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VAERS ID: 503457 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-15
Onset:0000-00-00
Submitted: 2013-09-20
Entered: 2013-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Migraine without aura; GARDASIL, Immunisation; 11/14/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: On 07-AUG-2013, Scan fetal heart had stopped.
CDC Split Type: WAES1309DNK008969

Write-up: Case of pregnancy follow up was received from a consumer or other non health care professional via the Health Authorities on 12-Sep-2013 under the references DK-DKMA-ADR 22234962 and DK-DKMA-EFO6778. Case is not medically confirmed. A 28-year-old female patient (weight 72 kg, height 170 cm) with a medical history of migraine without aura, had received a complete vaccination series with three doses of GARDASIL on 14-Nov-2012 (D1, lot-no. not reported), on an unspecified date (D2, lot-no. not reported) and on 15-May-2013 (D3, lot-no. not reported). On 07-Aug-2013, a scan showed that the fetal heart had stopped. The patient was hospitalised. Subsequently a curettage was performed. The patient received no further treatment for the event. Other medications were given (not specified). At the time of reporting, the patient had not recovered.


VAERS ID: 503476 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-28
Onset:2013-08-31
   Days after vaccination:3
Submitted: 2013-09-23
   Days after onset:23
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Injection site pain, Injection site reaction, Muscle swelling, Ultrasound scan normal
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Echocardiography (31-AUG-2013): Haematoma in the right deltoid muscle was denied (not detected); 08/28/2013, Body temperature, 36.5 degrees C
CDC Split Type: WAES1309JPN003463

Write-up: This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. On 28-JUN-2013 and 28-AUG-2013 the patient was vaccinated with quadrivalent human papillomavirus recomb. vaccine (manufacturer unknown) (lot #, expiration date and anatomical location unspecified) intramuscular. On 31-AUG-2013, the patient experienced injection site pain, muscle swelling and skin red. The outcome of muscle swelling, injection site pain and skin red was unknown. The reporter considered injection site pain, muscle swelling and skin red to be related to Quadrivalent Human Papillomavirus Recomb. Vaccine (manufacturer unknown). Initial and follow-up information have been received from a physician via the agency concerning a 12-year-old female patient. In the pre-vaccination interview form about underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, ADR history and status of growth, the patient had no problem. She had no family history. Her body temperature before vaccination was 36.5 C. On 28-AUG-2013, the patient received the second vaccination of GARDASIL IM injection drug 0.5 ml in the right deltoid muscle. No concomitant medication was reported. On 28-JUN-2013, the patient received the first vaccination of GARDASIL injection drug. No adverse reaction appeared. On 28-AUG-2013, as mentioned before, the patient received the second vaccination of GARDASIL injection drug (lot number: 9QN09R) in the right deltoid muscle. On 31-AUG-2013, the patient went to a hospital on foot on her own and complained of the injection site pain. And, the muscle swelling in the injection sight which was a hen''s egg-sized in the right deltoid muscle observed. Also, the skin red was observed too. Haematoma in the right deltoid muscle was denied (not detected) on echography. At the time of this report, the patient had no recovered from the muscle swelling in the injection sight and the injection site pain, but the outcome of the skin red was unknown. Reporting physician''s comment: None. The reporting physician assessed that the muscle swelling in the injection sight and injection site pain are related to GARDASIL, and did not assess the relationship between the skin red and the vaccine. The physician did not consider that there was other possible cause of the events. The physician assessed the muscle swelling in the injection sight and injection site pain as serious (other important medical events) and did not assess the seriousness of the skin red. Additional information has been requested.


VAERS ID: 503489 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-12-07
Onset:2010-01-01
   Days after vaccination:25
Submitted: 2013-09-23
   Days after onset:1360
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Fatigue, Hypoaesthesia, Lumbar puncture abnormal, Myelitis, Nuclear magnetic resonance imaging abnormal, Restlessness, Sensory disturbance, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
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, Immunisation; GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Lumbar puncture, not provided; Nuclear magnetic resonance imaging, myelitis
CDC Split Type: WAES1309DNK007724

Write-up: Case received from a health care professional via the Health Authorities on 12-Sep-2013 the references DK-DKMA-ADR 2223706 and DK-DKMA-EFO6812. Case is medically confirmed. A 16-year-old female patient (weight 80 kg, height 172 cm) had received a complete vaccination series with three doses of GARDASIL IM on 26-Nov-2008 (D1, lot-no. not reported), on 15-Feb-2009 (D2, lot.no. not reported) and on 07-Dec-2009 (D3, lot-no. not reported). On an unspecified date in Dec-2009, the patient developed expressed tiredness, concentration difficulty, problems with sensation in the legs and numbness from the navel down starting in the left leg and unrest. On 23-Dec-2009, the patient was hospitalised due to fainting and effects on vision. The cause of the events was not found. In January 2010, the patient was referred to a neurologist. MRI and lumbar puncture were performed. MRI revealed myelitis. At the time of reporting, the patient had not recovered from myelitis. The patient had recovered from fainting and effects on vision in an unspecified timeframe. The outcome of all other events was unknown.


VAERS ID: 503490 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-29
Onset:2013-03-10
   Days after vaccination:101
Submitted: 2013-09-23
   Days after onset:196
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Atrioventricular block complete, Blood pressure decreased, Bundle branch block right, Electrocardiogram abnormal, Eyelid oedema, Eyelid ptosis, Fatigue, Headache, Heart rate decreased, Hepatic enzyme increased, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EUTHYROX
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ECG: AV block 3rd degree, RBBB (right bundle branch block); 06/2013, Blood pressure, low; 06/2013, Electrocardiogram, AV block 3rd degree, Right bundle branch block, Abnormal; 06/2013, Heart rate, low; 06/2013, Liver function test, increased
CDC Split Type: WAES1309CZE007728

Write-up: Eyelid ptosis and oedema started on 10Mar2013 and persisted until the start of corticoids therapy, symptoms disappeared in June 2013. 30May2013 14 days lasting moderate fatigue, headache, increased levels of liver enzymes, blood pressure decreased, slow pulse. AV block 3rd degree with RBBB found. Child was sent to the hospital, corticosteroid therapy administered during hospitalization. OTHER INFO: AV block 3rd degree, RBBB (right bundle branch block). SUMMARY: 10th March, 2013 ptosis and eyelid oedema appeared, it disappeared after administration of steroids in June 2013. 30th May, 2013 About 14 days felt patient tired and had headaches. Increased liver tests, low blood pressure, low pulse rate, ptosis. ECG revealed AV block 3rd degree + RBBB. Patient was received to the hospital for medical examination and further hospitalisation with steroid treatment.


VAERS ID: 503495 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-23
Onset:0000-00-00
Submitted: 2013-09-23
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Back pain, Dysmenorrhoea, Fatigue, Headache, Insomnia, Mood swings, Nausea, Neck pain, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation; GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK007720

Write-up: Case of misuse (drug dose administration interval too long) received from a health care professional via the Health Authorities on 11-Sep-2013 under the references DK-DKMA-ADR 22231077 and DK-DKMA-EFO6735. Case is medically confirmed. A female patient (weight 60 kg, height 165 cm), had received a complete vaccination series with three doses of GARDASIL IM on 24-Mar-2010 (D1, batch no not reported), on 15-Jun-2011 (D2, batch no. not reported) and on 23-Aug-2012 (D3, batch no. not reported). On an unspecified date, the patient developed headache, nausea, sleeplessness, tremor, mood swings, chronic pain in joints, neck and back, abdominal pain, increased menstrual pain and tiredness. It was unknown if laboratory tests were performed. The patient had 6 days of absence during the academic year 2011/2012 and 40 days of absence during the academic year 2012/2013. At the time of reporting, the patient had not recovered. Drug administration interval too long between D1 and D2 and between D2 and D3.


VAERS ID: 503497 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-14
Onset:0000-00-00
Submitted: 2013-09-23
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J004851 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Joint swelling, Joint warmth
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Psoriatic arthropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK008314

Write-up: Case received from a health care professional (physician) via the Health Authorities on 11-Sep-2013 under the reference DK-DKMA-ADR 22233639 and DK-DKMA-EFO6765. Case is medically confirmed. A 26-year-old female patient with a medical history of psoriatic arthritis, had received the third dose of GARDASIL IM on 14-Aug-2013. D1 of GARDASIL (batch and lot no. J000160) IM given on 13-Mar-2013. On 14-Mar-2013, the patient developed pain in the joints (mostly small joints of hands, feet and back). The patient''s movement was restricted and she could not lift heavy things. On an unspecified date, the patient also developed swelling of joints in the fingers and increased heat of joints in the fingers. D2 of GARDASIL (batch and lot no. J000160) given on an unspecified date. After D2 the patient still experienced the same symptoms. The patient indicated that the symptoms occurred after D1 and have deteriorated after D2 and D3. No examination or laboratory tests were performed. At the time of reporting, the patient had not recovered.


VAERS ID: 503499 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-13
Onset:2009-08-28
   Days after vaccination:15
Submitted: 2013-09-23
   Days after onset:1487
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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: 03/26/2009, GARDASIL, Immunisation; 01/22/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Tilt table test, Reflex syncope and POTS
CDC Split Type: WAES1309DNK009116

Write-up: Case received from a health care professional via the Health Authorities on 11-Sep-2013 under the references DK-DKMA-ADR 22231340 and DK-DKMA-EFO6751. Case is medically confirmed. A 12-year-old female patient (weight 61 kg, height 168 cm) had received a complete vaccination series with three doses of GARDASIL IM on 22-Jan-2009 (D1, batch number not reported), on 26-Mar-2009 (D2, batch number not reported) and on 13-Aug-2009 (D3, batch number not reported). On 28-Aug-2009, the patient developed postural orthostatic tachycardia syndrome. On 29-Aug-2009, the patient also developed syncope vasovagal. Syncope occurred several times a month and several times with noticeable long lasting loss of consciousness up to 17 minutes. The patient was hospitalised. Tilt table test was performed at syncope center and clinical physiological department. Results revealed reflex-syncope of mixed type and POTS. The patient was treated with FLORINEF leading to improvement. At the time of reporting, the patient was recovering.


VAERS ID: 503723 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-08-22
Onset:2012-03-30
   Days after vaccination:221
Submitted: 2013-09-24
   Days after onset:543
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G004958 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Dysaesthesia, Fatigue, Presyncope, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 04/18/2011, GARDASIL, immunisation; 02/08/2011, GARDASIL, immunisation
Allergies:
Diagnostic Lab Data: Investigation, Unspecified
CDC Split Type: WAES1309DNK010874

Write-up: Case received from health care professional via the Health Authorities on 16-Sep-2013 under the reference number 22242715 and EFO6858. Case medically confirmed. A 13 year old female patient (weight 55 kg and 175 cm) had received an injection of GARDASIL (dose 3, batch number G004958, site not reported, intramuscular route) on 22-Aug-2011 and concomitant PRIORIX (other MFR, dose in series not reported, batch number not reported, site and route not reported) on 08-Feb-2011 later on , 30-Mar-2012, she developed lipothymia, convulsions, severe tiredness, dysesthesia and tachycardia. Patient had previously two GARDASIL vaccinations. First dose (batch number not reported, intramuscular route, site of administration not reported) on 08-Feb-2011. Second dose (batch number NN02290, intramuscular route, site of administration not reported) on 18-Apr-2011. Investigation (unspecified tests and procedures) was carried out during hospitalization (dates not specified) at hospital. At the time of reporting, the outcome was not recovered.


VAERS ID: 503739 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-05
Onset:0000-00-00
Submitted: 2013-09-23
Entered: 2013-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Blindness, Blood test normal, CSF culture negative, Headache, Migraine with aura, Nuclear magnetic resonance imaging normal
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Migraine
Preexisting Conditions: GARDASIL, Hemiparesis; GARDASIL, Immunisation, Sensory disturbance; 09/05/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: CSF Culture: Normal; MRI: Normal; Blood test: Normal; Blood pressure: Normal
CDC Split Type: WAES1309DNK008321

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 12-Sep-2013 under the references DK-DKMA-ADR 22234963 and DK-DKMA-EFO6779. Case is not medically confirmed. This case is linked with case E2013-07052 (same patient, different reactions after D2). A 24-year-old female patient (weight 104 kg, height 169 cm) with a medical history of migraine, had received the third dose of GARDASIL, (batch number not reported) IM on 05-Mar-2013. On an unspecified date in Mar-2013, the patient developed severe constant headache, numerous and severe migraine attacks with aura and migraine with aura. The patient took several different medications, but nothing helped. Sometimes the patient could not see, walk and more. The patient was hospitalised. CSF samples, MRI, blood tests and blood pressure (measured 24 hours) were all normal. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 05-Sep-2012 (batch no. not reported) and D2 (batch no. not reported) on an unspecified date. After second vaccination, on an unspecified date, the patient developed sensory disturbances and reduced strength in the left side.


VAERS ID: 503781 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-24
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309FRA010903

Write-up: Case received from a physician on 13-Sep-2013. A female patient had received GARDASIL (batch number not reported) five years earlier and within an unspecified timeframe, she developed optic neuritis and subsequently a flare-up of multiple sclerosis. The outcome was not reported. Upon medical review the company upgraded the case to serious due to ''other medically important condition''.


VAERS ID: 503837 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-24
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Petechiae, Thrombocytopenia, Viral upper respiratory tract infection
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN010352

Write-up: Health Authority report: This spontaneous report as received from a physician refers to a 27 year old male patient. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. On an unknown date the patient experienced petechiae (hospitalization), viral upper respiratory tract infection (hospitalization) and thrombocytopenia (hospitalization). The outcome of these events is unknown. It is unknown if the events were related to therapy with GARDASIL. Additional information is not expected.


VAERS ID: 503951 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-20
Onset:2012-12-14
   Days after vaccination:24
Submitted: 2013-09-24
   Days after onset:283
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G020676 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram head normal, Feeling abnormal, Headache, Phonophobia, Photophobia, Vertigo
SMQs:, Dementia (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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: Irritable bowel syndrome; Syncope
Allergies:
Diagnostic Lab Data: Blood tests and CT scan of head were normal.
CDC Split Type: WAES1309DNK010699

Write-up: Case received from health care professional via the Health Authorities in a foreign country on 12-Sep-2013 under the references DK-DKMA-ADR 22236361 and DK-DKMA-EFO6803. Case is medically confirmed. A 27-year-old female patient with a medical history of previous lipothymia and irritable bowel syndrome, had received the second dose of GARDASIL (batch no. G020676) IM on 20-Nov-2012. On 14-Dec-2012, the patient developed vertigo, cephalgia, photophobia, phonophobia and feeling strange (being next to herself). The patient was hospitalised on 04-Apr-2013 due to sudden worsening heavy headache. No cause was found by a neurologist. Blood tests and CT scan of head were normal. No other vaccines or medications were given. At the time of reporting, the patient was recovering. The patient received D1 of GARDASIL (lot-no. G020676) on 17-Sep-2012 and D3 on 24-Apr-2013. Toleration was not reported.


VAERS ID: 503953 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-08
Onset:0000-00-00
Submitted: 2013-09-24
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN43360 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Back pain, Blood count, Blood glucose, Constipation, Feeling hot, Laboratory test, Liver function test, Metabolic function test, Night sweats, Renal function test, Spinal pain, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Confusional state, Fatigue, Memory impairment, Insomnia, Dizziness, Headache~HPV (Gardasil)~1~0.00~Patient|Vaginal haemorrhage,
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory tests included liquid counts, metabolic and infectious parameters, blood sugar, kidney counts, liver function tests and blood count. Results were not provided.
CDC Split Type: WAES1309DNK010697

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 11-Sep-2013 under the references DK-DKMA-ADR 22233844 and DK-DKMA-EFO6772. Case is medically confirmed. This case is linked to cases E2013-07101 and E2013-07102 (same patient, different events after previous doses). A 28-year-old female patient (weight 70 kg, height 176 cm), had received a complete vaccination series with three doses of GARDASIL IM on 24-Apr-2012 (D1, batch-no. G009615, lot-no. NN43360, exp 01-DEC-2013), on 04-Jul-2012 (D2, batch-no. G009615, lot-no. NN43360, exp 01-DEC-2013) and on 08-Mar-2013 (D3, batch-no. G009615, lot-no. NN43360, exp 01-DEC-2013). On 25-Apr-2012, the patient developed pain in chest, shoulders, arms and legs and vaginal bleeding. On an unspecified date in Jul-2012, the patient developed diffuse headache, dizziness, violently nauseous, sleep difficulty, major problems with the short term memory, severe tiredness and was confused. On an unspecified date in Mar-2013, the patient developed severe pain in lumbar, severe back pain, severe lower abdominal pain, felt febrile, periodic blurred vision, periodic abdominal pain, feeling of constipation, severe night sweats and worsening of pain during nights. Laboratory tests included liquid counts, metabolic and infectious parameters, blood sugar, kidney counts, liver function tests and blood count. Results were not provided. At the time of reporting, the patient had not recovered.


VAERS ID: 503967 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-27
Onset:2010-11-01
   Days after vaccination:5
Submitted: 2013-09-25
   Days after onset:1059
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK10770 / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Bone pain, Groin pain, Laboratory test normal, Pain in extremity, Spinal pain
SMQs:, Dementia (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, The patient''s medical history includes a vaccination with GARDASIL (dose 1, batch number NL30750, intramuscular route, site not reported) on 25-Aug-2010.
Allergies:
Diagnostic Lab Data: Unspecified laboratory tests have been performed on the patient on non-specified dates in 2013 with normal results.
CDC Split Type: WAES1309DNK010706

Write-up: Case received from health care professional via the Health Authorities on 16-Sep-2013 under the reference number 22241897 and EFO6856. Case medically confirmed. A 12 year old female patient (weight 55 kg and height 166 cm) had received an injection of GARDASIL (dose 2, batch number NL48770, lot number NK10770, exp 31-JAN-2012, intramuscular route, site not reported) on 27-Oct-2010 and concomitant with PRIORIX (other mfr, dose in series and batch number not reported, site and route not reported) on 25-Aug-2010 and later on 01-Nov-2010 she developed pain in groins, pain in the entire spine, pain in feet, pain in knees and pain in tibias. She had stopped taken part in sports activities as a result. The patient has also received GARDASIL vaccination (dose 3, batch number NL53870, intramuscular route, site not reported) on 02-Mar-2011. Unspecified laboratory tests have been performed on the patient on non-specified dates in 2013 with normal results. The patient has no other medications. The patient''s medical history includes a vaccination with GARDASIL (dose 1, batch number NL30750, intramuscular route, site not reported) on 25-Aug-2010. At the time of reporting, the outcome was not recovered.


VAERS ID: 503968 (history)  
Form: Version 1.0  
Age: 37.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-17
Onset:2013-06-17
   Days after vaccination:61
Submitted: 2013-09-25
   Days after onset:100
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0542AE / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Incomplete course of vaccination, Nuclear magnetic resonance imaging brain normal, Trigeminal neuralgia
SMQs:, Demyelination (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Anxiety disorder
Allergies:
Diagnostic Lab Data: MR cerebrum was normal (performed on non-specified date).
CDC Split Type: WAES1309DNK010601

Write-up: Case received from health care professional via the Health Authorities on 16-Sep-2013 under the reference number 22242719 and EFO6861. Case medically confirmed. A 37 year old female patient had received an injection of GARDASIL, (dose 1, batch number HO19462, intramuscular route, site not reported) on 16-Feb-2013 and 5-6 weeks post vaccination she developed severe headache (HA coded onset 2013). She was hospitalized (acute, on unspecified date). There was no explanation for this reaction. MR cerebrum was normal (performed on non-specified date). She received GARDASIL (dose 2, batch number HO19462, intramuscular route, site of administration not reported) on 17-Apr-2013. Her condition developed to trigeminal neuralgia in left side of her face, that aggravated significantly after dose 2 (HA coded onset 17-Jun-2013). She is treated with gabapentin (other mfr) and now relatively without symptoms. Patient does not wish to receive the third dose GARDASIL. No other vaccines. No other medications. Patient medical history includes anxiety neurosis (health anxiety and OCD). No further information specified. At the time of reporting, the outcome was recovering.


VAERS ID: 504043 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-12-28
Onset:2012-03-01
   Days after vaccination:64
Submitted: 2013-09-25
   Days after onset:572
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test abnormal, Computerised tomogram, Crying, Discomfort, Dyspnoea, Electrocardiogram, Electromyogram, Facial paresis, Fall, Fatigue, Feeling abnormal, Movement disorder, Muscular weakness, Myasthenia gravis, Nuclear magnetic resonance imaging, Speech disorder, Syncope, Thymectomy, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/26/2011, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Unknown date: Blood test: Myasthenia; Unknown date: CT scan: not provided; Unknown date: MRI: not provided; Unknown date: ECG: not provided; Unknown date: EMG: not provided
CDC Split Type: WAES1309DNK010595

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 12-Sep-2013 under the references DK-DKMA-ADR 22237786 and DK-DKMA-EFO6815. Case is not medically confirmed. A 13-year-old female patient (weight 46 kg, height 165 cm) had received a dose of GARDASIL (batch no. not reported) via intramuscular route on 28-Dec-2011. On an unspecified, the patient began to faint. The patient said several times that she felt that her body was wrong. She woke up often and had difficulty breathing. She was very tired and cried often in spring 2012 after the vaccination because her body felt completely wrong. She said that she could not lie down and read because she was too weak in the arms to keep the book. She could not read for very long time because the text flowed. She began to smack when she ate, she bumped into things and had difficulty controlling movements, especially in the evening. Later in the year she presented to the doctor talking about her passing out more often. She felt uncomfortable. In January and February 2013, she began to fall when she walked, ran and biked. In March she could not smile anymore and her voice was so indistinct that others could not understand what she was saying. She began to drop food and water out of her mouth. The muscles were not longer working properly and she had difficulty seeing. She was so weak that she can not manage to bathe anymore. She was hospitalised first in May-2013 and diagnosed with myasthenia gravis through a blood test. Various blood tests were performed. In addition a CT scan, MRI, EMG, ECG and numerous neurological examinations as well as surgeries (removal of thymus) were done. Results were not further specified. At the time of reporting, the patient had not recovered from myasthenia gravis. The outcome of all other events were unknown. The patient received D1 of GARDASIL on 26-May-2011. Toleration was not reported. Noteworthy: Myasthenia gravis was diagnosed in May-2013, but Mar-2012 was reported as onset date by the HA.


VAERS ID: 504044 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-25
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Papilloma viral infection, Vulvar dysplasia
SMQs:, Reproductive premalignant disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 2010, Malignant melanoma; 2010, Endometriosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK008317

Write-up: Case received from consumer via the Health Authorities in a foreign country on 11-Sep-2013 under the reference numbers DK-DKMA-ADR 22233677 and DK-DKMA-EFO6767. Case not medically confirmed. This is considered as a study case as the patient was part of a study. A 31-year-old female patient (weight 75 kg and height 174 cm) had received an injection of GARDASIL (batch number not reported, number of doses not rep., site and route of administration not reported) on unspecified date in 2006. Later on in 2012 she developed severe vulva dysplasia. The patient has received the following treatment for the side effect: Operation x 2 (expect possibly a third). According to the report the patient was hospitalized (no details reported). The patient was 10 years ago in a trial where she received placebo. In the study she was tested along the way (blood, scraping mm.). In the trial, she got a placebo. Afterwards, the patient was vaccinated. None of the patient''s family has had genital cancer. The patient was HPV-infected when she received the vaccine. The patient had infertility endometriosis and melanoma in 2010. The patient was diagnosed with vulvar dysplasia. At the time of reporting, the outcome was not recovered.


VAERS ID: 504099 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-19
Onset:2012-09-19
   Days after vaccination:0
Submitted: 2013-09-25
   Days after onset:371
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN43360 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Blood glucose normal, Blood test normal, Blood thyroid stimulating hormone normal, Headache, Liver function test normal, Myalgia, Nausea, Renal function test normal, Rheumatoid factor negative, Scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Scans (unspecified) and blood samples (TSH, Rheumatoid test, infection values, blood glucose, liver and kidney values) were carried out, results normal, no cause of reactions was found. No results reported.
CDC Split Type: WAES1309DNK010898

Write-up: Case received from health care professional via the Health Authorities in a foreign country on 16-Sep-2013 under the reference number 22241136. Case medically confirmed. A 21 year old female patient (weight 64 kg and height 178 cm) had received an injection of GARDASIL (dose 1, batch number G009615, intramuscular route, site not reported) on 19-Sep-2012 and later on, the same day, she developed headache, abdominal pain, nausea, joint pain and muscle pain. Patient has experienced symptoms from multiple organ systems. Patient had no other medications. Scans (unspecified) and blood samples (SH, Rheumatoid test, infection values, blood glucose, liver and kidney values) were carried out, normal result, no cause of reaction was found. At the time of reporting, the outcome was not recovered.


VAERS ID: 504178 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-13
Onset:2011-01-01
   Days after vaccination:598
Submitted: 2013-09-25
   Days after onset:997
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Connective tissue disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 03/04/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK008362

Write-up: Case received from a health care professional via the Health Authorities on 12-Sep-2013 under the references DK-DKMA-ADR 22238048 and DK-DKMA-EFO6818. Case is medically confirmed. A 14-year-old female patient had received a dose of GARDASIL, (batch number NK05560, lot number 0773X, expiration date 16-JUN-2011) IM on 13-May-2009. On 01-Jan-2011, the patient developed connective tissue disorder. Investigations were performed, but not specified. No other vaccines were given. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 04-Mar-2009 (batch no. not reported). Toleration was not reported.


VAERS ID: 504198 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-26
Entered: 2013-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood cadmium increased, Blood heavy metal test, Blood lead increased, Borrelia test negative, Epstein-Barr virus test negative, Fatigue, Guillain-Barre syndrome, Hyporeflexia, Muscular weakness, Myalgia, Nerve conduction studies normal, Neurological examination abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood heavy metal test, Increased, lead, cadmium and nickel; Borrelia test, Negative; Epstein-Barr virus test, Negative; Neurological examination, decreased abdominal reflexes; Neurological examination, normal nerve conduction velocity
CDC Split Type: WAES1309DEU011392

Write-up: Case was received from a healthcare professional on 19-Sep-2013. Case is medically confirmed. An approximately 16-year-old female patient received a third dose of GARDASIL, (lot-no. not reported) on an unspecified date in 2011. "Few days or weeks" later she developed muscle pain, severe muscle weakness and fatigue. A Guillain-Barre syndrome was suspected. Further tests showed increased heavy metals, among others lead, calcium and nickel. No lumbar puncture for CSF testing was carried out. "Recently", on an unspecified date, neurological investigation showed decreased abdominal reflexes and normal nerve conduction velocity. Serology was negative for Borrelia and EBV (Epstein-Barr virus). Between 2011 and 2013 she presented to an alternative medicine practitioner who treated the patient with "homeopathic detoxification". As the symptoms did not improve a complete neurological investigation (including CSF) was planned at the time of reporting.


VAERS ID: 504254 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-26
Entered: 2013-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Congenital anomaly, Foetal exposure during pregnancy, Foetal heart rate abnormal, Foot deformity
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Foetal heart rate abnormal; Caesarean section
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK011266

Write-up: Case of pregnancy follow up received from health care professional via company representative on 19-Sep-2013. Case medically confirmed. The case is linked to case E2012-11218 (mother case). The patient''s (boy) mother had received an injection of GARDASIL (dose 3, batch number not reported, route: im and site arm) on 07-Nov-2012 (gestation week 3). The patient had received the vaccine through transplacental route. The boy was born 22-Jul-2013 at week 39. After a prolonged water discharge and effected heart rated, the baby boy was delivered with an caesarean section. At the time of birth the boy was assessed as normal (weight 3 kg, height 50 cm head circumference 24 cm). During an examination at the age of 5 weeks underdeveloped toes was noticed. Upon medical review the company decided to assess the case as serious. At the time of reporting the outcome was not provided.


