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VAERS ID: 498287 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-18
Onset:2013-06-26
   Days after vaccination:8
Submitted: 2013-08-01
   Days after onset:36
Entered: 2013-08-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000282 / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood alkaline phosphatase normal, Blood thyroid stimulating hormone normal, Bundle branch block right, Electrocardiogram abnormal, Electroencephalogram abnormal, Epistaxis, Gaze palsy, Loss of consciousness, Malaise, Musculoskeletal stiffness, Ophthalmological examination normal, Thyroxine free normal, Tremor, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (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), Conduction defects (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARISTELLE
Current Illness: Unknown
Preexisting Conditions: Vomiting; Syncope
Allergies:
Diagnostic Lab Data: 06/26/2013, Blood alkaline phosphatase, 0.65 SI; 06/26/2013, Blood thyroid stimulating hormone, 5.01 SI; Electrocardiogram, Uncomplete right bundle branch block N/A; Electroencephalogram, Centralised spike potential N/A; 06/26/2013, Electrocardiogram, Increased, Increased cerebral susceptibility to seizures N/A; 06/26/2013, Thyroxine free, 21.2 SI
CDC Split Type: WAES1307DEU015738

Write-up: Case was received from the Health Authorities in a foriegn country on 25-Jul-2013 (reference no. PEI2013042492). Case is medically confirmed. A 16-year-old female patient with a medical history of relapsing syncopes including vomiting during menstruation since 2011, received a third dose of GARDASIL (batch and lot-no. J000282) IM into the left upper arm on 18-Jun-2013. Eight days prior to vaccination, on 10-Jun-2013 use of hormonal contraceptive (ARISTELLE) was started. Eight days p.v., on 26-Jun-2013 in the morning, she developed severe nose bleeding and felt unwell. Subsequently her mother found her lying on the floor, stiff and trembling. Her eyes rolled upwards. Symptoms resolved after one minute and she slowly regained consciousness but was still not responsive. On arrival of the emergency doctor she had completely recovered, was awake and responsive again. She was hospitalised on the same day. Examination at admission showed no pathological findings. Lab test was normal except for alkaline phosphatase 0.65 SI (normal: 0.82-5.50), TSH 5.01 SI (normal: 0.27-4.2), free T4 21.2 SI (normal: 12.6-21.0). EEG showed evidence for increased cerebral susceptibility to seizures on temporoparietal right side. Sleep-deprivded EEG showed centralised spike potential. ECG revealed an uncomplete right bundel branch block. Ophthalmological examination showed normal results. A first "questionable seizure" was diagnosed. She was discharge in a good general condition on 28-Jun-2013. The patient had received D1 of GARDASIL, batch and lot-no. H009962, on 10-Sep-2012 and D2 of GARDASIL, batch and lot-no. H019318, on 12-Feb-2013. Both does were given IM into the left upper arm and well tolerated. Upon medical review the company added the following AE, which was mentioned in the hospital report but not coded by HA: severe nose bleed.


VAERS ID: 498288 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-01
Onset:2013-07-01
   Days after vaccination:150
Submitted: 2013-08-02
   Days after onset:32
Entered: 2013-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Condition aggravated, Hypoaesthesia, Muscle disorder, Pain, Paralysis, Quadriplegia, Stupor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Pain; Quadriplegia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN017304

Write-up: This spontaneous report as received from a 14 year old female consumer refers to herself. In February 2013 the patient was vaccinated with GARDASIL, injection, intramuscular. In July 2013 the patient was hospitalized for quadriplegia and pain. The patient originally had quadriplegia and pain but then had numbness of limbs (right upper and lower limbs), stupor and paralysis complaining that she could not put some muscle at all. During observation period on her hospital stay, she could not walk because of difficulty in using muscles of right lower limb although she was gradually becoming able to use muscle of upper limbs. Quadriplegia, pain in extremity and numbness of limbs (right upper and lower limbs) were not recovered. Reporter''s comment: The symptoms are unlikely due to an organic disease but likely adverse drug reactions or psychogenetic. The reporting physician did not assess the causal relationship of the quadriplegia, pain in extremity and numbness of limbs (right upper and lower limbs) to GARDASIL. The reporting physician considered the quadriplegia and pain in extremity as serious (hospitalization). The reporting physician did not assess the seriousness of the numbness of limbs (right upper and lower limbs). Additional information is not expected.


VAERS ID: 498399 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-18
Onset:2013-06-06
   Days after vaccination:19
Submitted: 2013-08-02
   Days after onset:57
Entered: 2013-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Convulsion, Hypoaesthesia, Muscle disorder, Pain, Pain in extremity, Paralysis, Quadriplegia, Stupor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (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? 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: WAES1308JPN000128

Write-up: Initial information has been received from a physician concerning a female (age unknown), who on 18-MAY-2013 received the second injection of recombinant quadrivalent human papillomavirus vaccine IM (dose, injection site and indication not provided). No concomitant medication was reported. On 21-MAR-2013, the patient received the first injection of recombinant quadrivalent human papillomavirus vaccine IM (dose, injection site and indication not provided). On 06-JUN-2013, seizure developed in the patient. On an unspecified date, the seizure developed secondly. The event was being treated with an antiepileptic drug. At the time of this report, the outcome of the seizure was unknown. Reporter''s comment: The patient has been taking the anti epileptic drug as she had a continuous series of two seizure. At this moment, this drug is planned to be continued at least until the end of AUG-2013. The reporting physician considered that the seizure was related to recombinant quadrivalent human papillomavirus vaccine. The reporting physician did not assess the seriousness of the seizure. Upon internal review, the seizure was determined to be serious due to other important medical report. No further information is expected. Follow-up information has been received from a 14-year-old female patient, who in FEB-2013 received an injection of recombinant quadrivalent human papillomavirus vaccine (formulation unknown) IM (dose, injection site and indication not provided). No concomitant medication was provided. In FEB-2013, the patient received the injection of recombinant quadrivalent human papillomavirus as mentioned above. As of JUL-2013, the patient was hospitalized for quadriplegia (estesia, motion) and pain. The patient originally had quadriplegia and pain but then had numbness of limbs (right upper and lower limbs), stupor and paralysis complaining that she could not put some muscle at all. During observation period on her hospital stay, she could not walk because of difficulty in using muscles of right lower limb although she was gradually becoming able to use muscles of upper limbs. Quadriplegia (estesia, motion), pain in extremity and numbness of limbs (right upper and lower limbs) were not recovered. Reporter''s comment: The symptoms are unlikely due to an organic disease but likely adverse drug reactions or psychogenetic. The reporting physician did not assess the causal relationship of the quadriplegia (estesia, motion), pain in extremity and numbness of limbs (right upper and lower limbs) to recombinant quadrivalent human papillomavirus. The reporting physician considered the quadriplegia (estesia, motion) and pain in extremity as serious (hospitalization). The reporting physician did not assess the seriousness of the numbness of limbs (right upper and lower limbs). Additional information was requested.


VAERS ID: 498530 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-01
Onset:0000-00-00
Submitted: 2013-08-06
Entered: 2013-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Muscle spasms, Pain, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate; ORENCIA
Current Illness: Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1306JPN013994

Write-up: This spontaneous report was received from a other health professional concerning a 39 year old female patient. On an unknown date in December 2012, the patient was vaccinated with a dose of quadrivalent Human Papillomavirus (manufacturer unknown) (lot number, expiry date and dose unspecified), intramuscularly. On an unknown date, the patient was vaccinated with other two doses of Quadrivalent Human Papillomavirus (manufacturer unknown) (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. On an unknown date, in February 2013, the patient experienced foot cramps. Approximately on an unknown date in 2013, the patient recovered from foot cramps. The reporter considered foot cramps to be related to Quadrivalent Human Papillomavirus (manufacturer unknown). Follow-up information has been received from a health professional concerning the 39 year-old female patient vaccinated with Quadrivalent Human Papillomavirus (manufacturer unknown). It was reported that, on an unknown date, the patient experienced generalised aching and numbness. The outcome for generalised aching and numbness was unknown. The reporter considered generalised aching and numbness to be related to Quadrivalent Human Papillomavirus (manufacturer unknown). Follow-up information has been received from a physician (gynecologist) concerning a 39-year-old female patient with a concurrent disease of rheumatism, who in December 2012 received a third dose of GARDASIL IM injection drug 0.5 ml once a day (third time) (injection site not reported). Her concomitant medication included: methotrexate (manufacturer unknown) (daily dose, route and indication were unknown) and ORENCIA (daily dose unknown, injection parenteral) for rheumatoid arthritis. On an unspecified date, the patient received the first dose of GARDASIL intramuscular (IM) injection drug (first time) (dose and injection sire not reported). On an unspecified date, the patient received a second dose of GARDASIL intramuscular (IM) injection drug (second time) (dose and injection site not reported). Around September 2012, sensory disturbance developed. In December 2012, the patient received the third dose of GARDASIL intramuscular (IM) injection drug 0.5 ml once a day (third time) (injection site not reported) as stated above. In February 2013, foot cramps (in both legs) developed. On an unspecified date, the foot cramps resolved. On an unspecified date, generalized aching and numbness developed. At the time of this report, the patient had not recovered from the generalized aching or numbness. Comment of the reporting physician: As tot he foot cramps, this was unlikely related to GARDASIL because there was a rime lag between the vaccination and the development of the event. The patient just worried about it from the vaccine article on the newspaper. The physician considered this event was due to psychogenetic. as the sensory disturbance, the physician recommended the patient to consult with a neurologist but she did not want to do it. The physician heard that she contacted the victims association of the vaccine by herself and was said that vaccine should be detoxed, etc. The reporting physician assessed the foot cramps as unrelated to GARDASIL and the sensory disturbance as related to the vaccine. The reporting physician did not assess the relationship of the generalised aching and the numbness to GARDASIL. The reporting physician assessed the sensory disturbance as serious (disability) and did not assess the seriousness of the foot cramps, generalized aching and numbness. Additional information is not expected.


VAERS ID: 498650 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-06
Entered: 2013-08-07
   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: Diabetes insipidus, Hypophysitis
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: WAES1308DEU002147

Write-up: Case received from a health care professional in a foreign country on 01-Aug-2013. Case medically confirmed. An 18-year-old female patient received the second dose of GARDASIL (lot-no. not reported) on an unspecified date. On an unspecified date, the patient developed hypophysitis with diabetes insipidus. The final outcome was not reported. D1 of GARDASIL (lot-no. not reported) was given on an unspecified date, toleration was not reported.


VAERS ID: 498809 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-13
Onset:2012-05-01
   Days after vaccination:109
Submitted: 2013-08-08
   Days after onset:464
Entered: 2013-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Retinal vasculitis, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Vasculitis (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: Immunisation
Preexisting Conditions: GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK001951

Write-up: Case received from a health care professional via the Health Authorities on 01-Aug-2013 under the reference DK-DKMA-ADR 22199493 and DK-DKMA EFO6450. Case is medically confirmed. A 41-year-old female patient (weight 85 kg, height 168 cm) had received the third injection of GARDASIL (batch number not reported) via intramuscular route on 13-Jan-2012. 16 weeks later, on 01-May-2012, the patient developed visual disorders and retinal vasculitis. The patient was examined for arthritis and connective tissue disorders without finding the cause. The patient was monitored every two months in rheumatology clinic and eye clinic, because the symptoms could be long termed, progressive and leading to visual disabilities. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given on 24-Nov-2010 (D1) and on 11-Feb-2011) (D2), toleration was not reported.


VAERS ID: 498891 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-03
Onset:0000-00-00
Submitted: 2013-08-08
Entered: 2013-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Demyelination, Nuclear magnetic resonance imaging brain abnormal, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Nuclear magnetic resonance imaging brain, demyelination of optic chiasm
CDC Split Type: WAES1308GRC003572

Write-up: Case received from paediatrician on 15-Jul-2013 via the contractual partner VIANEX under the reference number SPV13031. Case medically confirmed. A 12-year-old female patient had received the first dose of GARDASIL, (batch number not reported) 6 weeks before 15-Jul-2013 and 3 weeks post-vaccination, she developed decreased visual acuity. Brain MRI revealed demyelination foci in the area of optic chiasm. The patient''s status remained stable up to now. No treatment was administered. The patient had no relevant medical history, no concurrent medication were administered. The patient had a family history of demyelinating disorder. The reporting paediatrician considered the case as possibly related to vaccination.


VAERS ID: 498902 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-16
Onset:2012-10-16
   Days after vaccination:0
Submitted: 2013-08-08
   Days after onset:296
Entered: 2013-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood glucose, Disturbance in attention, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache, Hypoaesthesia, Memory impairment, Metabolic function test, Myalgia, Nausea, Oral herpes, Paraesthesia, Rash, Syncope, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERDOLECT; ABILIFY; EFEXOR DEPOT; METFORMIN ACTAVIS; ELTROXIN
Current Illness: Polycystic ovaries; Social phobia; Myxoedema; Schizophrenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, ECG; Metabolic function test and Ultrasound scan: Not reported
CDC Split Type: WAES1308DNK001938

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 30-Jul-2013 under the references DK-DKMA-ADR 22196072 and DK-DKMA EFO6424. Case not medically confirmed. A 27-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 an injection of GARDASIL (batch number not reported) 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. Laboratory and diagnostic tests included metabolic function test, blood glucose, ECG and ultrasound of the heart. Results were not provided. 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. The patient was treated with IBUMETIN, PANODIL and asthma inhaler. The patient received a further injection of GARDAIL on 20-APR-2013, toleration was not reported. At the time of reporting, the patient had not recovered.


VAERS ID: 498932 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-17
Onset:2013-07-17
   Days after vaccination:0
Submitted: 2013-08-09
   Days after onset:23
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000731 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose normal, Feeling hot, Gaze palsy, Headache, Hypertension, Loss of consciousness, Pallor, Vision blurred
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), Hypertension (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Syncope, Medical history of vasovagal syncope since childhood fuelled by strong emotions.
Allergies:
Diagnostic Lab Data: Physical examination was normal. Blood pressure was at 77/33 (hypertension), heart rate at 45 and blood glucose normal at 0.8g/L.
CDC Split Type: WAES1308FRA003336

Write-up: Case received from the Health Authorities under reference number PB20130699 on 02-Aug-2013. Case medically confirmed. A 12-year-old female patient with a medical history of vasovagal syncope since childhood fuelled by strong emotions, had received a dose of GARDASIL (batch/lot number J000731, exp 30-JUN-2015) via intramuscular route on 17-Jul-2013. Five minutes post-vaccination she experienced prodroma such as feeling of warmth, cephalgia, blur vision, pallor and then loss of consciousness for less than 1 minute. She had a fixed gaze. She did not have any abnormal movements. Blood pressure was at 77/33 (hypertension), heart rate at 45 and blood glucose normal at 0.8 g/L. The patient gradually recovered and physical examination was normal. Upon medical review, the company considered the case as serious due to other medically important condition: loss of consciousness. The Health Authority assessed the causal relationship between the reported reactions and vaccination as doubtful (C2 S1 B3 l1) according to the updated method of assessment.


VAERS ID: 498933 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-16
Onset:2013-04-14
   Days after vaccination:57
Submitted: 2013-08-09
   Days after onset:117
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Asthenia, Atrophy, Convulsion, Dyskinesia, Electroencephalogram normal, Epilepsy, Fatigue, Grand mal convulsion, Hypoacusis, Nuclear magnetic resonance imaging brain abnormal, Tinnitus, Tongue biting, Unresponsive to stimuli, Urinary incontinence, Urticaria, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (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? No
Previous Vaccinations:
Other Medications: ADROSTAT; PROVAMES
Current Illness: Immunisation
Preexisting Conditions: Polycystic ovaries; Dyspraxia; GARDASIL, She had received the first dose of GARDASIL (batch number not reported) via intramuscular route on 22-Dec-2012.
Allergies:
Diagnostic Lab Data: MRI recently performed evidenced a slight atrophy of the biparietal region. EEG: no anomaly
CDC Split Type: WAES1308FRA003339

Write-up: Case received from the Health Authorities under reference number NT20130961 and NT20130960 on 02-Aug-2013. Case medically confirmed. To be noted that case NT20130960 was considered as non serious by the Health Authorities. But as the adverse event reported in NT20130960 occurred after the same dose and upon internal review, the company judged relevant to merge both cases in one. Case is considered as serious. A 17-year-old female patient had received the second dose of GARDASIL (batch number not reported) via intramuscular route on 16-Feb-2013. On an unspecified time to onset, in Feb-2013, the patient experienced asthenia, which resolved within a few days. On 14-Apr-2013, while at home, she experienced a first seizure with abnormal movements, suffocation for few minutes without cyanosis, tongue biting and urine loss inducing her hospitalization. Tonic-clonic seizure recurred, which resolved with RIVOTRIL. Since Apr-2013, the patient had experienced several seizures, which seemed to be generalized tonic-clonic seizure of typical course in 3 phases with tongue biting and urine loss. The patient experienced times to times ear buzzing for 1 or 2 minutes with sudden onset and sudden disappearance. Therefore, it was difficult to distinguish between generalized epilepsy and a partial secondary generalization seizure. Sometimes the patient had visual disorder and the feeling that noises faded away for several minutes but always within a context of fatigue. When the patient was last seen in the neurology department, she had a generalized seizure and might have had a partial seizure as she broke contact during 1 minute: she did not answer to her mother and was wild-eyes. This fit started with an ear buzzing. MRI recently performed evidenced a slight atrophy of the biparietal region. No other relevant abnormality was noticed. The patient was on LAMICTAL twice but urticarial-like cutaneous reaction occurred each time. Corrective treatment with KEPPRA was then initiated. Dosage started at 250mg twice a day (morning and evening) for 1 week, and increased to 500mg twice a day (morning and evening). The patient was also on URBANYL but treatment was scheduled to be tapered. Neurological follow-up was on-going. The patient had a medical history of visospacial dyspraxia and polycystic ovarian syndrome. She had received the first dose of GARDASIL (batch number not reported) via intramuscular route on 22-Dec-2012. ANDROCUR and PROVAMES were taken as long-term treatments. At the time of reporting, the patient had not recovered from epilepsy. The Health Authority assessed the causal relationship between epilepsy and vaccination as doubtful (C1 S1 l1 B4 Nl2) according to the updated method of assessment. The Health Authority assessed the causal relationship between asthenia and vaccination as doubtful (C2 S1 B3 l1) according to the updated method of assessment.


VAERS ID: 498934 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-16
Onset:0000-00-00
Submitted: 2013-08-09
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Colonoscopy normal, Diarrhoea, Endoscopy upper gastrointestinal tract normal, Enteroclysis, Epilepsy, Erythema, Gastrointestinal disorder, Inflammation, Inflammatory marker increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Hypersensitivity; Epilepsy; GARDASIL, Vomiting; GARDASIL, Diarrhoea; 09/07/2012, GARDASIL, Abdominal pain; 07/12/2012, GARDASIL, Abdominal pain
Allergies:
Diagnostic Lab Data: Exams performed while hospitalized evidenced a slight inflammatory syndrome. Gastroscopy and colonoscopy performed in Mar-2013 were normal.
CDC Split Type: WAES1308FRA003343

Write-up: Case received from the Health Authorities under reference number MP20130792 on 02-Aug-2013. Case medically confirmed. A 17-year-old female patient with a medical history of epilepsy and allergy had received the third dose of GARDASIL (batch number not reported) via intramuscular route on 16-Jan-2013. A 0, 2, 6 month vaccination schedule was followed. She received the first dose on 12-Jul-2012 and the second dose on 07-Sept-2013 (batch numbers not reported) both via intramuscular route. Between the first and second injection she experienced 2 fits with abdominal pain, diarrhea and vomiting. The second one was stronger. Between the second and third injection she experienced fit once a month with similar symptoms. One month after the third dose, fit recurred, which lasted for 12 hours leading to hospitalization. Exams performed while hospitalized evidenced a slight inflammatory syndrome. Gastroscopy and colonoscopy performed in Mar-2013 were normal. In Apr-2013 fit recurred 3 times. In addition to digestive symptoms she experienced erythema on 2 of those fits. On 19-May-2013, i.e. 4 months after the third dose, the patient had another fit. CT enteroclysis performed on an unspecified date was unremarkable. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the adverse event: "erythema" which was mentioned by the CA in the narrative but not coded. The Health Authority assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 498943 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-20
Onset:2013-06-06
   Days after vaccination:17
Submitted: 2013-08-09
   Days after onset:64
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Electroencephalogram, Extremity contracture, Hypotension, Muscle spasms, Nuclear magnetic resonance imaging, Paraesthesia, Paralysis, Tetany, Tongue disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (narrow), Dehydration (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: Low blood pressure
CDC Split Type: WAES1308KOR000497

Write-up: This spontaneous report as received from a nurse via company representative refers to a 28 year old female patient (inappropriate age). On 20-MAY-2013 the patient was vaccinated with a dose of GARDASIL (route, dose and lot # were unknown). The patient drank alcohol on the day before the vaccination. Subsequently, the patient experienced limbs shrinking, low blood pressure, and twistered tongue on an unspecified date in June 2013, and body tetany on an unspecified date in 2013. The patient experienced body tingling and body paralysis on 06-JUN-2013 and recovered on the same day. She had muscle spasm and body paralysis on 13-JUN-2013 and recovered on the same day. She went to a hospital and Magnetic Resonance Imaging (MRI) and electroencephalograph (EEG) were performed with no result provided. Also, she received treatment at the neurology department. The outcome of other events was reported as recovered/resolved on an unspecified date in 2013. Upon internal review, both episodes of body paralysis were considered to be medically significant events. Additional information is not expected.


VAERS ID: 498962 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-26
Onset:2012-02-01
   Days after vaccination:6
Submitted: 2013-08-09
   Days after onset:554
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1336Z / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Electroencephalogram abnormal, Epilepsy, Metamorphopsia
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Retinal disorders (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN001820

Write-up: Initial information has been received from a physician via agency (2012/01) concerning a 16 year old female patient. Medical history interview including underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, past history of ADR, status of growth, were not reported. On 26-JAN-2012, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (batch number 9QN01R, Lot # 1336Z) IM. No concomitant medications were reported. Around February 2012, metamorphopsia and epilepsy developed. On 29-MAR-2013, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (batch number 9QN01R, Lot # 1336Z) IM. On 15-JUN-2012, the patient visited the reporting physician''s hospital where she was admitted for investigation. Prior to 15-JUN-2012, she had visited a hospital and psychosomatic medicine of hospital. Abnormal brain wave was observed and epilepsy was suspected. On an unspecified date she was referred to psychiatry medicine of hospital. On 19-OCT-2012, the patient was recovering from metamorphopsia. The outcome of epilepsy was unknown. Upon internal review epilepsy was considered to be medically significant. Reporter''s comment: none. The reporter did not assess the relationship of metamorphopsia to GARDASIL. Other possible causes were ruled out. He considered metamorphopsia and epilepsy as serious (hospitalization). Additional information has been requested.


