route, lot number and expiry date unknown). On an unknown date several patients died following vaccination (death). The outcome of several cases of death following vaccination was reported as fatal. Follow up information was received on 24-MAR-2014. According to the physician she saw the television six months ago, and there was a report on one female patient who died after receiving GARDASIL vaccine. In addition, she read in the Internet all kinds of articles around the "noise on GARDASIL" but did not remember exactly what. Additional information is not expected.


VAERS ID: 526933 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-28
Entered: 2014-03-28
Vaccin­ation / Manu­facturer Lot / Dose