VAERS ID: 504365 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-08
Onset:2013-08-08
   Days after vaccination:0
Submitted: 2013-09-27
   Days after onset:50
Entered: 2013-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1334X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Disturbance in attention, Muscle tightness, Oropharyngeal pain, Pain, Paraesthesia, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 06/11/2013, GARDASIL, D2 (batch no. unknown) on 11-Jun-2013; 12/17/2010, GARDASIL, D1 of GARDASIL (batch no. J002122) on 17-Dec-2010
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK012269

Write-up: Case of misuse (drug dose administration interval too short) received from a health care professional via the Health Authorities on 17-Sep-2013 under the references DK-DKMA-ADR 22245945 and DK-DKMA-EFO6899. Case is medically confirmed. A 27-year-old female patient (weight 51 kg, height 164 cm) had received the third dose of GARDASIL (batch number NL37230, lot number 1334X, exp 17-OCT-2011) IM on 08-Aug-2013. On the same day, the patient developed visual problems, lack of concentration, fainting (see stars and it becomes black before her eyes occasionally), varying pain in body, tension in neck and jaws, feeling of getting a sore throat, burning and prickling sensation in head, and arms and legs like rubber. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL (batch/lot no. J002122, exp 31-AUG-2015) on 17-Dec-2010 and D2 (batch no. unknown) on 11-Jun-2013. Toleration was not reported. Noteworthy. Case of misuse added, schedule of GARDASIL should be performed in one year and the interval between D2 and D3 should be at least of 3 months (drug dose administration interval too short).


VAERS ID: 504367 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-11
Onset:0000-00-00
Submitted: 2013-09-27
Entered: 2013-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose, Fatigue, Type 1 diabetes mellitus, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient visited her physician on a non-specified date who measure the blood glucose (lab date and results not reported).
CDC Split Type: WAES1309DNK012271

Write-up: Case received health care professional via company representative on 18-Sep-2013. Case medically confirmed. 12 year old female patient had received an injection of GARDASIL (dose 1, batch number not reported, intramuscular route, site of administration not reported) and concomitant with MMR (trade name not reported, mfr unknown, dose not reported, route- and site of administration not reported) on 11-Dec-2012 and later on a non-specified date she developed extremity tired and weight loss. The patient visited her physician on a non-specified date who measured the blood glucose (lab date and results not reported). On 23-Jan-2013 the patient was diagnosed with type 1 diabetes. At hospital, where the patient has been under observation, they state that the GARDASIL has caused the diabetes. It was not reported whether the patient was hospitalised, or not. No medical history reported. Upon medical review the company considered onset of diabetes as a medically important event and considered the case as serious. Company note: According to the reporter, the MMR vaccine was considered as concomitant vaccine. The company coded it as suspect. Causality assessment: AEs were coded as related to the vaccination due to the statement of the reporter. At the time of reporting, the outcome was not provided.


VAERS ID: 504368 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-27
Entered: 2013-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Congenital foot malformation, Foetal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK012274

Write-up: Case of pregnancy follow up received from health care professional via a company representative in a foreign country on 19-Sep-2013. Case medically confirmed. This case is linked to E213-07140 (mother case). A newborn baby (initials unknown, gender not reported, age not reported) had received an injection of GARDASIL (batch number not reported, dose not reported, site not reported, route transplacental) on unspecified date. The child''s mother was vaccinated with GARDASIL. It was not reported whether the mother was vaccinated before or during pregnancy. Later on the baby was born with underdeveloped toes (no further information specified). At the time of reporting, the outcome was not recovered.


VAERS ID: 504382 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-21
Onset:0000-00-00
Submitted: 2013-09-25
Entered: 2013-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003687 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Circulatory collapse, Dizziness, Dyspnoea, Intensive care, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DEU011264

Write-up: Case received from a health care professional on 18-Sep-2013. Case is medically confirmed. A 16-year-old female patient (weight 59 kg, height 170 cm) had received the second dose of GARDASIL (lot-no. J003687, expiration date, 31-AUG-2015) IM on 21-Aug-2013. 12 hours after vaccination, the patient developed wheals (localisation not specified). 24 hours after vaccination, the patient also developed generalised rash, dizziness, dyspnea and circulatory collapse. An allergic shock was concluded. The patient was admitted to hospital (ICU) on 22-Aug-2013. No details concerning the course or therapy were given. She was discharged on 23-Aug-2013. Further treatment was carried out by a dermatologist. The final outcome was reported to be "not recovered". The reporter assessed the events as probably - possibly related to the vaccination. D1 of GARDASIL was given on an unspecified date and well tolerated.


VAERS ID: 504630 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-06-21
Onset:2013-06-01
   Days after vaccination:1806
Submitted: 2013-09-27
   Days after onset:118
Entered: 2013-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Cervix carcinoma stage 0, Colposcopy normal, Human papilloma virus test positive, Inappropriate schedule of drug administration, Intra-uterine contraceptive device insertion, Smear cervix 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), Medication errors (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Smear cervix normal; GARDASIL, Immunisation, second dose of GARDASIL (batch number: N639260); GARDASIL, Immunisation, first dose of GARDASIL (batch number: N639320)
Allergies:
Diagnostic Lab Data: After vaccination, in 2009, a cytology was performed with normal results. In 2011 other cytology was performed with normal results, also HPV test was performed in 2011 with negative results for HPV. In 2012 colposcopy and biopsy were performed with negative results. In 2013 the patient presented with ASC-US. A colposcopy and biopsy were performed on an unspecified date and showed cervical intraepithelial neoplasia III. According to the result report the detection test for HPV was CLARTAHPV2, it was performed on 13-MAY-2013, and it showed positivity for serotype 16 of human papillomavirus, the rest of serotypes of HPV tested were negative. Pathological report (date not reported): Macroscopic description: Refer conization specimen measuring 1.7 x 1.6 x 1.2 cm and is coated reddish epithelium with irregular bleeding dotted areas and edges with signs of electrocoagulation. Microscopic description: Using a clock system distribution, at 3, 8 and 10 hours, was observed an alteration of epithelial maturation pattern characterized by the presence of cells, with hyperchromatic nuclei with increased nuclear-cytoplasmic ratio and atypical mitosis, affecting the entire epithelial thickness and intraglandual content. Similar alterations but limited to the lower third epithelium observed in 12 and 1 zone and affecting the lower two thirds of the epithelium in 2, 9 and 11 zones. The ends of surgical removal cannot be assessed due to artifact marked by electrocoagulation. Pathological diagnosis: Part of conization by electrocoagulation: Carcinoma "in situ" with intraglandular extension (severe dysplasia, High grade SIL) in hour zones 3, 8 and 10. CIN 2 (moderate dysplasia) in the 2, 9 and 11 zones. CIN 1 (mild dysplasia) in 12 and 1 hours. The ends of surgical removal cannot be assessed due to artifact marked by electrocoagulation. PAP smear in 2009 and 2011 normal.
CDC Split Type: WAES1305ESP015039

Write-up: Case of possible vaccination failure received from a physician through a company representative on 17-MAY-2013, 21-MAY-2013 and 23-MAY-2013. Case medically confirmed. A 23 year-old female patient had received the third dose of GARDASIL (batch number and route not reported) in 2008 (exact date not reported) and 4 years later, in 2012 (date not reported) the patient presented with ASC-US (colposcopy and biopsy were performed with negative results). In 2013 the patient presented with ASC-US and she was positive for serotype 16 of human papillomavirus. A colposcopy and biopsy were performed on an unspecified date and showed cervical intraepithelial neoplasia III. According to the physician the detection test for HPV was CLARTAHPV2. After vaccination, in 2009, a cytology was performed with normal results. In 2011 other cytology was performed with normal results, also HPV test was performed in 2011 with negative results for HPV. In 2011 an intra-uterine contraceptive device was implanted and she changed her sexual partner. The patient had received two doses of GARDASIL (batch number and route not reported) in 2008 (dates not reported). It was not reported whether the patient had any adverse event or not after vaccination. The first cytology was performed in 2004, it was normal. The patient was under treatment with oral contraception (start date not reported). Before vaccination (in 2008) the HPV detection test had not been performed, but pap smear tests performed before 2008 (in 2005, 2007 and 2008; dates not reported) were normal. According to the physician a conization will be performed. The result report of the detection test for HPV has been provided on 23-MAY-2013. According to the result report the detection test for HPV was CLARTAHPV2, it was performed on 13-MAY-2013, and it showed positivity for serotype 16 of human papillomavirus, the rest of the serotypes of HPV tested were negative. No further information was reported. Follow-up information received on 28-MAY-2013 from the physician. It was reported that: The first dose of GARDASIL (batch number: N639320) was administered on 21-FEB-2008. The second dose of GARDASIL (batch number: N639260) was administered on 21-APR-2008. The third dose of GARDASIL (batch number was not recorded in the vaccination card) was administered on 21-JUN-2008 only two months after the second dose which was a misuse (drug dose administration interval too short). No further information was reported. Follow up information received by email, on 18-SEP-2013 and clarified by phone on 23-SEP-2013 and 24-SEP-2013. The reporter sent a pathological report that contained the following information: Macroscopic description: Refer conization specimen measuring 1.7 x 1.6 x 1.2 cm and is coated reddish epithelium with irregular bleeding dotted areas and edges with signs of electrocoagulation. Microscopic description: Using a clock system distribution, at 3, 8 and 10 o''clock position, was observed an alteration of epithelial maturation pattern characterized by the presence of cells, with hyperchromatic nuclei with increased nuclear-cytoplasmic ratio and atypical mitosis, affecting the entire epithelial thickness and intraglandual content. Similar alterations but limited to the lower third epithelium observed in 12 and 1 zone and affecting the lower two thirds of the epithelium in 2, 9 and 11 zones. The ends of surgical removal cannot be assessed due to artifact marked by electrocoagulation. Pathological diagnosis: Part of conization by electrocoagulation: Carcinoma "in situ" with intraglandular extension (severe dysplasia, High grade SIL) 3, 8 and 10 o''clock position. CIN 2 (moderate dysplasia) in 2, 9 and 11 o''clock position. CIN 1 (mild dysplasia) in 12 and 1 o''clock position. The ends of surgical removal cannot be assessed due to artifact marked by electrocoagulation. The reporter was contacted on 23-SEP-2013 and clarified that the patient was diagnosed with CIN 3 due to histology test, with HSIL due to cytology and Carcinoma in situ due to pathologic test. According to the physician "Intraglandular extension" meant that it did not affect the ectocervix but to the internal zone of the uterine cervix. The reporter clarified the dates: a cytology performed on 19-FEB-2013 showed ASCUS. The biopsy of the sample taken during the cytology of 19-FEB-2013 showed (results provided on MAR-2013) CIN 3. The conization was performed in the first week of June, and the pathological test report was written on 07-JUN-2013. Patient outcome was not reported. Upon medical review the company upgraded the case to serious on 23-SEP-2013 with other medically important condition (Carcinoma in situ) as criteria.


VAERS ID: 504632 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-10
Onset:2013-09-10
   Days after vaccination:0
Submitted: 2013-09-27
   Days after onset:17
Entered: 2013-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Fall, Gaze palsy, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Pallor, Syncope, Unresponsive to stimuli
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), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Circulatory collapse, nausea, headache, vaccination site swelling~Meningococcal (no brand name)~0~0.00~Patient
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Heart rate Normal; Blood pressure, 110/70
CDC Split Type: WAES1309DEU012180

Write-up: Case was received from a health care professional in a foreign country on 17-Sep-2013. Case is medically confirmed. A 16-year-old female patient received a first dose of GARDASIL (lot-no. not reported) into the left upper arm on 10-Sep-2013. Immediately p.v. she developed syncope with loss of consciousness, pallor, gazing upwards with her eyes and short twitching of her arms and hands for approx. 40 seconds; she fell from the examination couch. A convulsive syncope was assumed. Few minutes later the patient was responsive again, the further course was normal. Blood pressure was 110/70 and pulse rate was normal. She recovered completely. A blood sample was taken immediately before vaccination. On internal medical review the company judged the case as serious (other medically important event: loss of consciousness). On 23-Feb-2012 the patient had received a first dose of MENCEVAX (GSK, lot-no. not reported) into the right upper arm and had developed circulatory collapse, nausea, headache and vaccination site swelling.


VAERS ID: 504636 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-11
Onset:2013-06-01
   Days after vaccination:813
Submitted: 2013-09-27
   Days after onset:118
Entered: 2013-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Back pain, Dizziness, Fatigue, Headache, Incorrect route of drug administration, Memory impairment, Muscle twitching, Presyncope, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Back pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK012010

Write-up: Case of misuse (wrong route of administration) received from a health care professional via the Health Authorities in a foreign country on 17-Sep-2013 under the references DK-DKMA-ADR 22244118 and DK-DKMA-EFO6876. Case is medically confirmed. A 24-year-old female patient with a medical history of back pain in 2007 (ongoing), had received the third dose of GARDASIL (batch number not reported) SC on 11-Mar-2011. On 01-Jun-2013, the patient developed tiredness syndrome. On an unspecified date in 2013, the patient also developed increasing headache, dizziness, forgetfulness, twitching in right arm and lower extremities, had strange bubble in the lower back which felt swollen and hurt, lack of energy and near fainting. The patient thought that the problems were associated with the vaccine. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 15-Sep-2010 and D2 on 15-Nov-2010. Toleration was not reported. Noteworthy: Case of misuse (wrong route of administration) as the vaccine has been administered via SC route.


VAERS ID: 504872 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-01
Onset:2013-03-01
   Days after vaccination:912
Submitted: 2013-09-30
   Days after onset:212
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Vaccination failure, Vulvovaginal human papilloma virus infection, Wart excision
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/2010, GARDASIL, second dose in May 2010 (GARDASIL, batch numbers not reported, 0.5 mL) intramuscularly; 03/2010, GARDASIL, She had received the first dose in March 2010
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309PRT013061

Write-up: Case of vaccination failure received from the Health Authorities on 19-Sep-2013 under the reference number C201309-53 via the local site Sanofi Pasteur MSD. The primary reporter was a physician. A 33-year-old female patient developed vulval condyloma in March 2013, 2 years and a half after she had received the third dose of GARDASIL (batch number not reported) 0.5 mL intramuscularly in September 2010. She had received the first dose in March 2010 and the second dose in May 2010 (GARDASIL, batch numbers not reported, 0.5 mL) intramuscularly. The patient was taking no concomitant medication. It was unknown whether she had experienced previous adverse events to other drugs. In early July the patient underwent a surgical excision of the condyloma. HPV virus serotype that caused the condyloma was unknown. The adverse reaction lasted 4 months and resolved on 05-Jul-2013. The Health Authorities assessed the causal relationship between the reported reaction/vaccination failure and vaccination as possible according to the global introspection.


VAERS ID: 504912 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Disability, Fatigue, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309GBR012812

Write-up: This case was identified as part of a phone call in program on a national television show during which GARDASIL vaccination was discussed on 20-Sep-2013, this case reported by the patients mother. This case is not medically confirmed. A female patient, who was 15 at the time of reporting, with a family history of cancer who previously danced competitively, played sports at school and was bright and healthy received GARDASIL vaccine, batch route and site not reported on an unreported date. An unreported time post vaccination, on an unreported date, it was as if a grenade had gone off in the patients body and she experienced muscle weakness, excruciating joint pain and was tired. The patient could only attend school for 2 hours per day, sometimes 5 hours a day. The patients mother stated that the patient was disabled and if she does not get better she will never be able to work or hold down a job. The patient had not recovered at the time of reporting.


VAERS ID: 504914 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-03-02
Onset:2009-03-09
   Days after vaccination:7
Submitted: 2013-09-30
   Days after onset:1666
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Asthenia, Blood immunoglobulin G increased, Dizziness, Fatigue, Headache, Heart rate increased, Herpes zoster, Hypersomnia, Hypotension, Infection, Lymphocyte count abnormal, Memory impairment, Monocyte count abnormal, Muscle tightness, Muscle twitching, Neutrophil count abnormal, Pain in extremity, Sensory disturbance, Swelling face, Weight decreased
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown date: blood test: result not provided; Unknown date: Immunoglobulin G: G4 reduced; Unknown date: Lymphocyte count: Out of range; Unknown date: Monocyte count: Out of range; Unknown date: Neutrophil count: out of range; Blood immunoglobulin G, G4 reduced not provided; Lymphocyte count, out of range not provided; Monocyte count, out of range not provided; Neutrophil count, out of range not provided
CDC Split Type: WAES1309DNK010592

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 11-Sep-2013 under the references DK-DKMA-ADR 22231073 and DK-DKMA-EF06732. Case is not medically confirmed. A 14-year-old female patient (weight 50 kg, height 170 cm) had received the first dose of GARDASIL on 02-Mar-2009. 1 week later, on 09-Mar-2009, the patient developed severe persistent headache, pronounced muscle tension in neck, swelling in face, involuntary twitch in arm and leg, exhausting and severe tiredness, slept up to 19 hours per day, sensory disturbance, dizziness, reduced strength in arm and leg, low blood pressure, intermittent high pulse rate, sever pain in right leg (also starting in the left), difficulties to remember, infection after infection including Varicella-zoster, much agitation in body and weight reduction of 7 kg. The patient was a dancer before she had been vaccinated. She interrupted her studies and was, at the time of reporting, at home and could not do anything due to the reactions. The patient was hospitalised. All usual blood tests were done. Immunoglobuline G4 was reduced. Infection specialist and GP had written in their medical records that immunoglobuline treatment should be considered, but he patient did not receive the treatment. The patient received TOPIMAX, HEXOBOTIN, SIRDALUD and metoprolsuccinate. The patient also received physiotherapy. After end of treatment, the patient developed a new infection. Lymphocytes, monocytes and neutrophils were often out of range. The patient was examined at several clinics, but no serious reactions. The patient also presented to a psychiatrist who believed that she tackled all her challenges very reasonable and rational. At the time of reporting, the patient was getting pain relief at a pain clinic. The patient had not recovered. The patient received a further dose of GARDASIL on 21-Sep-2009 (not further specified). Notworthy: varicella-zoster infection was not coded by the HA but mentioned in the narrative.


VAERS ID: 504952 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-30
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Hearing impaired, Injection related reaction, Loss of consciousness, Pallor, Visual impairment
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), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013910

Write-up: Health Authority Report: This spontaneous report from a health authority as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, .5 ml, intramuscular as prophylaxis. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced dizziness (medically significant), visual impairment (medically significant) and hearing impaired (medically significant). The outcome of dizziness, visual impairment, pallor, loss of consciousness, injection related reaction and hearing impaired is unknown. It is unknown if these events are related to GARDASIL. Additional information is not expected.


VAERS ID: 504956 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-29
Onset:2012-11-22
   Days after vaccination:24
Submitted: 2013-09-30
   Days after onset:311
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H002607 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-neuronal antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positive, Antiphospholipid antibodies negative, Arthralgia, Arthritis, Aspartate aminotransferase increased, Aspartate aminotransferase normal, Blood creatine phosphokinase increased, Blood culture negative, Blood folate normal, Blood glucose normal, Blood immunoglobulin G, Blood immunoglobulin G decreased, Blood immunoglobulin M, Blood lactic acid normal, Borrelia test negative, CSF culture, CSF oligoclonal band present, CSF white blood cell count, Cardiac fibrillation, Cardiolipin antibody, Central nervous system lesion, Coagulation test normal, Depressed mood, Ear, nose and throat examination normal, Electrocardiogram normal, Electromyogram abnormal, Electroneurography, Erythema, Foot deformity, Gait disturbance, Hand deformity, Hypertonia, Hypotonia, Infection susceptibility increased, Laboratory test normal, Ligament pain, Muscle atrophy, Muscle contractions involuntary, Muscle rigidity, Myositis, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Ophthalmological examination normal, Pain, Protein total normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sleep disorder, Swelling, Ultrasound scan abnormal, Urinary tract infection, Urine analysis normal, Visual evoked potentials abnormal, Vitamin B12 normal, Vitamin D
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (narrow), Tachyarrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEKRISTOL
Current Illness: Immunisation; Vitamin D deficiency
Preexisting Conditions: Fatigue; Disturbance in attention
Allergies:
Diagnostic Lab Data: Anti-neuronal antibody, Negative, All negative in CSF not provided; Antineutrophil cytoplasmic antibody, Negative, Negative; Antinuclear antibody, Negative, Negative not provided; Antinuclear antibody, Positive, ANA-IFT 1:80 positive not provided; Antiphospholipid antibodies, Negative, Negative not provided; Aspartate aminotransferase, 38 U/L; Blood creatine phosphokinase, 945 U/L; Blood folate, 7.2 ng/mL; Blood test, Normal, Normal; Brain stem auditory evoked response, Affection of right auditory tract; CSF glucose, Normal, Normal not provided; CSF immunoglobulin G index, 0.9 not provided; CSF lactate, Normal, Normal not provided; CSF oligoclonal band, Intrathecal synthesis of IgG not provided; CSF protein, Normal, Normal not provided; CSF test, IgG 75.5, IgM 2.7 mg/l; CSF white blood cell count, 8/uL; Cardiolipin antibody, <5 not provided; Coagulation test, Normal, Normal not provided; 04/12/2013, Ear, nose and throat examination, Normal, Normal; 04/08/2013, Electrocardiogram, Normal; 04/10/2013, Electromyogram, Increased muscle tones; 04/08/2013, Electroneurography, No signs of neuropathy; 04/09/2013, Electroneurograpy, MEP: affection; Lyme disease, Negative, Negative; Myositis, Negative, Negative; Neurological examination, Fasciculation of the tongue; Nuclear magnetic resonance imaging, Mild joint inflammation; 04/08/2013, Nuclear magnetic resonance imaging, Single lesion of the thoracic myelon left sided; 04/16/2013, Nuclear magnetic resonance imaging, Normal, Whole body: normal; 04/05/2013, Nuclear magnetic resonance imaging brain, Several lesions of central white matter; 04/17/2013, Ophthalmological examination, Normal, Normal; Physical examination, Normal, Normal; Red blood cell sedimentation rate, 10 mm; Rheumatoid factor, <1 IU/ml; Somatosensory evoked potentials, Normal, Normal; Ultrasound scan, Small amount of residual urine; Urine analysis, Normal, Normal not provided; Visual evoked potentials, Normal, Normal; Vitamin B12, 277 pg/mL; Vitamin D, 46 ng/mL; Extractable nuclear antibody: Negative; Lupus anticoagulant: Negative; Borrelia burgdorferi infection: Normal
CDC Split Type: WAES1309DEU012013

Write-up: Case was received from the Health Authorities on 18-Sep-2013 (reference no. PEI2013054039). Case is medically confirmed. A 17-year-old female patient with a medical history of vitamin-D deficiency treated with 20000 IU DEKRISTOL once weekly, had received the first dose of GARDASIL (lot-no. H002607) IM into the left upper arm on 29-Oct-2012. Since Jun-2012 the patient had suffered from increased tiredness during daytime and impaired concentration. According to the hospital report, in November 2012 (reported as 22-Nov-2012 by the reporter) the patient experienced pain, swelling and slight redness of the upper ankle and the metatarsophalangeal joint. MRI showed a mild inflammation of the joint. The pain in the joints was felt even during the nighttime. In the further course the patient developed high arching feet and deformities of the fingers (clawhand). There were no specifics in the family medical history or in the patient''s individual medical history explaining these symptoms. Since 20-Dec-2012 the patient suffered from increased susceptibility to infections and relapsing urinary tract infections. She had a depressive mood and sleep disturbance. She recovered from these complaints in spring 2013. The patient was hospitalised from 04-Apr-2013 to 12-Apr-2013. General examination showed no pathological findings. Neurological examination showed fasciculation of the tongue at rest. Pes Cavus and clawhands on both sides were described. The patient showed dysbalance of muscle tonus distal with hypertone muscle tension. Spontaneous fasciculation in the area of the deltoid muscles on both sides were observed. Foot dorsoflexion on both sides was weakened. Coordination tests were normal. Laboratory tests revealed normal total and differential blood picture. Exhaustive blood tests showed normal values except for creatine kinase was 945 U/l, GOT 38 U/l. Coagulation parameters, erythrocyte sedimentation rate (10 mm after the first hour according to Westergren), Vitamin B12 and Vitamin D3 levels were normal. Rheumatologic screening revealed ANA-IFT positive (1:80), ENA screening negative, rheumatoid factor < 1.0 U/ml, Lupus anticoagulant negative, ANCA (IFT) negative, Cardiolipin antibodies < 5 U/l, folic acid 7.2 ng/ml, Borrelia testing negative and myositis testing negative. Urinalysis was normal. Spinal fluid examination showed leukocytes at 8/ul, protein, glucose and lactate within physiological range. IgG was 75.5 mg/l, IgM 2.7 mg/l and the IGG index was 0.9. Oligoclonal bands (IgG) were positive in spinal fluid, negative in blood serum which suggested intrathecal synthesis of IgG. Neuronal antibodies in spinal fluid were negative. Neurography on 08-Apr-2013, did not show signs of neuropathy. Motor evoked potentials of efferent nerve tracts to both legs performed on 09-Apr-2013, showed affection. Electromyography on 10-Apr-2013, revealed an increased muscle tonus with repetitive fibrillation. Acoustic evoked potentials showed affection of the right central auditory tract. Visual evoked potentials and somatosensory evoked potential of the nervus tibialis were normal. Cranial MRI on 05-Apr-2013, showed several lesions of the central white matter which would be consistent with multiple sclerosis. Spinal cord MRI on 08-Apr-2013, showed one single lesion of the thoracic myelon on the left side. No pathological findings of the muscles in the MRI of whole body performed on 16-Apr-2013. Sonographic examination revealed a small amount of residual urine. Ear-nose-throat examination on 12-Apr-2013 was normal. Electrocardiography and ophthalmologic examination on 08-Apr-2013 were normal. Rheumatological examinations, especially taken into account the clawhand was discussed to be in favour of a myopathy setting out from distal. During physical examination, therapy mild gait instability was observed. In conclusion, the patient had a rigid tonus of all affected muscles with partially painful swollen and reddened joints. In conclusion, although MRI showed lesions typical for multiple sclerosis, the diagnosis of MS was not consistent with the symptoms of high arching feet, finger deformities and spontaneous muscle fasciculations. As alternative explanation a late onset of spinal muscle atrophy type III was taken into consideration. No final diagnosis was established. A causal relation with vaccination against human papillomavirus was assessed as possible. At the time of reporting the patient had not recovered. Despite ongoing symptoms, the second dose of GARDASIL was administered on 20-Dec-2012. Upon medical review the company added the following AE, which was mentioned in the reporting form but not coded by HA: increased susceptibility to infections, suspicion of late onset of spinal muscle atrophy type III.


VAERS ID: 504992 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-01
Entered: 2013-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Body temperature fluctuation, Confusional state, Dizziness, Headache, Hyperacusis, Hypoaesthesia, Irritable bowel syndrome, Menorrhagia, Migraine, Nausea, Night sweats, Pain, Photophobia, Rash, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013914

Write-up: Health Authority Report: this spontaneous report as received from a consumer or other non health professional refers to a 13 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, 1 DF, intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced amenorrhoea (hospitalization, medically significant and disability), vomiting (hospitalization, medically significant and disability), syncope (hospitalization, medically significant and disability), rash (hospitalization, medically significant and disability), photophobia (hospitalization, medically significant and disability), pain (hospitalization, medically significant and disability), night sweats (hospitalization, medically significant and disability), nausea (hospitalization, medically significant and disability), migraine (hospitalization, medically significant and disability), menorrhagia (hospitalization, medically significant and disability), irritable bowel syndrome, (hospitalization, medically significant and disability), hypoaesthesia (hospitalization, medically significant and disability), hyperacusis (hospitalization, medically significant and disability), headache (hospitalization, medically significant and disability), dizziness (hospitalization, medically significant and disability), confusional state (hospitalization, medically significant and disability) and body temperature fluctuation (hospitalization, medically significant and disability). The outcome of amenorrhoea, vomiting, syncope, rash, photophobia, pain, night sweats, nausea, migraine, menorrhagia, irritable bowel syndrome, hypoaesthesia, hyperacusis, headache, dizziness, confusional state and body temperature fluctuation was reported as not recovered/not resolved. It is unknown if these events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505006 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-01
Entered: 2013-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309JPN013385

Write-up: Initial information has been received from a pharmacist concerning a female (age: around 20 year old). On an unspecified date, she was vaccinated with GARDASIL IM injection drug (first, second and third time of vaccination)(dose, injection site or indication was not reported). No concomitant medication was reported. On an unspecified date, she was vaccinated with GARDASIL IM injection drug (first time of vaccination) (dose, injection site or indication was not reported). On an unspecified date, she was vaccinated with GARDASIL IM injection drug (second time of vaccination) (dose, injection site or indication was not reported). On an unspecified date, she was vaccinated with GARDASIL IM injection drug (third time of vaccination) (dose, injection site or indication was not reported). On an unspecified date, since about a half year after the third vaccination, she sometimes had experienced convulsions. Also, she had felt numbness on the half of the face during the daytime. As of reporting date, the outcome of convulsion and numbness in face was unknown. Comments from the reporter: The patient told to her physician about the convulsion which he considered unrelated to the vaccination. Then she consulted me. The reporting pharmacist did not assess the seriousness of convulsion and numbness in face or their relationship to the GARDASIL. Upon internal review, convulsion was determined as serious other important medical event. Additional information is not expected.