VAERS ID: 499055 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-14
Onset:2013-06-18
   Days after vaccination:4
Submitted: 2013-08-12
   Days after onset:55
Entered: 2013-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Back pain, Blood bicarbonate decreased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Metabolic acidosis, Metabolic function test abnormal, Renal colic, Renal failure, Renal function test normal, Spinal pain, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Arthritis (broad), Tumour lysis syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CEBUTID; Meteospasmyl; Acetaminophen
Current Illness: Immunisation; Back pain
Preexisting Conditions: Back pain; 11/2012, Renal failure; 11/2012, Pyelonephritis acute
Allergies:
Diagnostic Lab Data: Ultrasound scan: no lithiasis. Lab test on 14-JUN-2013: renal insufficiency and metabolic acidosis. 06/14/2013, Blood bicarbonate, 22.6 mmol/l; 06/20/2013, Blood bicarbonate, 19.9 mmol/l; 06/25/2013, Blood bicarbonate, 25.8; 06/14/2013, Blood creatinine, 123 umol/l; 06/20/2013, Blood creatinine, 111 umol/l; 06/25/2013, Blood creatinine, 17.3; 06/20/2013, Blood potassium, 5.21 mmol/l; 06/25/2013, Blood potassium, 5.44; 06/25/2013, Blood urea, 2.4; 06/14/2013, Laboratory test, renal sufficiency and metabolic acidosis; Ultrasound scan, no lithiasis
CDC Split Type: WAES1308FRA003970

Write-up: Case received from the Health Authorities under reference number CF20130358 on 02-Aug-2013. Case medically confirmed. A 14-year-old female patient, who went to see her physician on 11-Jun-2013 due to lumbago, had received a dose of GARDASIL (batch number not reported) via intramuscular route on the same day. She was given CEBUTID 100 (twice a day) from 11-Jun-2013 to 14-Jun-2013 per os and paracetamol as corrective treatment for lumbago. Three days post-vaccination she experienced abdominal pain and went back to see her physician. She was given METOSPAMYL per os from 14-Jun-2013 to 18-Jun-2013 and paracetamol as corrective treatment. The patient went to the ER due to too intensive pain and was hospitalized on 18-Jun-2013. Upon admission, laboratory tests performed showed renal insufficiency and metabolic acidosis. Bicarbonate level was at 22.6 mmo/l and creatinine was at 123umol/l. Renal colic was evoked to explain the lumbar pain but ultrasound performed did not evidence any abnormalities, in particular no urolithiasis. The patient did not make any wrong moves. She had right spinal pain. It was concluded that lumbar pain was not a symptom of the renal insufficiency. On 20-Jun-2013 lab data showed: Potassium at 5.21 mmol/l; Bicarbonate level at 19.9 mmol/l; Creatinine at 111umol/l; On 25-Jun-2013 lab data showed: Urea at 2.4; Potassium at 5.44; Bicarbonate level at 25.8; Creatinine at 17.3; She had a medical history of acute pyelonephritis of infectious origin associated with renal insufficiency in Nov-2012. At the time of reporting the patient had recovered. Upon medical review the company judged relevant to code the adverse event: "lumbar pain" which was mentioned by the CA in the narrative but not coded. To be noted that CEBUTID 100 and Meteospasmyl were also considered as suspect by the Health Authorities. The Health Authorities assessed the causal relationship between the reported reaction(s) and both medications as doubtful (C2 S1 l1) according to the method of assessment. The Health Authorities assessed the causal relationship between the reported reaction(s) and GARDASIL as doubtful (C1 S1 l1) according to the method of assessment.


VAERS ID: 499086 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-12
Entered: 2013-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dizziness, Headache, Laboratory test normal, Nerve conduction studies normal, Paraesthesia, Paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examination for sclerosis, calcifications, nerve function, thrombosis, cardio etc. were performed there (on unspecified dates) with negative results. Brain tumor (Unknown date): Negative
CDC Split Type: WAES1308DNK003736

Write-up: Case received from patient via the Health Authorities on 05-Aug-2013 under the reference number DK-DKMA-ADR 22197565 and DK-DKMA-EFO6429. A 19-year-old female patient had received an injection of GARDASIL (dose not reported, batch number not reported, site-, route- and form of administration not reported) on unspecified date in 2006 and later on shortly p-v she developed daily headache, abdominal pain, paralysis in body parts, dizziness, vomiting and constant tingling in the body. The adverse reactions have been unchanged. The patient states that she has in vain visited a private physician on several occasions (on unspecified dates) for her symptoms, therefore she contact her private insurance company who sent her on to a private clinic. Examination for sclerosis, calcifications, nerve function, thrombosis, cardio etc. were performed there (on unspecified dates) with negative results. The patient has not been hospitalized due to the adverse reactions. The patient has no other medications. The patient has in general no other health problems. The agency has requested a medical confirmation on the case and awaits an answer. At the time of reporting, the outcome was not recovered.


VAERS ID: 499198 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-12-17
Onset:0000-00-00
Submitted: 2013-08-13
Entered: 2013-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM46680 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Delivery, Exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1107USA01744

Write-up: This pregnancy follow up case was received from Health Authority on 07-Jul-11 under the reference number 2011-004740. This case is medically confirmed. A 13 year old female patient with an unreported medical history and concomitant medication received the first dose of a GARDASIL, (NM46680) route and site not reported on 06-Jun-10 and subsequently received the second dose of a GARDASIL on 17-Dec-10. The patient was due to received the third dose on 20-May-11 but this dose was not given because the patient had a baby the previous day on 19-May-11. No further information was reported. The IMB considered the pregnancy to be serious due to other medically important condition which required intervention. Follow up received from the IMB on 29-Aug-11. According to the reporter the duration of the patient''s pregnancy was 39 weeks. The weight of the infant was 2.910 kilograms. There were no complications at birth, a normal spontaneous vaginal delivery. The mother is breast feeding and the baby is doing fine so far. Follow up received from the IMB on 06-Aug-2013: The IMB coded the event of no adverse reaction to better capture the outcome of the pregnancy.


VAERS ID: 499312 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-24
Onset:2008-08-01
   Days after vaccination:69
Submitted: 2013-08-14
   Days after onset:1839
Entered: 2013-08-14
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, Blood test, Colitis ulcerative, Functional gastrointestinal disorder, Hemiplegia, Hypoaesthesia, Melaena, Micturition disorder, Paraesthesia, Sensory disturbance
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: GARDASIL, Immunisation; 11/08/2007, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood samples had been taken, but results were not provided.
CDC Split Type: WAES1308DNK005318

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 06-Aug-2013 under the references DK-DKMA-ADR 22202249 and DK-DKMA EFO6483. A 21-year old female patient (weight 64 kg, height 170 cm) had received the third injection of GARDASIL (batch number not reported) via not reported route and site of administration on 24-May-2008. Approximately 2 months later, on 01-Aug-2008, the patient developed stomach pain, melena and ulcerative colitis. On an unspecified date, later that year, the patient developed sensory disorders in the left arm, leg and abdomen, paralysis on the right side (both arm and leg), urination problems, bowel problems, numbness in extremity and tingling sensations in extremities. The patient was hospitalised. Blood samples had been taken, but results were not provided. The patient received drug therapy for ulcerative colitis, and medical care and rehabilitation for paralysis. At the time of reporting, the patient had not recovered from stomach pain, melena, ulcerative colitis, sensory disorders in the left arm, leg and abdomen, numbness in extremities and tingling sensations in extremities. The outcome of paralysis on the right side, urination problems and bowel problems was unknown. Previous dose of GARDASIL was given on 08-Nov-2007 (D1). The patient received D2 on an unspecified date. Toleration of the vaccinations was not reported. Noteworthy: The company corrected the patient''s age at onset of events to 21 years, HA reported 26 years (patient was born in 1987)


VAERS ID: 499424 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-19
Onset:0000-00-00
Submitted: 2013-08-15
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP00860 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Vacuum extractor delivery
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? 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: WAES1212IRL008959

Write-up: This case was received from the health authority on 13-Dec-2012. Ref 2012-015659. This case is medically confirmed. The primary reporter is a nurse. A 17-year-old female patient, with no reported medical history or concomitant medication, received an injection of GARDASIL (batch no. G019345, dose in series and site of administration not reported) 0.5 mL intramuscularly on 19-Sep-2012. Post vaccination the patient discovered she was pregnant. The reporter indicated that the patient was approximately 3 months into the pregnancy at the time of reporting and the baby was due in Jun-2013. At the time of reporting the outcome was unknown. The agency considered this case to be serious as an other medically important condition. Follow up received from the agency on 07-Aug-2013: The reporter indicated that the patient had a baby girl on 12-Jun-2013 at 40 weeks +2 days, weighing 7lb 4oz, by vacuum delivery. Both baby and mother were doing well. The agency coded the event of no adverse reaction.


VAERS ID: 499427 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-18
Onset:2012-04-18
   Days after vaccination:0
Submitted: 2013-08-15
   Days after onset:484
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN43380 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Nasal congestion, The patient was taking concomitant nasal spray (unspecified) for a blocked nose.
Preexisting Conditions: 12/08/2011, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210IRL001044

Write-up: This pregnancy follow-up case was received from the health authority on 13-Sep-2012. Ref 2012-013856. This case is medically confirmed. A 16 year old female patient received the second dose of GARDASIL (batch number G014502, lot number NN43380, expiry 11-2013), route and site not reported, on 18-Apr-2012. The patient was subsequently found to be pregnant at the time of the second dose. Her LMP was 01-Apr-2012 and her EDD was 27-Nov-2012. The patient received her first dose of GARDASIL (batch number NN33040, lot number NN43380, expiry 01-2013) on 08-Dec-2011. The patient was taking concomitant nasal spray (unspecified) for a blocked nose. At the time of reporting the patient outcome was unknown. The agency considered that case serious due to be medically significant. Follow-up information was received from the reporting physician on 07-Aug-2013: The patient gave birth to a baby girl weighing 3.06 kg on 18-Nov-2012. She was 38 +/-5 gestation weeks and the baby''s Apgar was 9/9. The reporter indicated that there has been no complications or worries since. The delivery was vaginal vacuum delivery. It was reported that the patient experienced no adverse effect. According to agency coding, the patient was recovered.


VAERS ID: 499570 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-30
Onset:2013-07-30
   Days after vaccination:0
Submitted: 2013-08-16
   Days after onset:17
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Arthralgia, Blood test normal, CSF test normal, Dysphagia, Injected limb mobility decreased, Injection site pain, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (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 (broad), Eosinophilic pneumonia (broad), Arthritis (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01-AUG-2013: Deep reflex was not observed. At admission: no clear abnormal finding was found in blood tests or cerebrospinal fluid examination. In head MRI, high intensity area with small wave-like pattern was found in the white matter of the right frontal lobe on the T2 and FLAIR. 07/30/2013, Body temperature, 36.7 degrees C
CDC Split Type: WAES1308JPN005025

Write-up: Initial and follow-up information have been received from a physician via the agency concerning a 12-year-old female patient with no family history. No important point (underlying disease, allergy, past vaccination/disease during recent one month, concomitant medications, past ADR history or status of growth) on the patient was described on the vaccination coupon. Her body temperature before the vaccination was 36.7 degrees C. On 30-JUL-2013, the patient received the second (syringe-type) GARDASIL IM injection drug (lot No. 0989AA, batch No. 9QN08R, expiring on 21-JUN-2014) on the right upper arm (dose and indication not reported). No concomitant medication was reported. On an unspecified date, the patient received the first GARDASIL IM injection drug. On an unspecified date, myalgia developed, and also she complained of pain in arms and legs. On an unspecified date, around 3 weeks after the development, the myalgia resolved. On 30-JUL-2013, at 15:00, the patient received the second GARDASIL IM injection drug (lot No. 0989AA, batch No. 9QN08R, expiring on 21-JUN-2014) in the right upper arm. Just after the vaccination, the patient had difficulty raising her right upper limb. She complained of injection site pain, and about 2 hours later, she had difficulty raising the arm up above the shoulder. In that night, she complained that she could not go upstairs due to pain legs. On 01-AUG-2013, the patient had difficulty swallowing solid food, gonalgia and difficulty going up and down stairs. She visited a nearby hospital and then was referred and admitted to the hospital of the reporting physician since deep reflex was not observed. At admission, no clear abnormal finding was found in blood tests or cerebrospinal fluid examination. In head MRI, high intensity area with small wave-like pattern was found in the white matter of the right frontal lobe on the T2 and FLAIR. On 02-AUG-2013 (next day of the admission), the difficulty swallowing and difficulty raising the right upper limb resolved. The patient became able to go up and down stairs thereafter. On 05-AUG-2013, the myalgia, gonalgia and muscle weakness of lower limbs improved, and the patient was discharged from the hospital. Reporter''s comment: (physician who vaccinated) It was revealed after the second vaccination that the patient thought the myalgia which had developed after the first vaccination was a muscle pain by her club activity. (physician who treated) Considering clinical course and examination results, it is unlikely that the adverse events were due to other factor other than the vaccination. The physician assessed that the myalgia, gonalgia, muscle weakness of lower limbs, difficulty swallowing and difficulty raising right upper limb were serious (hospitalization) and related GARDASIL. The physician did not consider there was other possible cause of the events. The physician did not assess the seriousness of the myalgia (which developed after the first vaccination) or the causal relationship between the event GARDASIL. Additional information has been requested.


VAERS ID: 499571 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-23
Onset:2013-04-01
   Days after vaccination:434
Submitted: 2013-08-15
   Days after onset:136
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP23380 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Dizziness, Fatigue, Multiple sclerosis relapse, Nausea, Nuclear magnetic resonance imaging abnormal, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)

Life Threatening? No
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: Hypothyroidism; Immunisation
Preexisting Conditions: 11/11/2011 GARDASIL; Drug Indication: Immunisation
Allergies:
Diagnostic Lab Data: MRI (11-APR-2012): Diagnosis of multiple sclerosis; 04/11/2012, Nuclear magnetic resonance imaging, diagnosis of multiple sclerosis N/A
CDC Split Type: WAES1308FRA006268

Write-up: Case received from the Health Authorities on 06-Aug-2013 under the reference number MA20131385. Case not medically confirmed (also reported as other health professional as primary source). Source reported by the patient. A 20-year-old female patient had received a dose of Meningo A+C, (batch number F25172, exp date: Sep-2012) via intramuscular route on 19-Dec-2011 and on 23-Jan-2012, she received a second dose of GARDASIL (batch/lot number NP23380, exp date: Apr-2012) and a dose of ENGERIX B20, (other manufacturer, batch number AHBV060AE, exp date: Feb-2014) via intramuscular route. About 5 days later, the patient experienced fatigue, nausea and dizziness, and ten days later, she experienced paresthesia in limbs. To be noted that she received the first dose of GARDASIL (batch/lot number NP39110, exp date: Apr-2012) on 11-Nov-2011, i-e two months before the second dose. In March 2012, she consulted as these symptoms were persisting. On 11-APR-2012, she was hospitalized. An MRI was performed and the diagnosis of multiple sclerosis was made. She received corrective treatment with corticoids with SOLUMEDROL as per 1g/day during 3 days. On 24-May-20121, she was administered the third dose of GARDASIL (batch number HO02423- exp date: June 2014), i-e six months after the administration of the second dose. A multiple sclerosis relapsing occurred in May 2012 (no precise date). Homecare treatment with oral corticotherapy was set up. A third relapsing occurred in August 2013 with hospitalization. All in all, in July 2013, since the first hospitalization in April 2012, the patient experienced 7 MS-relapsing from which 4 with hospitalization and 3 treated as outpatient. The patient had not recovered. Outcome for limbs paresthesia was unknown. To be noted that the patient had no medical history of neurological disorder except a hypothyroidism treated by levothyrox 75ug since the age of 15. The patient grand-mother was diabetic. Upon internal review, the company judged relevant to code the adverse reactions "fatigue", "nausea" and "dizziness" which were mentioned by the health Authorities in the narrative but not coded. The Health Authorities assessed the casual relationship between the reported reactions ans vaccinations as doubtful (C2 S1 l1) according to the method of assessment.


VAERS ID: 499573 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-29
Onset:2013-07-29
   Days after vaccination:0
Submitted: 2013-08-16
   Days after onset:18
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fall, Head injury, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308ITA006395

Write-up: Case received from Health Authority (case n. 213727) on 09-AUG-13. Case initially reported by a Health Care professional. Case medically confirmed. A 12 year old female patient with no medical history reported was vaccinated on 29-JUL-13 with GARDASIL (batch n. not reported), 0.5 ml, intramuscularly and the same day on 29-JUL-13 she presented with lipothymic episode preceded by blurred vision, she fall to the ground and presented an head trauma. The patient''s outcome was not reported. Upon medical review, the company judged relevant to add the adverse event "head injury" which was mentioned in the narrative but not coded by HA. HA performed causality assessment for suspect products through an algorithm for vaccines on 09-AUG-2013, that results as "possibly related".


VAERS ID: 499582 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-01
Onset:2012-12-24
   Days after vaccination:114
Submitted: 2013-08-15
   Days after onset:233
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test abnormal, Blood thyroid stimulating hormone increased, Cervical conisation, Cervical dysplasia, Dizziness postural, Hypothyroidism, VIIth nerve paralysis
SMQs:, Reproductive premalignant disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Hearing impairment (broad), Uterine and fallopian tube malignant tumours (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; 08/16/2011, Fatigue; 08/16/2011, Anaemia; 01/2012, Cervical dysplasia
Preexisting Conditions: 05/2012, GARDASIL, Second dose, Immunisation; 03/2012, GARDASIL, First dose, Immunisation
Allergies:
Diagnostic Lab Data: Blood test: Abnormal; TSH: Increased
CDC Split Type: WAES1308ESP006740

Write-up: Case received from a consumer and from a physician on 06-AUG-2013 and 12-AUG-2013. Case medically confirmed. A 30-year-old female patient had received three doses of a GARDASIL (batch number not reported, route and site not reported), she received the first dose on MAR-2012 (exact date not reported), the second dose of GARDASIL on 30 or 31-MAY-2012 and the third dose of GARDASIL was administered on SEP-2012, batch numbers, route and site of administration not reported. Before vaccination, a cytology was performed on JAN-2012 and on FEB or MAR-2012 the results showed a cervical intraepithelial neoplasia III. A conization was performed on 29 or 30-MAY-2012. According to the patient she was healthy until vaccination. According to the patient, she gave birth on 16-AUG-2011 and since this moment she felt tired, she had anemia and strange values of iodine. According to the physician the patient had increased TSH (start date not reported), she was diagnosed with hypothyroidism (date not reported), she will start the treatment to treat it (EUTHYROX, dosage not reported). According to the patient on 24-DEC-2012 she had facial paralysis (confirmed by the physician) in both sides of the face during 2-3 weeks. Also, she presented with dizziness when she stand up from seat, loss of strength of knees and alterations in blood tests (onset dates not reported). According to the patient she was healthy until vaccination. The patient did not know whether she considered these events as related to vaccination, she could not remember dates of onset but she thought she should be recovered after giving birth and she was not. Therefore the company did not know whether the adverse events were part of the patient''s medical history. Clarifications have been requested to both, the patient and the physician. According to the physician, the patient went to the specialists and they considered the picture as not related with the vaccination. At the time of reporting the patient had not recovered. Upon internal review the company considered the case as serious with other medically important condition as criteria. No further vaccination was reported.


VAERS ID: 499634 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-18
Onset:2013-06-26
   Days after vaccination:8
Submitted: 2013-08-16
   Days after onset:51
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Burning sensation, Dizziness, Fatigue, Headache, Muscle contractions involuntary, Muscular weakness, Neuritis, Pain in extremity, Palpitations, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), 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: 01/18/2013, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood test, Normal
CDC Split Type: WAES1308DNK006725

Write-up: Case received from health care professional via the Health Authorities on 08-Aug-2013 under the reference number DK-DKMA-ADR 22205026 and DK-DKMA-EFO6514. Case medically confirmed. A 24-year old female patient had received an injection of GARDASIL (batch number not reported, intramuscular route of administration, form and site of administration not reported) on 18-Feb-2013 and later on the same day she developed discrete nervous system symptoms in form of heart palpitations, tingling in the left arm and pain in the left arm. These symptoms decreased slightly until she received the third injection of GARDASIL (dose 3, batch number not reported, route, form, and site of administration not reported) on 18-Jun-2013 and later on 26-Jun-2013, one week post-vaccination, she developed severe symptoms from the nervous system. The patient had headaches, tingling and tickling under the skin, burning sensation that goes down the neck, neuritis, nerve fasciculation''s, involuntary muscle contractions from the neck and legs in a severe form of nature, fatigue, dizziness and muscle weakness. Blood tests were performed on unspecified date and all the results were normal. The patient was hospitalized (reported by HA) on unspecified date. No further information on this occasion has been specified. The patient''s medical history includes an injection of GARDASIL (dose 1, batch number not reported, form, route and site of administration not reported) on 18-Jan-2013. At the time of reporting, the outcome was not recovered.


VAERS ID: 499718 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-03
Onset:2012-08-01
   Days after vaccination:120
Submitted: 2013-08-18
   Days after onset:382
Entered: 2013-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Affect lability, Asthenia, Dizziness, Fear, Hallucination, auditory, Head injury, Hyperventilation, Hypoaesthesia, Irritability, Memory impairment, Pain, Pain in extremity, Tinnitus
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN005262

Write-up: Initial information has been received from a physician concerning a 15-year-old female patient with no underlying/concurrent disease or medical history. On 01-OCT-2011, 01-DEC-2011, 03-APR-2012, the patient respectively received the first, the second and the third doses of GARDASIL (IM injection 0.5 ml once, lot# not reported). Concomitant therapy included Japanese encephalitis virus vaccine. Nothing happened to the patient at time of the vaccination. Around July 2012, 3 months after the third vaccination, the patient had loss of energy. Around August 2012 (4 months after the vaccination), the patient had auditory hallucination. Around October 2012 (6 months after the vaccination), the patient had pain in feet. Around November 2012, during the school test period, she could not concentrate on study because of emotional instability. She got yelled by her father for that and had hyperpnoea. She then saw a psychotherapist, who judged there was no problem with her. On unspecified dates, tinnitus, giddiness, pain in feet, forgetfulness, irritation, fear feeling, swaying and body pain subsequently developed in the patient, and she hit her over the head against the floor and slap her body by herself because of the body pain. On 25-MAR-2013, the patient received a Japanese encephalitis virus vaccine at the reporter''s clinic, when she told nothing about her symptoms at all. In August 2013, no abnormality was found at an orthopedic department where the patient visited for numbness in feet. At the time of this report, the patient had not recovered from the loss of energy, auditory hallucination, or pain in feet. The outcome the emotional instability, hyperpnoea, tinnitus, giddiness, forgetfulness, irritation, fear feeling, swaying, body pain and numbness in feet was unknown. Reporter''s comment: It was unknown about the casual relationship of these events to the GARDASIL, because the development of the events was too late for inactivated vaccine-induced events. The patient''s parent wanted to have her examined by a specialist and would refer to another hospital. The name of hospitals (departments of psychological and orthopedic) the patient visited was unknown. The patient did not complain of anything at the time of Japanese encephalitis virus vaccine. The patient would not revisit the physician after she was referred to the hospital. The reporting physician did not assess the causal relationship of the loss of energy, auditory hallucination, pain in feet, emotional instability, hyperpnoea, tinnitus, giddiness, body pain, forgetfulness, irritation, fear feeling, swaying and numbness in feet to GARDASIL. The reporting physician assessed the loss of energy, auditory hallucination and pain in feet as serious due to other important medical events, and did not assess the seriousness of the emotional instability, hyperpnoea, tinnitus, giddiness, body pain, forgetfulness, irritation, fear feeling, swaying and numbness in feet. Additional information is not expected.