VAERS ID: 505013 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-01
Entered: 2013-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013916

Write-up: This spontaneous report as received from a health authority via a physician refers to a 15 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, .5 ml, intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced anaphylactic reaction (life threatening and medically significant) and tachycardia (life threatening and medically significant). The outcome of anaphylactic reaction and tachycardia was reported as recovered/resolved. It is unknown if the events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505118 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-01
Entered: 2013-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Flank pain, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013917

Write-up: This spontaneous report as received from a physician refers to an 18 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, 3 DF, intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced fatigue (medically significant), pyrexia (medically significant), myalgia (medically significant), headache (medically significant) and flank pain (medically significant). The outcome of fatigue, pyrexia, myalgia, headache and flank pain is unknown. It is unknown if these events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505152 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Bone pain, Cyanosis, Decreased appetite, Eye swelling, Fatigue, Feeling of body temperature change, Menstrual disorder, Mobility decreased, Myalgia, Night sweats, Oedema mouth, Palpitations, Photosensitivity reaction, Rash generalised, Serum sickness, Urticaria, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Product used for unknown indication
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013918

Write-up: Health Authority Report: this spontaneous report as received from a consumer or other non health professional refers to a 14 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, .5 ml, intramuscular. Concomitant therapies included BOOSTRIX. On an unknown date the patient experienced arthralgia (medically significant), visual impairment (medically significant), urticaria (medially significant), serum sickness (medically significant), rash generalized (medically significant), photosensitivity reaction (medically significant), palpitations (medically significant), oedema mouth (medically significant), oedema mouth (medically significant), night sweats (medically significant), myalgia (medically significant), mobility decreased (medically significant), menstrual disorder (medically significant), feeling of body temperature change (medically significant), fatigue (medically significant), eye swelling (medically significant), decreased appetite (medically significant), cyanosis (medically significant), bone pain (medically significant) and asthenia (medically significant). The outcome of arthralgia, visual impairment, urticaria, serum sickness, rash generalised, photosensitivity reaction, palpitations, oedema mouth, night sweats, myalgia, mobility decreased, menstrual disorder, feeling of body temperature change, fatigue, eye swelling, decreased appetite, cyanosis, bone pain and asthenia was reported as recovered/resolved. It is unknown if the events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505242 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Nausea, Psychomotor retardation
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron (unspecified); Vitamins (unspecified)
Current Illness: Product used for unknown indication
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013919

Write-up: Health Authority Report: this spontaneous report as received from a physician refers to a 26 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, .5 ml, intramuscular. Concomitant therapies included iron (unspecified) and vitamins (unspecified). On an unknown date the patient experienced abdominal pain (medically significant), psychomotor retardation (medically significant), nausea (medically significant), dizziness (medically significant) and diarrhoea (medically significant). The outcome of abdominal pain, psychomotor retardation, nausea, dizziness and diarrhoea was reported as recovered/resolved. It is unknown if the events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505255 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Back pain
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013921

Write-up: Health Authority Report: This spontaneous report as received from a consumer or other non health professional refers to a 14 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, 3 DF, intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced arthralgia (disability and medically significant) and back pain (disability and medically significant). The outcome of arthralgia and back pain reported as not recovered/not resolved. It is unknown if the events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505452 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Crying, Decreased appetite, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Product used for unknown indication
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013925

Write-up: Health Authority Report: This spontaneous report as received from a physician refers to a 10 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. Other suspect therapies included TWINRIX. On an unknown date the patient experienced abdominal pain (medically significant), vaccination site pain (medically significant), myalgia (medically significant), decreased appetite (medically significant), crying (medically significant) and anxiety (medically significant). The outcome of abdominal pain, vaccination site pain, myalgia, decreased appetite, crying and anxiety was reported as recovered/resolved. It is unknown if the events are related to GARDASIL. Additional information is not expected.


VAERS ID: 505458 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Grand mal 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hemp
Current Illness: Product used for unknown indication
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013922

Write-up: Health Authority Report: This spontaneous report as received from a physician refers to a 22 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, .5 mg, intramuscular. Concomitant therapies included HEMP. On an unknown date the patient experienced grand mal convulsion (medically significant). The outcome of grand mal convulsion is unknown. It is unknown if the event is related to GARDASIL. Additional information is not expected.


VAERS ID: 505543 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-09-16
Onset:2013-09-16
   Days after vaccination:0
Submitted: 2013-10-03
   Days after onset:17
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Insomnia, Nausea, Neurological examination normal
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neurological examination, no signs of neurological damage
CDC Split Type: WAES1309USA012599

Write-up: This spontaneous report as received from a patient''s parent refers to a 16 year old male patient. On 16-SEP-2013 the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date were not reported). The reporter stated that on 16-SEP-2013 the patient felt light headed, weak, nauseous and he had trouble sleeping after receiving GARDSAIL, he sought medical attention and was seen by the physician. Neurological test was performed and it revealed no signs of neurological damage. At the time of this report the patient did not recover from his adverse events. The relatedness between the light headed, weakness, nausea, trouble sleeping and the vaccination with GARDASIL was not reported. Additional information has been requested.


VAERS ID: 505573 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:2013-06-01
   Days after vaccination:81
Submitted: 2013-10-03
   Days after onset:124
Entered: 2013-10-03
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, Blood test, Computerised tomogram, Dizziness, Fatigue, Heart rate increased, Hypoacusis, Hypoaesthesia, Hypotension, Insomnia, Lumbar puncture, Malaise, Muscle spasms, Muscular weakness, Nausea, Neuralgia, Nuclear magnetic resonance imaging, Presyncope, Sensory disturbance, Tinnitus, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENGERIX-B
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient has been seen by own physician several times to have blood tests performed. The patient has been seen by a neurologist at Y Hospital, MRI scan has been performed twice, and she has had CT-scan with contrast performed. The patient has had a lumbar puncture performed and a VEB and SEP examination. The patient has been elucidated at Medical ward, X Hospital. Received from the physician on 24-SEP-2013: Elucidated by neurological and medical regime. Has now been referred to the Research Unit at Y Hospital, who should have special knowledge within this area.
CDC Split Type: WAES1309DNK012502

Write-up: Adverse events: Nerve pain, dizziness, nausea, fog hearing, very low blood pressure, very high pulse, sensory disturbances, sleeping arms, fingers and feet, muscle cramps, sleeplessness, weight loss, ringing in ears, several episodes, where the patient has been near fainting, tiredness, exhaustion, weakness of the right arm. The patient has received the following treatment for the adverse events: PANODIL, DOLOL, Gabapentin, Imipramin, Amitriptylin, LYRICA. Both GARDASIL and SILGARD are stated as suspected drugs. The patient''s general practitioner does not know the batch numbers for GARDASIL and SILGARD. The patient has not been hospitalized due to the adverse event. Other medication: No. Remarks: The patient has been completely healthy until she received the second HPV vaccine on 11-MAR-2013. The patient has been ill for 6 months; she has been on sick leave from her job, as a registered nurse for 2 months. The patient is still on part-time sick leave. She daily takes medication for her pain, she is dizzy and has nausea. She has lost 6 kg and suffers from very low blood pressure and high pulse. In brief, her life has been a nightmare for the last 6 months. Follow-up received (spontaneously) from the patient''s physician: The patient has been vaccinated with GARDASIL 08-JAN-2013 and with SILGARD on 12-MAR-2013. Just after the second vaccine the patient experienced increasing nerve pain in all extremities and increasing tiredness. Three months later problems with hypotension and fainting feeling occurred. Other vaccine that the physician does not suspect to have caused the adverse reactions: ENGERIX-B administered on 08-JAN-2013. The adverse reactions caused: Disability or significant function reduction. Remark from the Health Authority: The patient did receive SILGARD on 12-MAR-2013 and not on 11-MAR-2013. The physician has also reported both SILGARD and GARDASIL as suspected drugs. Start date for Hypotension and Near fainting was changed from 13-MAR-2013 (reported by the patient) to JUN-2013 (reported by physician).


VAERS ID: 505581 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-15
Onset:2012-11-11
   Days after vaccination:241
Submitted: 2013-10-03
   Days after onset:325
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN43360 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram head, Dizziness, Electroencephalogram normal, Electromyogram normal, Extensor plantar response, Fatigue, Mobility decreased, Nuclear magnetic resonance imaging brain normal, Pain, Pain in extremity, Paraesthesia, Paresis, Sensory disturbance, Syncope, Thyroid function test normal, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 11/2010, Menarche
Allergies:
Diagnostic Lab Data: CT brain (no remarks, lab test not reported); Thyroid tests and blood tests normal (lab dates not reported); 11/13/2012, Babinski reflex test, missing bilaterally; Blood test, Normal; Computerised tomogram head, no remarks; Electroencephalogram, Normal; Electromyogram, without remarks, Normal; Nuclear magnetic resonance imaging, Normal; Thyroid function test, Normal not provided; X-ray, without remarks, Normal
CDC Split Type: WAES1310SWE001079

Write-up: Case received from health care professional via Health Authorities on 23-Sep-2013 and 27-Sep-2013 under the reference number 133063. The primary reporter was a physician (in hospital). Case medically confirmed. A 15 year old female patient (initials unknown), developed syncope, repeated faintness, pain, paresis and sensory disturbance (outcome not reported) on 11-Nov-2012 and tiredness (onset about a year back, calculated from the date of reporting 13-Nov-2012, outcome not reported) after she had received an injection of GARDASIL (batch number G011353) via not reported route of administration in not reported site of administration on 15-Mar-2012. About a year of repeated dizziness and faintness attacks. Investigated at a care center with CT brain (no remarks, lab test not reported), it had often been related to rising up or when she had not eaten well. About a year back (calculated from the date of reporting 13-Nov-2012), it appeared that the patient started being tired, went often to bed and rested some hour after school. Thyroid tests and blood tests normal (lab dates not reported). Menarche two years ago (calculated from the date of reporting 13-Nov-2012) and after that irregular menstruation. MS disease runs in the family (no further information specified). Remitted from the emergency room on 13-Nov-2012 with sudden occurring paresis symptoms and pain in right arm. Did not move right hand, except that she could wiggle the wrist a bit. She could not move her fingers at all. Indicated reduced sensibility for touch in the right forearm in general, otherwise normal sensibility. Babinski missing bilaterally. One month later, when she fainted, she tried to rise up, she could not stand on the right leg and did not sense the right foot and lower leg (crus). Also syncope tendencies post-vaccination. Investigated samples, X-ray and EMG performed without remarks. Even undergone MRI brain and EEG which were also normal. The symptoms occurred immediately after the third GARDASIL dose given. Has now no longer syncope. Gradual improvement of symptoms recent months but not yet fully recovered. The patient''s medical history includes: Primary and secondary dose of GARDASIL (batch number not reported) received via not reported route of administration in not reported site of administration on an unspecified date. HA comment: complementation on 22-Aug-2013, when the batch number had been requested it appeared that the third vaccination was given 15-Mar-2012 and the symptoms in Nov-2012. The judgement is according to regulatory authority still possible (causality). At the time of reporting, the outcome was recovered for syncope and faintness, not recovered for pain and paresis and not reported for sensory disturbance and tired. HA only coded syncope, faintness, pain and paresis. Company also coded tired and sensory disturbance to scope the "reduced sensibility", "Babinski missing" and "did not sense right foot and lower leg'' (only mentioned by HA in the narrative).


VAERS ID: 505594 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-03
   Days after onset:15
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005626 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Feeling hot, Malaise, Nausea, Paraesthesia, Retching
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR001084

Write-up: This case was received from the health authority on 26-Sep-2013. GB-MHRA-ADR 22250538. This case is medically confirmed. A 12-year-old female patient, with no reported medical history, was vaccinated on 18-Sep-2013 with a first 0.5 mL dose of GARDASIL (batch n. reported as JOO5626 but entered as J005626 according to vaccine batch number format) intramuscularly (site of administration not reported) and a few minutes later she complained of severe abdominal pain. The patient remained unwell though recovering slowly an hour after having received the vaccine (coded as feeling unwell by the regulatory authority but the onset date was not reported). On an unreported date she also complained of feeling very hot, nauseated (coded as nausea by the regulatory authority) and retching, she had pins and needles in her left foot. Her parents were called and advised to see their general practitioner for further assessment. At the time of reporting the patient was recovering. This case was considered serious by the regulatory authority as an other medically important condition.


VAERS ID: 505598 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-07
Onset:2009-11-01
   Days after vaccination:178
Submitted: 2013-10-03
   Days after onset:1432
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acoustic stimulation tests, Acoustic stimulation tests normal, Activities of daily living impaired, Arthralgia, Blood test normal, Chest discomfort, Depressed mood, Dizziness, Fatigue, Headache, Infection, Lumbar puncture normal, Lymphadenopathy, Malaise, Mouth haemorrhage, Myalgia, Nausea, Neck pain, Nuclear magnetic resonance imaging, Oral discomfort, Pain in extremity, Pyrexia, Swelling face, VIIth nerve paralysis, Wound complication
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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; GARDASIL, VIIth nerve paralysis; 10/15/2008, GARDASIL, Headache
Allergies:
Diagnostic Lab Data: Hearing test (March 2009): results not reported. MRI (March 2009): results not reported. Lumbar puncture (March 2009): results not reported. 10/2008, Acoustic stimulation tests, Normal not provided; 10/2008, Blood test, Normal not provided; 10/2008, Lumbar puncture, Normal not provided
CDC Split Type: WAES1310DNK001241

Write-up: Case received from non-healthcare professional and patient insurance company via health authority on 25-Sep-2013 under the reference number 13-5884 and 22249342. Case no medically confirmed. A 13-year-old female patient had received an injection of GARDASIL (batch number NK05560, dose 3) on 07-May-2009 and later on unspecified date in June 2009 she developed another left-sided facial paralysis (her third). In August 2009 she developed facial swelling at her cheek, that doesn''t decrease, as well as severe swelling of lymph. In November 2009 she developed another facial paralysis on her left side, which was later moved over to the right side like a big swelling that doesn''t disappear. Further she had, with a few weeks in between, severe discomfort in her mouth, painful wounds and red/blue/brown bleeding from the mucosa. Treatment at all occasions have been valaciclovir (3 x daily for 7 days), penicillin (several treatments), prednisolone (25 mg, 2 x daily for 2 days + 25 mg/day for 3 days), ZOVIR, and pain killers. For 11 months she was taking ZELETRIX (3 x daily) as preventive measure, without much effect. In between these events of paralysis she has had a lot of fever, infections, feeling generally unwell, nausea, dizziness, pain in all joints (pain in elbows and knees), tiredness, headache, pain in neck and chest pressure. The patient still suffers on a daily basis from pain in head and neck, generally unwell, tiredness, pain in fingers, elbows and knees, dizziness, nausea, fever, chest pressure, muscle pain and she is sad and resigned. The patient received the first dose of GARDASIL on 15-Oct-2008 (batch number NJ01850) and later on an unspecified date a few days later she developed severe pain behind both ears and on 19-Oct-2008 she developed left-sided facial paralysis (on the fourth day). Later on unspecified date in March 2009 she developed a right-sided facial paralysis. The patient received the second dose of GARDASIL (batch number NJ21220) on an unspecified date. At the time of reporting, the outcome of these events was unknown. The girl was hospitalized in October 2008 and many different examinations were performed, including blood tests, hearing tests and lumbar puncture, all tests were normal. After the second face paralysis in March 2009 she was again admitted to hospital with hearing test, MR scan and lumbar puncture (results not rep). According to the report, the events after the first dose was not assessed by the hospital as connected to the vaccination. The girl had been hospitalized in connection to the facial paralysis events (no details reported) and she has been out of school due to infections and fever. The outcome was reported as not recovered for facial swelling, fever, malaise, recurrent infection, nausea, dizziness, joint pain, chest pressure, pain in fingers, muscle pain, feeling sad and headache. Outcome for other events was unknown.


VAERS ID: 506035 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-11
Onset:0000-00-00
Submitted: 2013-10-03
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008041 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Back pain, Headache, Malaise, Pain in extremity, Pain in jaw, Paraesthesia, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Acetaminophen; pizotyline
Current Illness: Migraine prophylaxis; Immunisation; Pain
Preexisting Conditions: Migraine; CERVARIX, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR001035

Write-up: This case was received from the health authority on 23-Sep-2013. GB-MHRA-ADR 21894723. This case is medically confirmed as it was reported by a pharmacist. A female patient (age not reported, weight 48.15 kg) was vaccinated on 11-Oct-2012 with a dose of GARDASIL (batch n. H008041) intramuscularly, dose and site of administration not reported, on an unreported date she experienced headache and joint pain (coded as painful joints by the regulatory authority), pins and needles in hands, was feeling sick and had sore joints (coded as painful joints by the regulatory authority) in jaw, limbs, back and feet, she had fever and rash on right shoulder. The headache was in frontal area then moved across whole head, throbbing. The patient''s medical history included migraine. She had received two doses of human papilloma virus vaccine (reported as CERVARIX) on unreported dates. Concomitant treatment included paracetamol for pain and pizotifen 750 ug orally from 2012 for migraine prophylaxis. The regulatory authority considered this case to be serious due to hospitalisation.


VAERS ID: 506036 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-03
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Postural orthostatic tachycardia syndrome, Tilt table test positive
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Tilt table test, Positive for POTS
CDC Split Type: WAES1310DNK001352

Write-up: Case received from a healthcare professional in a foreign country on 20-Sep-2013. The primary reporter was a physician. This is a cluster of 7 cases of Postural Orthostatic Tachycardia Syndrome (POTS) confirmed by the reporting physician at the syncope clinic at a hospital. 7 female patients had received unknown number of doses of HPV vaccine type 6, 11, 16 and 18 (brand name, batch number route and site not reported) on unknown date and post vaccination developed Postural Orthostatic Tachycardia Syndrome (POTS0. The diagnosis have been confirmed with tilt table test. The diagnosis of POTS was made at a hospital for the following cases E2009-10326, E2013-06782, E2013-06882 and E2013-02832. These cases are potential four of the seven cases of POTS confirmed by the reporting physician. At the time of reporting the outcome was unknown.


VAERS ID: 506141 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-04
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Dizziness, Gait disturbance, Headache, Hypotension, Malaise, Nausea, Vision blurred, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR001439

Write-up: This case was received from the health authority on 23-Sep-2013. GB-MHRA-ADR 21921021. This case is not medically confirmed as it was reported by a consumer. This case is linked to case E2012-09423 (same health authority report, same reporter, same vaccine). Three girls from the same school were experiencing ongoing side effects after the first dose of GARDASIL (batch n. route, dose, site of administration not reported). Ten percent of the girls from this school became ill and were sent home, 4% had more serious side effects. The date of vaccination was not reported. It was reported that the school took the decision to withdraw from the programme. The reporter stated that the parents of two of the girls had also recorded a yellow card and that the parents of the third girl were about to do the same. The outcome was unknown for became ill and serious side effects. The regulatory authority did not provide any seriousness criteria for this case which was considered as serious by the company due to the reporting that girls experienced serious side effects. The reporter is a parent of a 12-year-old female patient from the same school who experienced low blood pressure, blurred vision, dizziness, headache, joint pain, nausea, sickness, vomiting and walking difficulty after she had received a first dose of GARDASIL on 26-Sep-2012 (see case E2012-09423).


VAERS ID: 506145 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-18
Onset:2013-07-01
   Days after vaccination:13
Submitted: 2013-10-04
   Days after onset:95
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002122 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Facial paresis, Seasonal allergy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conjunctival disorders (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cetirizine hydrochloride
Current Illness: Immunisation
Preexisting Conditions: Seasonal allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK002041

Write-up: Case received from a health care professional via the Health Authorities on 25-Sep-2013 under the reference number 22255653 and EFO7006. The primary reporter was a physician. Case is medically confirmed. A 27 year old female patient had received the first injection of GARDASIL (batch number J002122) via not reported route of administration in not reported site of administration on 18-Jun-13 and on 01-Jul-2013 she experienced unilateral peripheral facial paresis. The patient had received cetirizine on 02-Jul-2013 for hay fever (end date not reported) reported as concomitant medication by HA. She had no other vaccinations. At the time of reporting, the outcome was recovering.


VAERS ID: 506146 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-14
Onset:2013-09-20
   Days after vaccination:190
Submitted: 2013-10-04
   Days after onset:14
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000160 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sensation in eye, Back pain, Balance disorder, Blood glucose, CSF test normal, Cold sweat, Disturbance in attention, Dizziness, Headache, Hypoaesthesia, Memory impairment, Muscular weakness, Nausea, Neck pain, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Petit mal epilepsy, Protein total, Red blood cell count, Somatosensory evoked potentials, Speech disorder, Vision blurred, Visual evoked potentials normal, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Intervertebral disc protrusion
Allergies:
Diagnostic Lab Data: MRI scan of the entire cerebrum including spine showed normal conditions. The small median prolapse from the 4th lumbar level was found without any pressure on the nerve roots. Spinal fluid test showed clear and transparent liquid. Laboratory tests including WBC, proteins, sugar and red blood cells were performed, but results were not provided. Neurophysiological examination consisting of VEP and SSEP was normal.
CDC Split Type: WAES1310DNK002044

Write-up: Case received from a health care professional via the Health Authorities on 25-Sep-2013 under the reference DK-DKMA-ADR 22255937. Case is medically confirmed. A 22-year-old female patient with a medical history of asthma and small disc herniation L4-5 level, had received the first dose of GARDASIL (batch number H007797) intramuscular on 06-Sep-2012. On 20-Sep-2013, the patient developed dizziness, muscle weakness all over the body, back pain, neck pain, numbness in leg, balance problem, headache, pressure in the back of the eye, difficult speaking, blurry vision, cold sweat, memory problems, concentration difficult, absences and nausea. MRI scan of the entire cerebrum including spine showed normal conditions. The small median prolapse from the 4th lumbar level was found without any pressure on the nerve roots. Spinal fluid test showed clear and transparent liquid. Laboratory tests including WBC, proteins, sugar and red blood cells were performed, but results were not provided. Neurophysiological examination consisting of VEP and SSEP was normal. At the time of reporting, the patient had not recovered. The patient received D2 (batch no. H016967) of GARDASIL on 08-Nov-2012 and D3 (batch no. J000160) on 14-Mar-2013.


VAERS ID: 506151 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-06
Onset:2013-02-19
   Days after vaccination:105
Submitted: 2013-10-04
   Days after onset:226
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / ID

Administered by: Other       Purchased by: Other
Symptoms: CSF test normal, Incorrect route of drug administration, Myelitis, Nuclear magnetic resonance imaging brain abnormal, Visual evoked potentials normal
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Psoriasis
Allergies:
Diagnostic Lab Data: CSF test, Normal; Nuclear magnetic resonance imaging, white matter changes in 10th; Visual evoked potentials, Normal
CDC Split Type: WAES1310DNK001464

Write-up: Case of misuse (wrong route of administration) was received from a health care professional via the Health Authorities in a foreign country on 25-Sep-2013 under the references DK-DKMA-ADR 22249314 and DK-DKMA-EFO6920. Case is medically confirmed. A 27-year-old female patient (weight 64 kg, height 170 cm) with a medical history of psoriasis, had received the second of GARDASIL (batch number unknown) intradermal on 06-Nov-2012. On 19-Feb-2013, the patient developed myelitis. MRI revealed white matter changes in the 10th. Spinal fluid and VEP was normal. No other vaccines or medications were given. At the time of reporting, the patient was recovering. The patient received D1 of GARDASIL on 04-Sep-2012 and D3 on 11-Mar-2013. Toleration was not reported.


VAERS ID: 506173 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-10
Onset:2011-08-30
   Days after vaccination:81
Submitted: 2013-10-04
   Days after onset:766
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acupuncture, Disturbance in attention, Fatigue, Headache, Myalgia, Nausea, Paraesthesia, Paralysis, Syncope, Vision blurred, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK002046

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 25-Sep-2013 under the references DK-DKMA-ADR 22251683 and DK-DKMA-EFO6956. Case is not medically confirmed. A 12-year-old female patient (weight 68 kg, height 175 cm) had received the second of GARDASIL (batch number not reported) on 10-Jun-2011. On 30-Aug-2011, the patient developed nausea, abdominal pain, tiredness, headache, vomiting, muscle pain in leg, back and shoulder, fainting, tingling sensation in leg and arm, periodic paralysis, concentration problems, blurred vision (flicker of the eye) and anxiety. The patient received chiropractic treatment and acupuncture. The patient was examined due to abdominal pain. No cause was found. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 01-Apr-2011 and D3 on 16-Nov-2011. Toleration was not reported.


VAERS ID: 506174 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-19
Onset:2008-01-12
   Days after vaccination:24
Submitted: 2013-10-04
   Days after onset:2091
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1340F / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: A variety of test performed and diagnosed with multiple sclerosis (MS).
CDC Split Type: WAES1310DNK001466

Write-up: Case received from a health care professional via the Health Authorities on 25-Sep-2013 under the reference number 22248529 and EFO6918. Case medically confirmed. A 23 year old female patient had received the first injection of GARDASIL (batch number NF12400) via intramuscular route of administration in not reported site of administration on 19-Dec-2007 and on 12-Jan-2008 she experienced disseminated sclerosis with relapse. Patient received GARDASIL vaccinations at the gynecologist. She received second injection of GARDASIL (batch number NF12400) via intramuscular route of administration in not reported site of administration on 23-Jan-2008. The third vaccine was not given. The patient was hospitalised on 29-Jan-2008 (duration not reported) where she was examined and a variety of test was performed and diagnosed with multiple sclerosis (MS). No medical history reported. At the time of reporting, outcome of disseminated sclerosis with relapse is not recovered.


VAERS ID: 506357 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-15
Onset:2012-09-15
   Days after vaccination:0
Submitted: 2013-10-03
   Days after onset:383
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007797 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gait disturbance, Mental disorder, Muscle spasms, Pain, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001354

Write-up: Case received from non-health professional via Health Authorities on 26-Sep-2013 under the reference numbers 22252694 and 13-6626 (patient insurance company). The primary reporter was a lawyer from patient insurance company. Case is not medically confirmed. A 20 year old female patient, developed on 15-Sep-2012 sensory disturbance, cramps, unsteady walking mode and pain in association with the cramps, after she had received primary injection of GARDASIL (batch and lot number H007797) via not reported route and in not reported site of administration on 15-Sep-2013. HA: Case received on 17-Sep-2013 from the patient insurance company J. no. 13-6626 in terms of the patient''s initial notification. Note that the patient insurance company has not taken a decision on the matter yet. Adverse reactions: Cramping and pain associated with the cramps, sensory disturbance in both legs and feet and unsteady walking mode. Description of the adverse reactions: The patient cannot run anymore and feel that the adverse reactions have had major psychological consequences. The patient is undiagnosed despite hospitalizations and various examinations. The patient has received medical treatment for the adverse reactions (she has not reported which). Physician''s vaccination service informs the on 26-Sep-2013 that first vaccination was given on 15-Sep-2012 has the batch number H007797 and second vaccination given on 10-Nov-2012 have the same batch number as the first vaccination i.e. H007797 and number H007797 and second vaccination given on 10-Nov-2012 have the same batch number as the first vaccination i.e. H007797 and the third vaccination given on the 12-Mar-2013 has the batch and lot number J000160, exp. 30-JUN-2015. No information on medical history reported. At the time of reporting, the outcome was not recovered.


VAERS ID: 506393 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-28
Onset:2013-03-01
   Days after vaccination:93
Submitted: 2013-10-04
   Days after onset:216
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN06R / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Fatigue, Headache, Loss of consciousness, Malaise, Orthostatic hypotension, Orthostatic intolerance, Somnolence
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Systolic pressure (??-MAR-2013): 100 mmHg, in the spine position; Diastolic pressure (??-MAR-2013): 60 mmHg, in the spine position; Systolic pressure (??-MAR-2013): 72 mmHg, when standing up; Systolic pressure (??-MAR-2013): 58 mmHg, when standing up
CDC Split Type: WAES1310JPN000196

Write-up: Initial information has been received from a physician via the agency concerning a 13 year old female patient. The revaccination interview form (her underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, adverse drug reaction (ADR) history, status of growth) and her family history were not described. On 18-MAR-2013, she received the third injection of GARDASIL intramuscular injection drug (dose and injection site not reported) against cervical cancer. No concomitant medication was reported. On 24-SEP-2012, she received the first injection of GARDASIL (lot No. 9QN05R). On 28-NOV-2012, she received the second injection of GARDASIL (lot No. 9QN06R). On 18-MAR-2013, as stated above, she received the third injection of GARDASIL (Batch No. 9QN08R/lot No. 0989AA). In March 2013, the patient had generalized malaise, severe fatigue, headache, difficulty in awaking in the morning, strange sleepiness in the daytime, frequent absence from school, and orthostatic hypotension. Her blood pressure (BP) levels in the spine position and when standing up were 100/60 mmHg and 72/58 mmHg respectively. She lost her consciousness 3 minutes after her standing up. She developed orthostatic dysregulation. On 02-SEP-2013, the patient was recovering from the orthostatic dysregulation. Comment from the reporter: The orthostatic dysregulation can explain all the above symptoms. The reporting physician assessed that the orthostatic dysregulation was related to the GARDASIL. The physician assessed the orthostatic dysregulation as serious (other important medical event). Additional information is expected.


VAERS ID: 506396 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-10
Onset:2013-08-01
   Days after vaccination:113
Submitted: 2013-10-04
   Days after onset:64
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Amenorrhoea, Blood glucose, Blood test, Dyskinesia, Echocardiogram, Electrocardiogram, Fatigue, Hot flush, Metabolic function test, Muscle spasms, Muscle tightness, Muscular weakness, Oedema, Palpitations, Speech disorder, Total lung capacity
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELTROXIN; SERDOLECT; ABILIFY; EFEXOR DEPOT; Metformin Actavis
Current Illness: Immunisation
Preexisting Conditions: Polycystic ovaries; Social phobia; Myxoedema; Schizophrenia; GARDASIL, Dose number 2; GARDASIL, Oral herpes; GARDASIL, Metrorrhagia; GARDASIL, Paraesthesia; GARDASIL, Fatigue; GARDASIL, Syncope; GARDASIL, Nausea; GARDASIL, Myalgia; GARDASIL, Memory impairment; GARDASIL, Arthralgia; GARDASIL, Dizziness; GARDASIL, Dyspnoea; GARDASIL, Disturbance in attention; GARDASIL, Dose number 1, Headache
Allergies:
Diagnostic Lab Data: Laboratory and diagnostic tests included metabolic function test, blood glucose, ECG and ultrasound of the heart. Results were not provided. In addition to the already reported tests, the patient has also reported following tests to the patient insurance company: lung capacity, blood tests and blood pressure.
CDC Split Type: WAES1310DNK001071

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 27-Sep-2013 under the references DK-DKMA-ADR 22196072 and DK-DKMA EFO6424. Case medically confirmed. This case is linked to E2013-05787 (AE after dose 1) as same patient developed different AE after dose 1 and 3 vaccination. A 28-year-old female patient (weight 114 kg, height 170 cm) with a medical history of schizophrenia, social phobia, myxoedema and polycystic ovarian syndrome, had received third injection of GARDASIL (batch number H019870) via not reported route in not reported site on 10-Apr-2013 and in Aug-2013 patient developed cramps, edema, exhaustion, muscle tension, movement involuntary. And on unspecified date she also experienced muscle tension, weakness in legs, mild abdominal pain, hot flushes, palpitations, mumbles and has a hard time getting the words out and absence of menstruation. Concomitant medication included SERDOLECT since 2007 for schizophrenia, ABILIFY since 2011 for schizophrenia, EFEXOR DEPOT since 2005 for social phobia, METFORMIN ACTAVIS since 2010 for polycystic ovarian syndrome and ELTROXIN since 2010 for myxoedema. HA received follow up information from the patient on 20-Sep-2013: The patient describes she also has experienced the side effects: cramps, muscle tension, involuntary movements and edema. The patient has not received treatment for these side effects. HA received follow up information on 24-Sep-2013: Case received from the Patient Insurance in terms of the patient''s own report. Note that the Patient Insurance Association has not made a decision on the matter yet. Following side effects were reported (onset date not reported): muscle tension, weakness in legs, mild abdominal pain, hot flushes, palpitations, mumbles and has a hard time getting the words out and lack of menstruation. Laboratory and diagnostic tests included metabolic function test, blood glucose, ECG and ultrasound of the heart. Results were not provided. In addition to the already reported tests, the patient has also reported following tests to the patient insurance company: lung capacity, blood tests and blood pressure. FOLLOW UP received 26-Sep-2013 from patient''s doctor concerning batch numbers and vaccination dates of GARDASIL. He stated patient has received three vaccinations: the third vaccination was given by him on 10-Apr-2013. The vaccine has batch number: H019870. The other two vaccines were given by patient''s previous doctor who''s practice is closed. The patient''s medical record is not sent to the patient''s current doctor so he does not have the information on the batch numbers or vaccination dates of the first two vaccines. HA stated: Base on new information from the patient, Patient Insurance company and the patient''s general practitioner the following were added; side effects: cramps (onset Aug-2013), edema (onset Aug-2013), exhaustion (onset Aug-2013), muscle tension (onset Aug-2013), movements involuntary (onset Aug-2013), muscle weakness lower limb (onset not reported), stomach ache (onset not reported), hot flashes (onset date not reported), palpitations (onset not reported), speech disorder (onset not reported) and amenorrrhea (onset not reported). Date of third GARDASIL vaccine has changed from 20-Apr-2013 to 10-Apr-2013. Batch Number of the third vaccine is added. The patient''s initials are changed from SF to SCF. Examinations, lung capacity, blood tests and blood pressure is added. At the time of reporting, outcome of all AE was not recovered. Medical history includes 2 doses of GARDASIL. First vaccination of GARDASIL (batch number unknown) via not reported route in not reported site on 16-Oct-2012 On the same day, the patient developed headache, concentration impaired, difficulty breathing, dizziness, joint pain, memory impairment, muscle pain, nausea, fainting, tiredness, numbness and tingling in the feet and hands, spotting and herpes outbreaks in the mouth. The patient was hospitalised. Second vaccination of GARDASIL (batch number unknown) via not reported route in not reported site on unspecified date. Company note: HA changed onset age to 28 years old. Company note: Initial report from HA received on 30-Jul-2013. Follow up information received on 26-Sep-2013 from the health authority. New AE were reported after dose 3 vaccination hence this case created on 27-Sep-2013.


VAERS ID: 506398 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-30
Onset:0000-00-00
Submitted: 2013-10-04
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H018411 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Sensory disturbance, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN
Current Illness: Blood cholesterol increased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001345

Write-up: Case received from non-health care professional via Health Authorities on 23-Sep-2013 under the reference number 13-6665, EFO6795 and 22236202 (HA ref no.). The reporter was a lawyer from the patient insurance company. The case is not medically confirmed. This case is linked to E2013-06975 and E2013-07305 and the patient experienced different AEs after D1 and D2. A 21 year old female patient, developed on an unspecified date (post-vaccination) sudden headache attacks, sudden visual disturbances and sudden sensory disturbances in right side of the face and in right arm, after she had received the third injection of GARDASIL (batch and lot number H018411, exp. 31-MAR-2015) via not reported route of administration in not reported site of administration on 30-Jan-2013. These attacks occur 4-6 times per month and the sensory disturbances in the face has not yet subsided. The patient has received other concomitant medication, SIMVASTATIN (other mfr, oral route of administration) for high cholesterol. No further information specified. The patient has informed the patient insurance company that she has been hospitalized from 23-Jun-2013 to 24-JUn-2013 (duration of 2 days) because of the adverse reaction. The patient''s medical history includes: D1 GARDASIL 17-Sep-2012 (batch number G020674, Lot number NP00860). AEs after D1: severe headache, dizziness and nausea (described in case E2013-06975). D2 GARDASIL 22-Oct-2012 (batch and lot number H007797). On 05-Dec-2012 the patient experienced vomiting and pain in arm (described in case E2013-07305). At the time of reporting, the outcome was not recovered.


VAERS ID: 506401 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-29
Onset:0000-00-00
Submitted: 2013-10-04
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Epilepsy, Fatigue, Headache, Malaise
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001902

Write-up: Case received from a lawyer via the Health Authorities in a foreign country on 24-Sep-2013 under the reference DK-DKMA-ADR 22249424. Case is not medically confirmed. A 14-year-old female patient, had received the third dose of GARDASIL (batch number NK05560) on 29-Apr-2009. On 30-Apr-2009, the patient developed severe seizure. In Jul-2010 and in Feb-2011, the patient again had seizures. In Feb-2011, the seizures lasted 20 minutes and the patient was hospitalised. During hospitalisation, no cause was found. In Apr-2012, the patient developed the fourth seizure with duration around 20 minutes. She was admitted again due to she might had epilepsy. The patient was examined and received epilepsy medication. Since that the patient had no seizures, but suffered a lot from headaches, tiredness and malaise. The outcome of epilepsy and seizure was reported as unknown. At the time of reporting, the patient had not recovered from all other events. The patient received D1 of GARDASIL on 15 Oct 2008 (batch no. NJ01850) and D2 on 17-Dec-2008 (batch no. NJ01850). Toleration was not reported.


VAERS ID: 506406 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-01
Onset:2013-03-01
   Days after vaccination:0
Submitted: 2013-10-04
   Days after onset:216
Entered: 2013-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: 06/2012, 10/2012, Hospitalisation; 06/2012, 10/2012, Eating disorder
Allergies:
Diagnostic Lab Data: Examinations performed at departments of psychiatry and neurology showed no abnormality.
CDC Split Type: WAES1310JPN001305

Write-up: Initial information was received from a physician concerning 17-years-old female whose underlying disease was unknown. She had a history of hospitalization (from JUN-2012 to OCT-2012) due to eating disorder. On 01-MAR-2013, the patient received the second vaccination with GARDASIL IM injection drug 0.5 ml (injection site not reported). No concomitant medication was reported. On 26-DEC-2012, the patient received the first vaccination of GARDASIL with no problem. On 01-MAR-2013, as mentioned above, the patient received the second vaccination of the GARDASIL injection drug. After the vaccination, the patient seemed to be unable to hold chopsticks due to disabled hands. Around this time, numbness developed. Examinations performed at departments of psychiatry and neurology showed no abnormality. At the time of this report, the outcome of the numbness and "unable to hold chopsticks due to disabled hands after the vaccination" was unknown. Comment from the reporting physician: I just had a call from the patient''s parent, and I don''t know about details. The reporting physician assessed that the numbness was related to the GARDASIL. The physician assessed the numbness as serious (other important medical event). The physician did not assess the relationship of the "unable to hold chopsticks due to disabled hands after the vaccination" to the vaccine, or the seriousness of the event. Additional information has been requested.


VAERS ID: 506410 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-22
Onset:2012-12-05
   Days after vaccination:44
Submitted: 2013-10-03
   Days after onset:301
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007797 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Pain in extremity, Sensory disturbance, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: Nausea, Dizziness, Headache~HPV (Gardasil)~0~0.00~Patient
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Blood cholesterol increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001342

Write-up: Case received from non-health care professional via Health Authorities on 23-Sep-2013 under the reference number 13-6665, EFO6795 and 22236202 (HA ref no.). The reporter was a lawyer from the patient insurance company. The case is not medically confirmed. This case is linked to E2013-06975 and E2013-07293 as the patient experienced different AEs after D1 and D3. A 21 year old female patient, developed on 05-Dec-2012 vomiting and pain in arm, after she had received the second injection of GARDASIL (batch/lot number H007797) via not reported route of administration in not reported site of administration on 22-Oct-2012. The patient has received other concomitant medication, Simvastatin (other mfr, oral route of administration) for high cholesterol. No further information specified. The patient has informed the patient insurance company that she has been hospitalized from 23-Jun-2013 to 24-Jun-2013 (duration of 2 days) because of the adverse reactions. The patient''s medical history includes: D1 GARDASIL on 17-Sep-2012 (batch number G020674, lot # NP00860). AEs after D1: severe headache, dizziness and nausea (described in case E2013-06975). Post dose 3 of GARDASIL (batch/lot number H018411, expiration date 31-AUG-2015, administered on 30-Jan-2013 the patient experienced headache, visual disturbance and sensory disturbance in right arm and right side of face (described in case E2013-07293). At the time of reporting, the outcome was not recovered.


VAERS ID: 506412 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-10-30
Onset:2010-01-01
   Days after vaccination:63
Submitted: 2013-10-03
   Days after onset:1370
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Lumbar puncture, Nuclear magnetic resonance imaging, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 06/22/2009, GARDASIL, Immunisation; 04/17/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: In connection to the patient investigation, blood tests, lumbar puncture and MR-scanning were performed on an unspecified date with no results reported.
CDC Split Type: WAES1310DNK000806

Write-up: Case received from health care professional via the Health Authorities on 23-Sep-2013 under the reference number 22248330 and EFO6915. The primary reporter was a physician. Case medically confirmed. A 19 year old female patient, developed sensory disturbance on an unspecified date in Jan-2010, after she had received the third injection of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on 30-Oct-2009. The patient experiences sensory disturbance and is because of this hospitalized on 01-Jul-2012. No other vaccinations or medications. The batch numbers of the GARDASIL vaccinations which the patient has received are unknown to the reporter, they were not noted in the medical journal where the vaccine was given. In connection to the patient medical investigation, blood tests, lumbar puncture and MR-scanning were performed on an unspecified date with no results reported. The patient''s medical history includes: Primary and secondary injection of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on 17-Apr-2009 and 22-Jun-2009. Toleration of the vaccinations were not reported. At the time of reporting, the outcome was not recovered.


VAERS ID: 506414 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-09-23
Submitted: 2013-10-04
   Days after onset:11
Entered: 2013-10-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000633 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRI-CYCLEN
Current Illness: Product used for unknown indication
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN012117

Write-up: This spontaneous report as received from a pharmacist refers to a 24 year old female patient. On 23-SEP-2013 at 17:06, the patient was vaccinated with GARDASIL lot # J000633. Concomitant therapies included TRI-CYCLEN. The patient got vaccinated at the pharmacy on 23-SEP-2013 at 17:06 and within 2 minutes of having received the vaccine, she had a seizure which lasted about 15 seconds. The patient''s parents came to pick her up at the pharmacy soon after she had the seizure as she had driven there. Pharmacist advised that she got to the hospital after but when pharmacist followed up with the patient 3 hours later, she advised that she was fine and had decided not to go to the hospital. The outcome of the seizure was reported as recovered/resolved. The reporter considered the seizure to be related to GARDASIL. Additional information has been requested.


VAERS ID: 506427 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-12-27
Onset:2011-12-28
   Days after vaccination:1
Submitted: 2013-10-07
   Days after onset:648
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Feeling abnormal, Grip strength decreased, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Allergy to plants, cedar, cypress and ragweed
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN014839

Write-up: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient''s medical history was unknown. In October 2011, May 2012, and on an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16,18), (injected intramuscularly). In October 2012, the patient experienced grip strength decreased and feeling strange. The outcome of grip strength decreased and feeling strange was reported as not recovered/not resolved. The reporter considered grip strength decreased and feeling strange to be related to quadrivalent human papillomavirus types 6, 11, 16, 18). Follow up information was received regarding the 16 year old female patient. On an unknown date in December 2011 (previously reported as October 2012), the patient experienced hypoaesthesia and feeling of weakness to be related to quadrivalent human papillomavirus (manufacturer unknown). Follow up information has been received from a physician via PMDA concerning a fifteen year old female without concurrent conditions. She had phyto-allergy (cedar, cypress and ragweed). On 27-DEC-2011, for prophylaxis for Cervix carcinoma, she was vaccinated with GARDASIL IM, (second time of vaccination) 0.5mL (injection site was not reported). No concomitant medications were reported. On 25-OCT-2011, she was vaccinated with GARDASIL IM injection drug, (first time of vaccination) at A hospital. On 27-DEC-2011, she was vaccinated with GARDASIL IM injection drug, (second time of vaccination) at A hospital. At that time, the patient did not complain of Feelings of weakness or Hypoaesthesia. On 28-DEC-2011, Grip strength decreased, Feeling strange, fingers, Feeling of weakness, right fingertips and Hypoaesthesia, fingers developed. On 07-MAY-2012, she was vaccinated with GARDASIL IM injection drug, (third time of vaccination) at A hospital. On 26-AUG-2013, patient''s parent visited B hospital where he/she talked about his/her daughter. No treatment was taken about the patient. On 28-AUG-2013, it was reported that the patient experienced those symptoms about 4 times per week. She had the symptoms for about two hours at the longest. She was introduced to C hospital (pediatric department). No diagnosis or test results were received. As of reporting date, grip strength decreased, feeling strange, fingers, feelings of weakness, right fingertips and hypoaesthesia, fingers persisted. The physician of B hospital felt that Grip strength decreased, feeling strange, fingers, feeling of weakness, right fingertips and hypoaesthesia, fingers were related to recombinant quadrivalent human papillomavirus . He felt that it was unknown if there was other causes than the vaccination. The physician of B hospital considered grip strength decreased, feeling strange, fingers, feeling of weakness, right fingertips and hypoaesthesia, fingers were serious due to other important medical events. Additional information has been requested.


VAERS ID: 506442 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-20
Onset:0000-00-00
Submitted: 2013-10-03
Entered: 2013-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007250 / 3 UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arrhythmia, Blood test, Chest X-ray, Chest discomfort, Chest pain, Computerised tomogram, Dyspnoea exertional, Echocardiogram, Electrocardiogram, Exercise test, Malaise, Myalgia, Palpitations, Scan myocardial perfusion, Sensation of heaviness, Supraventricular tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 03/29/2012, GARDASIL, Immunisation; 02/01/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood pressure, not reported; Blood test, not reported; Chest X-ray, not reported; Computerised tomogram, not reported; Echocardiogram, not reported; Electrocardiogram, not reported; Electrocardiogram ambulatory, not reported; Exercise test not reported
CDC Split Type: WAES1310DNK001468

Write-up: Case received from patient/consumer via the Health Authorities on 23-Sep-2013 under the reference numbers 22249326 and 13-6890. The primary reporter was a lawyer. Case medically confirmed (by HA). A 38 year old female patient, developed oppressive chest pain, dyspnea upon slightest exertion, malaise and heart palpitations on 24-Aug-2012, cardiac arrhythmia on 28-Mar-2013 and on unspecified dates supraventricular tachycardia, heavy legs and muscle pain, after she had received the third injection of GARDASIL (batch number H007250) via intramuscular route of administration in not reported route of administration on 20-Aug-2012. Blood tests, X-ray of thorax, echocardiography, heart-CT, myocardial scintigraphy, exercise test, B-test (no further information specified), Holter monitoring, ECG and blood pressure were performed (on unspecified dates with no reported results). The case was received from the patient insurance company, J. no. 13-6890, which was the patient''s own claim. Note that the patient insurance company has not yet made a decision in the matter. The patient received the last and third GARDASIL vaccination on 20-Aug-2012. The night between 23-Aug-2012 and 24-Aug-2012 the patient developed oppressive chest pain. The patient described that she had never experienced anything like it. Subsequently the patient developed dyspnea upon slightest exertion, malaise/tightness for many months and heart palpitations. This was eased a bit around Feb-2013, but came back in Mar-2013. 28-Mar-2013 the patient developed cardia arrhythmia which lasted for 20 minutes. The patient had been cardiac examined thoroughly and it has been found that she probably had a supraventricular tachycardia. The patient has been put on a treatment with beta-blockers per need. The patient still experienced heavy muscles, muscle pain and dyspnea upon slightest exertion. These symptoms were not persistent but fluctuating. The patient described that she has not been able to exercise, she has had difficulty in having to pick up the children in the bicycle trailer and overcome things at home. The patient had the following treatment for the adverse reaction: SELO-ZOK (other mfr) when needed. HA received follow up information from the patient''s physician on 23-Sep-2013: First vaccination was received 01-Feb-2012 with batch number G004211, second vaccination was given 29-Mar-2012 with batch number G007396 and third vaccination was given 20-Aug-2012 with batch number H007250. Toleration for the vaccinations was not reported. At the time of reporting, the outcome was recovered for oppressive chest pain, malaise, heart palpitations and cardiac arrhythmia and not recovered for dyspnea upon slightest exertion, supraventricular tachycardia, heavy legs and muscle pain.


VAERS ID: 506522 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-05-01
Submitted: 2013-10-07
   Days after onset:159
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310ISR002139

Write-up: This spontaneous report was received from a physician concerning a 32 year old female patient. On unknown dates in 2008, the patient was vaccinated with doses of GARDSIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date in May 2013, the patient was diagnosed with cervical cancer. The outcome of cervical cancer was unknown. The relatedness for cervical cancer was unknown for GARDASIL. Upon internal review, the cervical cancer was considered to as medically significant. Additional information has been requested.


VAERS ID: 506524 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-30
Onset:0000-00-00
Submitted: 2013-10-07
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN12630 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Alopecia, Chest pain, Dizziness, Headache, Memory impairment, Nausea, Palpitations
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 09/23/2011, Historical drug GARDASIL; Drug Reaction: Joint dislocation; 07/22/2011, Historical Drug GARDASIL; Drug Indication: Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001348

Write-up: Case received from a lawyer via the Health Authorities on 24-Sep-2013 under the reference DK-DKMA-ADR-22249541. Case is not medically confirmed. A female patient, born on 14-Feb-1996, had received the third dose of GARDASIL (batch number G007714, Lot # NN12630, Exp date 23-SEP-2013) on 30-JAN-2012. On an unspecified date, the patient developed abdominal pain, headache, chest pain, dizziness, hair loss, memory problems, nausea and rapid heart palpitation. On an unspecified date in 2012, the patient developed dislocation of the right shoulder. In Jul-2012, the patient underwent left shoulder surgery, but it was dislocated again after 2 months. The patient received physiotherapy without effect. The patient was hospitalised due to heart palpitations and chest pain, and was examined by a GP and neurologist. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 22-Jul-2011 (batch no. NN20948) and D2 on 23-Sep-2011 (batch no. G004958; Lot # NN08930, exp date 15-SEP-2013). After D2, on an unspecified date in 2011, the patient developed left shoulder dislocation.


VAERS ID: 506573 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:2013-04-23
   Days after vaccination:42
Submitted: 2013-10-07
   Days after onset:167
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H014677 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Disturbance in attention, Fatigue, Headache, Myalgia, Nausea, Palpitations, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK002003

Write-up: Case received from a lawyer via the Health Authorities in a foreign country on 24-Sep-2013 under the reference DK-DKMA-ADR 22249531. Case is not medically confirmed. A 22-year-old female patient had received the third dose of GARDASIL (batch number H014677) on 12-Mar-2013. On 23-Apr-0213, the patient developed headache, rapid heart palpitations, body shaking, muscle pain, concentration impaired, tiredness, nausea and reduced appetite. The patient was hospitalised. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 27-Sep-2012 (batch no. H003811) and D2 on 13-Nov-2012 (batch no. H016967). Toleration was not reported.


VAERS ID: 506591 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:0000-00-00
Submitted: 2013-10-07
Entered: 2013-10-07
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, Disorientation, Encephalitis, Headache, Mobility decreased, Paraesthesia, White blood cell count increased
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Increased white cell count.
CDC Split Type: WAES1310GBR001081

Write-up: This case was received from a health care professional on 26-Sep-2013. This case is medically confirmed as it was reported by a pediatric pharmacist. A 12 year old female patient, with no medical history reported, received on 18-Sep-2013 a first dose of GARDASIL (batch number not reported), route and site of administration not reported. The day after vaccination, the patient experienced tingling in her arm. Four days later, the girl became disoriented with a severe headache and was unable to move her arm or write. She was admitted to hospital on 24-Sep-2013 with suspected encephalitis but tests were negative except for a slightly raised white cell count. The symptoms resolved without treatment over 24 hour period, however at the time of reporting she was still under investigation at the hospital with a possible diagnosis of migraine. At the time of reporting the patient had recovered from disoriented, tingling in her arm, headache and unable to move her arm. The outcome of slightly raised white cell count and migraine was not reported. The outcomes for the other adverse events are not reported.


VAERS ID: 506599 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:2013-03-13
   Days after vaccination:1
Submitted: 2013-10-07
   Days after onset:208
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000160 / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Asthma, Back pain, Blood count abnormal, Cold sweat, Disturbance in attention, Dizziness, Dyspnoea, Fatigue, Fluid retention, Headache, Heart rate increased, Heat stroke, Hyporesponsive to stimuli, Influenza like illness, Malaise, Memory impairment, Monoplegia, Muscle spasms, Myalgia, Nausea, Neck pain, Pyrexia, Sensory disturbance, Speech disorder, Tremor, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Asthma
Preexisting Conditions: GARDASIL, Pyrexia; GARDASIL, Cold sweat; GARDASIL, Influenza like illness; GARDASIL, Asthma; GARDASIL, Dyspnoea; GARDASIL, Headache; GARDASIL, Dizziness; 01/15/2013, GARDASIL, Malaise
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001347

Write-up: Case received from non-health professional via Health Authorities on 25-Sep-2013 under the reference numbers 22245400 and 13-7070. The primary reporter was a lawyer from the patient insurance company. Case is medically confirmed (by HA). This case is linked to E2013-07332 (reactions after D1) since the patient experienced different AEs after D1 and D2. A 27 year old female patient, developed severe headache, dizziness and breathing problems one day post-vaccination 13-Mar-2013 and on 15-Mar-2013 sensory disturbance, muscle cramps in hands, legs and respiratory tract, difficulty speaking, nausea, abdominal pain, muscle pain, and joint pain and on a non-specified date difficulty concentrating, tiredness, visual disturbance, fluid retention in the body, tremor in legs and hands, high pulse, heat stroke, paralysis of the right leg for short periods, pain in neck / upper back, low blood percentage, poor responsiveness, severe cell changes and memory difficulties, after she had received second injection of GARDASIL (Batch/Lot number J000160, Exp date 30-JUN-2015) via not reported route in not reported site of administration on 12-Mar-2013. Patient''s notification received from the patient insurance company: The day after second vaccination on 12-Mar-2013 the patient experienced breathing problems, was dizzy and had a severe headache. 3 days later the patient was urgently hospitalized with severe breathing problems, sensory disturbance, muscle cramps in hands, legs and respiratory tract, difficulty speaking, dizziness, nausea, abdominal pain, pain in all joints and muscles. 4 days after, the patient experiences completely the same symptoms and was once again urgently hospitalized (no further information specified). The patient is investigated for everything from vitamin deficiency to sclerosis and brain tumors and neurological disorders (no specified tests, dates or results reported). At the time of the notification, the patient had still following adverse reactions: Severe sensory disturbance (pronounced on the right side), muscle cramps in hands, legs and respiratory tract, difficulty speaking, difficulty concentrating, severe headache, dizziness, pain in all joints and muscles, constant enervating tired, memory difficulties, cold sweat, fever, visual disturbance, fluid retention in the body (especially the abdomen, legs and head), tremors in legs and arms, high pulse, heat stroke, paralysis of the right leg for short periods, severe pain in the neck / upper back, low blood percentage, poor responsiveness and very severe cell change. The patient medical history includes: D1 GARDASIL (Batch/Lot # H016967) on 15-Jan-2013. On 16-Jan-2013 the patient develops the following AEs: becomes unwell and experienced dizziness, headache, breathing problems, mini asthma attacks, flu-like symptoms, cold sweat and fever. The patient has a known asthma, and has been continuously monitored, it has been completely stable and under control throughout the period (no further information has been specified). At the time of reporting the outcome was unknown for nausea and abdominal pain, not reported for breathing problems and not recovered for all other events. According to a physician, the reactions were related to the vaccination.


VAERS ID: 506600 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-15
Onset:2013-01-16
   Days after vaccination:1
Submitted: 2013-10-07
   Days after onset:263
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016967 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Cold sweat, Dizziness, Dyspnoea, Headache, Influenza like illness, Laboratory test, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK001334

Write-up: Case received from non-health professional via Health Authorities on 25-Sep-2013 under the reference numbers 22245400 and 13-7070. The primary reporter was a lawyer from the patient insurance company. Case is medically confirmed by a physician. This case is linked to E2013-07329 (same patient, AEs after D2 GARDASIL since the patient experienced different AEs after D1 and D2. A 27 year old female patient, developed on 16-Jan-2013 mini asthma attacks, flu-like symptoms, breathing problems, cold sweat, dizzy, becomes unwell, fever and headache, after she had received primary injection of GARDASIL (batch/lot number H016967) via not reported route in not reported site of administration on 15-Jan-2013. Case received from the patient insurance company in terms of the patient''s own notification. Note that the patient insurance company has not made a decision in the matter yet. The day after the first vaccination on 15-Jan-2013 the patient becomes unwell and experienced dizziness, headache, breathing problems, mini asthma attacks, flu-like symptoms, cold sweat and fever. The patient is investigated for everything from vitamin deficiency to sclerosis and brain tumors and neurological disorders (no specified tests, dates or results reported). A medical certificate is attached to the notification to the patient insurance company, and has the statement: After reading the patient''s record and heard about her medical history, there is no doubt that her many symptoms and condition is due to the after effects and adverse reactions of HPV vaccine which she got the first time in January 2013 and the second time in March 2013. On the basis of this medical report, the case considered as medically confirmed. The patient has not received the third dose. At the time of reporting, the outcome was unknown for becomes unwell, breathing problems, mini asthma attacks and flu-like symptoms and not recovered for dizziness, headache and cold sweat.