VAERS ID: 499720 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-19
Entered: 2013-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis
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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, dose 1, batch number not reported route and site of administration not reported on unknown date
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK007007

Write-up: Case received from a non-health care professional via the Health Authorities on 12-Aug-2013 under the reference number DK-DKMA-ADR 22210953. Case not medically confirmed. An adolescent female patient (birth date and initials not reported) had received an injection of GARDASIL (dose 2, batch number not reported, route and site of administration not reported) on unknown date (onset date not reported) and later on she developed sclerosis. HA has received the report from the patient''s mother. Her daughter has received the HPV-vaccine 2 times on unknown dates and has subsequently been diagnosed with sclerosis (onset dates not reported). Patient''s medical history includes: GARDASIL, dose 1, batch number not reported route and site of administration not reported on unknown date. The patient was diagnosed with sclerosis (coded by HA as multiple sclerosis). At the time of reporting, the outcome was not recovered.


VAERS ID: 499724 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-16
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN007222

Write-up: Initial information has been received from a physician (also reported as pharmacist) concerning a female patient of an unknown age who on an unknown date, was vaccinated intramuscularly with a dose of GARDASIL (dose, injection site and lot number not reported). No concomitant medication was reported. On an unspecified date, the patient received GARDASIL and after vaccination, the patient experienced nausea, floating feeling, giddiness and numbness of 4 limbs. The patient was observed for a while, and then she underwent examinations after admission to hospital. There was no abnormality in vital and no hyperventilation. The next day (date unknown), the patient was discharged from the hospital because she had recovered from the nausea, floating feeling, giddiness and numbness of limbs. I consider that there was some causal relationship between the adverse events and the GARDASIL because the patient''s condition changed just after the vaccination, but I could not identify the cause of the events at the moment. The reporting physician assessed that the nausea, floating feeling, giddiness and numbness of limbs were related to GARDASIL. The reporting physician assessed the nausea, floating feeling, giddiness and numbness of limbs as serious due hospitalization. Additional information has been requested.


VAERS ID: 499887 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-23
Onset:2013-07-23
   Days after vaccination:0
Submitted: 2013-08-20
   Days after onset:28
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness postural, Lip discolouration, Lip swelling, Paraesthesia, Rash, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Dizziness, with the first vaccine of GARDASIL
Allergies:
Diagnostic Lab Data: 07/23/2013, Heart rate, 96 not provided; 07/23/2013, Heart rate, 88 not provided; 07/23/2013, Respiratory rate, 32 not provided; 07/23/2013, Respiratory rate, 26-30 not provided
CDC Split Type: WAES1308AUS007892

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 12 year old female patient. On 23-JUL-2013 the patient was vaccinated with GARDASIL (batch # reported as H016666) dose 2, intramuscular. The patient was administered second dose of GARDASIL at approximately 10:10-10:15. She had felt dizzy with her first vaccine so we had her wait in close proximity to us sitting up. She remained sitting for approximately 15 minutes and checked on throughout. When she stood up to leave she felt dizzy so she was asked to stay and laid down with legs elevated. By 10:30 she had developed a fine rash on her inner forearm (itchy) and within a few minutes a welt like rash on her right side forehead/scalp. Pulse (P) was 96 Respiratory rate (RR) was 32. The patient was alert and talking feeling "ok". By 10:40 the HCP noted colour change of lips and slight swelling of lips, tingling sensation. She remained alert, no increased work of breathing (WOB) and strong regular pulse P88, RR 26-30. Rash began to subside and no further change in appearance (adrenalin was drawn up). Ambulance was called. The patient was assessed and monitored by paramedics and transferred to medical centre for further management. Subsequently, the patient was hospitalized. The patient said she was given some medications and observed and sent home later that day. Her mother does not speak the language so she was unable to further explain treatment given in emergency department (ED). The outcome of the events was unknown. The agency considered the events to be possibly related to GARDASIL. The original reporting source was State/Territory Health Department. Additional information is not expected.


VAERS ID: 499932 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-07-25
Onset:2013-07-27
   Days after vaccination:2
Submitted: 2013-08-20
   Days after onset:24
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, General physical health deterioration, Gianotti-Crosti syndrome, Malaise, Pyrexia, Rash, Rash macular
SMQs:, Liver infections (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, $g39 degree
CDC Split Type: WAES1308DEU008646

Write-up: Case was received from the Health Authorities on 13-Aug-2013 (reference no. PEI2013046128). Case is medically confirmed. A 26-year-old male patient received the first dose of GARDASIL (lot-no. not reported) IM on 25-Jul-2013. On 27-Jul-2013, the patient developed Gianotti-Crosti syndrome (all over skin multiple ($g200) disseminated, non itching erythematous maculae with central vesicula and normal mucosa), exanthem, feeling sick, fever ($g39 degrees C) and weakness. On 28-Jul-2013, patient presented to the emergency unit due to deterioration of his condition. The patient refused the recommended hospitalization. At the time of reporting the patient had not recovered. The case was assessed by HA as serious (other medical important condition).


VAERS ID: 500026 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-02-22
Onset:2013-02-28
   Days after vaccination:6
Submitted: 2013-08-20
   Days after onset:172
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. RN39011 / 1 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H001349 / 1 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC378078AH / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash, 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? 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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308AUS008096

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning to a 12 years old male patient. On 22-FEB-2013 the patient was vaccinated with the first dose of GARDASIL batch# H001349 (exp. 28-JUN-2014), the first adult dose of HBVAX II batch# G005881 (valid as lot# RN39011, exp. 16-NOV-2013), and the first dose of BOOSTRIX batch# AC378078AH. No administration route was provided. On 28-FEB-2013, the patient developed a rash and welts on inner thighs and under arms 6 days post vaccination. Patient attended to emergency department (ED) on 03-MAR-2013. ED discharge notes was requested and would be forwarded. The was recovered from rash on 11-MAR-2013. The reporter considered rash to be possible related to GARDASIL, HBVAX II and BOOSTRIX. The original reporting source was State/Territory Health Dep. Additional information is not expected.


VAERS ID: 500035 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-23
Onset:2012-07-01
   Days after vaccination:69
Submitted: 2013-08-20
   Days after onset:415
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Confusional state, Convulsion, Electroencephalogram normal, Muscle twitching, Musculoskeletal stiffness
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electroencephalograph (EEG): 12-FEB-2013: no abnormality detected
CDC Split Type: WAES1308AUS007332

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR323758) concerning a 12 year old female patient. On 29-FEB-2012, 23-APR-2012, and on approximately 30-JUN-2012 the patient was vaccinated with his first, second and third doses of GARDASIL respectively, intramuscularly (doses, and lot numbers not provided). The day after vaccinations, on 01-JUL-2012, the patient''s father found her having seizure and stiff twitching movements of all body. It lasted a few minutes. The patient was confused for some time afterwards. The patient backed to normal after some time. The patient recovered after 4 hours. On 12-FEB-2013, an electroencephalograph (EEG) showed no abnormality detected (NAD). The agency considered the events to be possibly related to GARDASIL. The original reporting source was State/territory Health Department. Upon internal review convulsion was considered medically significant. Additional information is not expected.


VAERS ID: 500036 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-06-24
Onset:2013-06-24
   Days after vaccination:0
Submitted: 2013-08-20
   Days after onset:57
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0613AE / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Hypoaesthesia, Loss of consciousness, Loss of control of legs, Restlessness, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (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), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308AUS007335

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR322400) concerning a 12 year old male patient. On 13-FEB-2013 the patient was vaccinated with his first dose of GARDASIL (dose, route and lot number not provided). On 24-JUN-2013 the patient was vaccinated with his second dose of GARDASIL lot # 0613AE, batch H019846, expiring 02-APR-2015, intramuscular (dose and site not provided). On 24-JUN-2013, at approximately 13:00 hours the patient presented at sick bay, was unable to walk properly, his legs were ''twisting'', he was ''blanking out'' but easily roused. The patient experienced numbness of left face. The patient was taken to the Hospital at 15:00 hrs by his parents. The patient presented with shakiness, restlessness and possible syncope. The patient complained of shortness of breath and was given VENTOLIN prn. On 25-JUN-2013 the patient was still feeling weak and limping left leg, and stayed home from school. On 26-JUN-2013, the patient still was not fully recovered, and remained weak. The patient was advised by Hospital to go to GP and consider follow up with Paediatric Neurologist if any symptoms persist. (Also reported as: The outcome of the events was reported as recovered (27-JUN-2013). The agency considered the events to be possibly related to GARDASIL. The original reporting source was state/territory health department. Additional information is not expected.


VAERS ID: 500039 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-21
Entered: 2013-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008260 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Dizziness, Face injury, Fall, Lip injury, Lymphadenopathy, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308GBR008475

Write-up: This case was received from the health authority in a foreign country on 13-Aug-2013. GB-MHRA-ADR 22203313. This case is medically confirmed. A 12-year-old patient (gender unknown), with no reported medical history, was vaccinated on an unreported date with an injection of GARDASIL (batch n. H008260; dose, dose in series, route and site of administration not reported). The patient fainted 5 minutes after the vaccination, hit face when falling and had sustained bruising, swelling to node and cut lip. She felt nauseated and dizzy and was collected from school. The patient returned to school on the following day. At the time of reporting the patient had recovered from dizziness, fainting and nausea (date of recovery not reported). The outcome was not reported for hit face when falling, sustaining bruising, swelling to node and cut lip. Upon internal review the company decided to add the adverse events "hit face when falling", "sustaining bruising", "swelling to node" and "cut lip" which were mentioned but not coded by HA. The events were considered to be serious as an other medically important condition.


VAERS ID: 500104 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-05
Onset:2012-09-15
   Days after vaccination:10
Submitted: 2013-08-21
   Days after onset:340
Entered: 2013-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H001349 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Immunoglobulin therapy, Neuropathy peripheral, Plasmapheresis
SMQs:, Peripheral neuropathy (narrow), 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? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308AUS008137

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 14 year old female patient. On 05-SEP-2012 the patient was vaccinated with a dose of GARDASIL (lot # H001349, 0.5 ml, intramuscular). On 15-SEP-2012, the patient experienced sensory predominant acute inflammatory neuropathy (almost complete loss of posterior column function). Steroids/ivig/plasmapheresis was ongoing. 20 days hospital admissions in all, as a work up for treatment +intravenous immunoglobulin (IVIG) and plasma exchange. The outcome of sensory predominant acute inflammatory neuropathy was reported as not recovered/not resolved. The reporter considered sensory predominant acute inflammatory neuropathy to be Incapacity/disability and to be possibly related to GARDASIL. The original reporting source was an other health professional. Additional information is not expected.


VAERS ID: 500105 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-01
Onset:0000-00-00
Submitted: 2013-08-22
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Dissociative disorder, Nonspecific reaction, Pyrexia, Syncope, Tonic clonic movements, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/2011, GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DEU009151

Write-up: Case was received from the Health Authorities on 14-Aug-2013 (reference no. PEI2013046170). Case is medically confirmed. A 13-year-old female patient received the second dose of GARDASIL (lot-no. not reported) IM on an unspecified date in Sep-2011. Following the vaccination, the patient developed fever and a severe general reaction lasting for one week. Two months after vaccination, the patient experienced poor concentration and general ill feeling. Patient missed school on a regular basis. Eight months after vaccination, the patient developed tremor, syncopes and tonic-clonic jerks in terms of dissociative seizures requiring several hospital stays. At the time of reporting to local HA on 21-Mar-2013, the outcome was unknown. D1 of GARDASIL (lot-no. not provided) given in May-2011 was well tolerated.


VAERS ID: 500106 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-25
Onset:2012-10-25
   Days after vaccination:0
Submitted: 2013-08-22
   Days after onset:301
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H006967 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Nausea, Rash erythematous, Tremor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: BRICANYL
Current Illness: Immunisation; Asthma exercise induced
Preexisting Conditions: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308SWE009122

Write-up: Case received from a health care professional via Health Authority on 14-Aug-2013 under reference number 132806. Case serious and medically confirmed. A 14 year old female patient had received an injection of GARDASIL (dose 2, batch number H006967, route intramuscular and site not reported) on 25-Oct-2012 and later on, the vaccination day, (onset date: 25-Oct-2012) she developed an anaphylactic reaction, heavy breathing, dizziness, nausea, shaking, red rash. According to the reporter the patient received the GARDASIL vaccination at 11:30 am, shortly post vaccination she developed dizziness, nausea, shaking and red rash. She received 0, 15 mg ANAPEN (mfr other) with successful effect. At 12:00 pm she also received BETAPRED (mfr other) 5 mg and TAVEGYL (mfr other) 1 mg by the ambulance team and when she arrived at the hospital she was no longer heavy breathing but she was still feeling dizzy and shaky. She was hospitalized for observation. At 21:00 pm she was discharged from hospital and returned to her home, at that time she was completely recovered and stable circulatory and respiratory. The patient has previously been vaccinated with GARDASIL (batch number, route and site not reported), date of vaccination not reported. The patient also has a disease history of asthma exercise induced, ongoing. Upon medical review the company judged relevant to code the following adverse events: dizziness, nausea, shaking, red rash and heavy breathing which were mentioned by the HA in the narrative, but not coded. At the time of reporting, the outcome was recovered.


VAERS ID: 500112 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-27
Onset:2012-05-28
   Days after vaccination:31
Submitted: 2013-08-22
   Days after onset:451
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythromelalgia, Gait disturbance, Immediate post-injection reaction, Injection site erythema, Injection site pain, Nerve block, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Mumps
Allergies:
Diagnostic Lab Data: Body temperature, 36.6 degrees C; 04/27/2012, Body temperature, 36.2 degrees C; 06/30/2012, Body temperature, 36.5 degrees C
CDC Split Type: WAES1308JPN008438

Write-up: Initial information has been received from a physician via the PMDA concerning a 12-year-old female patient, who on 27-APR-2012 received a GARDASIL (Lot # 9QN03R) intramuscular (IM) injection for the first time (dose and injection site not provided). In the immunization questionnaire (about underlying disease, allergy, past history of vaccination/ disease during recent one month, concomitant medications, past history of adverse drug reaction (ADR) and status of growth), it was reported that the patient had a history of mumps and no family history. Her body temperature before the vaccination was 36.2 C. No concomitant medication was reported. On 27-APR-2012, the patient received the GARDASIL injection drug (Lot# 9QN03R) for the first time as mentioned above. She then immediately had only injection site pain and redness. On 28-MAY-2012, the patient had pain in the soles of both feet and had to walk on her toes. The pain increased when they touched hot water. At the beginning of June 2012, the patient visited a department of dermatology and was given a diagnosis of erythromelalgia. The painkiller prescribed was ineffective. In the middle of June 2012, the patient had a nerve block at a pain clinic, which was ineffective. On 30-JUN-2012, the patient received the type GARDASIL (Lot # 9QN03R) for the second time. On 08-AUG-2012, the patient was admitted to the department of neurology of a hospital and had close examinations. She received medical treatment but did not improve. On 17-AUG-2012, the patient was discharged from the hospital. On an unspecified date, the patient received the GARDASIL (Lot # 9QN06R) for the third time. As of 05-JUL-2013, the patient still had pain of erythromelalgia, and it had slightly been affecting her daily and school like. Reporter comment: Nothing particular. The reporting physician assessed the causal relationship between the erythromelalgia and GARDASIL as unknown and did not assess the relationship of the injection site pain and injection site redness to the GARDASIL. The physician did not consider there was other possible cause (such as some disease) of the events. The reporting physician assessed the erythromelalgia as serious (hospitalization) and did not assess the seriousness of the injection site pain and the injection site redness. Additional information has been requested.


VAERS ID: 500211 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-02
Onset:2009-04-14
   Days after vaccination:12
Submitted: 2013-08-22
   Days after onset:1591
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cataplexy, Hypersomnia
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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: WAES1308DNK009140

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Aug-2013 under the reference number DK-DKMA-ADR 22209766 and DK-DKMA-EFO6547. Case medically confirmed. A 14-year old female patient had received an injection of GARDASIL (dose 3, batch number not reported, intramuscular route, site not reported) on 02-Apr-2009 and later on 14-Apr-2013 (ie 12 days p-v) she developed hypersomnia and cataplexy. The patient was hospitalized first time with attack on 14-Apr-2009 (date discharged not reported). Other vaccines: no. Other medications: no. The patient''s medical history includes: First GARDASIL vaccination (dose 1, batch number not reported, route and site of administration not reported) on 09-Oct-2008. Second GARDASIL vaccination (dose 2, batch number not reported, route and site of administration not reported) on 11-Dec-2008. At the time of reporting, the outcome was not recovered.


VAERS ID: 500212 (history)  
Form: Version 1.0  
Age: 42.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-12
Onset:2013-06-26
   Days after vaccination:14
Submitted: 2013-08-22
   Days after onset:57
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016574 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Computerised tomogram head abnormal, Confusional state, Depressed mood, Disturbance in attention, Dizziness, Impaired work ability, Libido decreased, Mental status changes, Musculoskeletal disorder, Myalgia, Nausea, Speech disorder, Stress, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT (cerebral) was performed on an unspecified date with nothing abnormal as result.
CDC Split Type: WAES1308DNK009746

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Aug-2013 under the reference number DK-DKMA-ADR 22208286 and DK-DKMA-EFO6541. Case medically confirmed. A 42 year old female patient (height 174 cm, weight 85 kilogram) had received an injection of GARDASIL (dose 2, batch number H016574, intramuscular route, site of administration not reported) on 12-Jun-2013 and later on 26-Jun-2013 (i.e. 14 days p-v) she developed Transient Cerebral Ischaemia (TCI), difficulty speaking and difficulty controlling right arm and leg. The patient was hospitalized due to the events. CT (cerebral) was performed on an unspecified date with nothing abnormal as a result. The patient''s medical history includes: First GARDASIL vaccination (dose 1, batch number not reported, site and route of administration not reported) on 06-Mar-2013. Previously healthy patient. At the time of reporting, the outcome was unknown. Additional information received from health authority on 19-Aug-2013. Additional reference number received: DK-DKMA-ADR 22213488 and DK-DKMA-EFO6584. HA received information from the patient. Patient initials, height: 165 cm, weight 89 kilogram updated and changed. According to the patient, she developed speech impairment, confusion, dizziness, nausea, concentration impaired, TCI/blood clots, tiredness, tender muscles, mentally unstable, anxiety, sadness, quickly stress, decreased sex drive. Due to these symptoms the patient was absent from work for 5 weeks and had to start seeing a psychologist. She is very sad all the time. The patient received the following treatment for the side effect: clopidogrel (other MFR) and simvastatin (other MFR). HA added AE with outcome and onset as follows: quickly stress: unknown (onset not reported), sadness: unknown (onset not reported), anxiety: unknown (onset not reported), decreased sex drive: unknown (onset not reported), confusion: not recovered (onset 26-Jun-2013), concentration impaired: not recovered (onset 26-Jun-2013), tender muscles: unknown (onset not reported), mentally unstable: unknown (onset not reported), dizziness: not recovered (onset 26-Jun-2013), tiredness: unknown (onset not reported), nausea: not recovered (onset 26-Jun-2013).


VAERS ID: 500389 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-25
Onset:2013-03-20
   Days after vaccination:54
Submitted: 2013-08-25
   Days after onset:158
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H017284 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Borrelia test negative, Computerised tomogram normal, Dizziness, Fatigue, Headache, Hypoaesthesia, Lumbar puncture normal, Malaise, Nuclear magnetic resonance imaging normal, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computerised tomogram, No TIA/stroke, multiple sclerosis or Borrelia; Lumbar puncture, No TIA/stroke, multiple sclerosis or Borrelia; Nuclear magnetic resonance imaging, No TIA/stroke, multiple sclerosis or Borrelia
CDC Split Type: WAES1308DNK010428

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 19-Aug-2013 under the references DK-DKMA-ADR 22210977 and DK-DKMA EFO6556. Case is not medically confirmed. A 38-year-old female patient (weight 60 kg, height 174 cm), had received an injection of GARDASIL (dose not reported, batch number not reported) via not reported route on 25-Jan-2013. On 20-Mar-2013, the patient developed headache, sensory disturbance and numbness in the right side of the body. On 21-Mar-2013, the patient developed general malaise. On an unspecified date the patient also developed sporadic dizziness and general fatigue. The patient was hospitalised. Lumbar puncture, MRI and CT scan were performed. No TIA/strike, multiple sclerosis or Borrelia were detected. In July 2013, the patient developed the same feelings in his left hand and foot. At the time of reporting, the patient had not recovered from headache, sensory disturbance and numbness in the right side of the body. The outcome of general malaise, sporadic dizziness and general fatigue was unknown. Noteworthy: The HA reported that the patient had received a previous dose in Apr-2013 which is not consistent with the suspect dose. Additional information received from a health care professional via Health Authority in a foreign country on 20-Aug-2013 under reference numbers DKMA 2214207 and DKMA EFO6596. Case is medically confirmed. The following information has been added/changed. Patient''s height is changed to 175. Batch number H017284 added for GARDASIL dose administered on 25-Jan-2013. Adverse event PARESTHESIA IN ENTIRE RIGHT SIDE added with start date 21-Mar-2013, outcome not recovered. On 03-Apr-2013 the patient received an injection of GARDASIL (dose not reported, batch number J0003947, route intramuscular and site not reported). On 11-Jul-2013 the patient developed a deterioration shown as paresthesias in left side of the body and face. After GARDASIL vaccination received on 25-Jan-2013 the patient develops paresthesia in the entire right side. She was hospitalized on a neurological department, apoplectical observation and disseminated sclerosis observation, neither existed. No signs of neurological infection. After GARDASIL vaccination received 03-Apr-2013 the patient developed a deterioration shown as paresthesias in left side of the body ad face, in addition, dizziness and fatigue. At the time of reporting the outcome for deterioration shown as paresthesias in left side of the body and face was not recovered.


VAERS ID: 500390 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-22
Onset:2013-07-22
   Days after vaccination:0
Submitted: 2013-08-25
   Days after onset:34
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test, Cold sweat, Depressed level of consciousness, Disturbance in attention, Dizziness, Dysgraphia, Dyspnoea, Fatigue, Headache, Hearing impaired, Heart rate increased, Hot flush, Hyporesponsive to stimuli, Influenza like illness, Libido decreased, Memory impairment, Monoplegia, Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Palpitations, Paraesthesia, Sensory disturbance, Speech disorder, Spinal pain, Tremor, Visual impairment
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), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (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), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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: 05/27/2013, GARDASIL, Drug Reaction: Influenza like illness; 05/27/2013, GARDASIL, Drug Reaction: Anogenital warts
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK010420

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 19-Aug-2013 under the references DK-DKMA-ADR 22213485 and DK-DKMA EFO6581. Case is not medically confirmed. A 31-year-old female patient (weight 56 kg, height 161 cm) had received the second injection of GARDASIL (batch number not reported) via not reported route on 22-Jul-2013. On the same day, the patient developed breathing problems, flu-like symptoms, cold sweat, sensory disturbances, visual disturbances, writing difficulty with pencil, difficulty in speaking, headache, dizziness, consciousness clouding (was in bubble), hearing impaired, nausea, pain in joints, pain in muscles, tiredness and difficulty getting out of the bed despite the fact that she was sleeping around 7 hours each night, difficulty concentrating, memory impairment, tremors in the legs and arms, high pulse, poor response, hot flush, decreased libido, heart palpitations, leg paralysis for short periods, severe pain in the upper neck, sleeping feet, pain in lumbar region and neck stiffness. Blood tests were performed, but results were not provided. At the time of reporting, the patient had not recovered. Previous dose of GARDASIL (D1) was given on 27-May-2013. On the same day, the patient developed flu-like symptoms. On an unspecified date in May-2013, the patient also developed genital warts and bumps in the vagina introitus.


VAERS ID: 500392 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-30
Onset:2013-06-23
   Days after vaccination:144
Submitted: 2013-08-23
   Days after onset:61
Entered: 2013-08-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019411 / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram normal, Diplopia, Headache, Hypoaesthesia, Neck pain, Nuclear magnetic resonance imaging normal, Paraesthesia, Subarachnoid haemorrhage
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Ocular motility disorders (broad), Arthritis (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Tension headache; MIgraine; 10/22/2012, GARDASIL, Immunisation, Dose 2. Batch number H007797; 09/17/2012, GARDASIL, Dose 1. Batch number G020674.
Allergies:
Diagnostic Lab Data: CT and MMR was normal. MMR or molecular MR is MRI with molecular imaging. 06/23/2013, Computerised tomogram, normal; 06/23/2013, Nuclear magnetic resonance imaging, Normal
CDC Split Type: WAES1308DNK008876

Write-up: Case received from a health care professional via company representative on 14-Aug-2013. Case medically confirmed. A 21 year old female patient had received an injection of GARDASIL (dose 3, batch number H019411, site and route of administration not reported) on 30-Jan-2013 and later about 5 months p-v, on 23-Jun-2013, she developed severe neck pain and was hospitalized with suspected arachnoidal hemorrhage. After half a day occurs diplopia and numbness in the arm from the elbow down. CT and MMR were normal and the patient was discharged the same evening (23-Jun-2013). She still has tingling in the right cheek and headache. To be noted that MMR or molecular MR is MRI with molecular imaging. Patient''s medical history includes: First vaccination with GARDASIL (Dose 1, Batch number G020674, lot number NP00860, site and route of administration not reported) on 17-Sep-2012. Second vaccination with GARDASIL (Dose 2, Batch number H007797, site and route of administration not reported) on 22-Oct-2012. Patient had previously suffered from migraine and tension headaches. At the time if reporting, the outcome was not reported for severe neck pain, suspected arachnoidal bleeding, diplopia and numbness in arm. Outcome of tingling in the right cheek and headache was not recovered.


VAERS ID: 500393 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-15
Onset:2013-01-20
   Days after vaccination:5
Submitted: 2013-08-25
   Days after onset:216
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test, Computerised tomogram, Dizziness, Ear, nose and throat examination, Fatigue, Headache, Hemiplegia, Impaired work ability, Memory impairment, Metabolic function test abnormal, Neurological examination, Nuclear magnetic resonance imaging spinal, Oedema peripheral, Sensory disturbance, Somnolence, Tic, VIIth nerve paralysis, Visual impairment
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), 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 (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT scan, MRI of spinal fluid, neurological tests and ear, nose and throat tests were performed. Results were not provided. Blood test, tabolism parameters were rising N/A
CDC Split Type: WAES1308DNK010406

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 19-Aug-2013 under the references DK-DKMA-ADR 22210979 and DK-DKMA EFO6558. Case is not medically confirmed. A 38-year-old female patient (weight 98 kg, height 176 cm) had received the first injection of GARDASIL (batch number not reported) via not reported route on 15-Jan-2013. 5 days later, on 20-Jan-2013, the patient developed headache, dizziness, paralysis/stunned face, left arm and leg, pain in joints, fatigue, feeling of grogginess, memory impaired, visual disturbances, tics and disturbances in fingers and water in the left leg. The symptoms were increasing and on 05-Aug-2013, the patient found it difficult to do her job. The patient was hospitalised. Blood tests showed that metabolism parameters were rising. CT scan, MRI of spinal fluid, neurological tests and ear, nose and throat tests were performed. Results were not provided. The patient was treated with metabolic medicine due to water in the legs and headache. The patient was also treated with cranio-sacral therapy and reflexology. At the time of this report, the patient had not recovered.


VAERS ID: 500534 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-25
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acne, Computerised tomogram, Infertility female, Menstruation irregular, Metabolic function test abnormal, Neurological examination, Nuclear magnetic resonance imaging
SMQs:, Fertility 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:
Allergies:
Diagnostic Lab Data: Computerized tomogram, MRI, Neurological examination and Ear, nose and throat examination performed, results not provided; Blood test, metabolism parameters were rising
CDC Split Type: WAES1308DNK010417

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 19-Aug-2013 under the references DK-DKMA-ADR 22210163 and DK-DKMA EFO6550. Case is not medically confirmed. A female patient, (weight 62 kg, height 170 cm), had received an injection of GARDASIL (batch number not reported) via not reported route on an unspecified date in 2005. On an unspecified date in 2005, the patient developed blemished skin, irregular menstruations and decreased fertility (cannot get pregnant). The patient had been rarely sick before the vaccination with GARDASIL, but since vaccination, the patient experienced approximately two episodes of sick leave per year. At the time of reporting, the patient had not recovered.


VAERS ID: 500640 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-03-01
Onset:2010-04-01
   Days after vaccination:31
Submitted: 2013-08-27
   Days after onset:1244
Entered: 2013-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis autoimmune, General physical health deterioration, Headache, Immunoglobulin therapy, Intensive care, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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:
CDC Split Type: WAES1308ISR009992

Write-up: This spontaneous report as received from a gynecologist refers to a 22 year old female patient with no history of sexual activity who was married with a young male with no history of sexual activity, both were not at risk group for HPV. In March 2010, the patient was possibly vaccinated with the first dose of GARDASIL (Lot # not reported, expiration date and route not specified). The physician reported that in April 2010, after one month of vaccination, following a day of hiking the patient complained to her husband at the evening about a headache and within a short time the patient lost consciousness. The patient was hospitalized at the intensive care unit under the diagnosis of autoimmune inflammation of the brain. Despite intensive treatments that included immunoglobulin therapy and wide and global consultations the patient''s condition deteriorated and the patient passed away after several days in April 2010. No post-mortem autopsy was performed. The physician felt that severe autoimmune inflammation of the brain was not related to vaccination with GARDASIL. The physician stated that hospital''s physicians did not relate the event to vaccination with GARDASIL and it was never raised as a cause. The reporter stated that the patient''s sister mentioned at one point that might be the patient was not vaccinated with GARDASIL after all and only had a prescription at that time. Additional information has been requested.


VAERS ID: 500815 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-03-01
Submitted: 2013-08-28
   Days after onset:179
Entered: 2013-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dysmenorrhoea, Hypomenorrhoea, Menstrual disorder, Menstruation delayed, Polymenorrhoea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility 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: No other medications
Current Illness: Rhinitis allergic, no medicinal treatment
Preexisting Conditions: Cardiac disorder, abnormality was pointed out in a high-school medical checkup, but no specific disease was diagnosed in a close examination, and she had been receiving no medical treatment; Diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxo, Pyrexia
Allergies:
Diagnostic Lab Data: 03/2013, Body temperature, 36.2 degrees C
CDC Split Type: WAES1308JPN004077

Write-up: Initial and follow up information was received from physician concerning a 16-year-old female patient. The following were revealed in the patient from the pre-vaccination medical history interview (such as underlying disease, allergy, past history of vaccination/ disease during recent one month, concomitant medications, past history of ADR and status of growth): the patient had allergic rhinitis with no medical treatment; abnormality in heart (abnormality was pointed out in a high-school medical checkup, but no specific disease was diagnosed in a close examination, and she had been receiving no medical treatment and having no regular medical checkup); and she had a fever at the time of the DPT vaccine. She had no specific family history. Her body temperature before the vaccination of GARDASIL IM injection drug was 36.2 C. On 16-MAR-2013, the patient received the GARDASIL IM injection drug (0.5 ml once a day) (third time) (injection site not provided). No concomitant medication was reported. On an unspecified date, the patient received the first GARDASIL IM injection drug (lot number and injection site not provided). On an unspecified date, the patient received the second GARDASIL IM injection drug (lot number and injection site not provided). On 16-MAR-2013, as mentioned above, the patient received the third GARDASIL (lot no. 9QN07R) (injection site not provided). Her menstruation had been stable with a 1-week period and a 4-week interval since her first menstruation was started when she was in the 6th grade of primary school, but the volume and the frequency decreased since after the third vaccination. She began to have severe abdominal pain and delayed menstruation (oligomenorrhoea) in MAR-2013 and started to receive a painkiller. On an unspecified date, her most recent menstruation lasted only for a few days with a small amount of bleeding, but she had a severe menstrual pain. Reporter''s comment: The causal relationship between the events and the recombinant quadrivalent human papillomavirus vlp vaccine was unknown. Thee physician was very dissatisfied with the country and the pharmaceutical company of the vaccine because they did not properly announce adverse reactions due to the vaccine and would not stop the use of the vaccine. The reporting physician did not assess the causal relationship of the abnormal menstruation (light periods, painful menses) and oligomenorrhoea to the recombinant quadrivalent human papillomavirus vlp vaccine. The physician considered that other cause of the events (such as any disease) was unknown as her symptoms had been checked by a department of gynecology. The outcome for menstruation abnormal (light periods, menses painful) and menstruation abnormal (light periods, menses painful) were not recovered and oligomenorrhoea was unknown. The reporting physician assessed the abnormal menstruation (light periods, painful menses) as serious and the oligomenorrhoea as non-serious. The events of menstruation abnormal (light periods, menses painful) and menstruation abnormal (light periods, menses painful) were considered as medically significant. Additional information has been requested. Narrative, products, patient and event were updated.


VAERS ID: 500854 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-08
Onset:0000-00-00
Submitted: 2013-08-28
Entered: 2013-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Back pain, Blood test normal, Condition aggravated, Disturbance in attention, Dizziness, Fall, Fatigue, Feeling abnormal, Formication, Headache, Hyperhidrosis, Mobility decreased, Muscle spasms, Muscular weakness, Myalgia, Nausea, Paralysis, Visual impairment, Vomiting, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (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), Termination of pregnancy and risk of abortion (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: Cardiac disorder; Asthma; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Blood test, Normal
CDC Split Type: WAES1308DNK011875

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 19-Aug-2013 under the references DK-DKMA-ADR 22213484 and DK-DKMA EFO6580. Case is not medically confirmed. A 21-year-old female patient (weight 67 kg, height 165 cm) with a medical history of asthma and unstable heart had received an injection of GARDASIL (batch number not reported) via not reported route and site of administration on 14-Feb-2013. On an unspecified date, the patient developed headache, paralysis (could not feel or move her legs or arms), cramps, vomiting, difficulty concentrating, severe pain in the back and constant back pain, sweating, nausea, weight loss (lost 10 kg in 1 month) and formication. On 08-Jul-2013 the patient received another injection of GARDASIL (batch number not reported) via not reported route and site of administration. After this vaccination the symptoms that the patient had experienced after the previous dose, aggravated. In addition, the patient developed spontaneous abortion, insane fatigue, decreased muscle strength, feeling abnormal (to be present and still not), dizziness (could not travel without being so dizzy that she was falling because everything grew dark before her eyes) and sore muscles on an unspecified date. Blood samples were normal. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the event "Condition aggravated".


VAERS ID: 500894 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-29
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Laboratory test normal, Local swelling, Mobility decreased, Nerve conduction studies normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Peripheral coldness, Somatosensory evoked potentials, Ultrasound scan normal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown date: MRI: R. arm and brachial plexus: no nerve injury; Nerve conduction studies, Normal; Somatosensory evoked potentials, Normal; Ultrasound scan, Normal
CDC Split Type: WAES1308DEU013656

Write-up: Case retrieved from the literature on 19-Aug-2013. Case is medically confirmed. A 14-year old girl received her first dose of GARDASIL (lot-no. not reported) IM into the right deltoid muscle on an unspecified date. Within 24 hours she developed severe pain, swelling, numbness, and coldness of the right arm and hand. Additionally she developed "lack of function" on an unknown date. Diagnostics with ultrasound, nerve conduction, and sensory evoked potentials were normal. The MRI scan of the right arm and brachial plexus showed no nerve injury. The symptoms improved under physical and occupational therapy. After 2 months skin temperature was normal and swelling reduced. Pain and lack of function were ongoing. The case was assessed as serious by the company (medical judgment).


VAERS ID: 500904 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-17
Onset:2013-08-18
   Days after vaccination:1
Submitted: 2013-08-29
   Days after onset:11
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ocular hyperaemia, Rash generalised, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hepatitis C; Colitis ulcerative
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN012005

Write-up: Initial information has been received from a physician concerning a 43-year-old female patient with underlying diseases of ulcerative colitis and hepatitis C. On 17-AUG-2013, the patient received the second dose of GARDASIL intramuscularly, injection drug 0.5 ml (injection site and indication not provided). Information of concomitant medication was not obtained. On 17-JUN-2013, the patient received the first dose of GARDASIL intramuscularly, injection drug, dose: 0.5ml, batch # 9QN09R, lot # 0989AA (indication not provided). Nothing happened in the patient at that time. Around 10 days before the second vaccination, the patient visited the reporting physician''s hospital for cystitis and received antibiotic. On 17-AUG-2013, at 12:00, the patient received the second dose of GARDASIL, intramuscularly, injection drug, batch # 9QN08R, lot # 0989AA expiration date: 21-JUN-2014 (Indication not provided) as mentioned above. On 18-AUG-2013, around 7:00, the following events developed (chronologically): Rash on right foot which expanded to generalized exanthema, swelling face, and ocular hyperaemia. On that day, the patient was in a foreign city on business and thus visited a hospital because the symptoms were the worst at that night. She was told at the hospital that the symptoms were due to the vaccination and she should visit the physician of the vaccination. No treatment or prescription was given to her. On 21-AUG-2013, the patient presented to the reporting physician''s hospital, where she received SOLULACT, ascorbic acid and VIT AMEDIN, and prescription of TATHION and oral RESTAMIN KOWA. On 22-AUG-2013, the reporting physician called the patient to check her conditions. She would be getting improvement but she could be hardly clearly recovered. So, she was recovering from generalized exanthema, swelling face and ocular hyperaemia. It was decided after the talk with the patient that the third vaccination would not be conducted, action taken regarding to GARDASIL was reported as withdrawn. Comment: This patient received the CERVARIX in February, March and August 2011 and then wanted to receive also the GARDASIL. She thus started to receive the vaccine after the consultation with hospital A. She also receives flu vaccine every year. Reporting physician assessed the generalized exanthema, swelling face and ocular hyperaemia as serious (other important medical events). Reporting physician assessed that the generalized exanthema, swelling face and ocular hyperaemia were related to the GARDASIL. Additional information has been requested.


VAERS ID: 500933 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2004-01-01
Onset:2005-01-01
   Days after vaccination:366
Submitted: 2013-08-29
   Days after onset:3161
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amenorrhoea, Arthralgia, Decreased activity, Dizziness, Dizziness postural, Hormone level abnormal, Immune system disorder, Loss of consciousness, Lymphadenopathy, Menstruation irregular, Muscle spasms, Myalgia, Neuropathy peripheral, Paraesthesia, Sensory disturbance, Skin burning sensation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK009477

Write-up: Case received from a non-health professional via other company in a foreign country on 08-Aug-2013. Case not medically confirmed. A 32-year-old female patient had received 3 doses of GARDASIL (batch numbers not reported, site and route not reported) on unspecified dates in 2004/2005 and later on unspecified date she developed various disorders; sensory disturbances, blackouts, muscle pain and joint pain. Exact information regarding the various disorders is missing. The patient''s medical history includes: Participation in a GARDASIL study which started on unspecified date in 2002 (end date not reported), where she received a placebo vaccine (no further information specified). The patient received the 3 doses of GARDASIL immediately after a study stop. At the time of reporting, the outcome was not provided. Follow-up information received from a health care professional via Health Authorities in a foreign country on 19-Aug-2013 under the reference number DK-DKMA-ADR 22203120 and DK-DKMA-EFO6503. According to HA, the patient participated in a clinical study with GARDASIL between 2002-2006 (exact start and end date not reported). She received placebo-injections on unspecified dates in 2002-2003 and active vaccines on unspecified dates in 2004-2006. HA coded GARDASIL given patient on 01-Jan-2004 (batch number unknown, intramuscular route) as suspected dose. The company presumes it was the first dose since HA has started GARDASIL not previously given. In the beginning of 2005 the patient began to have blackouts (onset date coded by HA as 01-Jan-2005)/fainting (onset in the beginning of 2005), but did not link it with the vaccine because she had been told that it did not give adverse reactions. Her menstrual cycles were also irregular (onset date not reported) and she started to feel dizzy (onset date 01-Jan-2005). In 2011 the patient''s symptoms began to worsen and she was on sick leave from her school almost the entire year of 2011. After 4 months of very low activity (onset date not reported), she gradually started to get better, but she was unable to work full time. She has continued dizziness (onset date 01-Jan-2005), muscle cramps (01-Jan-2011), severe muscle pain (onset date 01-Jan-2011), burning in the skin (onset date not reported), tingling in fingers and toes (onset date not reported), constantly swollen lymph nodes (onset date not reported), absent menstruation. HA has coded the adverse reactions: immune disorder (onset date 01-Jan-2011), neuropathy (onset date 01-Jan-2011) and hormonal imbalance (onset date 01-Jan-2005) but no further information is specified. The patient has had many questions for the emergency and for her own physician without them being able to explain her condition. According to HA th patient had not taken any other vaccines. It is unknown whether the patient had concomitant medications. The patient''s birth date and age at the time of event has been updated by HA. Patient''s date of birth is coded but age at the time of event is coded as 23 years (presumably a type failure of the age). Height (175 cm) and weight (75 kg) of the patient have also been updated. The company coded fainting and low activity (not coded by HA). At the time of reporting the outcome was not reported for fainting, low activity, sensory disturbances and joint pain and not recovered for blackouts, dizziness on standing up, cramp muscle, muscle pain, immune disorder (NOS), neuropathy, menstrual cycle also irregular/absent, burning in the skin, tingling in fingers and toes, hormonal imbalance and constantly swollen lymph nodes.


VAERS ID: 500935 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-12-01
Submitted: 2013-08-29
   Days after onset:270
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Asthenia, Autoantibody negative, Borrelia test negative, Brucella test negative, Coxiella test, Cytomegalovirus test negative, Epstein-Barr virus antigen positive, Headache, Hepatitis B test negative, Hepatitis C test negative, Laboratory test normal, Lumbar puncture normal, Meningeal disorder, Mononucleosis heterophile test, Nausea, Nuclear magnetic resonance imaging brain normal, Periarticular disorder, Pyrexia, Serology test, Toxoplasma serology negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: Gastrooesophageal reflux disease, since childhood; Immunisation
Preexisting Conditions: Urinary tract infection; GARDASIL
Allergies:
Diagnostic Lab Data: Autoantibody test, Negative; Body temperature, 38 degrees C; Borrelia test, Negative, serology negative; Brucella test, Negative; Coxiella test, Negative, serology negative; Cytomegalovirus test, Negative; Epstein-Barr virus test, former infection; Hepatitis B virus test, Negative, serology negative; Hepatitis C virus test, Negative, serology negative; Lumbar puncture, Normal; Nuclear magnetic resonance imaging brain, Normal; Serology test, Negative, Bartonella: negative; Toxoplasma serology, Negative; Viral test, infectious mononucleosis: non conclusive
CDC Split Type: WAES1308FRA013830

Write-up: Case received from the Health Authorities under reference number TO20131488 on 22-Aug-2013. Case medically confirmed. Case linked with non serious case E2013-06314 (same vaccine, similar adverse reactions). A 15-year-old female patient had received the second dose of GARDASIL (batch number unknown) via intramuscular route in autumn 2012. On 01-DEC-2012, at the approximate schedule date for the third dose, she experienced non specified meningeal syndrome including asthenia, headache, arthralgia and fever. Lumbar puncture, MRI and infectious mononucleosis viral test were non conclusive. In Feb-2013 asthenia and headache were persisting and were accompanied by abdominal pain, periarticular pain and nausea. Laboratory tests were normal. Relatives of the patient were also affected by similar symptoms, including her sister, who was also recently vaccinated with GARDASIL (batch number not reported). This was consistent with infectious origin. She was given as symptomatic treatment for headache with SOLUPRED, paracetamol, MYOLASTAN and LAROXYL. Headache regressed. In Jun-2013 symptoms were still persisting. Infectious or autoimmune origins were ruled out. Functional origin was favored. Viral context with fever up to 38 degrees C, infectious mononucleosis and flu infection were suspected as 2 other patient''s relative experienced similar symptoms. Lumbar puncture and brain MRI were normal. Serology for HBV, HCV, CMV, Bartonella, Toxoplasma and Brucella were negative. Borrelia and Coxiella tests were also negative. Epstein-Barr virus serology was consistent with a former infection. Autoantibody test screening was also negative. Therefore non drug-induced etiology was ruled out. The patient had a medical history of persisting gastroesophageal reflux disease since childhood and recurrent urinary tract infection. She had received the first dose of GARDASIL (batch number not reported) on an unspecified date. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the following adverse events: "arthralgia", "abdominal pain", "fever" and "nausea" which were mentioned by the CA in the narrative but not coded. The Health Authorities considered the case as serious due to "hospitalization" criterion. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 500941 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-06-22
Onset:2012-08-21
   Days after vaccination:60
Submitted: 2013-08-30
   Days after onset:374
Entered: 2013-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Blood pressure inadequately controlled, Body temperature fluctuation, CSF test abnormal, Computerised tomogram head normal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Myalgia, Nasopharyngitis, Nerve conduction studies, Pneumonia aspiration, Pyrexia, Reflex test normal, Tracheostomy
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Head computerised tomography (CT) (22-AUG-2012): no abnormality; The test on neurotransmission and spinal fluid (24-AUG-2012): Guillain-Barre syndrome was diagnosed; 08/22/2012, Computerised tomogram head, Normal
CDC Split Type: WAES1308JPN011255

Write-up: This spontaneous report as received from a pharmacist refers to a 34 year old female patient with no underlying disease or medical history. On 22-JUN-2012 the patient received the first GARDASIL, (lot # 9QN03R), 0.5 ml, intramuscular (injection site not reported). No concomitant medication was reported. On 21-AUG-2012, the patient felt numbness of limbs and hypoaesthesia. On 22-AUG-2012, the patient visited a nearby department of internal medicine, where head computed tomography (CT) showed no abnormality. The patient felt she had caught her child''s common cold. On 23-AUG-2012, the patient felt muscle pain and difficulty in walking, and then visited a department of neurology. She had normal neural reflex. At this night, she had to walk along the wall because of worsening of the symptoms. On 24-AUG-2012, the patient re-visited and was admitted to the department of neurology. Guillain-Barre syndrome was diagnosed after the tests on neurotransmission and spinal fluid. She received immune globulin for 5 days. She then had pneumonia aspiration and received temporal tracheostomy for treatment of respiratory impairment. She had difficulty in adjusting body temperature due to autonomic nervous system imbalance, for which her fever persisted. Blood pressure had also been controlled poorly. Therapy with GARDASIL was discontinued. On an unknown date in October 2012, the outcome of Guillain-Barre syndrome(numbness, hypoaesthesia) was recovering (also reported that the event stop date was in October 2012). The patient was discharged from hospital, and she then began rehabilitation. Around March 2013, the patient returned to part-time job. The outcome of temporal tracheostomy, pneumonia aspiration and autonomic nervous system imbalance was unknown. Reporter''s comment: The physician of the vaccination seems to consider that the events are unlikely related to the GARDASIL since the events developed long time after the vaccination. The reporting pharmacist assessed the Guillain-Barre syndrome(numbness, hypoaesthesia) as serious due to hospitalization. The reporting pharmacist did not assess the seriousness of the temporal tracheostomy, the pneumonia aspiration and autonomic nervous system imbalance. Upon internal review, the temporal tracheostomy and the review Guillain-Barre syndrome was decided as serious due to other important medical event. The reporting pharmacist assessed that the Guillain-Barre syndrome (numbness, hypoaesthesia) was unrelated to GARDASIL. The reporting pharmacist did not assess the causal relationship of the temporal tracheostomy, the pneumonia aspiration and autonomic nervous system imbalance to GARDASIL. This is amended report. The temporal tracheostomy was added as serious AE due to other important medical event. The outcome of temporal tracheostomy, pneumonia aspiration and autonomic nervous system imbalance was changed from" recovering" to "unknown". Additional information has been requested.