VAERS ID: 506603 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-02
Onset:2013-07-02
   Days after vaccination:0
Submitted: 2013-10-08
   Days after onset:98
Entered: 2013-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J004473 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Fall, Head injury, Headache, Hypertonia, Lip haemorrhage, Loss of consciousness, Somnolence, Tongue biting
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Blood pressure, 110/80 mmHg; 2013, Heart rate, 68/min
CDC Split Type: WAES1310POL002699

Write-up: The information has been received from Agency (HA) (agency # PL-URPL-N879/2013), the primary source was physician. On 02-JUL-2013 at 18:15, 16 years old female patient was vaccinated with SILGARD (lot # J004473, exp 12-OCT-2015), 0.5 ml intramuscular injection in left arm. On reporting form of post-vaccine reaction were noted the following adverse events: first episode of seizures. In the narrative part of the form the physician reported: After vaccination patient experienced loss of consciousness, non febrile seizures (first episode). The patient fell on the floor and hit her head on the floor. Increase of muscle tone- loss of consciousness for 15-20 seconds and bit tongue were observed. After the fall patient experienced headache, somnolence and was battered. Heart rate 68 per minute, heart rhythm regular, blood pressure 110/80 mm Hg. Due to head injury and bleeding from lip the patient was directed to hospital. According to reporting form reaction occurred on 02-JUL-2013 at 18:15. Medical outcome: The patient was still recovering in hospital. Reporter comment: In the past child did not experience any post-vaccine reaction. Sender''s comment: Seizures are unexpected and unknown reaction after vaccination with SILGARD. Syncope as short term loss of consciousness is expected and known reaction. Loss of consciousness was unexpected but known reaction. In WHO database there were reported 5 cases of loss of consciousness and 8 cases of syncope since 2010. Temporal relationship evidently suggested causal relationship. Initial reporter considered this report as non serious however Agency due to character of adverse event upgrades this report to serious. The child was hospitalized due to injury after fall, not due to post vaccine reaction. There were reported other post vaccine reactions after this lot number. Additional information is not expected.


VAERS ID: 506616 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2013-03-25
Onset:2013-05-01
   Days after vaccination:37
Submitted: 2013-10-08
   Days after onset:160
Entered: 2013-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Eyelid ptosis
SMQs:, Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310JPN002754

Write-up: Initial information has been received from a physician concerning a patient (sex and age were unknown). On an unknown date, the patient was vaccinated for the second time with GARDASIL (lot# not reported) intramuscular injection, 0.5 ml once a day (vaccination site and indication for use were not provided). Concomitant medication was not reported. On 25-MAR-2013, the patient was vaccinated for the first time with GARDASIL (lot # not reported) (vaccination site and indication for use were not provided) intramuscular injection, 0.5 ml once a day. On an unknown date, the patient was vaccinated for the second time with GARDASIL intramuscular injection, 0.5 ml once a day. On approximately end of May, the patient developed eyelid ptosis and the patient visited the neurologist''s office. On 27-SEP-2013, the patient was vaccinated for the third time with GARDASIL (lot# not reported) (vaccination site and indication for use were not provided), intramuscular injection, 0.5 ml once a day. The patient did not consult about eyelid ptosis with the physician prior to the vaccination, because the patient did not suspect the relationship with HPV vaccine. On 30-SEP-2013, the patient visited to the hospital with patient''s mother and informed the physician that eyelid ptosis was labeled in the package insert of GARDASIL. On 03-OCT-2013 at the time of the report, , the patient did not recovered from eyelid ptosis (outcome of the adverse event was also reported as unknown). The reporting physician felt that the relationship between eyelid ptosis and GARDASIL was unknown. The reporting physician considered that eyelid ptosis was non-serious. Upon internal review, eyelid ptosis was determined to be serious due to other important medical event. Physician''s comment: It was difficult to assess the relationship with the vaccine. Additional information has been requested.


VAERS ID: 506621 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-09
Onset:2013-09-11
   Days after vaccination:2
Submitted: 2013-10-08
   Days after onset:27
Entered: 2013-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013055 / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Acne, Condition aggravated, Infected bites, Inflammation, Intensive care, Local swelling, Malaise, Oropharyngeal pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Acne
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL002891

Write-up: This case was received on 27-Sep-2013. REF 2013-018284. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient was vaccinated on 09-Sep-2013 with a dose of GARDASIL (batch and lot n. H013055) in left arm (route, dose in series not reported). On the evening of vaccination, on 09-Sep-2013, the patient developed a high fever. One day post vaccination, on 10-Sep-2013, the patient was unwell. Two days post vaccination, on 11-Sep-2013, the patient developed a sore throat and swollen feet. The patient had no concomitant medication. The vaccine was administered by a nurse. Just before the vaccination, the patient had what the nurse thought to look like a pimple on her right arm that was not red. The patient was reported to be otherwise well. On 11-Sep-2013 the patient''s mother phoned the vaccinating nurse to inform that on the evening of the vaccination the patient developed a high fever and the high fever persisted overnight and that the patient''s pimple was also swollen and inflamed and looked infected. On 10-Sep-2013 in the morning the patient was unwell and she was taken to see her GP on 10-Sep-2013 who diagnosed an infected insect bite and prescribed antibiotics, antihistamines and paracetamol. On 11-Sep-2013 in the afternoon, the patient had not improved and was brought to A&E with a high temperature, sore throat and swollen feet. On 12-Sep-2013 in the morning the patient was transferred to ICU in another hospital. At the time of reporting the patient had not recovered. The company decided to add the seriousness criteria "hospitalisation". Upon medical review, the company decided to add the adverse events "swollen and inflamed reaction suspected to be insect bite" and "condition aggravated". The outcome was not reported for these adverse events.


VAERS ID: 506648 (history)  
Form: Version 1.0  
Age: 42.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-08
Entered: 2013-10-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Chest X-ray normal, Cough, Dyspnoea, Impaired work ability, Pneumonia, Pneumonia chlamydial, Pneumonia mycoplasmal, Total lung capacity decreased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 11/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: CHest X-ray, Clean not provided
CDC Split Type: WAES1310DNK002943

Write-up: Case received from healthcare professional via company representative on 20-Sep-2013. The primary reporter was a physician. Additional information received from the physician on 02-oct-2013. A 42 year old female patient had received the second dose of GARDASIL (batch number not reported) via not reported route of administration and site of administration on administration date in february 2013 and later on she developed bad breathing, chlamydia pneumonia, pneumonia mycoplasma, daily coughing attack and reduced lung capacity. After the second GARDASIL vaccination she developed bad breathing. It came slowly, like a little asthma. Thereafter she developed pneumonia. She was treated with unspecified treatment and was controlled and recovered, but had daily coughing attacks. She developed again pneumonia, this time due to mycoplasma. Patient was examined and thorax X-ray was clean but she can still not breath. Has only 44 % of her lung capacity and can not function as normal. According to the patient''s physician batch number is not available as the patient was vaccinated by her sister (who is another physician). The patient visited the reporting physician on 22-Feb-2013. At first she started to cough and then the cough infiltrated both lungs. She received penicillin therapy, the infiltration went away. After a few months the infiltration was back, the diagnose was chlamydia pneumonia. She received another treatment (brand not reported) and was referred to a respiratory ward at a hospital. They have given her a treatment but do not understand her sickness. Patient was completely healthy (respiratory) before Feb-2013. She has not smoked and has no allergies. Now she has only 1/3 of lung capacity and cough all the time. She has maximum asthma treatment and high doses of prednisolone treatment. The doctor says that the patient has lost her job and it is very tragic. Patient had previously received the first primary dose of GARDASIL (Batch number not reported) via not reported route of administration in not reported site of administration in Nov-2012. Patient received the third dose of GARDASIL (batch number not reported) via not reported route of administration and site of administration on unspecified date in Aug-2013. Company assessed seriousness criteria as other medically important event due to total lung capacity decreased. Discrepancy: Patient reported that she first experienced pneumonia and then again pneumonia due to mycoplasma. But the physician reported that she had first pneumonia and then chlamydia pneumonia. It is uncertain how many times she had pneumonia as well as chronological order of the events.


VAERS ID: 506650 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-16
Onset:0000-00-00
Submitted: 2013-10-09
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood glucose increased, Decreased appetite, Depression, Emotional distress, Fatigue, Pollakiuria, Polydipsia, Somnolence, Type 1 diabetes mellitus, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 12/11/2008, GARDASIL, Immunisation, Weight decreased; 10/09/2008, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood glucose, Increased
CDC Split Type: WAES1310DNK003420

Write-up: Case received from a consumer via the patient insurance company via the Health Authorities on 25-Sep-2013 under the reference number 22249747. The primary reporter was a lawyer/patient insurance company. The case is not medically confirmed. A 17 year old female patient had received a third injection of GARDASIL (batch number unknown) via not reported route of administration in not reported site of administration on 16-Apr-2009 and post vaccination she experienced weight loss, tiredness, loss of energy, drink water all the time, appetite lost, urinate 10-20 times a day, weight loss, hospitalized with high blood sugar (unspecified dates). She was diagnosed with diabetes type 1 on 19-May-2013. She is depressed because of diabetes. Case reported to HA by patient insurance company on 17-Sep-2013, with reference number J-nr 13-5738, as patient''s own report to the patient insurance company. Note that the Patient Insurance Association has not taken a decision on the matter yet. Description of Course from the patient: I got my first HPV vaccine on 09-Oct-2008 and second on 11-Dec-2008. After my second vaccine, I started to lose a lot of weight. I got my third vaccination on 16-Apr-2009, and I kept losing weight, I went from 68 to 52 kg in about 4-5 months time (from March to July 2009). I did nothing to lose weight and still ate the same and without any exercise. I began to be tired all the time for a very long time, I did not want to eat, I drank water all the time and had no energy. I did nothing but sleep and I had to urinate 10-20 times a day. The 19-May-2011 I went to see the doctor because I could not take it anymore. I took urine sample and the doctor told me there was a high possibility that I had diabetes type 1. I was shocked and upset and could not understand it. There is no one in my family who has diabetes. How could this happen to me? I was quick hospitalized with very high blood sugar and received treatment promptly. The doctors could not give me an answer why it has happen to me, since no one in my family has diabetes, and I do not eat unhealthy or live badly. It''s hard to live a whole new life and change everything and take medication every day so my body could be ok. A few months ago I found out that HPV vaccine, GARDASIL, has triggered my diabetes (no more information provided), it has for sure made a lot of changes in the cells in my body. If I knew that the HPV vaccine could cause so many symptoms, I would have not taken it as diabetes has changed and ruined my life completely! I cannot live my life as before, because I always need to take care of myself and think about what I eat and what I do. Patient''s life after the side effects: Diabetes will always be troublesome, because it follows me, my whole life and I can never stop it. I''m depressed because of my diabetes and I had lived a difficult life after I got the diagnose. Treatment of the adverse events: I get insulin and it is vital for me and I have control visit at Hospital. Health authority has been in telephone contact with the patient''s general practitioner to get the batch numbers on GARDASIL vaccines. These are not available. Medical history includes 2 doses of GARDASIL. First vaccination of GARDASIL (batch number unknown) via not reported route in not reported site on 09-Oct-2008. Second vaccination of GARDASIL (batch number unknown) via not reported route in not reported site on 11-Dec-2008 and on unspecified date she experienced weight loss. At the time of reporting, outcome of diabetes and depression is not recovered and outcome of the other adverse events was unknown.


VAERS ID: 506664 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-09
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Peripheral vascular disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DEU002923

Write-up: This case has been reported through a market research study for GARDASIL vaccination on 27-Sep-2013. Case is medically confirmed. This case is poorly documented. A female patient in her early twenties received a dose of GARDASIL (lot-no., injection route and site not reported) on an unspecified date about 3 years ago. On the same day, she was hospitalised due to suspicion of peripheral circulatory disorder. Duration and outcome were not reported. According to the reporter the reaction was related to the vaccination.


VAERS ID: 506668 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-10-01
Submitted: 2013-10-09
   Days after onset:1469
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Chronic fatigue syndrome
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR002905

Write-up: This case was received from the health authority on 27-Sep-2013. GB-MHRA-ADR 22251540. This case is not medically confirmed as it was reported by a consumer. A 14-year-old female patient (weight 53 kg), with no reported medical history, received on an unreported date an injection of human papilloma virus vaccine (mfr unknown; batch n., route, dose, dose in series and site of administration not reported) and in Oct-2009 she developed chronic fatigue syndrome. On an unreported date she also experienced activities of daily living impaired. She was unable to attend school or carry on normal life. At the time of reporting the patient had not recovered. The agency considered this case to be serious due to disability/incapacity and as an other medically important condition.


VAERS ID: 506812 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-19
Onset:2013-09-19
   Days after vaccination:0
Submitted: 2013-10-09
   Days after onset:20
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005992 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dizziness, Erythema, Headache, Hypoaesthesia, Induration, Injection site reaction, Malaise, Nausea, Oedema peripheral, Pallor, Pyrexia, Skin swelling, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 103/62 mmHg; Heart rate, 125 min
CDC Split Type: WAES1310POL002269

Write-up: Patient female on 19 September 2013 at 10:00 AM was vaccinated wtih Silgard (volume 0.5 ml) intramuscular in left arm (lot# J005992/ exp 11/2015), On reporting form of post-vaccine reaction (other than BCG) were noted the following adverse events: fever above 40.5 Celsius degrees, up to 48 hours, chills, vomiting, numbness of limbs, severe injection site reactions with a diameter greater than 10 cm. In the narrative part of the form the physician reported: About 45 minutes after vaccination: dizziness. About 2 PM severe headache, later edema and redness of left arm with thick, linear ridge running vertically in the direction of the elbow. Numbness of left hand and right leg. About 6 PM severe chills fever initially 39 Celsius degrees, at 12 PM 40.6 Celsius degrees, at 4:30 AM 39.5 Celsius digress. At examination in physician office- state average, pale, hard, swollen skin, chills, blood pressure 103/62 mmHg, cor - 125. Headache, nausea, vomiting. Feeling generally unwell. The patient was directed to hospital. According to reporting form reaction occurred on 19-SEP-2013 at 11:00. Medical outcome: the child is still traded at home. Case comment: In the past the patient did not experience any post-vaccine reactions.


VAERS ID: 506830 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-09
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amylase, Antiphospholipid antibodies positive, Arthralgia, Asthenia, Autoimmune disorder, Autoinflammatory disease, Blood culture negative, Cardiolipin antibody positive, Culture throat negative, Culture urine negative, Decreased appetite, Erythema, Headache, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging brain normal, Oropharyngeal pain, Protein urine absent, Pyrexia, Serum amyloid A protein increased, Skin lesion
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Raynaud''s phenomenom, defined by nailfold capillaroscopy
Preexisting Conditions: Beta haemolytic streptococcal infection, 1 year before admission; Tonsillitis, during childhood; Penicillin, Drug indication: Beta haemolytic streptococcal infection
Allergies:
Diagnostic Lab Data: Laboratory workup (date unspecified): revealed normochromic normocytic anemia; Autoantibodies profile (date unspecified): demonstrated persistent positivity of anti-cardiolipin IgM and LAC; Magnetic resonance imaging of the brain (date unspecified): excluded the presence of brain abnormalities consistent with antiphospholipid syndrome; Culture (unspecified date); Pharyngeal culture as well as urine and blood culture excluded active infections; Laboratory workup revealed normochromic normocytic anemia, slight increase of serum amyloid A (SAA) levels of 9 mg/l. Proteinuria was absent. Autoantibodies profile demonstrated persistent positivity of anti-cardiolipin IgM and lupus anticoagulant. Body temperature, Rose up to 39 degrees C, Increased
CDC Split Type: WAES1309ISR001892

Write-up: Information initially received and was described in linked case E2013-03484 which was updated with information of patient n. 1. The other 4 patients reports of the article were described in linked cases E2013-06723; E2013-06725; E2013-06727 and E2013-06728 (same vaccine, similar events, different patients). This case concerns patient n. 4. This literature marketed report as received from a physician refers to a 16 year old female patient. Her medical history was remarkable for recurrent tonsillitis during childhood and a streptococcus group B infection 1 year before admission, treated with penicillin. In addition the patient suffered from Raynaud''s phenomenon grade II, defined by nailfold capillaroscopy. Her family history was also remarkable for Raynaud disease of patient''s mother. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient was admitted the hospital with a preliminary diagnosis of FUO (fever of unknown origin), which appeared for the first time 3 weeks after the second dose of GARDASIL. Fever was prolonged, mainly present in the morning, and rose up to 39 degree Celsius (C). In addition, pharyngodynia, erythematous skin lesions of elbows and knees, generalized asthenia, anorexia, polyarthralgia, and headaches were present. Pharyngeal culture as well as the urine and blood cultures excluded active infections. Laboratory workup revealed normochromic normocytic anemia, slight increase of serum amyloid A (SAA) levels of 9 milligrams/liter. Proteinuria was absent. Autoantibodies profile demonstrated persistent positivity of anti-cardiolipin IgM and lupus anticoagulant (LAC). Magnetic resonance imaging of the brain excluded the presence of brain abnormalities consistent with antiphospholipid syndrome. Her medical history was remarkable for recurrent tonsillitis during childhood and a streptococcus group B infection 1 year before admission, treated with penicillin. In addition, the patient suffered from Raynaud''s phenomenon grade II, defined by nailfold capillaroscopy. Her family history was also remarkable for Raynaud disease of patient''s mother. On an unknown date, the patient was diagnosed with fever in a patient with antiphospholipid antibodies, possibly related to GARDASIL vaccination, compatible with the autoimmune/auto inflammatory syndrome induced by adjuvants (ASIA). She was treated with naproxen 500 milligrams (mg)/day for 2 months and omega-3 polyunsaturated fatty acids 2,000 mg/day for 4 months. The doses were very gradually tapered down. She was discharged with instructions to avoid sun exposure and to avoid further vaccination. At follow-up visit, the patient was in remission and in good health. The authors mentioned that based on the current data, a causal link between HPV vaccine and onset or relapse of SLE was plausible. The patient considered the event to be possibly related to GARDASIL. This is one of the several reports from the same source. Additional information has been requested. It has been determined that case # 1309ITA004643 is a duplicate of case # 1309ISR001892. Therefore, case # 1309ITA004643 is being deleted from our files and the cases consolidated into case # 1209ISR001892.


VAERS ID: 506842 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-09
   Days after onset:21
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL003239

Write-up: This case was received from the health authority on 30-Sep-2013. REF 2013-018318. This case is medically confirmed as it was reported by a physician. A 12 year old female patient, with a medical history of mild asthma, received on 18-Sep-2013 an injection of GARDASIL (batch number H019633) 0.5 mL intramuscularly, dose in series and site of administration not reported. On 18-Sep-2013, five minutes post vaccination, the patient experienced rash on trunk and face. It was also reported the patient presented with acute hypersensitivity reaction on 18-Sep-2013. The reporter indicated the patient''s vitals were stable and the patient had no bronchospasm. The patient received a corrective treatment with PIRITON 4 mg orally on an unreported date. Both reactions lasted only three hours. At the time of reporting, the patient had fully recovered. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 506957 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-02
Onset:2012-05-01
   Days after vaccination:89
Submitted: 2013-10-10
   Days after onset:527
Entered: 2013-10-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN12610 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Aspartate aminotransferase increased, Autoantibody positive, Blood 25-hydroxycholecalciferol decreased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Body temperature increased, Cell marker increased, Chest pain, Complement factor C3, Complement factor normal, Computerised tomogram thorax abnormal, Constipation, Depressed mood, Dysphagia, Fatigue, Frequent bowel movements, Gastrointestinal hypomotility, Haematochezia, Headache, Interstitial lung disease, Lipase normal, Local swelling, Muscle enzyme increased, Musculoskeletal pain, Myalgia, Myositis, Night sweats, Oesophageal disorder, Overlap syndrome, Pain in extremity, Peripheral coldness, Polymyositis, Raynaud's phenomenon, Respiratory distress, Scleroderma, Synovitis, Ultrasound abdomen abnormal, Ultrasound joint, Ultrasound scan abnormal, Vitamin D decreased, Vitamin D deficiency
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal haemorrhage (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), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, Dose 1. Lot number G005824.
Allergies:
Diagnostic Lab Data: Ultrasound joint: slight synovitis of both wrist. Ultrasound abdomen: expanded liver veins. CT scan: subpleural interstitial changes of lung tissue. ANA: positive. Autoantibody test: Anti-PM-Scl positive; 06/06/2013, Alanine aminotransferase, 55 U/L; 06/21/2013, Alanine aminotransferase, 48 U/L; Antinuclear antibody, Positive; 06/06/2013, Aspartate aminotransferase, 79 U/L; 06/21/2013, Aspartate aminotransferase, 84 U/L; Autoantibody test, Anti-PM/Scl positive; 06/06/2013, Blood 25-hydroxycholecalciferol, 9.9 ng/mL; 06/06/2013, Blood creatine phosphokinase, 1352 U/L; 06/06/2013, Blood creatine phosphokinase, 1763 U/L; 06/06/2013, Blood lactase dehydroginase, 393 U/L; Blood lactase dehydroginase, 415 U/L; Body temperature increased, 37.5 to 37.8 degrees C; 06/06/2013, Cell marker, Neopterin 17.4 mmol/l; 06/06/2013, Complement factor C3, 96 mg/dL; Computerised tomogram, subpleural interstitial changes of lung tissue; 06/21/2013, Lipase, 51 U/L
CDC Split Type: WAES1310DEU002902

Write-up: Case received from a health care professional on 30-Sep-2013. Case is medically confirmed. Case is linked to non-serious case E2013-5989 (same reporter, same vaccine, different reaction, different patient). A 15-year-old female patient (weight 59.9 kg, height 167 cm) received the second dose of GARDASIL (batch-no G017722, lot number NP00860) on 29-May-2012. On an unspecified date in May-2012, the patient developed polymyositis/scleroderma-overlap-syndrome including Raynaud''s pnenomenon, swollen fingers, changes to the capillary arteries, dysfunction of the oesophagus, suspicion of intestinal pseudoobstruction, intestinal lung disease, myositis with increased muscle enzymes. In the lab test ANA was positive with a nuclear pattern and anti-PM/Scl was positive. Since this time she was hospitalised frequently. The patient was hospitalised in May-2013. During this hospital stay a high-definition CT of the lung revealed subpleural interstitial changes of the lung tissue. Therapy with URBASONE was continued, azathioprine was replaced by MYFORTIC. Additionally, the patient started therapy with QUENSYL and rituximab. Furthermore, a therapy with amlodipine was started as well as MOVICOL. The patient received regular physiotherapy, massage and ergotherapy. Despite all this, there was no significant improvement of the symptoms. Since end of that hospitalization the patient experienced progressive health problems with continuing pronounced bifrontal headache, stomach ache, muscle and joint pain. The patient described periods of pronounced fatigue and persistent pain in both knees. Her temperature was slightly increased (37.5 to 37.8 degree C) and she experienced night sweat. All fingers were painful and cold. The patient experienced nightly respiratory distress with left-sided precordial chest pain. The patient was hospitalised from 05-Jun-2013 to 22-Jun-2013 with persisting symptoms including daily chronic headache, chronic cramp-like epigastric stomach pain, dysphagia, frequent defecation with hematochezia, arthralgia of the knees, myalgia of the right calf and pronounced swelling of the fingers with Raynaud''s phenomenon. Examination of joints showed pronounced constriction of active movement; passively a complete fist could be formed under pain. Both knees could be moved freely under pain. Ultrasound of the joints of both wrists showed a slight synovitis. Ultrasound of the abdomen revealed expanded liver veins with a diameter of 1.5 cm. Lab tests on 06-Jun-2013 revealed GOT 79/l, GPT 55 U/l, LDH 393 U/l, CK 1352 U/l, C3 96 mg/dl, Neopterin 17.4 nmol/l and 25-OH vitamin D 9.9 ng/ml. Lab tests on 21-Jun-2013 revealed GOT 84 U/l, GPT 48 U/l, LDH 415 U/l, CK 1763 U/l and Lipase 51 U/l. A secondary pain syndrome with daily chronic headaches and arthromyalgia was suspected. Vitamin-D deficiency was diagnosed and treated with Vigantoletten. After rituximab therapy methylprednisolone could be reduced and the patient''s depressive mood improved. For the persistent myositis with pronounced increased muscle enzymes and neopterin (as a marker for interferon-activated macrophages) an additional therapy with GAMUNEX IV was started. Further medication included: MYFORTIC, QUENSYL, MOVICO and SORBITOL due to chronic obstipation. At the time of reporting, the patient had not recovered. According to the reporter, the reactions were definitely related to the vaccination. Previous dose of GARDASIL (D1, batch-no. G005824, lot number NN12610, Exp. Date: 20-SEP-2013) was given on 02-Feb-2012. Toleration was not reported.


VAERS ID: 506968 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-05
Onset:2013-10-06
   Days after vaccination:1
Submitted: 2013-10-11
   Days after onset:5
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Blood test normal, Cold sweat, Crying, Dysstasia, Gait disturbance, Headache, Hypoaesthesia, Insomnia, Laboratory test normal, Malaise, Pain, Sensory disturbance, X-ray normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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:
Allergies:
Diagnostic Lab Data: Laboratory test (unspecified) (06-OCT-2013): no abnormalities were found; 10/06/2013, Blood test, normal, no abnormalities N/A
CDC Split Type: WAES1310JPN005136

Write-up: Initial information has been received from a physician concerning a 13-year-old female patient with no underlying disease or medical history. On 05-OCT-2013, the patient received the third time vaccination with a GARDASIL IM injection drug (dose, injection site and not provided). No concomitant medication was reported. On an unspecified date, the patient received the first time vaccination with the GARDASIL ()batch number: 9QN07R, lot number: 0788AA, expiry date: 05-JUN-2014). On an unspecified date, the patient received the second time vaccination with the GARDASIL (batch number: 9QN08R, lot number: 0989AA, expiry date: 21-JUN-2014) at a nearby internal medicine clinic. One hour later, she had cold sweat and malaise. After she went home, she repeated 3-hour-sleep and waking up for strange sensation, but she had an appetite. On 06-OCT-2013, around 1:00 in the midnight, the patient had symptoms with numbness of four limbs (joints lower than elbow and knees). She also had headache, abdominal pain and malaise. She could not sleep because of pain, but the pain disappeared in the morning. She was seeing what''s happening and then became unable to stand up due to weakness. The headache and numbness reappeared around at 14:00 and 16:00, respectively. She then urgently visited and was admitted to the reporting physician''s hospital because frequency of these symptoms gradually increased. At presentation to the hospital, the patient seemed to have difficulty walking and to be crying and suffering. She received only drip infusion at admission. No abnormalities were found in blood tests or radiographic findings. On 07-OCT-2013, the malaise and numbness of four limbs (joints lower than elbows and knees improved. The outcome of the cold sweat, headache, abdominal pain, and weakness was unknown. Mild numbness of legs was still persisted in the morning then disappeared in the early evening. Reporter''s comment: none. The reporting physician did not assess the causal relationship of the malaise, numbness of four limbs (joints lower than elbows and knees) as serious (hospitalization) and did not assess the seriousness of the cold sweat, headache, abdominal pain and weakness. Additional information has been requested.


VAERS ID: 506972 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-22
Onset:2009-07-01
   Days after vaccination:70
Submitted: 2013-10-11
   Days after onset:1563
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Amnesia, Aphasia, Arthralgia, Blood test, Chest pain, Disorientation, Dissociation, Dizziness, Ear, nose and throat examination, Eczema, Fatigue, Hypersensitivity, Impaired driving ability, Insomnia, Memory impairment, Muscle spasms, Palpitations, Photopsia, Radioallergosorbent test positive, Tremor, Vestibular function test, Visual acuity reduced
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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 (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Obsessive-compulsive disorder; Multiple allergies, Positive RAST; Altermaria; Timothy and Mugwort
Preexisting Conditions: Chest pain; Palpitations; Dermatitis atopic, on hands; 12/17/2008, GARDASIL, immunisation, Dose 2; 10/15/2008, GARDASIL, Immunisation, Dose 1
Allergies:
Diagnostic Lab Data: Several blood samples has been taken, abdomen has been examined, an ear-nose-throat specialist has examined the balance nerve. Unknown date vestibular function test was performed (no result was provided) Radioallergosorbent test, Positive RAST, Altermaria Timothy and Mugwort
CDC Split Type: WAES1309DNK001383

Write-up: Case received from a patient/consumer via a Health Authority on 21-Aug-2013 under the reference numbers EFO6579 and 22213483. Case not medically confirmed. A 19 year old female patient had received an injection of GARDASIL (dose, batch number, route and site not reported) on an unspecified date in 2009 and later on an unspecified date in 2009, she developed memory loss, dizziness. allergy and abdominal cramps. According to the reporter she has not been treated for the events and not hospitalized for the events. Several blood samples has been taken, abdomen has been examined, an ear-nose-throat specialist has examined the balance nerve. He has coded patient age as adolescent but according to data entry rules entered as adult. The patient was previously vaccinated with GARDASIL (dose, batch number, route and site not reported) on an unspecified date in 2008. The patient has a history of atopic eczema on hands, palpitations and chest pain. At the time of reporting, the outcome was not recovered. Follow up information from health care professional via health authority on 27-Sep-2013 under the reference number 22251473 and EFO6952. The reporter was a physician. On 02-Oct-2013 the HA confirmed that is was a duplicate identified with their case and merged with this current case. The following adverse reactions with different start date in 2009 were reported by the reporting physician: dizziness (Jul-2009), feeling remote (gold fish sensation) (Jul-2009), abdominal cramps (2009) poor memory and memory loss(Jul-2009), shaking of hands (Jul-2009), heart palpitations (Jul-2009), pain in chest (Jul-2009), eczema (Jul-2009), poor vision (Jul-2009), blackening and flickering for the eyes (Jul-2009), difficult finding words, sleeplessness (Jul-2009), orientation difficulty (Jul-2009), can not find words (Jul-2009), dares no longer drive, (start date not specified) cramp in left leg (Jul-2009), abnormally tired (Jul-2009), pain in knee and hip joint (Jul-2009). Has been examined by a number by a number of specialist physicians; ear-nose-throat physician, dermatologist, rheumatologist and orthopedic surgeon as well as psychiatrist because of OCD (but before the vaccination). The third dose was given 22-Apr-2009, batch number NK05560 with lotnumber 0773X and expiration date 16-JUN-2011. The patient was previously vaccinated with GARDASIL (dose 1 and 2, batch number NJ01850 with lotnumber 1941U and expiration date 12-DEC-2010 and NH31140 with lotnumber 1477U and expiration date 17-SEP-2010), intramuscular route, site not reported) on 15-Oct-2008 and 17-Dec-2008. The physician reports the following medical history; atopic eczema on hands, multiple allergy (positive RAST Altermaria, Timothy and Mugwort), palpitations and chest pain. Allergy was reported as an reaction by the patient.


VAERS ID: 507438 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-13
Onset:2013-06-21
   Days after vaccination:8
Submitted: 2013-10-11
   Days after onset:112
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G016868 / 3 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Albuminuria, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Electrophoresis normal, Flank pain, Glomerulonephritis acute, Haematuria, Inappropriate schedule of drug administration, Lymphadenopathy, Ultrasound abdomen abnormal, Ultrasound kidney normal
SMQs:, Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 12/13/2012, GARDASIL, No adverse event; 02/28/2012, GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data: 01-JUL-2013: Blood pressure 90/60, Heart rate 60, Ultrasound abdomen slight unsharp parenchyma of right and left kidney, Ultrasound Doppler renal arteries normal; 25-SEP-2013: Electrophoresis normal; 27-JUN-2013: ANA negative, p-ANCA negative; c-ANCA negative
CDC Split Type: WAES1310DEU004983

Write-up: Case of misuse (vaccination series completed after more than one year) received from a health care professional on 01-Oct-2013. Case is medically confirmed. A 17-year-old female patient (weight 62 kg, height 172 cm) received the third dose of GARDASIL (lot-no. G016868) IM into the upper arm on 13-Jun-2013. Concomitant medication included contraceptives since several months before vaccination. Eight days later on 21-Jun-2013, the patient developed an acute glomerulonephritis with albuminuria and microscopic hematuria. Additionally the patient had flank pain on both sides with changing intensity and swollen lymph nodes at the left side of the neck and left axilla. Electrophoresis performed on 26-Sep-2013 was within normal range. Laboratory tests performed on 27-Jun-2013 revealed negative ANA, c-ANCA and p-ANCA. Examinations performed on 01-Jul-2013 revealed blood pressure of 90/60 and heart rate of 60, sonography of the upper abdomen was normal except for slight unsharp parenchyma in the right and left kidney, and ultrasound Doppler of renal arteries was normal. Laboratory tests performed on 02-Jul-2013 were all normal. At the time of reporting, acute glomerulonephritis had resolved, renal function and proteinuria had normalised. Outcome of swollen lymph nodes and microscopic hematuria was not reported. The reporter considered the symptoms as possibly to probably related to the vaccination with GARDASIL. Previous doses of GARDASIL given on 28-Feb-2012 (D1) and on 13-Dec-2012 (D2) were well tolerated. Upon medical judgment the company assessed the case as serious.


VAERS ID: 507445 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-26
Onset:0000-00-00
Submitted: 2013-10-11
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007039 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Eye pain, Formication, Hypoaesthesia, Multiple sclerosis, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310FRA005000

Write-up: Case received from the Health Authorities in a foreign country under reference number LL20131194 on 04-Oct-2013. A 17-year-old female patient had received the first dose of GARDASIL (batch/lot number H007039) on 26-Sep-2012 and the second dose (batch/lot number not reported) on 26-Nov-2012. In Nov-2012 she experienced a first episode of sensory disturbance, i.e. no sensitivity in both legs. Symptoms had fully resolved within 3 weeks. In May-2013 she experienced a second episode of sensory disturbance in feet, which gradually spread up to the abdomen. Sensory disturbance improved within 3 weeks. Insensitivity of hands appeared as well as an episode of eye pain. In Jul-2013 the patient was hospitalized in the neurology department. Diagnosis of multiple sclerosis was made. According to the Health Authorities, the patient had not recovered from paraesthesia, formication, eye pain and multiple sclerosis. Outcome for hypoesthesia was unknown. To be noted that the case was reported as non-serious by the Health Authorities. Upon medical review, the company judge relevant to consider the case as serious due to serious criterion "Hospitalization". The Health Authority assessed the causal relationship between the reported reaction and vaccination as doubtful (C2 S1 B1 I1) according to the updated foreign method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigation which might be performed in the context of legal or out-of-court procedures for compensation". Additional information received on 10-Oct-2013. The Health Authorities confirmed that the case was serious (and not non-serious as initially reported) and will be upgraded. Lot number for the other dose was provided: H008693.


VAERS ID: 507449 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-02-09
Submitted: 2013-10-14
   Days after onset:246
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR005165

Write-up: This case was received from the health authority on 04-Oct-2013. GB-MHRA-ADR 22256326. This case is not medically confirmed as it was reported by a consumer. A 12-year-old female patient (weight: 31 kg), with no reported medical history, received on an unreported date an injection of GARDASIL, (batch n. not reported), route, dose in series and site of administration not reported) and on 09-Feb-2013 she experienced type 1 diabetes mellitus. It was unknown if the reaction was treated. However, it was reported that concomitant medication included insulin. At the time of reporting the patient had not recovered. The MHRA considered this case to be serious due to disability, hospitalisation and as a life threatening condition.


VAERS ID: 507450 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-03
Onset:2013-10-03
   Days after vaccination:0
Submitted: 2013-10-11
   Days after onset:8
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006838 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Convulsion, Encephalitis, Neurological symptom
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (narrow), 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310KAZ005452

Write-up: Information was received via medical advisor from Deputy Minister of Ministry of Health concerning a 12 year old female patient. On 03-OCT-2013, at 11:50, the patient was vaccinated with a dose of GARDASIL, suspension for i/m injection, 0.5 ml, intramuscular for HPV prophylaxis (Lot # J006838; expiration date 19-OCT-2015). After vaccination in the doctors room the patient experienced neurological symptoms, anaphylactic reaction like Quincke''s edema, encephalic reaction, convulsive syndrome. The patient was hospitalized. The patient state improved, it was reported that the patient recovered in 2013. GARDASIL, was discontinued. The reporter felt that adverse reactions were definitely related to therapy with GARDASIL. Upon internal review convulsive symptom was considered to be medically significant. Additional information has been requested.


VAERS ID: 507452 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-10-03
Submitted: 2013-10-14
   Days after onset:11
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006838 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Convulsion, Encephalitis, Neurological symptom
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (narrow), 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310KAZ005066

Write-up: This spontaneous report was received via medical advisor from Deputy Minister of Ministry of Health refers to a 12 year old female patient. On 03-OCT-2013 at 11:50 the patient was placed on therapy with GARDASIL, suspension for i/m injection, 0.5 ml, intramuscularly (lot # J006838, expiration date 19-OCT-2015). After vaccination in the doctors room the patient experienced neurological symptoms, anaphylactic reaction like Quincke''s edema, encephalic reaction and convulsive syndrome. The patient was hospitalized. The patient''s condition improved. GARDASIL was discontinued. The reporter felt that adverse reactions were definitely related to therapy with GARDASIL. Upon internal review, "convulsive syndrome" was considered to be a medically significant event. Additional information is not expected.


VAERS ID: 507802 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-04
Onset:2013-07-04
   Days after vaccination:0
Submitted: 2013-10-11
   Days after onset:99
Entered: 2013-10-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Suture insertion
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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310FRA004996

Write-up: Case received from the Health Authorities in a foreign country on 02-Oct-2013 under the reference number RN20131310. A 14-year-old female patient with no relevant medical history had received a dose of REPEVAX (batch number unknown) and a first dose of GARDASIL (batch number unknown) both via intramuscular route on 04-Jul-2013. Administration of both vaccines had been uneventful but whilst she was getting dressed she turned pale, fell backward and lost consciousness. She hit her head on the floor. The physician took her blood pressure. It was 8. She was given sugar, rehydration treatment and she regained consciousness. She was taken to the emergency room and she had one stitch. It is noteworthy that she had no long-standing treatment. At the time of reporting the patient had recovered. Early Sep-2013, the patient received the second dose of GARDASIL as per the vaccination schedule. A follow-up was scheduled. The Health Authorities considered the case as serious due to the criterion ''other medically important condition''. The Health Authorities assessed the causal relationship between the reported events and both vaccines as doubtful (C2 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". Upon medical review, the company judged relevant to code "loss of consciousness" and "head injury" which was mentioned by the Health Authorities in the narrative but not coded.


VAERS ID: 507807 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-17
Onset:2013-09-17
   Days after vaccination:0
Submitted: 2013-10-11
   Days after onset:24
Entered: 2013-10-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Fall, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL005014

Write-up: This case was received from the health authority in a foreign country on 03-Oct-2013. IMB-REF 2013-018317. This case is part of a cluster of 5 cases after human papilloma virus vaccination (same batch number, same period of vaccination, all received from the IMB) and is linked with cases E2013-07661, E2013-07663, E2013-07664, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 16-year-old female patient, with no relevant medical history, received on 17-Sep-2013 an injection of GARDASIL (batch and lot n. H019633), route, dose, dose in series and site of administration not reported. Eighty minutes post-vaccination, the patient was found lying on school corridor. She complained of very painful head. The patient was conscious but could not remember what had happened. The reporter indicated that the patient must have fainted and fallen backwards. The reporter indicated that due to the nature of the accident, the patient was sent to A&E by ambulance to rule out any head injury. No evidence of injury was discovered on investigations. The reporter indicated that the patient was observed for 8 hours in causality and discharged home. At the time of reporting the patient had made a full recovery. The IMB considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507823 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-17
Onset:0000-00-00
Submitted: 2013-10-14
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Surgery
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310KOR002880

Write-up: This spontaneous report was received from a female consumer of unknown age reporting on herself via a company representative reporting on herself. Medical history or concurrent conditions were not reported. On 10-JUN-2013, the patient was vaccinated with first dose of GARDASIL injection (vials) (concentration and lot number were not reported). On 17-AUG-2013, the patient was vaccinated with second dose of GARDASIL injection (vials) (concentration and lot number were not reported). Concomitant medication was not reported. The patient reported that the planned date for the third dose (also reported as second dose) was 17-DEC-2013 and after the vaccination a surgery was planned (surgery not specified). The outcome of the planned surgery was unknown. Causality was not reported. Upon internal review, the surgery was medically significant. Additional information is not expected.


VAERS ID: 507857 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:26
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Nausea, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004963

Write-up: This case was received from the health authority on 03-Oct-2013. Ref 2013-018323. This case is part of a cluster of 5 cases after human papilloma virus vaccination (same batch number, same period of vaccination, all received from the health authority) and is linked with cases E2013-07663, E2013-07664, E2013-07668, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient, with no relevant medical history, received on 18-Sep-2013 an injection of GARDASIL (batch and lot # H019633, exp date 31-MAY-2015) 0.5 ml intramuscularly (dose in series not reported) and 20 minutes later, on 18-Sep-2013, the patient experienced an itchy rash on her face and neck and was nauseous. The reactions persisted for 3 hours. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON 4 mg orally. The patient had no concomitant treatment. At the time of reporting the patient had made a complete recovery. The health authority considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507860 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:26
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Immediate post-injection reaction, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004961

Write-up: This case was received from the health authority on 03-Oct-2013. Ref 2013-0183219. This case is part of a cluster of 5 cases after HPV vaccination (same batch number, same period of vaccination, all received from the health authority) and is linked with cases E2013-07661, E2013-07663, E2013-07668, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient, with no relevant medical history, received on 18-Sep-2013 an injection of GARDASIL (batch/lot n. H019633, 31-MAY-2015) 0.5 mL intramuscularly (dose in series not reported) and immediately after the vaccination, on 18-Sep-2013, the patient experienced an itchy rash on her face and neck. The reaction persisted for 2.5 hours. The reporter described it as an acute hypersensitivity reaction. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON 4mg orally. The patient had no concomitant treatment. At the time reporting the patient had made a complete recovery. The regulatory authority considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507869 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-16
Onset:2013-09-16
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:28
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010590 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Drug hypersensitivity, Dyspnoea, Erythema, Muscle tightness, Oropharyngeal pain, Pallor, Tremor
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEMIR; NOVORAPID
Current Illness: Immunisation; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR004950

Write-up: This case was received from the health authority on 03-Oct-2013. GB-MHRA-ADR 22255597. This case is medically confirmed. A 12-year-old female patient was vaccinated on 16-Sep-2013 with a dose of GARDASIL (batch/lot n. H010590, expiration date 28-FEB-2015) 0.5 mL intramuscularly (dose in series and site of administration not reported). Five minutes post vaccination, on 16-Sep-2013, she complained of shakiness, she was unable to breathe, her chest was tight and she was pale. The reactions recovered 10 minutes later. Then, 30 minutes after the injection, she complained of a sore throat, cherry red neck and was tight around the neck. Her colour was good, she had no stridor and was alert. She was taken to her GP by her mum. The GP suggested a probable allergic drug reaction. No corrective treatment was given as the symptoms resolved. Concomitant medication included LEVEMIR and NOVORAPID both for diabetes. At the time of reporting the patient had fully recovered. The regulatory authority considered this case to be serious as an other medically important condition.


VAERS ID: 507870 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-03
Onset:2009-08-04
   Days after vaccination:1
Submitted: 2013-10-15
   Days after onset:1533
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Blood creatinine increased, Blood urine present, Chemotherapy, Glomerulonephritis, Plasmapheresis, Proteinuria, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/2010, Blood creatinine, $g450
CDC Split Type: WAES1310DNK006102

Write-up: Case of adverse event received from non health care professional via Health Authorities on 08-Oct-2013 under the reference number 22252552 and 13-5895. The primary reporter was a lawyer from patient insurance company (PIC). A 13 year old female patient had received the third dose of GARDASIL (batch number unknown) via not reported route of administration in not reported site of administration on 03-Aug-2009 and later on, 04-Aug-2009, she developed pain in back (around the kidney region), blood in urine, excretion of too much protein and chronic disease (Glomerulonephritis). HA received information from PIC on 17-Sep-2013, patient insurance number 13-5895, which was the patient''s initial notification to the PIC. PIC has not taken a decision on the case. Adverse reactions: Pain in the back (around the kidneys), chronic kidney disease (glomerulonephritis) which manifests in occasional compromised renal function with blood in the urine and excretion of too much protein. Vaccination: The first GARDASIL dose given on 15-Jan-2009, batch number is unknown to the patient''s physician, it has not been noted in the journal. Second GARDASIL vaccination is given on 26-Mar-2009 with batch number NJ38950. Third GARDASIL vaccine is given on 03-Aug-2009, batch number unknown to the patient''s physician, it has not been noted in the journal. Event around the adverse reactions: The patient was hospitalized from 22-Nov-2010 to 07-Dec-2010. The patient was hospitalized when her creatinine level was over 450. Patient was during her hospitalization treated with antibiotics, chemotherapy, plasmapheresis (seven times in 14 days), adrenal hormone and blood pressure lowering drugs to treat to kidneys. When the patient was discharged from the hospital she continued with blood pressure lowering drugs and adrenal hormone. The patient''s disease is currently stable but the disease is chronic and will under certain conditions (not specified) break out again at any time. Over the past three years, the patient has generally had high protein excretion, and blood in the urine for many times. The patient has recently stopped the blood pressure lowering medication. The patient has always been well and healthy. At the time of reporting, the patient had not recovered.


VAERS ID: 507873 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-15
Onset:2013-04-01
   Days after vaccination:45
Submitted: 2013-10-15
   Days after onset:197
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0542AE / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Fatigue, Haemorrhagic disorder, Headache, Memory impairment, Menstrual disorder, Pain, Pain in extremity, Palpitations, Pernicious anaemia, Sensory disturbance, Weight decreased
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPIMAX
Current Illness: Immunisation; Human papilloma virus immunisation; Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: This patient has been at the neurological outpatient clinic, and diagnostic center.
CDC Split Type: WAES1309DNK000911

Write-up: Case received from a health care professional via Health Authority in a foreign country on 20-Aug-2013 under reference number 22208215. Case medically confirmed. A 32 year old female patient had received an injection of GARDASIL (dose 1, batch number, intramuscular, site not reported) on 15-Feb-2013 and later on 01-Apr-2013 she developed MEMORY DIFFICULTIES, HEADACHE, DIFFICULTY CONCENTRATING, MENSTRUAL DISTURBANCE, TIREDNESS, PAIN IN ENTIRE BODY. HA coded drug end date as 18-Apr-2013, which presumably is the vaccination date of GARDASIL dose 2 because it is also reported by the HA that vaccination number 3 is not given. The patient''s medical history not reported. At the time of reporting, the outcome was not recovered. Follow up received from the foreign Health Authority on 10-OCT-2013: ADVERSE EVENTS: Memory problems, headache, tiredness, pain in the whole body, concentration difficulties, and menstruation disorders. The adverse events have not disappeared and the third HPV vaccine is not given. FOLLOW UP received on 26 SEP 2013 reported by the patient: ADVERSE EVENT: Pernicious anemia, bleeding disorders, weight loss, palpitation, sensory disturbances and pain in arms and legs. The patient has received the following treatment for the adverse event: B12 injection (pernicious anemia). She has been examined at the neurological outpatient clinic and diagnostic center. The patient was vaccinated with GARDASIL on 15 FEB 2013 (Batch No. H019462) and SILGARD on 18 APR 2013 (J000396). She has chosen not to receive the second vaccine because of the adverse events.


VAERS ID: 507878 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-09
Onset:2013-05-20
   Days after vaccination:742
Submitted: 2013-10-15
   Days after onset:148
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Borrelia test negative, CSF test normal, Sudden hearing loss
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 01/28/2011, GARDASIL, Drug Indication: Immunisation, batch number NN02290; 05/21/2010, GARDASIL, Drug Indication: Immunisation, batch number NL45420
Allergies:
Diagnostic Lab Data: A negative borrelia test including a cerebrospinal fluid test was performed on an unspecified date.
CDC Split Type: WAES1310DNK006354

Write-up: Case received from health care professional via Health Authority in a foreign country on 04-Oct-2013 under the reference numbers 22256262 and EFO7020. The primary reporter was a physician. Case is medically confirmed. A 15 year old female patient (weight:52 kg; height: 160 cm), had received the third dose of GARDASIL (batch number NN02290) via intramuscular route of administration in not reported site of administration on 09-May-2011 and later on 20-May-2013 she developed sudden deafness on the right ear. The Health Authority was in contact with the physician on 26-Sep-2013. A negative borrelia test including a cerebrospinal fluid test was performed on an unspecified date. The patient had no other medications. The patient had a history of vaccination with the first and second dose of GARDASIL (batch number NL45420 and NN02290) respectively) via intramuscular route of administration and not reported site of administration on 21-May-2010 and 28-Jan-2011. At the time of reporting, the patient had not recovered.


VAERS ID: 507886 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-15
   Days after onset:27
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004995

Write-up: This case was received from the health authority on 03-Oct-2013. REF 2013-018321. This case is part of a cluster of 5 cases after GARDASIL (same batch number, same period of vaccination, all received from the IMB) and is linked with cases E2013-07661, E2013-07664, E2013-07668, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient, with no relevant medical history, received on 18-Sep-2013 an injection of GARDASIL, batch and lot n. H019633) 0.5 mL intramuscularly (dose in series not reported) and 30 minutes later, on 18-Sep-2013, the patient experienced a rash on her face and neck and was nauseous. The reactions persisted for 3 hours. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON (chlorphenamine) 4 mg orally. The patient had no concomitant treatment. At the time of reporting the patient had made a complete recovery. The IMB considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507914 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-19
Onset:2009-03-21
   Days after vaccination:61
Submitted: 2013-10-15
   Days after onset:1669
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1941U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Arrhythmia, Atrial septal defect, Atrial septal defect repair, Blood pressure decreased, Bone pain, Cardiac murmur, Cardiovascular disorder, Computerised tomogram abnormal, Concussion, Contusion, Cyanosis, Dizziness, Dizziness postural, Dysaesthesia, Echocardiogram abnormal, Electrocardiogram PQ interval, Electrocardiogram QT interval normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram abnormal, Epistaxis, Erythema, Excoriation, Fall, Fatigue, Fundoscopy normal, Headache, Heart rate decreased, Hyperventilation, Local swelling, Loss of consciousness, Nasal inflammation, Nasopharyngitis, Nausea, Nuclear magnetic resonance imaging brain normal, Orthostatic hypotension, Paraesthesia, Periorbital contusion, Presyncope, Syncope, Tenderness, Tilt table test normal, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 10/23/2008, GARDASIL
Allergies:
Diagnostic Lab Data: 01-OCT-2010: EEG (electroencephalography): widespread dominant activity of 8-10 Hz sometimes activity above 13 Hz and 5-7 Hz activity diffuse amplitude up to 4 uV, no hemisphere difference. No focal or paroxysmal. Hyperventilation and photo stimulation: Nothing further. Sleep Stage I: normal pattern. Electrocardiogram Regular heart rate of 56, no abnormality; On an unknown date, Computerised tomogram (CT) scan: No suspected breach of maxillary/infraorbitalis; On an unknown date, Computerised tomogram (CT) scan: Nothing abnormal and sinus abnormal; On an unknown date Systolic blood pressure, 95; On an unknown date, Tilt table test: normal; On 26-JAN-2010: Pulse decreased 68; On 02-FEB-2010; Holter monitoring: normal; On 01-OCT-2010, Electroencephalogram: No abnormality; On 23-FEB-2010: Transesophageal echocardiography: Normal; ASD closure; On 01-JUN-2010, Echocardiography: Well fitting ASD occlusion no residual effect; On 21-MAY-2010, Ophthalmoscopy normal; On approximately June 2010 Echocardiography: Normal; On 16-DEC-2009, Electrocardiogram atrial septum defect; On 26-JAN-2010, Pulse decreased 68 (no units provided); On 07-JAN-2011, Tilt table test: Terminated without positive test, Pulse normal; On 15-FEB-2011, Nuclear magnetic resonance imaging brain (MRI) Brain no abnormality; On 16-FEB-2011, Electrocardiogram event monitoring ECG mild sinus rhythm; On 28-JUL-2011, Electroencephalogram (EEG) normal; On 19-DEC-2011, Electrocardiogram: Normal. PQ-distance and QT; 11/23/2009, Blood pressure, 119/73, Stand up for 4 min; 11/23/2009, Blood pressure, 113/65, Stand up for 3 min; 11/23/2009, Blood pressure, 117/65, Stand up for 2 min; 11/23/2009, Blood pressure, 104/67, Stand up for 1 min; 11/23/2009, Blood pressure, 96/58, Stand up for 2 min; 11/23/2009, Blood pressure, 109/70, Stand up for 1 min; 11/23/2009, Blood pressure, 108/65, (sitting); 01/26/2010, Blood pressure, 107/73; 02/15/2011, Blood pressure systolic, 95; 11/23/2009, Heart rate, 81, (sitting); 11/23/2009, Heart rate, 79, Stand up for 1 min; 11/23/2009, Heart rate, 76, Stand up for 2 min; 11/23/2009, Heart rate, 78, Stand up for 1 min; 11/23/2009, Heart rate, 70, Stand up for 2 min; 11/23/2009, Heart rate, 71, Stand up for 3 min; 11/23/2009, Heart rate, 65, Stand up for 4 min; 01/26/2010, Heart rate, 78; 05/21/2011, Intraocular pressure test, right eye, 13 mmHg; 05/21/2011, Intraocular pressure test, left eye, 12 mmHg; 01/26/2010, Respiratory rate, 16, Normal
CDC Split Type: WAES1310DNK004977