VAERS ID: 501084 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-03
Onset:0000-00-00
Submitted: 2013-08-30
Entered: 2013-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022181 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein normal, Headache, Liver function test normal, Musculoskeletal stiffness, Nausea, Pharyngeal erythema, Pyrexia, Urticaria, Viral infection, Vomiting, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Urticaria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: White blood (Unknown date): 4200; C-reactive protein (Unknown date): <1; Liver function tests: Normal
CDC Split Type: WAES1308FRA014252

Write-up: Case received from the Health Authorities under reference number MA20131596 on 12-Aug-2013 via our contractual partner Sanofi Pasteur. Case medically confirmed. An 11-year-old female patient with a medical history of 2 episodes of unexplained generalized urticaria, had received the first dose of GARDASIL (batch number H022181) via intramuscular route on 03-Aug-2013. Four hours post-vaccination she experienced nausea, vomiting, headache and fever. The patient went to the ER. She had mild neck stiffness nut no hepatosplenomegaly, no rash or adenopathy. She had mild pharynx redness. Lab tests performed showed white blood cell count was at 4200, C-reactive protein less than 1 and liver function test normal. Virosis was suspected. She was given paracetamol and VOGALENE as corrective treatment. The patient''s treating physician decided to discontinue the vaccination. On 07-Aug-2013 vomiting and headache had resolved. According to the patient''s mother, fever was persisting. To be noted that the patient was not seen again by her physician. At the time of reporting, the patient was recovering. Upon medical review the company judged relevant code the following adverse events: "virosis", "nausea" and "neck stiffness" which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the case as serious due to "Other medically important condition" criterion. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as probable (C3 S1 I3) according to the method of assessment.


VAERS ID: 501092 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-31
Onset:2013-03-01
   Days after vaccination:29
Submitted: 2013-08-30
   Days after onset:181
Entered: 2013-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN07R / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram normal, Dyskinesia, Endocrine test normal, Endoscopy normal, Epilepsy, Hemiparesis, Myoclonus, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Positron emission tomogram normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (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? Yes, 37 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Around March 2013, Results of head MRI were normal. In July 2013, brain imaging showed normal brain waves, and also normal results in MRI of head, thoracic spine and neck. MRI performed for possible spinal myoclonus, and it was normal. Possibility of infection was excluded in blood tests, and collagen disorder was also denied. MRI, contrast CT and PET also denied the malignant tumor. No abnormality in hormone system. An endoscope revealed no abnormality on Behcet''s disease or mixed collagen disorder. 2012, Body temperature, about 39, 39 degrees C; 2012, Body temperature, 38 degrees C; 06/19/2012, Body temperature, 36.9 degrees C; 07/02/2012, Body temperature, about 39, 39 degrees C; 12/2012, Body temperature, 37 degrees C
CDC Split Type: WAES1308JPN014199

Write-up: Information has been received from a physician via the agency concerning a 13-year-old female patient. According to the pre-vaccination interview 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. The patient had no family history. Her body temperature before the vaccination was 36.9 C. On 19-JUN-2012 at 11:40, the patient received the syringe-type first GARDASIL intramuscular injection drug (Lot number 9QN03R) (dose was not provided). No concomitant medication was reported. On 02-JUL-2012, the patient had pyrexia of 39 C at 8:00, and pyrexia of around 39 C continued thereafter. Possibility of infection was excluded in blood tests, and collagen disorder was also denied. MRI, contract CT and PET also denied the malignant tumor. No abnormality in hormone system. An endoscope revealed no abnormality on Behcet''s disease or mixed collagen disorder. The pyrexia was judged to be psychogenic pyrexia, and her clinical course was being followed up. On 23-AUG-2012, the patient was admitted to hospital. In autumn of 2012, the patient''s body temperature had been 38 C. On 27-SEP-2012, the patient received the second dose of GARDASIL intramuscular injection drug (lot No. 9QN06R) (dose was not provided). On 28-SEP-2012, the patient was discharged from hospital. At the end of December 2012, the temperature went down to 37 C. On 31-JAN-2013, the patient received the third dose of GARDASIL intramuscular injection drug (lot No. 9QN07R) (dose was not provided). Around March 2013, the patient had convulsion-like myoclonus during night sleep and weakness of right side of body in the daytime. Results of head MRI were normal, while sharp waves were observed at the right parietal region. During an observation period, the patient had had the myoclonic-like involuntary movements during sleep-time and the wakeful weakness in the daytime continuously. In July 2013, brain imaging showed normal brain waves, and also normal results in MRI of head, thoracic spine and neck. Valproic acid was administered for suspected epilepsy but did not improve her conditions. MRI performed for possible spinal myoclonus, and it was normal. As of 16-AUG-2013, the patient had not recovered from the myoclonic-like involuntary movements or pyrexia. Clonazepam had been administered for the myoclonic-like involuntary movements. The outcome of the weakness of right side of body was unknown. Reporter''s comment: The patient had pyrexia of 39 C of unknown origin since 02-JUL-2012 after the first vaccination on 19-JUN-2012. At the beginning, I had never thought that the event was due to the GARDASIL, and I judged that it was psychogenic pyrexia from the head examination results. I then came to think that the relation to the vaccine could completely not be denied from the fact that the myoclonic-like involuntary movements appeared in March 2013 after the second and third vaccinations. The reporting physician considered that the causal relationship of the myoclonic-like involuntary movements and pyrexia to GARDASIL was unassessable, and also considered that other possible causes of the event were epilepsy, spinal myoclonus, psychogenesis, etc. The reporting physician did not assess the causal relationship of the weakness of right side body to the vaccine. The reporting physician assessed the myoclonic-like involuntary movements as serious (possible disability) (also reported as medically significant) and pyrexia as serious (possible disability (also reported as medically significant) and hospitalization). The reporting physician did not assess the seriousness of the weakness of right side of body. Remarks: Serious (possible disability) is entered as serious OME due to internal procedures. Additional information has been requested.


VAERS ID: 501102 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-27
Onset:0000-00-00
Submitted: 2013-09-02
Entered: 2013-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Gait disturbance, Hypoaesthesia, Laboratory test normal, Muscular weakness, Nasopharyngitis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unspecified examination in a brain surgery department and a prefectural hospital (date unknown): no abnormality was found
CDC Split Type: WAES1308JPN014926

Write-up: Initial information has been received from a physician concerning a female patient in her 10''s. On 27-AUG-2012, she received the third GARDASIL intramuscular (IM) injection drug (injection site and lot number not provided). No concomitant medication was reported. On 29-SEP-2011, the patient received the first GARDASIL IM injection drug (at A hospital). On an unspecified date, the patient received the second GARDASIL IM injection drug (at A hospital). On 27-AUG-2012 as mentioned above, the patient received the third GARDASIL IM injection drug (at A hospital). On an unspecified date, 5 days after the third vaccination, the patient had cold symptoms and then numbness, gait disturbance and weakness of limbs. On an unspecified date, the patient visited a department of brain surgery and a prefectural hospital, where no abnormality was found. The patient then left the symptoms untreated. In NOV-2012, the patient complained of only cold symptoms at A hospital. In APR-2013, the patient presented to B hospital because symptoms such as numbness, gait disturbance and weakness of limbs appeared again. At the time of this report, the outcome of the numbness gait disturbance, cold symptoms and weakness of limbs was unknown. Reporter''s comment: A hospital: I did not know details about the patient''s symptoms because she complained of only cold symptoms when visited our hospital in NOV-2012. Her symptoms (numbness, gait disturbance and weakness of limbs) were reported by the B hospital after her 3 vaccinations. I have never seen her symptoms, so I can do nothing about them. B hospital: The GARDASIL is suspected to be related to the symptoms. The reporting physician assessed that the numbness, gait disturbance and weakness of limbs were related to GARDASIL. The reporting physician did not assess the causal relationship of the cold symptoms with GARDASIL. The reporting physician assessed the numbness, gait disturbance and weakness of limbs as serious (disability). The reporting physician did not assess the seriousness of the cold symptoms. Further information has been requested.


VAERS ID: 501300 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-01-07
Onset:0000-00-00
Submitted: 2013-09-04
Entered: 2013-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Candida infection, Chills, Drug administered to patient of inappropriate age, Headache, Hyperhidrosis, Immune system disorder, Influenza like illness, Pain, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Medication errors (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309GBR000546

Write-up: This case was received from a non health care professional on 23-Aug-2013. This case is not medically confirmed as it was reported by a member of the public. This case is linked to E2012-04561. A 34 year old male patient, with no medical history reported, received in Jan-2012 (exact date: 07-Jan-2012 according initial version of the linked case) the first dose of GARDASIL (batch number not reported), route and site of administration not reported. Vaccine was administered at private clinic/hospital and the patient was aware to be outside of recommended age for vaccine. It was reported the patient experienced flu-like symptoms (sweating, shivering, headache and aches/pains) 6-7 weeks later vaccination and also developed thrush and a rash on his body. The patient went to doctors who believed its vaccine was related to the adverse events but also believed that the patient''s immune system/body became stressed and hence caused his body to react. The patient was referred to neurologist by his doctor for investigations. No seriousness criterion was provided and the company considered that case serious and choose the "other medically important condition" criterion. The patient''s outcome was not reported. This case is one of the two linked cases (same patient, same reporter, same product, number of dose in series different).


VAERS ID: 501328 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-06
Onset:2012-11-01
   Days after vaccination:87
Submitted: 2013-09-03
   Days after onset:306
Entered: 2013-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0308AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase increased, Hypoaesthesia, Muscle spasms, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: No other medications
Current Illness:
Preexisting Conditions: Familial risk factor, Paternal grandfather; Familial risk factor, Maternal grandmother
Allergies:
Diagnostic Lab Data: 01/2013, Blood creatine phosphokinase, Increased, Temporal, not provided
CDC Split Type: WAES1309JPN000540

Write-up: Initial information has been received from a physician via the agency concerning a 12-year-old female patient. According to pre-vaccination interview 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 a family history of ALS (paternal grandfather) and leukaemia (maternal grandmother). On 06-AUG-2012, she received the second vaccination of the syringe-type recombinant with GARDASIL IM injection drug (dose and injection site not reported). No concomitant medication was reported. On 11-JUN-2012, the patient received the first vaccination with GARDASIL injection drug (Batch No. 9QN04R and Lot # 0308AA). On 06-AUG-2012, the patient received the second vaccination of the GARDASIL injection drug (Batch No. 9QN04R and Lot # 0308AA), as mentioned above. Around November 2012, pain in upper and lower limbs, weakness of upper and lower limbs (cramp-like symptom) and numbness of upper and lower limbs developed. On 17-DEC-2012, the patient received the third vaccination of GARDASIL injection drug (Batch No. 9QN06R and Lot # 0700AA). In January 2013, a temporal increase in blood creatine phosphokinase was observed. In April 2013, the pain in upper and lower limbs, numbness in upper and lower limbs, weakness in upper and lower limbs by which she could not move some muscle (because of cramp-like symptom) got worse. At the time of this report, the patient had recovered from the "blood creatine phosphokinase increased" (the level had returned to normal) but had not from the pain in upper and lower limbs, weakness of upper and lower limbs (cramp-like symptom) and numbness of upper and lower limbs. The symptoms of upper limbs were improving, but those of lower limbs were continuing, and the continuing symptoms were disturbing her daily life. Her clinical course had been observed. Reporter''s comment: Myositis and fasciitis after the vaccination of GARDASIL have been reported overseas. These symptoms are similar to those of this patient, but I still cannot judge whether or not this case is actually applicable to the overseas cases. The reporting physician assessed the causal relationship of the pain in upper and lower limbs and weakness of upper and lower limbs (cramp-like symptom) to GARDASIL as unassessable. The physician considered that it was unknown about the other possible cause (such as other disease) of the events. The physician did not assess the causal relationship of the "blood creatine phosphokinase increased" and numbness of upper and lower limbs to the vaccine. The reporting physician assessed the pain in upper and lower limbs and weakness in upper and lower limbs (cramp-like symptom) as serious (other important medical events) and did not assess the seriousness of the "blood creatine phosphokinase increased" and numbness of upper and lower limbs. Pain in upper and lower limbs and weakness in upper and lower limbs (cramp-like symptom) were considered to be other important medical event by the reporter. Additional information has been requested.


VAERS ID: 501481 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-27
Onset:2012-09-03
   Days after vaccination:7
Submitted: 2013-09-04
   Days after onset:366
Entered: 2013-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Lumbar puncture normal, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal
SMQs:, 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: MALONETTA
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examinations and laboratory tests: MRI showed myelitis to TH6-TH8. Lumbar puncture showed no signs of sclerosis.
CDC Split Type: WAES1309DNK001381

Write-up: Case received from health care professional via the Health Authorities on 26-Aug-2013 under the reference number 22218521 and EFO6612. Case medically confirmed. A 23 year old female patient had received an injection of GARDASIL (dose 1, batch number not reported, intramuscular route, site not reported) on 27-Aug-2012. She had also concomitant medication MALONETTA (other MFR) and later on (03-Sep-2012) she developed myelitis transverse. The patient was hospitalized due to the adverse event (dates not reported). She went through vaccination program without any further problems. Examinations and laboratory tests: MRI showed myelitis to TH6-TH8. Lumbar puncture showed no signs of sclerosis. No relevant medical history reported. At the time of reporting, the outcome was recovering.


VAERS ID: 501487 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-15
Onset:2009-08-01
   Days after vaccination:17
Submitted: 2013-09-05
   Days after onset:1496
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ28270 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cardiovascular evaluation, Dizziness, Headache, Laboratory test normal, Nausea, Neurological examination normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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: 03/10/2009, GARDASIL, immunisation; 01/12/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Cardiological examination and neurological examination have been performed on non-specified dates, withoit any findings.
CDC Split Type: WAES1309DNK001226

Write-up: Case received from a patient/consumer via a Health Authority on 27-Aug-2013 under reference numbers EFO6643 and 22222039. Case not medically confirmed. A 12 year old female patient had received an injection of GARDASIL (dose 3, batch number NK14370, route and site not reported) on 15-Jun-2009 and later on an unspecified date in Aug-2009 she developed dizziness, fainting, abdominal pain, nausea and headache. The patient has not been treated for the events and she has no other medication. The HA is awaiting answer for requested medical confirmation. Cardiological examination and neurological examination have been performed on non-specified dates, without any findings. The patient was previously vaccinated with GARDASIL (batch number NJ38950, route and site not reported) on 12-Jan-2009 and GARDASIL (batch number NJ50800, route and site not reported) on 10-Mar-2009. The patient has no other health problems. At the time of reporting, the outcome was not recovered.


VAERS ID: 501488 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-01
Onset:0000-00-00
Submitted: 2013-09-05
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Blood cortisol, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Cortisol free urine, Depressed mood, Dizziness, Ear pain, Electrocardiogram, Fatigue, Haematochezia, Headache, Heart rate increased, Hot flush, Hypoaesthesia, Hypotension, Infection, Lymphadenopathy, Memory impairment, Mood swings, Oropharyngeal pain, Ultrasound abdomen, Ultrasound urinary system, Urinary tract disorder, Visual impairment, Vitamin D decreased, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: 2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: The patient describes the following test: Various routine blood tests (unspecified(, urine test of cortisol, ECG, ultrasound scanning of urinary tract and ultrasound scan of lower abdomen. Results not reported. Blood cortisol, not reported; Blood immunoglobulin A, low; Blood immunoglobulin G, low; Electrocardiogram, not reported; Vitamin D, low
CDC Split Type: WAES1305DNK015645

Write-up: Case received from a health care professional via Health Authority on 17-May-2013 under reference numbers EFO5812 and 22116364. Case medically confirmed. A 14 year old female patient had received on injection of GARDASIL (dose 3, batch number NK36120, route intramuscular, site not reported) on 01-Apr-2009 and later on 01-Nov-2009 she developed neck pain, ear pain, adenopathy, frequent infections, lack of energy, weight gain, abdominal pains and daily headache. On an unspecified date pv in 2009 she also developed sadness and mood swings. Upon medical review the company judged relevant to code the following adverse events: sadness and mood swings which were mentioned by the HA in the narrative, but not coded. The patient has low levels of Vitamine D, IgA and IgG, but the levels have now been normalized. The patient was previously vaccinated with GARDASIL Dose 1 on an unspecified date ( batch number NK14370, route intramuscular, site not reported) and GARDASIL dose 2 on an unspecified date (batch number NK05560, route intramuscula, site not reported). At the time of reporting, the outcome was not reported for sadness and mood swings and not recovered for the other events. Follow up information received on 29-Aug-2013 from patient via the health authority. Adverse reaction from patient reported to HA: headache, dizziness, bloody stool, pointwise numbness in legs, little finger completely numb, continuous infections, no feeling during urination, periodic high resting heart rate, pointwise numbness in legs, memory impaired, fatigue, low blood pressure, numbness in feet, visual disturbance, dizziness, little finger completely numb and sudden hot flushes. Onset date for these AE is unspecified during 2010. Outcome for all AE not recovered. Vaccination date changed to 24-Apr-2013. All three vaccinations received during 2009. HA coded onset age 18 years but it should be 14 years and onset date in 2009. The patient describes the following test: various routine blood rests (unspecified), urine test of cortisol, ECG, ultrasound scanning of urinary tract and ultrasound scan of lower abdomen. Results not reported. An error was discovered upon review: The company has previously coded "neck pain" as and adverse event but it was discovered that HA had coded "throat pain". The company coded "throat pain" instead. HA changed upgraded this case to serious / other medically significant event.


VAERS ID: 501498 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-19
Onset:0000-00-00
Submitted: 2013-09-05
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002122 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: WAES1309DNK000531

Write-up: Case received from a patient/consumer and a health care professional via company representative on 14-Aug-2013. Case medically confirmed. A 12 year old female patient had received an injection of GARDASIL (dose 1, batch and lot number J002122, exp. 31-AUG-2015, route intramuscular, site not reported) on 19-Jun-2013 and later on 3-4 days post vaccination (date not specified) she experienced paralyzed hand with a duration of 1 minute, 2-4 weeks post vaccination (date not specified) she experienced feeble legs during walks. Upon medical review the company decided to assess the case as serious on 30-Aug-2013 (due to reported event "paralyzed hand"). At the time of reporting, the outcome was recovered.


VAERS ID: 501595 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-03
Onset:2013-05-04
   Days after vaccination:1
Submitted: 2013-09-05
   Days after onset:124
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015737 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Blood glucose normal, C-reactive protein increased, Headache, Inflammatory marker increased, Meningeal disorder, Nausea, Neutrophil count normal, Photophobia, Pyrexia, Red blood cell sedimentation rate increased, Renal function test normal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal 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: Immunisation
Preexisting Conditions: 02/2013, GARDASIL 1
Allergies:
Diagnostic Lab Data: 05/07/2013, Blood glucose, 4.87 mmol/l; Body temperature, 38 degrees C; 05/07/2013, C-reactive protein, 100 not provided; 05/10/2013, C-reactive protein, 23.5 not provided; 05/07/2013, Neutrophil count, 7771/mm3; 05/10/2013, Neutrophil count, 5575/mm3; Red blood cell sedimentation rate, 63 for 1st hour/106 for 2nd hour min; 05/07/2013, Renal function test, Normal; 05/07/2013, White blood cell count, 9900/mm3; 05/10/2013, White blood cell count, 7700/mm3
CDC Split Type: WAES1309FRA000554

Write-up: Case received from the Health Authorities under reference number BS20130614 on 27-Aug-2013. Case medically confirmed. A 15-year-old female patient with no relevant medical history had received the second dose of GARDASIL (batch number H015737) via intramuscular route on 03-Aug-2013. To be noted that she had received the first dose (batch number not reported) in Feb-2013. Therefore the second dose was late according to the recommendation. On 04-May-2013 in the evening she experienced headaches, which evolved into a meningeal syndrome with nausea, vomiting, fever at 38 degrees C and photophobia. Laboratory tests performed on 07-May-2013 evidenced an inflammatory syndrome with neutrophil count at 7771/mm3, C-reactive protein at 100. Circulating anticoagulant was suspected. Renal function test was normal. White blood cell count was at 9900/mm3 and blood glucose at 4.87 mmol/L. She was given as corrective treatment SOLUPRED 20mg per day for 3 days. The patient recovered from headaches, meningeal syndrome, nausea, vomiting, fever at 38 degrees C and photophobia. On 10-May-2013 C-reactive protein was at 23.5 and erythrocyte sedimentation rate was still above the norm with 63 minutes for the first hour and 106 minutes for the second hour. Neutrophil count was at 5575/mm3 and white blood cell count was at 7700/mm3. The patient did not go to school for 1 week. To be noted that she was not taken to the hospital as her father was anesthesiologist. At the time of reporting, the patient had not recovered from inflammatory syndrome according to the lab data dated 10-May-2013. Upon medical review the company judged relevant to code the following adverse events: "meningeal disorder", "nausea" and "inflammatory marker increased" which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C2 S1 I1) according to the method of assessment.