Write-up: Case received from healthcare professional via Health Authority on 01-Oct-2013 and 02-Oct-2013 under the reference number 22256170. The primary reporter is a physician. Case is medically confirmed. A 13-year old female patient had received the second and third dose of GARDASIL (batch number NJ01850, Lot # 1941U, exp date 12-DEC-2010 and NK05560 Lot # 0773X, exp 16-JUN-2011, respectively) via intramuscular route of administration and not reported site of administration on 19-Jan-2009 and 09-Jun-2009 and later on 21-Mar 2009 she developed several times vision disturbance/blackened for the eyes, syncope, presyncope, headache and on one occasion she fell down the stairs, bruise on right cheek and forehead, right cheek red and swollen, mild indirect tenderness at the clenching and skin abrasion on her left leg, easy nausea and amnesia and on 08-Aug-2009 she experienced dizzy. On 23-Nov-2009 she was diagnosed with orthostatic hypotension on 16-Dec-2009 diagnosed with atrial septum defect (corresponding to the fossa ovalis), on 26-Jan-2010 diagnosed with suspected hyperventilation and on 20-May-2010 diagnosed with nasal mucosa seen inflamed bilateral. On an unspecified date in the end of Aug-/beginning of Sep-2010 the patient experienced commotio-cerebri symptoms and big bulge in the neck and on 11-May-2011 the patient developed tired and on unspecified dates cold and slightly cyanotic fingers. The HA has received additional information from the reporting physician on 02-Oct-2013. The reporting physician has a suspicion that the patient''s orthostatic hypotension may be due to the patient''s treatment with GARDASIL. Summary from epicrisis 21-Mar-2009. The girl experienced blackened for the eyes and the patient fainted and fell down the stairs. She was unconscious, probably around 1 minute. She is now bruised on the right cheek, forehead skin abrasion on her right leg. Has amnesia for the event. No dizziness or vomiting. Mild headache localized to the right side. Easy nausea. Right cheek is red and swollen, mild indirect tenderness at the clenching. CT shows no suspected breach of either maxillary or infraorbitalis. Treatment: None. Note medical record 30-Jul-2009: Persistent sore facial skeleton after the accident. CT scan showed nothing abnormal. Note medical record 01-Sep-2009: Superficial lesion of the head without any specification. In March lipothymia where the patient fell and hit the right half of the face. The patient has no functional face problems, but still sense mild dysesthesia on the right cheek and pressure tenderness around the ulnar infraorbitalis dexter. No difficulty swallowing. Sinus scan normal conditions in both jaw caves. Cranium/Face: Symmetric conditions. No conture leaps at orbital ridges. Os zygomaticus symmetric and stable on the two sides. Is sore over the right ulnar infraorbitalis. The skin quite unremarkable. No swelling or subcutaneous accumulations. Eyes: Free eye movements in all planes. Normal pupils. Anterior mouth and neck normal. Improvement may be seen up to a year after this. Wait and see how the situation develops. There can be no treatment. Medical record 01-Sep-2009: The mother reports that the patient on 08-Aug-2009 has been malaise and dizzy and she has the same symptoms today. Medical record 02-Sep-2009: Again "attack" of dizziness and malaise, not fainting. 23-Nov-2009, Outpatient Clinic, Hospital. 14 year old girl referral from a GP due to dizziness. The patient was over the past half year had attacks of dizziness, where it blackened for the eyes and she became malaise. The dizziness comes primarily when the patient must concentrate and if she is stressed. The patient has no palpitations, no sweating, no nausea. There has been no loss of consciousness or convulsions. The patient has sometimes headaches associated with the dizziness attacks, but not always, and may also have a headache when there is no dizziness. The headache does not affect the patient''s everyday life, and it is only because the doctor asked about it, it was mentioned. No further complaints. Physical examination: Healthy girl. Totally normal movement. Blood pressure 131/67, pulse 63. The patient stands up: After 1 minutes: Blood pressure 96/58, pulse 78, at 2 minutes: Blood pressure 117/65, pulse 76, at 3 minutes: Blood pressure 119/73, pulse 79, at 4 minutes: Blood pressure 104/67, pulse 81. The patient becomes dizzy and unwell and must sit down. After sitting a few minutes, the blood pressure 109/70 and pulse 65. Stands up: After 1 minute: Blood pressure 113/65, pulse 71, after 2 minutes: Blood pressure 108/65, pulse 70. Heart sound: Regular. Systolic murmur grade 2-3. Possible mitral ejection sound? Pulmonary: normal air exchange, no murmur. Abdomen: Soft, not tender. No hepatosplenomegaly. Conclusion and plan: The history and blood pressure measurement indicates most that the patient has a degree of orthostatic hypotension, which can be reproduced in the outpatient clinic. The patient is advised to stand up slowly and sit down if she gets dizzy and take her head between her legs. Medical records 16-Dec-2009 Outpatient Clinic (Section H), Hospital Observation on suspicion of cardiac vascular disorder. Cardiac murmur has been heard, why patient referred for echocardiographic examination. Echocardiography shows a atrial septum defect (ASD) corresponding to foramen ovale with left-right flow and no volume load and slightly increased anti degree flow rate on the right side. No other accompanying malformations. Conclusion and plan: It is about a atrial septum defect corresponding to the fossa ovalis, that explain the murmur and there are undoubtedly treatment indication and probably it will be possible to make this of an interventional cardiac catheterization. If it is not possible, indication for an operative closure. 26-Jan-2010 Section H Hospital diagnose short-term loss of consciousness / syncope. The patient has briefly been dizzy and unwell and cold, perhaps slightly cyanotic fingers. Current situation: Was this morning slightly dizzy. Got improved fast. After a few hours she started feel dizzy and mild pressure upwards in the head, no headaches or vision disturbance, besides she gradually began to see black dots for eyes. There are plans for surgery date in week 8. Ambulance arrived and she was somewhat weak and dizzy. Blood pressure 107/73 and also the normal saturation of 100. The pulse is initially 78 and drops to 68, normal respiratory rate of 16. There has been no vomiting or disease with diarrhea, or similar. General condition: Good, completely unaffected (1 - S hours after the attack began). Normal nice colours. Normal tonus and strength of arms. Hear: earlier systolic murmur grade 2-3. Regular=heart rate = Peripheral pulse. No pulmonary abnormality. Neurology: can stand on one leg, but get dizzy in connection with the change from lying to standing up. Conclusion and plan: Initially does not sound like a cardiac-triggered problem. Looks more like hyperventilation. There is no indication for blood tests or other, and the patient goes home. Epicrisis 02-Feb-2010, Section H: results of Holter monitoring is now available which shows only sinus rhythm, including those times when palpitations and dizziness are described. There is thus no reason for any further and we await the convening of catheter-based closure of ASD. Discharge epicrisis 25-Feb-2012. The patient has been hospitalized 23-25Feb 2010 at the paediatric ward Hospital. Due to TEE (transoesophageal echocardiography) and catheter-based ASD closure. Uncomplicated procedure. Amplatzer ASD occluder has been inserted. Subsequently, the echo is completely normal. Discharged with MAGNYL 125 mg daily until the outpatient control in 3 months. Outpatient epicrisis 05-Mar-2010, Cardiology ward B, Hospital: The mother calling. The patient has after ASD occlusion developed severe headache and a few times nosebleeds. They gave PANODIL (other mfr) as a basis for headaches and supplements sometimes with IPREN (other mfr). The patient was before catheter occlusion informed that headache could be a problem, but usually transient. 04-Mar-2010: The mother calling again. The headache is now gone, but problems remain with nosebleeds. Epicrisis 20-May-2010 (Ear, Nose, Throat physician): The nasal mucosa is seen inflamed bilateral, septum centred. There is a fairly strong hurled vein on the right side of the transition between mucosa and skin. Similarly, on the left side. The area on the right side is lapis brushed. BACTROBAN (other mfr) on the basis of the strong irritation of the mucous membrane. Get time for lapis treatment on the left side in 6 weeks if there is bleeding. 21-May-2010 epicrisis, ophthalmologist: Episodes of flickering for the eyes. Eye pressure right 13.0mmHg left 12.0mmHg. Position sitting, motility and pupils normal examination, normal examination. Field of vision, examination normal. Slit lamp examination, clear media. No intraocular, ophthalmoscopy examination: normal, well defined papillae''s and age-related vascular and centre without pathology. No treatment. Control after need. Outpatient epicrisis 01-Jun-2010, Cardiology ward B, Hospital: The patient had after the catheter-based ASD occlusion some problems with headaches and nosebleeds, but this has now disappeared. She is now generally well and actively participate in any physical activity. The patient has repeatedly complained that during football games she can feel half-sided visual field failure. She was therefore examined by an eye specialist, found normal conditions. Echocardiography: Showing a well-fitting ASD occlusion no residual defect. There is no further enlargement of the right-side cavities. All valves function normally. Left sided arcus without ductus or coarctation. Conclusion: ASD is completely closed. The patient''s specific symptoms cannot be seen in the context of ASD occlusion, there is no evidence of peripheral embolic phenomena. MAGNYL treatment may cease in 3 months. Outpatient epicrisis 01-Sep-2010, Hospital: The patient had the last week a fainting episode when she was in the room, did not realize what was happening until she regained consciousness on the floor. There should be renewed ECHO and ECG. The patient is operated for ASD, successful outcome. Have made Holter monitoring that has been normal. We must consider whether there is a basis for tilt table test (which was previously found to be a tendency to orthostatic hypotension). Outpatient epicrisis 06-Sep-2010, H-ward, hospital: Short term loss of consciousness / syncope. Seen because of lipothymia. Had a week ago a fainting situation. Has amnesia of the event itself. May be the usual orthostatic problems. She had distinct commotio cerebri symptoms after the event and big bulge in the neck, but is completely recovered. Echocardiography shows completely normal. Conclusion and plan: The patient has no doubt, as previously noted, orthostatic problems, but have now had a slightly unexplained fainting reaction and ordered therefore EEG examination. Epicrisis 01-Oct-2010, N-ward, Hospital: EEG (electroencephalography): widespread dominant activity of 8-10 Hz sometimes activity above 13 Hz and 5-7 Hz activity diffuse amplitude up to 4 uV, no hemisphere difference. No focal or paroxysmal. Hyperventilation and photo stimulation: Nothing further. Sleep Stage I: normal pattern. ECG: Regular heart rate of 56. Conclusion: No abnormality. 08-Oct-2010: The patient has lately had 3 occasions of darkening for the eyes, but no actual fainting. EEG examination a week ago is normal. Outpatient epicrisis: 16-Nov-2010 hospital. Meetings with patient for readout of R test. The patient has had one episode with darkening of the eyes during a basketball game, where she got a friend to activate the button. R-test was not activated adequately why there is no data, no automatic recordings has been seen at that time. R-test attached again. Outpatient epicrisis 25-Nov-2010, B- patient ward, Hospital: patient meeting to readout R test. There has been no symptoms during the week. R-test attached again. Epicrisis 08-Dec-2010, B-ward, Hospital: R-test readout, no symptoms during the period. There is not much on the automatic recordings. Therefore instated with new R-testing device. Epicrisis 17-Dec-2010, B-ward, hospital: In the period there was an attack where the R test unfortunately was not attached. R-test has not worked during the period. Epicrisis 22-Dec-2010, B-ward, Hospital: No attack during the period. Epicrisis 07-Jan-2011, B-ward, Hospital: Studies: Tilt table test. During the test, the patient describes symptoms of tingling in the left arm and hand and left eye flicker tendency spread to both eyes. Throughout the session normal pressure and pulse. Terminated without positive test. Conclusion and plan: Completion. Informs the patient and the mother that they in the light of numerous examinations have not found anything cardiopulmonary suspicious, it is probably orthostatic hypotension, cannot either exclude an event of vasovagal problematic, but there in the light of current findings and examinations there is no indication for any further action, and the patient''s investigations are considered as terminated at the cardiology ward. Epicrisis 19-Jan-2011, H-ward, Hospital: the patient did the day before yesterday faint. Epicrisis 24-Jan-2011, H-ward, Hospital: The patient is annoyed that there is no explanation for her fainting. Epicrisis 01-Feb-2011, H-ward, Hospital: The patient experienced yesterday another fainting. Epicrisis 08-Feb-2011, B-ward, Hospital: R test attached. The patient has fainted 3 times since 14-Jan-2011. Also had a presyncope on 07-Feb-2011. She gets no warning. Epicrisis 15-Feb-2011, H-ward, Hospital: MRI of the cerebrum: No abnormality. Epicrisis 16-Feb-2011, B-ward, Hospital: R test is readout and removed. Event button was activated 2 times in the morning of 16-Feb-2011, when she has a typical attack. Epicrisis 18-Feb-2011, B-ward, Hospital: There has been response to R-test from 08-16Feb2011. It has been activated 2 times on the morning of 16-Feb-2011 at 06.40 and 06:52. Both times right after syncope, when she also was dizzy in the head. There is both times measured a sinus rhythm with 68-70 in frequency per minute. That is mild sinus arrhythmia. There is also recorded ECG during the attack, which also shows normal sinus rhythm. The other ECG printouts from monitoring period show the same sinus rhythm. Conclusion: Immediately the R-test does not give a reason to believe that the patient''s syncope is arrhythmia triggered. A tilt-table test was performed on 07-Jan-2011 when the patient had the same symptoms as during the R-test, but which neither showed pulse or blood pressure decrease. Immediately there is still no good explanation for the patient''s syncope tendencies. On the other hand, we can assume that the reason for the syncopes are harmless. Preliminary there is no indication for further investigation with regards to treatment. Epicrisis 04-Mar-2011, H-ward, Hospital: R test normal. Neither the mother nor the patient believes that further follow-up in this place is needed. It turns out that there are some school related problems that might influence the patient''s situation. At the same time there is the event of orthostatic hypotension, the patient must take adequate measures. Epicrisis 12-May-2011, H-ward, Hospital: contacted by the mother. The patient has continued fainting, the latest yesterday. She had in the evening a fainting attack, and was subsequently very tired. The mother has repeatedly noted that fainting attacks often happens in the evening. Renewed EEG will be performed. Epicrisis 28-Jul-2011, H-ward, Hospital: Answers to EEG: EEG is normal. The patient has not during the summer holiday fainted without notice, but probably tendency to orthostatic events in the hot south. Epicrisis 19-Dec-2011, B-ward, Hospital: The patient is bothered by the almost daily presyncope events, particularly in relation to postural change, and she has at the boarding school had a few episodes of lipothymia. She can stop attacks by lying down or have her head between her legs. No chest pain. No arrhythmia sensation. No family history of ischemic or structural heart disease, and there is no sudden death in the family. ECG taken today with normal PQ-distance and QT. There is no pre- or post-excitatory potentials. Conclusion and plan: Anamnestic, there are strong indications that the patient''s primary problems are a mixture of orthostatic hypotension and vasovagal syncope mixed, probably of neurovascular type. Have a low blood pressure and is before measured at 95 systolic. The patient started treatment tablet GUTRON (other mfr) 2.5 mg 3 times daily for the next 14 days and thereafter a potential dose increase. Epicrisis 01-Feb-2012, B-ward, Hospital: Syncope: 1, had forgotten pills a few days, otherwise no attack. Presyncope: None. No more discharge summaries attached. The patient was previously healthy, and was vaccinated with the first dose of GARDASIL (batch number NJ01850, Lot # 1941U, Exp date 12-DEC-2010) via intramuscular route of administration and not reported site of administration on 23-Oct-2008. At the time of reporting, the outcome was recovered with sequelae for syncope, presyncope, visual disturbance and orthostatic hypertension, recovered for ASD, commotio-cerebri symptoms, amnesia, headache, fell down stairs, nasal mucosa inflamed and big bulge in the neck, recovering for nausea and not reported outcome for all other events. According to the reporter, the reaction orthostatic hypertension was related to vaccination.


VAERS ID: 507916 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-15
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019078 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia, Nausea, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (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), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure: not reported; Heart rate: 140 bpm, 112 bpm and 130 bpm.
CDC Split Type: WAES1310GBR006530

Write-up: This case was received from the health authority on 04-Oct-2013. GB-MHRA-ADR 22258057. This case is medically confirmed. A 12 year female patient, with no medical history reported, received on an unreported date, an injection of GARDASIL, (batch and lot number H019078) 0.5 mL intramuscularly in the left arm, dose in series not reported. It was reported the patient experienced anaphylactic reaction described as follow: ten minutes after immunization, she left the medical office and then she went back to class with no problems at this time. One hour later she returned to the health care professionals, feeling nauseous, tingling in her fingers, and her left arm felt numb. She began complaining of dizziness, and she lay on the floor. She was also complaining of difficulty in swallowing and breathing and tingling on her face. No rashes or swelling present. Two hours fifteen minutes post-immunisation, a first dose of adrenaline was given and paramedics called. A second dose of adrenaline was given. Paramedics arrived. They recorded her blood pressure, saturations and heart rate: 104, 112 bpm and 130 bpm when paramedics arrived, then they stabilised her. At the time of reporting, the patient was recovering. The MHRA considered that case serious due to life threatening. Upon internal review the Company decided to code tingling in fingers and left arm felt numb which were mentioned in the narratives but not coded by the HA.


VAERS ID: 507918 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-19
Onset:2013-10-01
   Days after vaccination:12
Submitted: 2013-10-15
   Days after onset:14
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient, Dizziness, Headache, Migraine, Rash, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310SWE006529

Write-up: Case of adverse event received from health care professional via company representative on 03-Oct-2013. Additional information was received on 10-Oct-2013. The primary reporter (on both reported occasions) was a school nurse. A 11 year old female patient with no medical history reported, had received the first dose of GARDASIL, (batch and lot number H022294) via not reported route of administration in not reported site of administration on 19-Sep-2013 and later on 27-Sep-2013 she experienced rash (on right shoulder down to the chest, but also on back and arm). She visited a doctor for the rash, the doctor believed the rashes were caused by some kind of bite. In the evening of 01-Oct-2013, upon standing up, she developed headache, dizziness and temporary vision loss and/or blurred vision (unclear which or both). The symptoms continued the next day and on 02-Oct-2010 the patient visited the core hospital. They believed the rash was due to bites (as the previous visited doctor) and they suspect migraine. According to the reporter, none of the visited doctor''s were aware of the patient''s GARDASIL vaccination. She was better on 03-Oct-2013. The nurse was wondering if symptoms were due to vaccination hence she contacted company representative for more information. On 10-Oct-2013, the outcome for all events were reported as recovered.


VAERS ID: 507976 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-29
Onset:2012-09-26
   Days after vaccination:28
Submitted: 2013-10-16
   Days after onset:385
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H003811 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Chest pain, Dizziness, Dyspnoea, Fatigue, Headache, Musculoskeletal pain, Pyrexia, Renal pain, Systemic lupus erythematosus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MERCILON; ERCOQUIN
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302DNK003426

Write-up: Case received from a physician via the Health Authority on 23-Jan-2013 under the reference numbers DK-DKMA-ADR 21995878 and EFO4038. Case medically confirmed and assessed as non-serious. A 21-year-old female patient (weight and height not reported) with no relevant medical history reported, had received the first dose of GARDASIL (batch and lot number H003811) via not reported route and site of administration on 29-Aug-2011. 28 days later, on 26-Sep-2011, the patient developed thorax pain, shoulder pain, dyspnea and fatigue. Investigations performed (date not reported) showed systemic lupus erythematosis (SLE). Therefore the patient was examined in order to determine whether the events were symptoms of SLE. However, SLE was excluded by cardiologist and pulmonologist. There were no findings. No other medications were reported. At the time of reporting, the patient had not yet recovered. No causality assessment was provided. No further information expected. Follow up information received from patient insurance company via Health Authority on 04-Oct-2013. HA received follow up information on 17-Sep-2013: Case received from the patient insurance J. no. 13-6097 in terms of the patient''s own report. Note that the patient insurance company has not made a decision on the matter yet. Note from the HA: In the initial report, the reporting physician reporting that GARDASIL was given in 2011 and that the reactions started in 2011, but in the report from the patient to the patient insurance company 2012 was reported. HA has therefore been in contact with the reporting physician that confirms that the correct year is 2012. The second dose was given 08-Nov-2012 (batch and lot number H016967) the third dose has not been given. Patient''s description of the reactions: Around 12-Sep-2012, after the first HPV vaccination, she developed fever and pain in the area around the kidneys and was on sick leave. Thereafter the pain spread to the chest and to the back in the area around the lungs. In the same time feeling of chronic fatigue. After the second vaccination the pain became worse and addition of dizziness and headache. The patient was hospitalised on hospital rheumatology department. The patient has still problems. The patient had no longer fever, but constant pain in the area around the kidney''s, chest region and back around the lungs. Constant feeling of chronic fatigue, daily dizziness and periodic headache. The patient is treated with tramadol actiavis 50 mg 2 times daily, klorzoxazone "DAK" 250 mg and PANODIL 500 mg 6 times daily. The patient is on 100% sick leave due to the reaction. Fatigue has been changed to chronic fatigue, renal pain, back pain dizziness and headache has been added by the HA. MERCILON and ERCOQUIN has been added as concomitant medications.


VAERS ID: 507979 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-16
   Days after onset:28
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Psoriasis; Eczema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004965

Write-up: This case was received from the health authority on 03-Oct-2013. IMB-REF 2013-018320. This case is part of a cluster of 5 cases after human papilloma virus vaccination (same batch number, same period of vaccination, all received from the IMB) and is linked was cases E2013-07661, E2013-07663, E2013-07664, E2013-07668. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient received on 18-Sep-2013 an injection of GARDASIL (batch and lot #. H019633, Exp date 31-MAY-2015) 0.5 mL intramuscularly (dose in series not reported) and 10 minutes after the vaccination, on 18-Sep-2013, the patient experienced an itchy rash on her face and neck. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON 4 mg orally. The patient''s medical history included psoriasis and eczema as concurrent conditions. The patient had no concomitant treatment. At the time of reporting the reactions were persisting. The IMB considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507982 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-25
Onset:2010-11-18
   Days after vaccination:450
Submitted: 2013-10-16
   Days after onset:1062
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK006554

Write-up: Case of adverse event received from a non-health professional via Health Authorities in a foreign country on 04-Oct-2013 under the reference number EFO6969 and 22254006. The primary reporter was the patient''s mother. A 13 year old female patient (weight: 65 kg; height: 174 cm) had received probably second dose (not specified in the HA report) of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 24-Feb-2009 and later on, 02-May-2009, she developed absence attacks. The patient had probably received the third dose (not specified in the HA report) of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 25-Aug-2009 and later on 18-Nov-2010, she developed epileptic seizure. According to the HA report the absence attacks started between the second and the third dose of GARDASIL vaccine. She was not then treated for the absence attacks. on 18-Nov-2010 she experienced her first epileptic seizure and was hospitalized. She experienced additional epileptic seizures, one on 26-Dec-201 and another on 03-Jan-2013, and was hospitalized. On her last hospitalization (03-Jan-2013), the patient received medication/treatment for her seizures. She has no other medications. The health authority has requested medically confirmation as well as vaccination dates and batch numbers for all three GARDASIL vaccinations. Patient has no other health problems in general. At the time of reporting, the patient had not recovered. Company comment: The company also coded D3 as suspected vaccine due to the epileptic seizures occurring post-vaccination. Corrective version was created on 11-Oct-2013: Latency for epileptic seizure was added (D3).


VAERS ID: 508419 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-09-25
Submitted: 2013-10-17
   Days after onset:22
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Immunisation
Preexisting Conditions: Sinusitis; Dermatitis contact
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR006857

Write-up: This case was received from the health authority on 08-Oct-2013. GB-MHRA-ADR 22261135. This case is not medically confirmed as it was reported by a consumer. A 12 year female patient (weight: 31.29 kg) received on an unreported date an injection of GARDASIL (batch number not reported) intramuscularly, dose in series and site of administration not reported. She was also concomitantly treated with amoxicillin for sinus infection on an unreported date. On 24-Sep-2013, the patient experienced hives. The rash started appearing on the back of her hands around. It then started to spread quite rapidly to the rest of her body and became increasingly itchy on 25-Sep-2013 (coded as severe by the agency). By the time she had got home, around an hour and a half later on 25-Sep-2013, her rash was bright red and covered her from head to toe. She couldn''t stop herself from scratching and has got a doctor appointment. She was prescribed loratadine 5ml twice a day but the rash was worse, as did the itching, on the following day. Health professional suggested that she took PIRITON which can be taken every four hours so that there wasn''t such a gap between doses. The rash was very bad according to the patient''s daughter who wasn''t sure if it was an allergic reaction to the vaccine or Measles. The patient''s medical history included adhesive plaster sensitivity described as allergy to plasters and sinus infection which occurred the week before the vaccination. At the time of reporting the patient has not recovered from the adverse events. The agency considered that case serious due to be medically significant.


VAERS ID: 508450 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-28
Onset:2013-09-30
   Days after vaccination:2
Submitted: 2013-10-17
   Days after onset:17
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood count normal, Blood electrolytes normal, Blood glucose normal, C-reactive protein normal, Dizziness, Electrocardiogram normal, Fall, Head injury, Headache, Loss of consciousness, Malaise, Nausea, Wound
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), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Drug hypersensitivity
Preexisting Conditions: GARDASIL, Dose 2, No adverse event; GARDASIL, Dose 1, No adverse event
Allergies:
Diagnostic Lab Data: 30-SEP-2013: Blood glucose, blood count, blood electrolytes NOS, C-reactive protein, blood pressure and ECG, all normal.
CDC Split Type: WAES1310FRA006633

Write-up: Case received from the Health Authorities on 10-Oct-2013 under the reference number SE20130619. A 16-year-old female patient with a history of allergy to CLAMOXYL had received the third dose of GARDASIL (batch number not reported) on 28-Sep-2013 in the morning. On 28 and 29 September, she was doing well. On 30-Sep, when getting up at 6 am, the patient experienced headache, abdominal pain and nausea. As she went to the toilet, she experienced a malaise with dizziness and then lost consciousness. She fell and experienced a wound of the lip. She then fell a second time in the same context and this time was found to have occipital injury. She was admitted to the Emergency Unit Care. Blood glucose, blood count, blood electrolytes, C-reactive protein, blood pressure and ECG were normal. Physical examination was normal too. The emergency physician wondered about the causality of GARDASIL. To be noted that the patient had no usual treatment. She had received the first and second doses of GARDASIL uneventfully. At the time of reporting, the patient was recovering. 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 headache, abdominal pain and nausea which were mentioned by the Health Authorities in the narrative but not coded.


VAERS ID: 508467 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-12
Onset:2012-10-17
   Days after vaccination:5
Submitted: 2013-10-17
   Days after onset:365
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H011751 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK006598

Write-up: Case of adverse event received from health care professional via Health Authority on 09-Oct-2013 under the reference number 22257346 and EFO7030. The primary reporter was a physician. Case is medically confirmed. A 26 year-old female patient (weight: 60 kg; height: 165 cm) with no medical history reported, had received the first dose of GARDASIL, (batch/lot number H011751) via intramuscular route of administration in not reported site of administration on 12-Oct-2012 and later on, 17-Oct-2012, she developed lower back pain on the left side. Treatment refractory. She was thoroughly investigated with blood tests, urine tests and MRI-scan (results and lab dates not reported). She has no other vaccines or medications. At the time of reporting, the patient had not recovered.


VAERS ID: 508477 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-08
Onset:2013-03-09
   Days after vaccination:1
Submitted: 2013-10-17
   Days after onset:221
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H01899 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Amenorrhoea, Anti-VGKC antibody positive, Asthenia, Convulsion, Electroencephalogram normal, Encephalitis, Hypermetabolism, Hypometabolism, Immunoglobulin therapy, Lumbar puncture normal, Muscle spasms, Musculoskeletal stiffness, Myalgia, Neurological symptom, Opisthotonus, Pain, Positron emission tomogram abnormal, Scan normal, Speech disorder, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Menstruation normal
Preexisting Conditions: Hep B vaccine, No adverse event; MMR vaccine, No adverse event; DTaP vaccine, No adverse event
Allergies:
Diagnostic Lab Data: June 2013: Lumbar puncture normal. EEG normal including during episodes. Scan normal. PET/CT scan: hypermetabolism in bilateral fronto-opercular area; hypermetabolism in striatum; hypometabolism in posterior cingulum. Anti-VGKC antibody negative right after second cure. Anti-VCKB antibody, 260 IU/l
CDC Split Type: WAES1310FRA006590

Write-up: Case received from the Health Authorities on 10-Oct-2013 under the reference number MA20131901. This case was first reported to the Health Authorities by the patient''s mother. The symptomatology was confirmed by the neurologist who was following the patient. A 15-year-old female patient had received the first dose of GARDASIL (batch number H01899) via intramuscular route on 08-Mar-2013. She had no relevant medical history. Up to then her vaccinations (DTaP/IPV, MMR and HepB) had been uneventful. She had regular menstruation since 12 years old. On 09-Mar-2013, i.e. one day after vaccination, she spontaneously experienced a first spasmophilia-like fit with tremor and opisthotonus attitude. The fit lasted approximately for 5 minutes, and the patient subsequently complained from muscle pain. In the following days and weeks, the fits increasingly repeated following the same symptomatology, occurring up to 2 to 3 fits a day, and became protracted, lasting up to 10 minutes, despite a treatment with magnesium. On 01-Apr-2013 the patient was hospitalized. She presented then with severe asthenia. As the whole work-up was negative she was discharged. Added to the previously described seizures the patient also experienced two further types of fits: episodes of painful stiffness affecting electively the lower limbs and the shoulders with blockage and impossibility to walk. Those flare-ups could last up to half an hour. Regressive episodes with modification of speech: "the teenager spoke like a young child." These episodes were transient and uncontrollable although occurring consciously. In June-2013, the patient was hospitalized again in neurological service in order to widen the work-up. Lumbar puncture and EEG were normal in June 2013, including the EEG performed during the episodes. CT scan were normal. Search for antibodies showed slow positivity of anti-VGKC antibodies (potassium channels) at 260 IU/l. Except for that, the whole antibodies search was normal. PET/CT scan for the whole body was performed and showed marked hypermetabolism in bilateral fronto-opercular area, associated with a more moderate hypermetabolism in right striatum, and moderate hypometabolism in posterior cingulum. The remainder of brain metabolism seemed preserved, particularly in the limbic regions. Considering the positivity of anti-VGKC antibodies and the pictures found by PET scan, the whole picture could suggest encephalitis and it was then decided to perform immunoglobulin cures and to give TEGRETOL as corrective treatment. The first immunoglobulin cure was performed at the end of June 2013 and led to a clear regression of the symptoms. In the beginning of July a few episodes occurred again. A second immunoglobulin cure was performed and leg again to a regression of the symptoms with a few episodes less frequent and asthenia. Search for anti-VGKC antibodies was negative but performed right after immunoglobulin cure. They should be rechecked in Oct-2013. To be also noted an amenorrhea persisting since Apr-2013 (15 years old) whereas the patient was menstruated in a regular way since the age of 12. The Health Authorities report concluded to persisting complex neurological symptomatology occurring the day after a vaccination with the first dose of GARDASIL. The neurologist was called and the symptomatology was medically confirmed. The following arguments were compatible with a somatic origin: positivity of anti-VGKC antibodies (to be confirmed in a sample to be perform at distance from immunoglobulin cure), signs of hypermetabolism found by brain PET scan, regression of the symptoms under immunoglobulin cure. Furthermore, the child psychiatrists consulted ruled out a psychopathological-type pathology. However, questions arouse concerning atypical clinical symptomatology and concerning the assessment of GARDASIL considering the chronology (occurrence one day after receiving the first dose). The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S2 I1) according to the method of assessment. Upon medical review the company judged relevant to code the adverse events suspicion of encephalitis, speech disorder, walking difficulty and asthenia, which were mentioned by the Health Authorities in the narrative but not coded. At the time of reporting, the patient had not recovered.