VAERS ID: 501599 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-01
Onset:0000-00-00
Submitted: 2013-09-05
Entered: 2013-09-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia, Respiratory distress, Sensation of foreign body, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Sensation of foreign body; GARDASIL, Anxiety; GARDASIL, Respiratory distress; 11/2012, GARDASIL, Dose 1, Urticaria
Allergies:
Diagnostic Lab Data: At a re-visit to the doctor on 10-Jul-f2013 she did not present any symptoms. General appearance: no remarks, Heart and breathing: normal, saturation: 100%, mouth and throat: no remarks and skin: no remarks. 07/10/2013, Oxygen saturation, normal
CDC Split Type: WAES1307SWE012561

Write-up: Case received from a patient/consumer via health care professional on 05-Jul-2013. Case medically confirmed. This case is liked to E2013-05237 (coded AE after dose 1). Two cases were created as the patient had not developed the same symptoms after Dose 1 and Dose 2. A 18 year old female patient had received an injection of GARDASIL (dose 2, valid lot/batch number H016923, route and site not reported) on 01-Mar-2013 and later the same day (as the vaccination day, 01-Mar-2013) she developed numbness in cheek. On an unspecified date pv she also developed respiratory distress, anxiety and a feeling of a lump in the throat (rechallenge positive). According to the reporter she recovered from numbness in cheek but the respiratory distress gets worse after dose 2. Outcome of anxiety and feeling of a lump in the throat not reported after dose 2. On 01-Jul-2013 the patient also received an injection of GARDASIL (dose 3 valid lot/batch number H022294, route and site not reported). Before dose 3 vaccination she has almost recovered from the events, but after dose 3 the respiratory distress, anxiety and a feeling of lump in the throat got worse (rechallenge positive). According to the reporter the outcome was not recovered. The reactions come and go. The patient was previously vaccinated with dose 1, GARDASIL (valid lot/batch number H013250, route and site not reported) on an unspecified date in Nov-2012. Later on pv she developed urticaria all over the body, respiratory distress, anxiety and a feeling of a lump in the throat. According to the reporter the patient has never been afraid of needles, no disease history and the patients does not have any concomitant medication. The patient has a scheduled doctors visit within a week (approx 10-Jul-2013). Follow-up information received from health care professional via the HA on 29-Aug-2013 under the reference number 132811. HA coded Dyspnoea and Anxiety after dose 2 and dose 3 (date of onset in 2013 not rep). HA coded the dyspnoea as serious, due to a medically important event. The patient experienced short episodes of breathing difficulties with simultaneous anxiety several times daily, especially in the evening. She improved gradually, but was not fully recovered before receiving the third dose on 01-Jul-2013. After this she experienced more pronounced symptoms again. At a re-visit to the doctor on 10-Jul-f2013 she did not present any symptoms. General appearance: no remarks, Heart and breathing: normal, saturation: 100%, mouth and throat: no remarks and skin: no remarks. The patient received all three vaccinations intramuscular route. According to HA, the dyspnoea and anxiety was possibly related to vaccination. The final outcome coded by HA was not recovered.


VAERS ID: 501603 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-15
Onset:2012-11-15
   Days after vaccination:0
Submitted: 2013-09-06
   Days after onset:294
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Dizziness, Epilepsy, Malaise, Rash
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELOTROXIN; lamotrigine; KALEORID; CENTYL; GESTONETTE
Current Illness: Unknown
Preexisting Conditions: Epilepsy; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK001380

Write-up: Case received from consumer via the Health Authorities in a foreign country on 26-Aug-2013 under the reference number 22219015 and EFO6616. Case not medically confirmed. A 26 year old female patient (weight 120 kg and height 175 cm) had received an injection of GARDASIL (dose 1, batch number not reported, site and route of administration not reported) on 15-Nov-2012 and later on, the same day, she developed increased frequency of seizures. Concomitant drugs at the time of vaccination: ELTROXIN, Lamotrigin, KALEORID, CENTYL, GESTONETTE. The patient is suffering from epilepsy and prior to vaccination she had only one attack every 12 months. After the first vaccination (15-Nov-2012) with GARDASIL, she developed her first epileptic seizure since several months back. This time worse than ever. On 19-Nov-2012 (HA reported 19-Nov-2013, presumably type wrong) she developed malaise and again seizures. Now more than 6 months later, the seizure is still not under complete control and the patient is on sick leave. The patient was unsure whether she should receive the second vaccination. She then chose to receive it (GARDASIL, dose 2, batch number not reported, site and route of administration not reported, vaccination date unspecified in 2013) in order to clarify whether the seizure was worsening because of the vaccine (and according to patient it could actually be worse). Subsequently, she got rashes and dizziness as well as several attacks (even though she had experienced it previously). After the third vaccination (GARDASIL, dose 3, batch number not reported, site and route of administration not reported, vaccination date not reported) the symptom was not quite as bad. The patient has received the following treatment for the side effect: Epilepsy medication (product name not reported). The patient had not been hospitalised because of adverse reaction. The HA has requested medical confirmation and reply is awaited. HA has reported rechallenged. The patient thinks that the adverse events are related to vaccination but no one takes her seriously. The patient has a history of hypothyroidism and epilepsy. At the time of reporting, the outcome was recovering for increased frequency for seizures and unknown for dizziness, rash and malaise.


VAERS ID: 501605 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-12
Onset:2012-10-25
   Days after vaccination:13
Submitted: 2013-09-06
   Days after onset:316
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007022 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fibromyalgia, Hypoaesthesia, Paraesthesia, Tendonitis, Tension
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament 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: VALDOXAN
Current Illness: Immunisation
Preexisting Conditions: Muscle tightness; Tendonitis; Fibromyalgia; Dose 2, batch number H000245, Immunisation; GARDASIL, Dose 1, batch number G006099, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK001825

Write-up: Case received from health care professional via the Health Authorities on 28-Aug-2013 under the reference number 22220892 and EFO6629. Case medically confirmed. A 39 year old female patient had received an injection of GARDASIL (dose 3, batch/lot number H007022, site and route of administration not reported) on 12-Oct-2012 and later on (25-Oct-2012) she developed paraesthesia and reduced sensation in the face, front of the neck, arms and legs. The patient had concomitant drug VALDOXAN (antidepressant, other mfr) at the time of reactions. She was hospitalised at hospital for investigation. At first, the reduce sensation was suspected to be an adverse reaction of VALDOXAN treatment (which started 2 weeks earlier). But then concluded that the severe tension/tendinitis/fibromyalgia was the cause of the problem. The patient now (after the media attention of the vaccine) raised the suspicion of possible side effect of the vaccine. The doctor does not think that the reaction is related to the vaccination, but she does not have enough knowledge to be able to exclude a connection. Hospital was probably not aware that the patient had completed GARDASIL vaccination''s schedule. The patient''s medical history includes: Dose 1 (batch number G006099, lot number NN12610, exp 20-SEP-2013, site and route of administration not reported) on 16-Apr-2012. Dose 2 (batch number H000245, lot number NN51680 site and route of administration not reported) on 15-Jun-2012. Tension/tendinitis/fibromyalgia (no further information specified). At the time of reporting, the outcome was not recovered.


VAERS ID: 501670 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-14
Onset:2013-06-18
   Days after vaccination:35
Submitted: 2013-09-06
   Days after onset:80
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase normal, Blood fibrinogen increased, C-reactive protein increased, Chills, Cushing's syndrome, Cushingoid, Fibrin D dimer, Fibrin degradation products, Juvenile idiopathic arthritis, Liver function test normal, Pyrexia, Sensation of heaviness, Serum ferritin normal, Thyroid function test normal, Urine analysis, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arthritis (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, 68 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature; 20-JUN-2013, the patient had fever of 39 degree C with chills in the midnight; Body temperature; 22-JUN-2013, the patient''s body temperature went up to 39''s degree C and down repeatedly in the afternoon; Hepatic function; 27-JUN-2013, her hepatic function had showed no abnormality from 24-JUN-2013 to this date; 06/24/2013, Alanine aminotransferase, 9 IU/l, Normal; 06/26/2013, Blood fibrinogen, 412.3 mg/dL, Increased; 06/18/2013, Body temperature, 39.3 degrees C; 06/19/2013, Body temperature, 38-39 degrees C; 06/20/2013, Body temperature, 36 (daytime) degrees C; 06/20/2013, Body temperature, 39 (daytime) degrees C; 06/20/2013, Body temperature, 39 (midnight) degrees C; 06/22/2013, Body temperature, It is upper and lower up to 39 degrees C; 06/23/2013, Body temperature, 39 (at AM 2:00) degrees C; 06/24/2013, Body temperature, 36s-36.9 degrees C; 06/25/2013, Body temperature, 40.5 degrees C; 06/26/2013, Body temperature, 40s degrees C; 06/27/2013, Body temperature, 40s degrees C; 06/24/2013, C-reactive protein, 3.04 mg/dL, Increased; 06/26/2013, C-reactive protein, 2.56 mg/dL, Increased; 06/24/2013, Fibrin D dimer, 6.7 not provided, Increased; 06/26/2013, Fibrin D dimer, 6.2 not provided, Increased; 06/24/2013, Fibrin degradation products, 12.7 ug/l, Increased; 06/26/2013, Fibrin degradation products, 12.2 ug/l, Increased; 06/24/2013, Serum ferritin, 83.0 ng/mL, Increased; 06/26/2013, Serum ferritin, 87.0 ng/mL, Increased; 06/24/2013, White blood cell count, 6200/uL, Normal; 06/26/2013, White blood cell count, 3400/uL, Decreased
CDC Split Type: WAES1306JPN014033

Write-up: Follow-up information has been received from a physician concerning a 12-year-old female. The patient had no concomitant disease or medical history. On 14-MAY-2013, she was vaccinated with GARDASIL (lot No. 9QN08R), 0.5 ml one dose (number of times of vaccination, injection site or indication was not reported). No concomitant medication was reported. On 14-MAY-2013, the vaccination was performed at another clinic. On 18-JUN-2013, the patient felt heavy all the time at school and then had fever with 39.3 degree C after she went home. On 19-JUN-2013, the fever of 38''s-39''s degree C persisted, and the patient received drip infusion, BRUFEN, BIOFERMIN tablet and SESDEN at a nearby hospital. On 20-JUN-2013, the patient had fever of 39 degree C with chills in the midnight, 36''s degree C in the daytime, and 39 degree C with chills around noon. On 21-JUN-2013, the patient urgently visited the reporting physician''s hospital as the same symptoms were persisting. FIOMOX tablet, TSUMURA KAKKONTO and CALONAL 250 tablet were administered for treatment. On 22-JUN-2013, the patient''s body temperature went up to 39''s degree C and down repeatedly in the afternoon. On 23-JUN-2013 (Sunday), the body temperature was 39 degree C at 2:00, and the patient visited the physician''s hospital again, when her CRP and WBC were 2.67 and 7200, respectively. She also underwent urine tests. On 24-JUN-2013, she had spike fever twice (during daytime and midnight), however, the other time the body temperature was kept at 36''s degree C. Fever persisted, and she visited the pediatric department of the reporting physician''s hospital for the first time. No redness of the pharynx or change in lips was observed; the cause of the fever was not found. She was admitted to the hospital for follow-up as that day was the sixth day of the fever. On 27-JUN-2013, her hepatic and thyroid functions had showed no abnormality from 24-JUN-2013 to this date. Her CRP and WBC were 3.04 mg/dl and 6200, respectively. The patient had been observed with ferritin 83 ng/dl and FLUMARIN (drip infusion), but she had chills and shivering in the early evening and then had a spike fever of 40 degree C repeatedly. The patient had received MYNOMYCIN since 25-JUN-2013 but did not respond to this antibiotic drug. On 27-JUN-2013, she had a high fever (40''s degree C) again, and she was referred to another hospital. Reportedly her WBCs had gone up and down between 3000 and 7000 during her hospital stay. On an unspecified date, at the hospital, treatment was started on the basis that the relationship of the pyrexia to the HPV vaccine was unlikely. Spike fever persisted thereafter, and juvenile rheumatoid arthritis (JRA) was suspected; therapy with prednisolone 1 mg/kg/day was started. Then the spike fever subsided, and the patient had a diagnosis of JRA. On 30-AUG-2013, the pyrexia resolved. Her clinical course during the hospital stay had been good although she had steroid-induced adverse reactions such as moon face. She was discharged from the hospital. Steroid dose had been decreased to 18 mg/day with good controlling of the JRA. JRA; fever was recovering. At the time of this report, outcome of the moon face was unknown. Reporting physician''s comments: Pyrexia was probably not related to the vaccination. Patient''s parents became anxious seeing the news and I had an inquiry to know if there had been any patient reported who had pyrexia a week or more after the vaccination, and also to know the interval from the vaccination to the pyrexia and its outcome (if there was such the patient). Drug-induced pyrexia come in sight in the another hospital. The reporting physician felt that the JRA; fever was serious due to hospitalization. The reporting physician did not assess the serious criteria of moon face. The reporting physician did not assess the causal relationship of the JRA; fever to the GARDASIL. The reporting physician considered that the moon face was definitely not related to the GARDASIL, but definitely related to the steroid. Additional information is not expected.


VAERS ID: 501779 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody positive, Antiphospholipid antibodies positive, Arthralgia, Asthenia, Bacterial test negative, C-reactive protein increased, Influenza, Laboratory test abnormal, Lupus-like syndrome, Normochromic normocytic anaemia, Pyrexia, Red blood cell sedimentation rate increased, Skin lesion, Urine analysis normal, Viral test negative
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Raynaud''s phenomenon, Family History
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Extensive bacterial and viral screening (date unspecified): negative; Autoantibodies profile (date unspecified): revealed seropositivity for ANA and lupus anticoagulant (LAC); Laboratory examinations (date unspecified): revealed normochromic normocytic anemia with elevated CRP and ESR; Body temperature, 39.5 degrees C; C-reactive protein, Increased; Red blood cell sedimentation rate, Increased; Urine analysis, Normal
CDC Split Type: WAES1309ISR001862

Write-up: This literature marketed report was received from a other health professional refers to a 16 year old female patient. Her current and family histories were remarkable for Raynaud''s phenomenon while her maternal aunt was diagnosed with systemic sclerosis. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient was admitted to the Infectious Diseases Department because of high-grade fever (39.5 degree Celsius (C)), generalized asthenia, diffuse polyarthralgia, and, multiple erythematous annular cutaneous lesions on the face, trunk, and lower limbs which occurred 8 days after the first dose of GARDASIL. While she received the vaccine, she developed low-grade fever, which was interpreted as viral flu syndrome. Laboratory examinations revealed normochromic normocytic anemia with elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), an extensive bacterial and viral screening was negative and her urine sediment was normal. Autoantibodies profile revealed seropositivity for antinuclear antibody (ANA) and lupus anticoagulant (LAC). On an unknown date, a diagnosis of lupus-like syndrome was determined and the patient was treated with intravenous high-dose methylprednisolone followed by oral prednisone (PDN). Following initiation of treatment, her blood temperature normalized and her skin lesions significantly improved with almost complete resolution in a month, while receiving 50 milligrams (mg) of PDN. The latter was tapered down within 6 months, and at 1 year following vaccination the patient was in good health. The reporter considered the event to be related to GARDASIL. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A causal link between HPV vaccination and onset or relapse of SLE is plausible. This is one of the several reports from the same source. Additional information has been requested.


VAERS ID: 501782 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2013-09-06
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Condition aggravated, Laboratory test, Migraine, Paraesthesia, Sensory disturbance, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MINULET
Current Illness: Immunisation; Oral contraception
Preexisting Conditions: Migraine; GARDASIL, Paraesthesia; GARDASIL, Sensory disturbance; GARDASIL, Visual impairment; 03/13/2013, GARDASIL, Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK002708

Write-up: Case received from health care professional via the Health Authorities on 27-Aug-2013 under the reference number DK-DKMA-ADR 22212511 and DK-DKMA-EFO6569. Case medically confirmed. A 26 year old female patient (weight 86 kg, height 174 cm) had received an injection of GARDASIL (dose 2, batch number not reported, site and route of administration not reported) on 11-Jun-2013 and later on 17-Jun-2013 she developed migraine, visual disturbance, sensory disturbance on the right side, paresthesia and on a non-specified date she developed "suspected apoplexy". Cessation date for "migraine", "visual disturbance", "sensory disturbance on the right side" and "paresthesia" reported as 30-Jun-2013 (AE duration of 13 days). According to the reporter the patient had concomitant contraceptive treatment with MINULET (other mfr) started on 17-Mar-2013 and discontinued on 29-Mar-2013 (duration of 12 days). The patient did not receive other concomitant vaccinations. On 03-Jul-2013 the patient was hospitalized at a neurology ward. The reporter mentioned that examinations/laboratory tests were performed (no dates specified). The patient was diagnosed with apoplexy during hospitalisation. No further information was specified. The patient has a medical history of known migraine once a month but with other character. The patient was previously vaccinated with an injection of GARDASIL (dose 1, batch/lot number J000160, Expiration Date 30-Jun-2015, intramuscular route, site not reported) on 13-Mar-2013 and later on 16-Mar-2013 she developed similar symptoms as after the second dose, migraine, visual disturbance, sensory disturbance on the right side and paresthesia. Cessation date 23-Mar-2013. The HA mentioned in lab test that the patient had been hospitalized in neuro on 3-Jul-2013 and obs apoplexy was also reported. Base on this information the Company assumed that the patient had been hospitalized for evaluation of apoplexy. The case was therefore upgraded to serious. The company coded "apoplexy" and "sensory disturbance on the right side" (although mentioned in the narrative but not coded by HA). HA coded dose 1 as suspected and the following reactions as non-serious: migraine, visual disturbance, sensory disturbance on the right side and paresthesia. At the time of reporting, the outcome for "apoplexy" was not reported and recovered for "migraine", "visual disturbance", "sensory disturbance on the right side" and "paresthesia".


VAERS ID: 501783 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Antiphospholipid antibodies positive, Arthralgia, Arthritis, Butterfly rash, Cardiolipin antibody positive, Chest X-ray normal, Complement factor C4 decreased, Condition aggravated, Double stranded DNA antibody positive, Dyspnoea, Laboratory test abnormal, Leukopenia, Lymphadenopathy, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging brain normal, Rash, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Systemic lupus erythematosus rash
SMQs:, Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Systemic lupus erythematosus, Diagnosed 4 years prior
Preexisting Conditions: Hydroxychloroquine sulfate, Systemic lupus erythematosus; Corticosteroids, Systemic lupus erythematosus
Allergies:
Diagnostic Lab Data: Chest x-ray, Normal, no abnormalities; Complement factor, Decreased; Red blood cell sedimentation rate, Increased
CDC Split Type: WAES1309ISR001989

Write-up: This literature marketed report was received from a other health professional via a journalist concerning a 19 year old female patient. Current condition of the patient included systemic lupus erythematosus (SLE) diagnosed on an unknown date in 4 years prior due to the appearance of malar rash typical SLE skin rash, arthritis, positive serology for antinuclear antibody (ANA) and anti-dsDNA antibodies, as well as very low C4 complement levels. She was treated with corticosteroid and hydroxychloroquine (HCQ) and achieved a full clinical remission with normalization of complement and anti-dsDNA antibodies levels. Her maintenance therapy included low-dose HCQ and vitamins D. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Following the first dose of vaccine, she experienced mild arthralgia, dyspnea (with no abnormalities on her chest x-ray), cervical lymphadenopathy, and skin rash. Treatment with prednisone (PDN) 40 milligrams/day was commenced with good response and the dose was slowly tapered down. Although otherwise advised, the patient decided to receive the second boost of the vaccine. This time SLE-symptoms were more pronounced with very notable malar rash, severe skin rash, cervical lymphadenopathy of more than 3 centimeter (cm), alopecia, leucopenia, elevated erythrocyte sedimentation rate (ESR), and decreased complement levels. Corticosteroids dose was increased, and following discussions with the patient, therapy with belimumab (anti-BLyS) was commenced, which induced an improvement. The reporter considered the event to be relate to GARDASIL. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A casual link between HPV vaccination and onset or relapse of SLE is plausible. Upon internal review, SLE flare was considered as medially significant. This is one of the several reports from the same source. Additional information has been requested.


VAERS ID: 501789 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Anaemia, Antinuclear antibody positive, Aphthous stomatitis, Arthralgia, Asthenia, Blood creatine phosphokinase normal, Blood test normal, Blood thyroid stimulating hormone normal, Butterfly rash, C-reactive protein increased, Chest X-ray normal, Complement factor C3 decreased, Culture urine negative, Cytomegalovirus test negative, Decreased appetite, Double stranded DNA antibody positive, Endoscopy normal, Epstein-Barr virus test negative, Fatigue, Hepatitis viral test negative, Laboratory test abnormal, Leukopenia, Local reaction, Lymphadenopathy, Lymphopenia, Myalgia, Oropharyngeal pain, Parvovirus B19 test negative, Pyrexia, Rash, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Urine analysis normal, Urticaria, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Thyroid disorder, family history was remarkable
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lymphadenopathy (unspecified date): More than 3.5 centimeters (cm) Body weight (unspecified date) : Lost 10 kg of body weight Laboratory tests (unspecified) (date unspecified): anemia (without evidence of hemolysis), leucopenia, and lymphopenia. Autoantibodies screening (Date unspecified): showed positive antinuclear antibodies (ANA) with very high titers of anti-Ro (SSA) and anti-La (SSB) antibodies and high positive anti-dsDNA antibodies. Urine analysis (date unspecified): showed no active sediment and no evidence of infections was documented (i.e., normal blood and urine culture, negative serology for hepatitis, Epstein-Barr virus, cytomegalovirus, parvovirus). Chest radiography (date unspecified): Normal Blood creatine phosphokinase, Normal; Blood thyroid stimulating hormone, normal; C-reactive protein, Increased; Complement factor C3, Decreased, very low not provided; Endoscopy; Red blood cell sedimentation rate, increased
CDC Split Type: WAES1309ISR001342

Write-up: This literature marketed report was received from a other health professional concerning a 32 year old female patient. Her family history was remarkable for autoimmune thyroid diseases. Her medical history was unremarkable prior to vaccination. On an unknown date, the patient was vaccinated with first, second and third dose of GARDASIL (lot number, expiry date, dose and route unspecified). On an unknown date, the patient experienced mild weakness, facial malar rash, and hair loss following the first dose of vaccination (6 months prior to hospitalization). On an unknown date, the patient experienced local reaction to vaccination, fever, fatigue, mild rash, and arthralgia following the third dose of vaccination with GARDASIL. On admission, she suffered from general weakness, severe myalgia, polyarthralgia, anorexia, severe skin rash (urticaria like), malar rash, aphtous stomatitis, pharyngodynia, cervical lymphadenopathy (more than 3.5 centimeters) and hair loss. In addition, in the 4 weeks prior to her hospitalization she lost 10 kg of body weight. Laboratory tests demonstrated elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), anemia (without evidence of hemolysis), leucopenia, and lymphopenia. Autoantibodies screening showed positive antinuclear antibodies (ANA) with high titers of anti-Ro (SSA) and anti-La (SSB) antibodies and high positive anti-dsDNA antibodies. Antiphospholipid antibodies were undetectable. Complement (C3) levels were very low. Urine analysis showed no active sediment and no evidence of infections was documented (normal blood and urine culture, negative serology for hepatitis, Epstein-Barr virus, cytomegalovirus, parvovirus). Creatine phosphokinase (COK) and thyroid stimulating hormone (TSH) levels were normal, as well as chest radiography and endoscopy. On an unknown date, the patient was diagnosed with systemic lupus erythematosus (SLE). The patient was treated with high-dose prednisone (PDN) and hydroxychloroquine (HCQ) with gradual clinical improvement. PDN therapy was tapered slowly up to 5 milligrams (mg)/day, HCQ was continued at 400 mg/day along with supplementation of calcium and vitamin D. Eight months afterwards, the patient was in remission, with normalization of inflammatory laboratory parameters (CRP, ESR), as well as blood considered systemic lupus erythematosus to be related to GARDASIL. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A casual link between HPV vaccination and onset or relapse of SLE is plausible. This is one of th several reports from the same source. Additional information has been requested.


VAERS ID: 501790 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Anaemia, Antinuclear antibody positive, Biopsy kidney abnormal, C-reactive protein normal, Complement factor C3 decreased, Complement factor C4 decreased, Convulsion, Fatigue, Leukopenia, Local swelling, Lupus nephritis, Lymphadenopathy, Malaise, Mesangioproliferative glomerulonephritis, Periorbital oedema, Petechiae, Pyrexia, Rash, Rash erythematous, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Thrombocytopenia, Weight decreased, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Pityriasis rosea; Rash; Infection
Allergies:
Diagnostic Lab Data: Further evaluation (date unspecified): documented seropositivity for ANA, anti-RNP, anti-Smith and anti-RO/SSA antibodies C-reactive protein, Normal; Complement factor C3, Decreased; Compliment factor C4, Decreased; Leukopenia, 2100 cells /mm3; Red blood cell sedimentation rate, increased
CDC Split Type: WAES1309ISR002035

Write-up: This literature marketed report as received from a other health professional via a journalist concerning a 13 year old female patient. Her personal medical history was remarkable only for common infections, rash due to pityriasis rosea treated and resolved several months before vaccination. Her family history revealed several members of the family with autoimmune diseases including systemic lupus erythematosus (SLE). 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 approached her general physician 3 weeks following the second dose of vaccination due to swelling of her index finger and a rash. During the following couple of months, she developed erythematous rash on her face, fever, periorbital edema, weight loss, malaise, fatigue, cervical, axillary and inguinal lymphadenopathy as well as mild anemia. She was referred to a rheumatologist who noted that she had a petechial rash, alopecia, leucopenia of 2100 cells per cubic millimeter and mild thrombocytopenia. Further evaluation documented seropositivity for antinuclear rate (ESR). The C-reactive protein (CRP) level was normal. On an unknown date, the patient was diagnosed with systemic lupus erythematosus (SLE). The patient was treated with hydroxychloroquine and prednisone. Despite therapy, disease progression was documented with the appearance of CNS (i.e. seizures) and kidney involvement. Renal biopsy was compatible with mesangial proliferative glomerulonephritis, class II lupus nephritis. Thus, therapy was enhanced with high-dose steroids, cyclophosphamide, as well as antiepileptic medications. Under this therapy, there was gradual remission of the SLE. The outcome of the events was reported as resolving. The reporter considered SLE to be related to GARDASIL. The relatedness for seizures was unknown. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A casual link between HPV vaccinations and onset or relapse of SLE is plausible. Upon internal review, systemic lupus erythematosus (SLE) and seizures were considered as medically significant. This is one of the several reports from the same source. Additional information has been requested.


VAERS ID: 501791 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-20
Onset:2012-02-20
   Days after vaccination:0
Submitted: 2013-09-01
   Days after onset:558
Entered: 2013-09-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK29900 / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), 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? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Anaphylaxis - over 80 episodes requiring EPIPEN, ambulance, hospitalization. Under the care of hospital.


VAERS ID: 501792 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-09
Entered: 2013-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC12B030AE / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC071BH / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H004182 / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 195C / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER G015119 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Culture urine positive, Cystogram normal, Escherichia test positive, Foetal exposure during pregnancy, Pyelocaliectasis, Ultrasound kidney abnormal, Ureteric dilatation, Urinary tract infection
SMQs:, Retroperitoneal fibrosis (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Chronic kidney disease (broad), Infective pneumonia (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:
Allergies:
Diagnostic Lab Data: Culture urine, E.coli; Cystogram, Normal; Ultrasound kidney, dilatation of excretory system in left pelvis
CDC Split Type: WAES1309PRT003097

Write-up: Case of pregnancy follow-up received from the Health Authorities on 28-Aug-2013 under the reference number L201209-119 via the local site Sanofi Pasteur MSD. The primary reporter was a nurse. Case medically confirmed. This case is linked with the n E2012-07414 (patient''s mother). A male neonatal patient was found to have dilatation of the excretory system in the left renal pelvis coexisting to some proximal ureteric ectasia after being exposed in utero to vaccines administered in the mother during pregnancy. The patient''s mother had received a dose of M-M-RVAXPRO (batch number G011386), a dose of GARDASIL (batch number G017911), a dose of MENJUGATE KIT (other manufacturer, batch number 490011A), a dose of ENGERIX B (other manufacturer, batch number AHBVC071BH), a dose of POLIO vaccine SSI (other manufacturer, batch number 194B), and a dose of DITANRIX Adult (other manufacturer, batch number AC12B030AB) on 08-May-2012. She had also received a dose of M-M-RVAXPRO (batch number G015119), a dose of GARDASIL (batch number H004182), a dose of ENGERIX B (other manufacturer, batch number AHBVC071BH), a dose of POLIO vaccine SSI (other manufacturer, batch number 195C), and a dose of DITANRIX Adult (other manufacturer, batch number AC12B030AE) on 29-Aug-2012. On 14-Sep-2012 a first pregnancy visit showed the mother was 21 weeks and 6 days pregnant. The patient was born after 41 weeks of pregnancy on 29-Jan-2013. He was 47 cm tall. His head circumference was 34 cm. As reported by the nurse to HA on 20-Aug-2013, the patient had psychomotor development, weight and height growth that fitted his age (6 months). He was hospitalised in June due to urinary infection. Urine culture showed E. coli. The patient received cefuroxime intravenously. Cystography was performed and found normal results. Renal ultrasound found dilatation of the excretory system in the left renal pelvis with antero-posterior diameter of 8 mm, coexisting to some proximal ureteric ectasia that measured 2.6 mm. The baby was breastfed. The outcome was unknown. Upon internal review the company judged relevant to capture ureteric ectasia, renal pelvis dilatation and urinary tract infection that occurred to the baby and were mentioned by the HA but not coded. The company assessed ureteric dilatation and renal pelvis dilatation as congenital anomaly.


VAERS ID: 501793 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Antinuclear antibody increased, Arthritis, Asthenia, Biopsy bone marrow normal, Butterfly rash, Complement factor decreased, Diarrhoea, Double stranded DNA antibody positive, Inflammatory marker increased, Photosensitivity reaction, Protein urine present, Protein-losing gastroenteropathy, Proteinuria, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Weight decreased
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), 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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Autoimmune disorder, family medical history (unremarkable)
Preexisting Conditions: Cervical dysplasia, related human papilloma virus (HSV) months before vaccination; Splenectomy, normalization of her platelet counts and abortion of additional therapies; Autoimmune thrombocytopenia, diagnosed several years before immunization; Pneumococcal vaccine, as required, before splenectomy with no adverse events; Globulin, immune; Prednisone
Allergies:
Diagnostic Lab Data: Physical examination (date unspecified): revealed malar rash, photosensitivity, arthritis, and alopecia; Antinuclear antibody, high titers not provided; Biopsy bone marrow, Normal; Complement factor, Decreased; Double stranded DNA antibody, high titers not provided; Proteinuria, 1 g/day; Red blood cell sedimentation rate, not provided, Increased
CDC Split Type: WAES1309ISR001816

Write-up: This literature marketed report was received from a other health professional concerning a 29 year old female patient. Her medical history included immune thrombocytopenia diagnosed several years before immunization. At that time, she had normal bone marrow biopsies and no detectable serum autoantibodies, including ANA. She was treated with prednisone (PDN) and intravenous immunoglobulins. Two years prior to vaccination, she underwent splenectomy with normalization of her platelet counts, and abortion of additional therapies. Historical drug included pneumococcal vaccine (manufacturer unknown), as required, before splenectomy with no adverse events. In addition, the patient was diagnosed with early cervical intraepithelial neoplasia related human papilloma virus (HPV) months before vaccination. Her family medical history was unremarkable for autoimmune disorders. 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 to the hospital 3 weeks following the second dose of GARDASIL due to severe weakness, diarrhea, and elevated markers of inflammation. On admission, her physical examination revealed malar rash, photosensitivity, arthritis, and alopecia. In the next couple of months, she lost 30 percent of her body weight and remained hospitalized. Laboratory tests demonstrated elevated erythrocyte sedimentation rate (ESR), high titers of antinuclear antibody (ANA) and anti-dsDNA antibodies, low levels of complement, and proteinuria of 1 gram/day. On an unknown date, the patient was diagnosed with systemic lupus erythematosus (SLE) and severe protein-losing enteropathy. She was treated with high-dose corticosteroids, azathioprine (AZA) and hydroxychloroquine (HCQ) with gradual remission of her symptoms which were followed by slow down-tapering of PDN and AZA doses. Two years following the diagnosis of SLE, the patient two years following the diagnosis of SLE, the patient seropositivity and traces of protein in her urine. Her present therapy comprises of HCQ and calcium/vitamin D supplementation. The outcome of the events was reported as resolving. The reporter considered systemic lupus erythematosus to be related to GARDASIL. The relatedness for severe protein-losing enteropathy was unknown for GARDASIL. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A causal link between HPV vaccination and onset or relapse of SLE is plausible. This is one of the several reports from the same source. Additional information has been requested.


VAERS ID: 501945 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-01
Onset:2008-05-01
   Days after vaccination:90
Submitted: 2013-09-09
   Days after onset:1957
Entered: 2013-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0484U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Type 1 diabetes mellitus
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309FRA000556

Write-up: Case received from the Health Authorities in a foreign country under reference number NT20131121 on 27-Aug-2013. Case medically confirmed. A 14-year-old female patient with a medical history of autoimmune hyperthyroidism treated with LEVOTHYROX since 2006, had received the second dose of GARDASIL (batch number NG29170, lot number 0484U, Exp. Date: 23-MAR-2010) via intramuscular route on 01-Feb-2008. In May-2008 she developed insulin dependent diabetes. To be noted that she had received the first dose of GARDASIL (batch number NG01510, lot number 1358F, Exp. Date: 28-NOV-2009) on 24-Dec-2007 and the third dose of GARDASIL (batch number NH00400, lot number 1146U, Exp. Date: 27-JUL-2010) on 02-Jul-2008. At the time of reporting, the patient had not recovered. The Health Authorities considered the case as serious due to "hospitalization" criterion. The Health Authority assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1 B1 NI2) according to the updated method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation".


VAERS ID: 501964 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-10
Entered: 2013-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pneumothorax
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: WAES1309JPN003131

Write-up: Initial information has been received from a physician concerning a female patient in her 10''s with no underlying disease or medical history. She had no problem before vaccinations. On an unspecified date, the patient received the first vaccination of GARDASIL Intramuscular (IM) injection drug (dose, injection site, indication and lot number not provided). No concomitant medication was reported. On an unspecified date, as mentioned above, the patient received the first vaccination of GARDASIL. On an unspecified date, 2 weeks after the vaccination, pneumothorax developed in the one side of lungs. On an unspecified date, the patient received Intramuscular (IM) with the second vaccination of GARDASIL. On an unspecified date, 2 weeks after the second vaccination, pneumothorax developed in the other side of lungs. At the time of this report, the outcome of 2 episodes of the pneumothorax was unknown. Reporter''s comment: None. The reporting physician did not assess the causal relationship between the pneumothorax (2 episodes) and GARDASIL. The reporter assessed the pneumothorax (2 episodes) as serious (other important medical event). No further information is available.


VAERS ID: 501971 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-20
Onset:2013-08-20
   Days after vaccination:0
Submitted: 2013-09-09
   Days after onset:20
Entered: 2013-09-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J001831 / 2 RA / IM

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

Life Threatening? No
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: GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data: 08/20/2013, Blood pressure, 95/60 mmHg
CDC Split Type: WAES1309DEU000553

Write-up: Case was received from the Health Authorities on 26-Aug-2013 (reference no. PEI2013048663). Case is medically confirmed. A 15-year-old female patient received the second dose of GARDASIL (batch and lot-no. J001831, exp. 31-AUG-2015) IM into the right upper arm on 20-Aug-2013. Subsequently, on the same day, the patient developed unconsciousness and pallor. Suspicion of orthostatic dysregulation was established. Blood pressure was 95/60 mmHg. An unspecified outpatient treatment was carried out. The patient recovered within 3 seconds. Previous dose of GARDASIL (D1: lot-no. not reported) given on 25-Jun-2013, had been well tolerated. The case was assessed as serious by the company (OME/unconsciousness).


VAERS ID: 501972 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-12
Onset:2013-07-12
   Days after vaccination:0
Submitted: 2013-09-10
   Days after onset:60
Entered: 2013-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Loss of consciousness, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DEU003099

Write-up: Case received from the Health Authorities on 02-Sep-2013 (reference PEI2013050036). Case is medically confirmed. A 15-year-old female patient (weight 57 kg, height 170 cm) had received the first dose of GARDASIL (lot-no. and injection site not reported) IM on 12-Jul-2013. On the same day, 10 minutes after the vaccination, the patient developed circulatory collapse with unconsciousness and subsequently sleepiness. The patient recovered from circulation collapse and unconsciousness within 20 seconds. Sleepiness lasted for more than 30 minutes and the patient was hospitalised for monitoring. Symptomatic treatment was carried out (not specified), the patient recovered completely. Duration of sleepiness was not reported.


VAERS ID: 501991 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-10
Entered: 2013-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Intensive care, Local swelling, Neuralgic amyotrophy, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: NUVARING
Current Illness: Menorrhagia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature (unknown date): the patient had fever.
CDC Split Type: WAES1309ZAF003457

Write-up: This spontaneous report as received from a physician via a company representative refers to a female patient with currently 20 years old, that came in with menorrhagia (prolonged/heavy menstrual periods). On an unknown date, the patient started therapy with the first dose of GARDASIL (Lot #, dose and route not reported, in the left arm). Other suspect therapies included NUVARING (dose, frequency and route not reported) for menorrhagia (prolonged/heavy menstrual periods). Concomitant therapies was not reported. On an unknown date, after the patient was given the vaccine, the patient experienced parsonage turner syndrome. Also, the patient had swollen arm and fever. The patient was admitted one week after vaccine and was in intensive care unit (ICU) due to parsonage turner syndrome. It was reported that the patient arm improved after a week of being vaccinated. It was unknown the outcome of parsonage turner syndrome and fever. The reporter considered parsonage turner syndrome, swollen arm and fever to be not related to NUVARING and possibly not related to GARDASIL. This case was serious due to hospitalization. Additional information has been requested.


VAERS ID: 502043 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-26
Onset:2013-05-01
   Days after vaccination:36
Submitted: 2013-09-11
   Days after onset:133
Entered: 2013-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Bed rest, Blood test, Dizziness, Dyspepsia, Electrocardiogram, Endoscopy upper gastrointestinal tract, Fatigue, Heart rate increased, Hypotension, Malaise, Memory impairment, Menorrhagia, Muscular weakness, Musculoskeletal chest pain, Nausea, Pain in extremity, Pruritus, Scan, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Numerous blood tests have been taken on a non-specified date. Heart scan, gastroscopy, blood pressure meter for 24 hours and holter for 24 hours were performed on a non-specified date. 05/01/2013, Blood pressure, Decreased, 70/43; Electrocardiogram ambulatory; Endoscopy upper gastrointestinal tract
CDC Split Type: WAES1309DNK003832

Write-up: Case received from patient/consumer via Health Authorities on 02-Sep-2013 under the reference number DK-DKMA-ADR 22222392 and DK-DKMA-EFO6647. Case medically confirmed. A 36 year old female patient (weight 85 kg, height 165 cm) had received an injection of GARDASIL (dose 1, batch number unknown, intramuscular route, site not reported) on 26-Mar-2013 and later on 01-May-2013 she developed abdominal pain, itching, constant nausea, loss of muscle strength, pain under the ribs, sensory disturbance in legs, generally ill, hypotension (low blood pressure 70/43), high pulse, pain/pain in body, low pulse, short-term memory problem, sudden severe menstruation, itching under the feet, pain in the legs and soles of the feet, extreme tiredness, dizziness and heartburn. For each day the symptoms were aggravated and new ones were generated (no further information specified). The patient has not been treated for the AEs. At the time of vaccination the patient had concomitant treatment with oral antidiabetes (trade name not reported, active substance metformin, other mfr). The patient had no other vaccinations. The patient received an injection of GARDASIL (dose 2, batch number unknown, intramuscular route, site not reported) on 13-Jun-2013. According to the reporter, the patient has to bed rest approximately every 2 -3 days because of the AEs. She has been hospitalized two times because of pain and is generally ill. Numerous blood tests have been taken on a non-specified date (no results reported). Heart scan, gastroscopy, blood pressure meter for 24 hours and holter for 24 hours were performed on a non-specified date (no results reported). No medical history reported. HA has coded both dose 1 and 2 as suspected doses (presumably because the patients symptoms aggravated at the time of second vaccination). HA has assessed the case as life-threatening. At the time of reporting, the outcome was not recovered.


VAERS ID: 502046 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-15
Onset:2013-08-15
   Days after vaccination:0
Submitted: 2013-09-11
   Days after onset:27
Entered: 2013-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003267 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Computerised tomogram head, Headache, Migraine with aura, Nausea, Photophobia, Sensory disturbance, Throat tightness, Visual impairment
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (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: Blood test; Computerised tomogram head
CDC Split Type: WAES1309DNK003901

Write-up: Case received from a health care professional via the Health Authorities on 03-Sep-2013 under the references DK-DKMA-ADR 22222338 and DK-DKMA-EFO6646. Case is medically confirmed. A 27-year-old female patient (weight 59 kg, height 164 cm) had received an injection of GARDASIL (J003267) on 15-Aug-2013. 1 minute after the vaccination, the patient developed classic migraine with aura, tightness in throat, tension in arm radiating to the right arm, visual disturbance and sensory disturbance. After 10 minutes, the patient developed throbbing headache, light sensitivity and nausea. The patient received ibuprofen and PAMOL. The patient was hospitalised on the next day. CT scan of cerebrum as well as blood test were performed. Results were not provided. Migraine resolved after 71 hours. At the time of reporting, all over events had resolved within an unspecified timeframe. After a 30 hour migraine-free interval, the patient was referred to neurology due to a recurrent migraine attack. At the time of reporting, migraine was resolving. Noteworthy: Upon review by the Company the AE "migraine with aura" as coded twice in order to capture the recurrence of migraine as clinical diagnostic criteria.


VAERS ID: 502051 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-30
Onset:0000-00-00
Submitted: 2013-09-11
Entered: 2013-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute vestibular syndrome, Multiple sclerosis, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Acne; 09/20/2008, GARDASIL, no adverse event; 07/23/2008, GARDASIL, no adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309FRA003886

Write-up: Case received from a physician on 03-Sep-2013 and medically confirmed. A 18-year-old female patient with a history of acne had received the three doses of GARDASIL (batch number not reported) on 23-Jul-2008, GARDASIL on 20-Sep-2008 and 30-Mar-2008. The two first doses had been uneventful. In the end of 2010 she developed a vestibular syndrome associated with vertigo and vomiting. She was hospitalized from 25 to 28 January 2001 in neurological service for a check up. Multiple sclerosis was diagnosed. At the time of reporting, the patient was treated with a cure of TYSABRI with a good efficiency. To be noted that there was no familial history of autoimmune disease.


VAERS ID: 502144 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-11
Entered: 2013-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Anaemia, Anti-SS-A antibody positive, Antinuclear antibody positive, Biopsy kidney abnormal, C-reactive protein normal, Complement factor C3 decreased, Complement factor C4 decreased, Convulsion, Fatigue, Leukopenia, Local swelling, Lupus nephritis, Lymphadenopathy, Malaise, Mesangioproliferative glomerulonephritis, Periorbital oedema, Petechiae, Pyrexia, Rash, Rash erythematous, Red blood cell sedimentation rate increased, Renal disorder, Systemic lupus erythematosus, Thrombocytopenia, Weight decreased, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Immunisation
Preexisting Conditions: Pityriasis rosea
Allergies:
Diagnostic Lab Data: White blood cell count: 2100 cell/mm3; Anti-SS-A antibody, Positive; Antinuclear antibody, Positive; Antinuclear antibody, Positive; Antinuclear antibody, Positive; Antinuclear antibody positive, Positive; C-reactive protein, Normal; Complement factor C3, Decreased, Low; Complement factor C4, Decreased; Erythrocyte sedimentation rate, Increased
CDC Split Type: WAES1309ITA004606

Write-up: Case retrieved from the literature on 02-SEP-13. Case medically confirmed. The abstract initially received on 02-MAY-2013 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; E2013-06726 and E2013-06727 (same vaccine, similar events, different patients). This case concerns patient n. 6: a 13-year-old female approached her general physician 3 weeks following immunization with the second dose of GARDASIL due to swelling in her index finger and a rash. During the following couple of months, she developed erythematous rash on her face, fever, periorbital edema, weight loss, malaise, fatigue, cervical, axillary and inguinal lymphadenopathy, as well as mild anemia. At this stage, she was referred to a rheumatologist who noted that she had a petechial rash, alopecia, leucopenia of 2,100 cells/mm3, and mild thrombocytopenia. Further evaluation documented seropositivity for ANA, anti-RNP, anti-Smith and anti-RO/SSA antibodies as well as low C3 and C4, elevated ESR. The CRP level was normal. The patient was diagnosed with SLE. Hydroxychloroquine and prednisone treatment was started. Despite therapy, disease progression was documented with the appearance of CNS (i.e., seizures) and kidney involvement. Renal biopsy was compatible with mesangial proliferative glomerulonephritis, class II lupus nephritis. Thus, therapy was enhanced with high-dose steroids, cyclophosphamide, as well as antiepileptic medications. Under this therapy, there was gradual remission of the SLE. Notably, her personal medical history was remarkable only for common infections and a rash due to pityriasis rosea treated and resolved several months before immunization. Her family history revealed several members of the family with autoimmune diseases including SLE. The case is closed. The authors mentioned that based on the current available data, a causal link between HPV vaccine and onset or relapse of SLE is plausible. Upon internal review the Company assessed the case as serious.