VAERS ID: 508566 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-02
Onset:2013-09-02
   Days after vaccination:0
Submitted: 2013-10-17
   Days after onset:45
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypotonia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RHINOCORT; VENTOLIN
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR007134

Write-up: This case was received from the health authority on 08-Oct-2013. GB-MHRA-ADR 22261134. This case is medically confirmed. A 13 year old female patient, with no medical history reported, received on 02-Sep-2013 an injection of GARDASIL (batch number J005923) 0.5 mL intramuscularly, dose in series and site of administration not reported. She was also concomitantly treated by inhalation with RHINOCORT and VENTOLIN. Three to four minutes post vaccination, the patient became floppy but not unconscious with arm and head shakes. An ambulance was called and the patient had no concerning features from their assessment but was taken to hospital to be seen by a doctor. Within 30 minutes of the incident, the patient walked normally out to the ambulance and is back in school this afternoon. At the time of reporting the patient had fully recovered. The regulatory authority considered that case serious due to patient''s hospitalization.


VAERS ID: 508755 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-10
Onset:2013-10-01
   Days after vaccination:52
Submitted: 2013-10-18
   Days after onset:17
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Smear cervix normal
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smear cervix normal
Allergies:
Diagnostic Lab Data: 10/01/2013, Biopsy, CIN grade III type 16 N/A; Smear cervix, Normal
CDC Split Type: WAES1310ISR006929

Write-up: This spontaneous report as received from a 33 year old female nurse refers to herself. Prior to vaccination the patient had repeating normal pap smears. On 10-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose and route unspecified). On approximately 01-OCT-2013 the patient was diagnosed with (Cervical Intraepithelial Neoplasia) CIN grade III type 16 on biopsy. The patient was placed on treatment (unspecified). GARDASIL second dose was not administered yet. The event outcome was unknown. Upon internal review CIN grade III type 16 was considered to be medically significant. Additional information has been requested.


VAERS ID: 508765 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-01-15
Submitted: 2013-10-18
   Days after onset:641
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hysterectomy, Lymphadenectomy, Lymphadenopathy, Positron emission tomogram abnormal, Smear cervix normal, Uterine cancer, Vaginal discharge, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Familial risk factor, patient''s grandmother; Familial risk factor, Patient''s father
Allergies:
Diagnostic Lab Data: Physical examination (2012): Patient was in a general good condition, the examination showed a sprained cervix and the tumor was located in the cervix canal surrounded by cervix tissue that appeared to be normal. The size of the tumor was 5 centimetres (cm). Rectal examination (2012): Right parametrium with a lump up to 1 cm was palpable characteristic to the tumor distrubution of the pelvis. Positron Emission Tomography-Computed Tomography (PET CT) (2012): Imaged lymphadenopathy from both sides of the pelvis reaching the level of L4-L5, 1.5 cm lymph node under the aorta bifurcation, peri-sacral and peri-aortic lymph nodes up to 2 cm. PET.CT (unknown date following treatment and before surgery): reduction in the above findings but they were not eliminated. Abdominal exploratory test: identifies normal intestine and peritoneum, pelvis lymph nodes in different sizes up to 2 cm, about 4 cm lymph nodes at the common iliac bifurcation on the left under the branching of the cervix, 1 cm peri-aortal lymph nodes. Human papilloma virus test, Normal; 09/2011, Smear cervix, Normal
CDC Split Type: WAES1310ISR008137

Write-up: Information has been received from a gynecologist concerning a single 29 year old usually healthy female with no children with a familial history of colon cancer (patient''s father) and stomach cancer (patient''s grandmother) who was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported) on an unknown date. The patient was vaccinated with GARDASIL when there was no history of sexual activity. On an unknown date in September 2011 the patient experienced transparent vaginal discharge and had PAP smear which was normal. Several weeks later the patient experienced vaginal bleeding and after an investigation was diagnosed with uterine cervix adenocarcinoma on 15-JAN-2012. Under physical examination the patient was in a general good condition, the examination showed a sprained cervix and the tumor was located in the cervix canal surrounded by cervix tissue that appeared to be normal. The size of the tumor was 5 centimeters (cm). On rectal examination right parametrium with a lump up to 1 cm was palpable characteristic to the tumor distribution to the pelvis. Positron Emission Tomography-Computed Tomography (PET C.T) imaged lymphadenopathy from both sides of the pelvis reaching the level of L4-L5, 1.5 cm lymph node under the aorta bifurcation, peri-sacral and periaortic lymph nodes up to 2 cm. The patient received three treatments of Carboplatin and TAXOL. Following treatment and before surgery PET C.T imaged a reduction in the above findings but they were not eliminated. Human Papilloma Virus (HPV) was found to be normal under laboratory examination. The patient underwent lymph nodes removal, ovary preservation and lifting due to a planned radiation therapy. It was determined to keep the uterine in order to avoid intestine loops entering the pelvis. Therefore the patient did have a hysterectomy at that point. The findings during surgery were cervix with an intracervical tumor in a sprained right parametrium. Abdominal exploratory identifies normal intestine and peritoneum, pelvis lymph nodes in different sizes up to 2 cm, about 4 cm lymph nodes at the common iliac bifurcation on the left under the branching of the cervix, 1 cm peri-aortal lymph nodes. The outcome of the events were unknown. Causality was not reported. Upon internal review uterine cervix adenocarcinoma and hysterectomy were considered as medically significant. Additional information has been requested.


VAERS ID: 508781 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-24
Onset:0000-00-00
Submitted: 2013-10-20
Entered: 2013-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Computerised tomogram normal, Gait disturbance, Impaired work ability, Nuclear magnetic resonance imaging normal, Pain, Ultrasound scan normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Computerised tomogram, Normal; 2013, Nuclear magnetic resonance imaging, Normal; 2013, Ultrasound scan, Normal
CDC Split Type: WAES1310KOR008108

Write-up: This spontaneous report was received from a guardian of the patient via a company representative concerning a female patient of unknown age. On 24-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in 2013 (reported as subsequently), the patient experienced an adverse event (unspecified), so she visited several hospitals and computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound were performed but there was no abnormal result found. Symptomatic treatments were done but the pain was getting severe. At the time of report, the patient reported it was hard to walk due to the pain and also there was impact to her work. The outcome of all the events was unknown. The relatedness for the events was unknown for GARDASIL. Additional information is not expected.


VAERS ID: 508784 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-10
Onset:2013-09-11
   Days after vaccination:1
Submitted: 2013-10-20
   Days after onset:39
Entered: 2013-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013135 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema nodosum, Fatigue, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Lymphadenopathy; Hiatus hernia
Allergies:
Diagnostic Lab Data: 09/19/2013, Physical examination, no swollen glands nor organomegaly N/A
CDC Split Type: WAES1310IRL008301

Write-up: This case was received from the health authority on 10-Oct-2013. REF 2013-018389. This case is medically confirmed as it was reported from a physician. A 17 year old female patient received on 10-Sep-2013 a first dose of GARDASIL (batch number H013135), 0.5 mL intramuscularly, site of administration not reported. Twenty four hours post vaccination, on 11-Sep-2013, the patient experienced erythema nodosum on her skin and on her right thigh, a sore throat for 5 days and fatigue for 6 days (sore throat and fatigue coded as not recovered by the regulatory authority). The patient had a medical history included hiatus hernia and lymphadenopathy (swollen glands in her neck), but none was palpated on 19-Sep-2013 and no organomegaly was noted on 19-Sep-2013 either. The corrective treatment included paracetamol and DISPRIN for sore throat. At the time of reporting, the patient has not recovered from all the adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 508799 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-21
Entered: 2013-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK008116

Write-up: Cluster case of adverse event received from consumer via other company (Merck) and company representative on 09-Oct-2013 under the reference number 1-8925713306. The primary reporter was the mother of a patient. This is a cluster case of hundreds of females, reported to suffer from various adverse events after vaccination with GARDASIL. No details were provided on these cases so it was not possible to identify if they were previously reported. This cluster case is linked to the case E2013-06782, concerning the daughter of the reporter, developing similar symptoms. A number of female patients (reported as hundreds of girls and women) had received an injection of GARDASIL (batch number not reported) on unspecified dates and later on they developed feeling ill and unspecified adverse events, similar to the patient in the linked case (constant headache, dizziness, nausea, abdominal pains, muscle pains, temperature regulation problems, paraesthesias, numbness, the diagnosis POTS and fainting after feeling very dizzy and bad). According to the reporter, some patients have tried i.v. immunoglobulin as treatment (no details reported). At the tie of reporting, the outcome was not provided.


VAERS ID: 508815 (history)  
Form: Version 1.0  
Age: 52.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-07
Onset:2011-08-05
   Days after vaccination:29
Submitted: 2013-10-21
   Days after onset:808
Entered: 2013-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK41800 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Blood creatine phosphokinase increased, Pain in extremity, Sensory disturbance, Urinary incontinence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folinic acid; VIBEDEN
Current Illness: Immunisation
Preexisting Conditions: Hypovitaminosis; 03/15/2011, GARDASIL, Immunisation; 01/12/2011, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood creatine phosphokinase, Transient increase
CDC Split Type: WAES1310DNK009226

Write-up: Case of adverse event received from health care professional via Health Authority on 17-Oct-2013 under the reference number DK-DKMA-ADR 22271247 and DK-DKMA-EFO7154. The primary reporter was a physician. Case is medically confirmed. A 52 year old female patient (weight: 89 kg ; height: 173 cm), had received the third dose of GARDASIL, (batch number NP16140) via intramuscular route of administration in not reported site of administration on 07-Jul-2011 and later on 05-Aug-2011 she developed urination involuntary, balance problems, pain in lower extremities and soles and sensory disturbance in lower extremities. The patient had concomitant treatment with VIBEDEN, (other mfr) started on 10-Mar-2011 and folinic acid (trade name not reported, other mfr) also started on 10-Mar-2011, for vitamin deficiency. The patient had no other vaccines. According to the reporter, the patient has been investigated for connective tissue disorder on a non-specified date. There has been a transient increase of creatine kinase (lab date not reported). The patient had previous been vaccinated with GARDASIL dose 1: on 12-Jan-2011 (batch number NL31810) and dose 2: on 15-Mar-2011 (batch number NN10280). Both doses were given intramuscular. The patient has a history of vitamin deficiency. At the time of reporting, the outcome was recovering.


VAERS ID: 508819 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-03-18
Onset:0000-00-00
Submitted: 2013-10-21
Entered: 2013-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Plasmapheresis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DICILLIN
Current Illness: Wound infection staphylococcal; Immunisation
Preexisting Conditions: Arthropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK010604

Write-up: Case received from patient via the Health Authorities in a foreign country on 16-Sep-2013 under the reference number 22239224 and EFO6830. Case not medically confirmed. A 15 year old female patient (weight 54 kg, height 182 cm) had received an injection of GARDASIL (dose not reported, batch number not reported site and route of administration not reported) on unspecified date in Mar-2010 and concomitant drug DICILLIN (other mfr) in Jun-2011 and later on, unspecified date in Jun-2011, she developed Guillain Barre Syndrome (cessation in Jan-2012). Patient was hospitalized because of the reaction on an non-specified date. Patient was treated with unspecified medication and plasmapheresis. Health authority has requested medical confirmation and information on vaccination dates and batch numbers from patient''s GP. At the time of reporting, the outcome was recovered. Medical history includes: Knee problems. Patient previously received a dose of GARDASIL vaccine (dose not reported, batch number not reported, site and route of administration not reported) on unspecified date in Nov-2009. Company note: it is unknown how many doses the patient received. HA reported 2 different vaccination dates. But no information on dose number in series or the total number of vaccinations have been reported. Follow up report received on 24-Sep-2013: It was reported that the case had been received on 18-Sep-2013 from the Patient Insurance company J. nr 13-6899 in terms of the patient''s initial report. It was noted that the Patient Insurance Association had not taken a decision on the matter yet. The patient''s mother had reported adverse reaction GBS to the Patient Insurance Association. Follow up information was received on 14-Oct-2013: Follow up was received HA on 26-Sep-2013 from the patient''s physician upon the request of HA: The physician can confirm, that the patient has experienced Guillain Barre Syndrome, but the physician does not know, if it is a case of an assumed adverse reaction to the treatment with GARDASIL. The matter is therefore still not medically confirmed according to the HA. The first GARDASIL vaccine was given on 29-Sep-2009, the second GARDASIL vaccine on 30-Nov-2009 and the third GARDASIL vaccine was given on 18-Mar-2010. HA has tried to obtain the batch numbers, but they cannot be informed. Upon medical review the company considered that the case has now become medically confirmed. Correction was made to the report, the indication for the concomitant drug DICILLIN was previously reported as wound infection staphylococcal which had not been captured in the database. Upon medical review the company decided to code wound infection staphylococcal as an adverse event (onset and outcome not reported).


VAERS ID: 508828 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-08-22
Submitted: 2013-10-22
   Days after onset:61
Entered: 2013-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK AR / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003184 / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Dyspnoea, Malaise, Nausea, Sense of oppression, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310FRA009272

Write-up: Case received from the Health Authorities in a foreign country on 14-Oct-2013 under the reference number MA20131891. An 11-year-old female patient had received intramuscularly the first dose of GARDASIL (batch-lot number J003184, expiration date 30-JUN-2015) in the deltoid and the booster dose of TETRAVAC (batch number J0313) in the opposite deltoid at 3pm on 22-Aug-2013. In the evening around 7-8pm, she was not feeling well, feeling anxious whereas usually rather "zen". She presented with nausea, vertigo, oppression in both chest and throat, dyspnea and abdominal pain. The on-call physician was called in and gave her VOGALENE. After a night of sleep, the symptoms had resolved. The Health Authorities assessed the causal relationship between the reported reactions on both vaccinations as doubtful according to the foreign method of assessment. The Health Authorities considered the case as serious due to the criterion ''other medically important condition''. Upon medical review the company judged relevant to code the adverse event anxiety, which was mentioned by the CA in the narrative but not coded.


VAERS ID: 508996 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-24
Onset:2013-07-28
   Days after vaccination:4
Submitted: 2013-10-22
   Days after onset:86
Entered: 2013-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Addison's disease, Arthralgia, Back pain, Cyanosis, Decreased appetite, Diarrhoea, Discomfort, Disturbance in attention, Emotional disorder, Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Hypoaesthesia, Injection site pain, Insomnia, Muscle tightness, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neurological examination normal, Paraesthesia, Quality of life decreased, Sensory disturbance, Skin discolouration, Stress, Tic, Vision blurred, Visual impairment, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (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), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions: 2007, Carcinoma in situ, The patient was recommended the vaccine by own physician due to carcinoma in situ in 2007; Colitis
Allergies:
Diagnostic Lab Data: Neurological normal test has been performed by the general practitioner, but the patient will be seen by a neurologist on 06-AUG-2013 for investigation.
CDC Split Type: WAES1308DNK003370

Write-up: Update: Duplicate identified, DK-DKMA-EFO6485 (ADR 22202251) has been merged with this master case. The case has been received from the patient''s physician; numbness/constant tingling in the left arm/leg, headache, visual disturbances on the left eye, stomach pain. The patient''s general feeling in the body is much changed - she is feeling comfortable with marked changes in emotion and feels that it worsens. She has also not tensions in the shoulder/neck, and when pressure is put on, the patient feels that the left arm is paralyzed. The patient has not been treated for the adverse event. The patient has not been hospitalized due to the adverse event. Added adverse events: Ache stomach, Headache, Neck stiffness and Visual disturbance. The patient''s initials have been changed. Follow-up received on 10-OCT-2013 from the patient insurance board in form of the patient''s own initial report to the patient insurance board, J. no 13-7626. Please note, the patient insurance board has not made a decision in the case yet. Description of the drug injury: Four days after the patient received the last injection with HPV vaccine (the last one was SILGARD Lot number 01946) is an invalid lot number for SILGARD, the two other was GARDASIL, Batch and lot # H017284 and Batch and Lot #J001201, Exp date 04-JUL-2015 she developed very strange sensory disturbances in the left arm. It appeared suddenly and affected that the left hand became clenched all the time. Further the nerve in the hand contracted constantly. It buzzed in the arm, as if there was water running under the skin. It only became worse in the following days and thereafter came more symptoms, such as chronic pain in the upper part of the back between the shoulder blades, pain on the middle of the backbone (that feeling has been there since early summer), headache, tiredness, sleeplessness (the patient could lie awake for 2-3 times a night, because her body works and the arm/legs sleeps), stretch marks on the arms, when she carries her daughter (it is deep furrows in the skin, which disappears again after 5 minutes), diarrhea, pain in the stomach, lack of appetite, which has resulted in weight loss, diffuse, feeling of being in a bubble, stress feeling, lack of sex drive; prolonged cycle (prior to HPV vaccine it was exactly 26 days between menstruation, now it is typically 32 days or more!), tics in the eye, leg and arms, increasing sweating and freezes more, blue fingers, swollen lymph nodes on the throat and in the groin and lump on the chest (which is going to be examined in mammography on 06-OCT-2013), muscle/joint pain in the whole body, lack of strength in the left upper arm (can no longer train with it, has lost much muscle mass and it hurts at the injection site), blurred vision and less able to focus and concentrate. The latest adverse event occurred yesterday with yellow dots in the palms, the physician suspects Addison disease (is going to be elucidated for this)! More and more strange symptoms constantly occur. The patient still has the above mentioned inconveniences due to the drug injury. The patient is on partial sick leave due to the drug injury (had to go home before time some days or meet later due to pain or various doctor visits/elucidation). Other remarks: As described the patient has for the last approx. 2 months only experienced more and more unpleasant adverse events, which makes it difficult for the patient to 1) manage her job, 2) be optimally well, 3) be good, spacious and happy. The patient sincerely hopes that it all will become better and that she can regain her old life back without pain and with a lot of happiness and surplus. The patient further mentions that she due to sensory disturbances has had a MRI scan of the brain performed - though, the neurologist has not yet sent the result to her own physician. In addition the patient awaits the date for the elucidation of the autoimmune disease, Addison disease as well the patient is going to have a mammography/ultrasound performed of the lump on the breast on 05-OCT-2013 and the dermatologist in connection with the "stretch marks" on her arm. Note: Please do not return cases received from the regulatory authority unless you have received new information regarding the case. Please note that the reference number for this case is: DK-DKMA-EFO6485. Also, please note that information should not be deleted from the case only appended (e.g. translation of narrative, patient characteristics).


VAERS ID: 508998 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-28
Onset:2013-07-06
   Days after vaccination:128
Submitted: 2013-10-23
   Days after onset:109
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Feeling hot, Headache, Memory impairment, Nausea, VIIth nerve paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK009529

Write-up: Case of adverse event received from non-health care professional via Health Authorities on 14-Oct-2013 under the reference number EFO7063 and 22261035. The primary reporter was not specified. A 23 year old female patient (weight: 90 kg; height: 164 cm), with no other health problems in general, had received the first dose and the second dose of GARDASIL (batch number H018411 and H019870) via not reported route and site of administration on 10-Oct-2012 and 28-Feb-2013 and later on, 07-Jan-2013, she developed headache, nausea, vomiting and tiredness. On 08-Feb-2013 she experienced internal heat (fever, not specified). On 16-Mar-2013 she developed memory impairment and 06-Jul-2013 partial paralysis of the face (on the left side). Patient has not been treated for the adverse events. Patient has also received the third dose of GARDASIL (Batch number J004851) on 16-Jul-2013. HA has requested medically confirm from the patient''s doctor, on 11-Oct-2013, waiting for answer. At the time of reporting, the outcome of partial paralysis of the face was recovered and outcome of the other AE was not recovered. HA assess this case as serious with seriousness criteria hospitalization (dates unspecified, no more information provided).


VAERS ID: 509002 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-09
Onset:0000-00-00
Submitted: 2013-10-23
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Effusion, Gait disturbance, Groin pain, Lymphadenopathy, Nuclear magnetic resonance imaging abnormal, Therapeutic aspiration
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Nuclear magnetic resonance imaging, tiny effusion
CDC Split Type: WAES1310GBR009535

Write-up: This case was received from a health care professional on 14-Oct-2013. This case is medically confirmed. A 12 year old female patient, with no medical history reported, received on 09-Sep-2013 a first dose of human papillomavirus vaccine (manufacturer unknown, batch number not reported) in the deltoid, route of administration not reported. One week later, she attended the GP with 2 day history of painful left hip and limp. She was then seen and admitted to the local reporter''s hospital and ortopaedics discovered that patient had an effusion (onset date not reported), which was aspirated, then the MRI reported in tiny effusion. It was also noted that the patient had an enlarged lymph node in the left groin (onset date not reported), which seemed to be the focus of the pain. The patient was eventually discharged with physiotherapy and hydrotherapy. She should have received second dose but the patient''s mother has declined further vaccine at the moment. The patient has not recovered from limp and hip painful, she was recovering from effusion and the patient''s outcome for enlarged lymph node was not reported.


VAERS ID: 509005 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-25
Onset:2013-09-26
   Days after vaccination:1
Submitted: 2013-10-23
   Days after onset:27
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash pruritic, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL009500

Write-up: This case was received from the health care authority on 16-Oct-2013. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient, with no medical history reported, received on 25-Sep-2013 a first dose of GARDASIL (batch number H019633), route and site of administration not reported. Within approximately 24 hours of vaccination, on 26-Sep-2013, the patient developed a rash that described as little spots (almost like chicken pox) first noticed on patient''s chest, then stomach, legs and on to her back. The spots were very itchy. Corrective treatment included ZYRTEC reported as ''ZIRTEX'', clarithromycin and EURAX Cream. At the time of reporting, the patient has not recovered. The agency considered that case serious due to be medically significant.


VAERS ID: 509008 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-30
Onset:2013-07-30
   Days after vaccination:0
Submitted: 2013-10-22
   Days after onset:84
Entered: 2013-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000731 / 1 AR / SC

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Hypotension, Incorrect route of drug administration, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (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), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: [therapy unspecified], No adverse event, vaccines
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308FRA000774

Write-up: Case received from a physician on 30-Jul-2013. Case medically confirmed. Case linked with case E2013-05777 (same report, similar adverse reaction). A 16-year-old female patient had received the first dose of GARDASIL (batch and lot number J000731, Exp date 20-JUN-2015) on 30-Jul-2013. Immediately post vaccination she experienced vasovagal syncope associated with tonic clonic movements. Blood pressure was taken and was low (value not reported). She did not hurt herself during syncope. She did not have any cutaneous allergic signs nor respiratory difficulties. To be noted that the patient was sitting during vaccination. She did not have any relevant medical history and previous vaccinations were uneventful. At the time of reporting, the patient had recovered. Follow-up information received on 15-Oct-2013: Upon medical review, the case was assessed as serious by the company upon the basis of the following information. This was a case of misuse. The patient had received the first dose of GARDASIL via subcutaneous route - instead of intramuscular as recommended - in the arm. Following the vaccination she experienced syncope and convulsive seizure. At the time of reporting, she had recovered.


VAERS ID: 509044 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-31
Onset:2013-08-27
   Days after vaccination:27
Submitted: 2013-10-23
   Days after onset:57
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003267 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cytomegalovirus test positive, Epstein-Barr virus antibody positive, Hepatic enzyme increased, Hepatitis A, Hepatitis B test negative, Hepatitis C test negative, Hepatitis acute, Hepatitis viral test negative, Injection site swelling, Local swelling
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
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, Immunisation
Allergies:
Diagnostic Lab Data: Examination and lab tests have been performed: Liver enzymes have decreased, but are still not normal, and there is negative Hepatitis A, B and C virus, EBV and CMV indicate previous infections. 06-SEP-2013: Hepatic enzyme decreased but still not normal. Hepatitis A virus test negative. Hepatitis B virus test negative. Hepatitis C virus test negative. CMV antibody positive indicates previous infection. EBV antibody positive indicates previous infection. Body temperature not febrile.
CDC Split Type: WAES1310SWE010008

Write-up: Case of adverse event received from health care professional via Health Authority on 17-Oct-2013 under the reference number DK-DKMA-ADR 22262405 and DK-DKMA-EFO7080. The primary reporter was a physician. Case is medically confirmed. A 22 year old female patient, had received the second dose of GARDASIL (batch/lot number J003267, expiration date 30-JUN-2015) via intramuscular route of administration in not reported site of administration on 31-Jul-2013 and later on 27-Aug-2013 she developed elevated liver enzymes, possible viral infection and diffuse swelling of the right upper arm and mild swelling of the left upper arm. The patient has informed that on the 27-Aug-1013 a swelling began of the right upper arm. The physician met the patient on 30-Aug-2013, with a swelling of the right upper arm without redness and warmth, and a mild swelling of the left upper arm was observed. The patient was sent to the hospital. Examination and lab tests have been performed: Print from the medical ward: Latest visit: 06-Sep-2013. Main diagnose: DB178, other acute viral hepatitis. Other diagnosis and surgeries: DZ038, observation because of suspected other disease or condition. DB159A, Hepatitis A without specification. Epicrisis: the patient arrives with parents, they are informed that the liver enzymes have decreased, but are still not normal, and there is negative Hepatitis A, B and C virus, EBV and CMV indicate previous infections. Patient has a general well-being, not febrile, and has not been febrile previously. Left arm has started to swell. Immediately the most possible cause could be a virus infection (evaluation). Plan: Control of liver enzymes in the following week. If the patient is well she can receive a telephone call answer, otherwise renewed clinical control here. The patient had no other medications. The patient had a history of the primary dose of GARDASIL (batch/lot number J003267, expiration date 30-JUN-2015) via intramuscular route of administration in not reported site of administration on 18-Jun-2013. At the time of reporting, the outcome was recovering.


VAERS ID: 509294 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-02
Onset:2013-10-05
   Days after vaccination:3
Submitted: 2013-10-24
   Days after onset:19
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Benign intracranial hypertension
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310MLT009773

Write-up: This spontaneous report as received from a physician refers to a 13 year old female patient. Approximately on 02-OCT-2013 ("three days before adverse event") the patient vaccinated with first dose of SILGARD (lot#, expiration date, dose, indication, route not reported). Approximately on 05-OCT-2013 ("approximately 2 weeks ago"), the patient was diagnosed with benign intracerebral hypertension after administration of SILGARD. Patient was hospitalized 3 days after the first dose of SILGARD. The outcome of the event was unknown. Additional information has been requested.


VAERS ID: 509338 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-25
Onset:2013-09-25
   Days after vaccination:0
Submitted: 2013-10-24
   Days after onset:29
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR010512

Write-up: This case was received from the health authority on 18-Oct-2013. GB-MHRA-ADR 22274912. This case is medically confirmed. A 12 year old female patient, with no medical history reported, received on 25-Sep-2013 an injection of GARDASIL, (batch number not reported) intramuscularly, dose in series and site of administration not reported. The same day on 25-Sep-2013, within a couple of hours post vaccination, the patient experienced rash all over the body, particularly on the legs. The patient received a corrective treatment with PIRITON (chlorphenamine) that day on 25-Sep-2013 by first aiders at school and rash subsided. At the time of reporting, the patient has not received an other dose of HPV as it may result in worse reaction. The patient has recovered on 25-Sep-2013. The MHRA considered that case serious due to be medically significant.


VAERS ID: 509482 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-08
Onset:2013-10-08
   Days after vaccination:0
Submitted: 2013-10-24
   Days after onset:16
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019078 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Depressed level of consciousness, Dizziness, Dyspnoea, Heart rate decreased, Hyporesponsive to stimuli, Muscle twitching, Presyncope
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? N