VAERS ID: 502195 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-10
Onset:2013-08-07
   Days after vaccination:240
Submitted: 2013-09-12
   Days after onset:36
Entered: 2013-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0308AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody positive, Arthralgia, Hepatic function abnormal, Rash, Systemic lupus erythematosus
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Hypersensitivity (narrow), Arthritis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Anti-nuclear antibody (24-JUL-2013): Positive; hepatic function (24-JUL-2013): Abnormal.
CDC Split Type: WAES1309JPN003126

Write-up: Initial information has been received from a physician via the agency concerning a 12-year-old female patient. On 10-DEC-2012, the patient received the third time of vaccination with a (syringe-type) GARDASIL IM injection drug (dose and injection site not reported). No concomitant medication was reported. On 11-JUN-2012, the patient received the first time of vaccination with the GARDASIL injection drug (lot number unknown). On 11-AUG-2012, the patient received the second time of vaccination with the GARDASIL injection drug (lot number unknown). On 10-DEC-2012, as mentioned above, the patient received the third time of vaccination with the GARDASIL injection drug (lot number: 9QN04R). In January 2013, coxalgia developed in the patient. On 24-JUL-2013, the patient visited the orthopedic department of the reporting physician''s hospital because of persistent coxaglia, where abnormal hepatic function and a positive anti-nuclear antibody were pointed out. On 07-AUG-2013, the patient was referred to the department of the reporting physician. She had a diagnosis of SLE there because she had skin eruption specific to the SLE based on the diagnostic criteria of SLE. On 23-AUG-2013, the patient was admitted to a hospital. At the time of this report, the outcome of the coxalgia, abnormal hepatic function and SLE was unknown. Reporter''s comment: SLE was a collagen disease of unknown origin; it could not be completely denied that the GARDASIL triggered the SLE. The reporting physician assessed the causal relationship of the coxalgia between the GARDASIL as unknown, and considered that the SLE was other possible cause. The reporting physician did not assess the causal relationship of the abnormal hepatic function and SLE to the GARDASIL. The reporting physician assessed the coxalgia as serious (hospitalization and possible disability), and did not assess the seriousness of the abnormal hepatic function and SLE. Upon internal review, SLE was decided as serious (other important medical events). Further information has been requested. Remarks: The serious criteria of "possible disability" was coded as "other important medical events" due to SOP.


VAERS ID: 502263 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2013-07-22
   Days after vaccination:257
Submitted: 2013-09-11
   Days after onset:51
Entered: 2013-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Exposure during pregnancy
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? 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: WAES1301DNK002457

Write-up: Case of pregnancy follow-up received from a health care professional via a company representative on 19-Dec-2012. Case medically confirmed. A 32-year-old female patient had received an injection of GARDASIL (dose 3, batch number not reported, i.m, arm) on 07-Nov-2012 and later on it was discovered that she was pregnant at the time of vaccination. This was her first pregnancy. The patient was, probably in gestation week 3 at the time of vaccination. The last menstrual period date was 17-Oct-2012. The patient received GARDASIL dose 1 on 18-Apr-2012 and dose 2 on 21-Jun-2012 (batch numbers not reported). At the time of reporting, the outcome was unknown. Follow up information received from healthcare professional via company representative on 26-Aug-2013. On 22-Jul-2013 the patient delivered a normal baby boy at week 39 via caesarean section after a normal pregnancy. At the time of birth the boy was: Height: 50 cm Weight: 3 kg Head circumference: 34 cm. Upon medical review the company considered this case as serious, due to caesarean section.


VAERS ID: 502329 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-05
Onset:2013-05-08
   Days after vaccination:3
Submitted: 2013-09-12
   Days after onset:127
Entered: 2013-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death, Neurological decompensation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-08
   Days after onset: 0
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: WAES1309COL004119

Write-up: This spontaneous report as received from a regulatory authority (AE13CO0200) refers to an 11 year old female patient. On 05-MAY-2013 the patient was vaccinated with her first and only dose of GARDASIL, 0.5 ml, intramuscular (site and lot number not provided). Three days after, on 08-MAY-2013, the patient experienced fever, seizures, neurological deterioration and death. The outcome of seizures, fever and neurological deterioration was reported as fatal. The cause of death was not reported. According to the investigation performed by the regulatory authority, the patient was healthy previous to the vaccination; the events were experienced only after the vaccination. No evidences of external issues as the cause of the events were found. As additional information, no samples of cerebrospinal fluid were taken (in order to discard meningitis). The causal relationship was not reported. Upon internal review, seizures was medically significant. Additional information has been requested.


VAERS ID: 502330 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-16
Onset:2013-03-01
   Days after vaccination:105
Submitted: 2013-09-13
   Days after onset:195
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016967 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Arthralgia, Biopsy liver, Disorientation, Dizziness, Gastric disorder, Liver disorder, Memory impairment, Mood swings, Myalgia, Paraesthesia, Speech disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: LAMICTAL; MALONETTA; TELFAST
Current Illness: Unknown
Preexisting Conditions: Urticaria; Epilepsy; Contraception
Allergies:
Diagnostic Lab Data: Biopsy liver, not reported
CDC Split Type: WAES1309DNK004810

Write-up: Case received from consumer via Health Authorities in a foreign country under the reference number 22224960. Case not medically confirmed. A 27 year old female patient (weight 75 kg, height 175 cm) had received an injection of GARDASIL (dose 2, batch number H016967, intramuscular route, site not reported) on 16-Nov-2012 and later on 01-Mar-2013 she developed dizzy, stomach problems, memory failure, anxiety, hepatic disorder NOS, speech difficulty, orientation problems, pain in joints, pain in muscles, tingling in fingers and toes and mood swings. Concomitant treatment at the time of vaccination, antiepileptic treatment LAMICTAL (lamotrigine, other mfr) started on 01-Jan-2000, hormonal contraceptive for systemic use MALONETTA (other mfr) started on 01-Jan-2000 and antihistamine for systemic use TELFAST started on 01-Jan-2000. The patient had also received an injection of GARDASIL (dose 3, batch number HO11751, intramuscular route, site not reported) on 15-Mar-2013. The patient was HPV vaccinated during the winter 2012/2013. After she experienced the symptoms. On a non-specified date the patient had been investigated at the medical ward including a liver biopsy performed on a non-specified date (no results reported). The patient''s medical history includes first injection of GARDASIL (dose 1, batch number J000160, intramuscular route, site not reported) on 14-Sep-2012. The patient has a also a history of epilepsy and urticaria. No further information specified. As per HA report: According to the reporter, the patient''s physician has only helped the patient to report the adverse events but the physician has not suspected that there is a correlation between GARDASIL vaccination and the symptoms. The report is therefore not medically confirmed. HA has coded hospitalization of patient but no further details are specified. HA has coded onset age as 26 years, but the company coded 27 years after comparing date of birth to the time of event. The company coded dose 2 as suspected because there is an uncertainty whether the symptoms occurred after dose 3 or if they aggravated. At the time of reporting, the outcome was not recovered. According to the physician (reported by a consumer), the reaction was unlikely related to vaccination.


VAERS ID: 502331 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-13
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Antinuclear antibody positive, Arthritis, Butterfly rash, Complement factor C4 decreased, Complement factor decreased, Condition aggravated, Double stranded DNA antibody positive, Leukopenia, Lymphadenopathy, Rash, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Systemic lupus erythematosus rash
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (narrow), Hypersensitivity (narrow), Arthritis (narrow), 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? No
Previous Vaccinations:
Other Medications: Hydroxychloroquine sulfate; Vitamin D (unspecified)
Current Illness:
Preexisting Conditions: Systemic lupus erythematous; Rash; Lymphadenopathy; Dyspnoea; Arthralgia; Hydroxychloroquine sulfate; Corticosteroids (unspecified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309ITA004963

Write-up: Case retrieved from the literature on 02-SEP-13. Case medically confirmed. The abstract initially received on 02-MAY-13 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; E2013-06726 and E2013-06728 (same vaccine, similar events, different patients). This case is also linked to case E2013-06784 (same patient, same vaccine different dose and events). This case concerns patient n. 5: a 19-year-old SLE patient was diagnosed with SLE flare 10 days following the second dose of GARDASIL while in retrospect minor symptoms were already acknowledged following the first immunization. The patient was diagnosed with SLE 4 years prior due to the appearance of malar rash, typical SLE skin rash, arthritis, positive serology for ANA and anti-dsDNA antibodies, as well as very low C4 complement levels. She was treated with corticosteroid and hydroxychloroquine and achieved a full clinical remission with normalization of complement and anti-dsDNA antibodies levels. Her maintenance therapy included low-dose hydroxychlorquine and vitamin D. Following the first dose of HPV immunization, she experienced mild arthralgia, dyspnea (with no abnormalities on her chest x-ray), cervical lymphadenopathy, and skin rash. Treatment with prednisone 40 mg/day was commenced with good response and the dose was slowly tapered down. Although otherwise advised, the patient decided to receive the second boost of the vaccine. This time SLE-symptoms were more pronounced with very notable malar rash, severe skin rash, cervical lymphadenopathy of more than 3 cm, alopecia, leucopenia, elevated ESR, and decreased complement levels. Corticosteroids dose was increased, and following discussions with the patient, therapy with anti-BLyS was commenced, which induced an improvement. The case is closed. Upon internal review the Company assessed the case as serious. The authors mentioned that based on the current data, a causality between HPV vaccine and onset or relapse of SLE was plausible.


VAERS ID: 502332 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-13
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Antinuclear antibody positive, Arthritis, Asthenia, Butterfly rash, Complement factor decreased, Diarrhoea, Double stranded DNA antibody positive, Inflammatory marker increased, Photosensitivity reaction, Protein urine present, Protein-losing gastroenteropathy, Proteinuria, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Weight decreased
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309ITA004996

Write-up: Case retrieved from the literature on 02-SEP-2013. Case medically confirmed. The abstract initially received on 02-MAY-13 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 E2013-06727; E2013-06725; E2013-06726 and E2013-06728 (same vaccine, similar events, different patients). This case concerns patient no. 2: a 29-year-old woman was admitted to the hospital 3 weeks following the second dose of GARDASIL due to severe weakness, diarrhea, and elevated markers of inflammation. On admission, her physical examination revealed malar rash, photosensitivity, arthritis, and alopecia. In the next couple of months, she lost 30% of her body weight and remained hospitalized. Laboratory tests demonstrated elevated ESR, high titers of ANA, and anti-dsDNA antibodies, low levels of complement, and proteinuria of 1g/day. The patient was diagnosed with SLE and severe protein-losing enteropathy. Her medical history included immune thrombocytopenia diagnosed several years before immunization. At that time, she had normal bone marrow biopsies and no detectable serum autoantibodies, including ANA. She was treated with prednisone and intravenous immunoglobulins. Two years prior to the administration of HPV vaccine, she underwent splenectomy with normalization of her platelet counts, and abortion of additional therapies. Of note, the patient was immunized with pneumococcal vaccine, as required, before splenectomy with no adverse events. In addition, the patient was diagnosed with early cervical intraepithelial neoplasia related to HPV months before immunization with GARDASIL. Her family medical history was unremarkable for autoimmune disorders. Following immunization and diagnosis of SLE, she was treated with high-dose corticosteroids, azathioprine and hydroxychloroquine with gradual remission of her symptoms which were followed by slow down-tapering of prednisone and azathioprine doses. Two years following the diagnosis of SLE, the patient achieved clinical and serological remission excluding ANA seropositivity and traces of protein in her urine. Her present therapy comprises of hydroxychloroquine and calcium/vitamin D supplementation. The case is closed. The authors mentioned that based on the current data, the causality link between HVP vaccine and onset or relapse of SLE is plausible.


VAERS ID: 502368 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-13
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (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: Vaccines, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309SWE004595

Write-up: Case received from healthcare professional company representative on 04-Sep-2013. Case medically confirmed. A female patient (initials unknown, date of birth and age not reported) had received an injection of GARDASIL (dose 1, batch number, route and site not reported) on unspecified date and later on 3 days post vaccination she developed a tingling/prickling sensation in her legs. No reduction in sensation or strength. The symptoms fluctuated but subsided after 1.5 weeks. The reporter had read about Guillain Barre Syndrome (GBS) as an uncommon side effect, but believes that it is to close to the vaccination. As GBS may have been suspected by the HCP, the case was assessed as serious by the Company. The patient has previously not reacted on other vaccines, has no allergies or immunological diseases. At the time of reporting, the outcome was not recovered (also reported as recovered).


VAERS ID: 502378 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-09
Onset:2013-09-09
   Days after vaccination:0
Submitted: 2013-09-13
   Days after onset:4
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Delirium febrile, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 09/09/2013, Body temperature, fever, fever raising in the evening not provided
CDC Split Type: WAES1309THA005040

Write-up: This spontaneous report as received from a pharmacist via company representative refers to a 13 year old female patient. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, strength, indication, route of administration not reported). On 09-SEP-2013 at around 10:00 AM (on an approximately 10:00 AM), the patient was vaccinated with second dose of GARDASIL (intramuscular, dose, strength, lot not reported). There was no concurrent conditions. After 1 hour from vaccination with GARDASIL (on an approximately 09-SEP-2013 at 11:00 AM), subject experienced fever and fever was raising in the evening (exact values and units not provided) had febrile delirium. Parent has cleaned subject''s body with water to make fever decreased and then subject was admitted in the hospital in the night of that day (09-SEP-2013). On the morning of 10-SEP-2013, subject was in the hospital and the event was resolving. Parent worried about the vaccination with GARDASIL, since the subject was healthy. The causality by pediatrician was not specified caused by vaccination with GARDASIL. It may be caused from other factors. The causality by gynecologist who was the consultant of vaccination with GARDASIL was not likely related to vaccination since subject has received second dose of GARDASIL, and no adverse event was reported for first dose of GARDASIL (date, dose, strength, indication, route of administration not reported). Pharmacist did not provide causality for GARDASIL. The parent worried and informed the hospital that the subject will receive third dose of GARDASIL in the hospital, not school for closely monitoring of adverse event in the hospital further. Additional information has been requested.


VAERS ID: 502535 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-25
Onset:2012-06-01
   Days after vaccination:37
Submitted: 2013-09-15
   Days after onset:471
Entered: 2013-09-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Erythema, Pruritus generalised, Rash generalised, Skin irritation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (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? 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: 04/25/2012, Body trmperature, 36.7 degrees C
CDC Split Type: WAES1309JPN003734

Write-up: Initial information has been received from a physician via the PMDA (agency# PMDA_2012/04) concerning a 35-year-old female patient. According to the pre-vaccination interview form on underlying disease, allergy past history or vaccination/disease during recent one month, concomitant medications, ADR history and status of growth, the patient had no problem. The body temperature before vaccination was 36.7 C. On 25-APR-2012, she received the first vaccination of a syringe-type GARDASIL IM drug (dose and injection site not reported). No concomitant medication was reported. On 25-APR-2012, as mentioned above, the patient received the first vaccination (lot No. 9QN03R). On 30-APR-2012, the patient had itching of palms and itching of plantae which expanded on legs subsequently (irritated leg skin). She visited a nearby dermatologist, but no cause was found. The symptoms temporarily ameliorated thereafter. In June 2012, the patient visited a department for abdominal pain and then was admitted to hospital to receive treatment with drip infusion. On unspecified date, the patient was discharged from the hospital. The outcome of the abdominal pain was not described. On 31-AUG-2012, the patient revisited the department for abdominal pain(onset date was 30-AUG-2012) and was admitted to hospital again. Then the patient was recovering from the abdominal pain. In August 2012, the patient had been taking herbal preparation because she had generalised rash with itching all over body (eczema-like). She had been receiving oral treatment although itching was not remarkable affecting her daily life. The patient was recovering from the itchy symptoms. At the time of the reporting, the outcome of the itching of palms, itching of plantae which expanded on legs subsequently, generalised rash with itching all over the body was recovered but sequela (remaining itching and redness). Reporter''s comment: The causal relationship was unknown. The patient had a severe abdominal pain at admission to hospital. The reporting physician assessed the causal relationship of the itching of palms, itching of plantae which expanded on legs subsequently and abdominal pain to GARDASIL as unassessable, and did not assess the relationship of generalised rash with itching all over the body to the vaccine. The physician considered that the other possible cause of the events was unknown. The physician assessed the itching of palms, itching of plantae which expanded on legs subsequently as non-serious and the abdominal pain as serious (hospitalization), and did not assess the seriousness of the generalised rash with itching all over the body. Further information has been requested.


VAERS ID: 502538 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-13
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody positive, Antiphospholipid antibodies positive, Arthralgia, Asthenia, Bacterial test negative, C-reactive protein increased, Erythema annulare, Influenza, Lupus-like syndrome, Normochromic normocytic anaemia, Pyrexia, Red blood cell sedimentation rate increased, Skin lesion, Urine analysis normal, Viral test negative
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Raynaud''s phenomenon
Allergies:
Diagnostic Lab Data: Laboratory examinations revealed normochromic normocytic anemia with elevated CRP and ESR, an extensive bacterial and viral screening was negative, and her urine sediment was normal. Autoantibodies profile revealed seropositivity for ANA and lupus anticoagulant (LAC).
CDC Split Type: WAES1309ITA004642

Write-up: Case retrieved from the literature on 02-SEP-13. Case medically confirmed. The abstract initially received on 02-MAY-13 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; E2013-06727; E2013-06726 and E2013-06728 (same vaccine, similar events, different patients). This case concerns patient n. 3: a 16-year-old high school girl was admitted to the Infectious Diseases Department because of high-grade fever (39.5 degrees C), generalized asthenia, diffuse polyarthralgia, and multiple erythematous annular cutaneous lesions on the face, trunk, and lower limbs which occurred 8 days after the first dose of GARDASIL. While she received the vaccine, she developed low-grade fever, which was interpreted as viral flu syndrome. Laboratory examinations revealed normochromic normocytic anemia with elevated CRP and ESR, an extensive bacterial and viral screening was negative, and her urine sediment was normal. Autoantibodies profile revealed seropositivity for ANA and lupus anticoagulant (LAC). Her medical and family histories were remarkable for Raynaud''s phenomenon while her maternal aunt was diagnosed with systemic sclerosis. A diagnosis of "lupus-like" syndrome was determined and the patient was treated with intravenous high-dose methylprednisolone followed by oral prednisone. Following initiation of treatment, her blood temperature normalized and her skin lesions significantly improved, with almost complete resolution in a month, while receiving 50 mg of prednisone. The latter was tapered down within 6 months, and at 1 year following immunization, the patient was in good health. The case is closed. The authors mentioned that based on the current data, a causal link between HPV vaccine and onset or relapse of SLE was plausible.


VAERS ID: 502541 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-13
Entered: 2013-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antiphospholipid antibodies positive, Arthralgia, Asthenia, Blood culture negative, Cardiolipin antibody positive, Culture throat negative, Culture urine negative, Decreased appetite, Headache, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging brain abnormal, Oropharyngeal pain, Pyrexia, Rash erythematous, Serum amyloid A protein increased, Systemic lupus erythematosus
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Raynaud''s phenomenon; Beta haemolytic streptococcal infection; Tonsillitis
Allergies:
Diagnostic Lab Data: 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 mg/l. Proteinuria was absent. Autoantibodies profile demonstrated persistent positivity of anti-cardiolipin IgM and lupus anticoagulant. Magnetic resonance imaging of the brain excluded the presence of brain abnormalities consistent with antiphospholipid syndrome.
CDC Split Type: WAES1309ITA004643

Write-up: Case retrieved from the literature on 02-SEP-13. Case medically confirmed. The abstract initially received on 02-MAY-13 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: a 16-year-old high school girl was admitted to 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 degrees 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 mg/l. Proteinuria was absent. Autoantibodies profile demonstrated persistent positivity of anti-cardiolipin IgM and lupus anticoagulant. 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. The patient was diagnosed with fever in a patient with antiphospholipid antibodies, possibly related to GARDASIL vaccination, compatible with the autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA). She was treated with naproxen 500 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 case is closed. The authors mentioned that based on the current data, a causal link between HPV vaccine and onset or relapse of SLE was plausible.


VAERS ID: 502755 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-26
Onset:2013-04-15
   Days after vaccination:20
Submitted: 2013-09-17
   Days after onset:155
Entered: 2013-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Burning sensation, Cognitive disorder, Computerised tomogram, Disturbance in attention, Dizziness, Fatigue, Headache, Heart rate increased, Hyperhidrosis, Hypotension, Memory impairment, Mitochondrial cytopathy, Muscular weakness, Myalgia, Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Postural orthostatic tachycardia syndrome, Presyncope, Syncope, Tilt table test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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, Rash; GARDASIL, Pyrexia
Allergies:
Diagnostic Lab Data: Computerised tomogram, No remark; Nuclear magnetic resonance imaging, No remark; 09/2013, Tilt table test, Confirmed POTS not provided
CDC Split Type: WAES1309DNK006736

Write-up: Case received from the two different news paper via company representative on 06-Sep-2013 and 09-Sep-2013. These reports were not medically confirmed. Additional information received from health care professional via health authority on 11-Sep-2013 under reference number EFO6758 and 22232405. Case medically confirmed. The case is linked to case E2013-06798 same patient experienced different reactions after the first vaccination. A 13-year-old female patient had received an injection of GARDASIL (dose 2, i.m. batch number or site not reported) on 26-Mar-2013. 2 days post vaccination, on 28-Mar-2013, she developed fainting and at unspecified dates concentration difficulties, muscle pain, memory impaired, dizziness, tiredness, increased heart rate, low blood pressure and constant headache and was later diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS). HA coded Postural orthostatic tachycardia syndrome (onset 15-Apr-2013), syncope vasovagal (28-Mar-2013), headache (onset 15-Apr-2013), near syncope, dizziness, muscular weakness, cognitive impairment, disturbance in skin sensation, nausea, sweating increased and muscle pain (date of onset not reported, unless specified). The patient has previously received a injection of GARDASIL (dose 1, batch number route and site not reported on 24-Jan-2013), and later on developed high fever and rash on her body. She has not been able to go to school for a long time and can not take part in daily activities. Normal pain killers like paracetamol does not reduce the pain. She is currently treated with natural medicines (not further specified). According to the not medical confirmed reports (consumer/newspaper), the outcome was not recovered for POTS, concentration difficulties, muscle pain, memory impaired, dizziness, tiredness, headache, and not reported for low blood pressure, increased heart rate and fainting. According to the patient and her relatives, there is no doubt that reactions are related to vaccination, and according to the article the reactions are assessed as possible related to the vaccination by the physicians. HA reported patient initials as SHN and confirms that is the same patient. Patient''s date of birth 12-Jul-2000, height 153 cm and weight 46 kg. HA reports that two days, 28-Mar-2013, post vaccination the patient developed fainting (syncope vasovagal) once. On 15-Apr-2013 she developed severe POTS and on unspecified date frequent near syncope. On unspecified date she developed dizziness, weakness when standing/feeling of muscle weakness, cognitive symptoms, burning/tinging discomfort in the soles/palms, nausea, increase sweating, muscle pain. She was unable to attend school she has constantly headaches (since 15-Apr-2013) with periodical exacerbations. Tilt-test (fainting test) was performed on unspecified date in Sep-2013 (result not reported). She was diagnosed with POTS. CT and MRI was performed without remarks (dates not rep). The patient has been examined (not further specified in HA-report) regarding endocrinological and mitocondrial disturbance. According to HA, the family reports that she has a mitochondrial disturbance. According to additional information received from HA the patient received GARDASIL dose 1 on 24-Jan-2013 (intramuscular route, site not reported, batch number unknown). At the time of reporting outcome POTS and chronic headache was not recovered. Outcome of fainting was recovering. Outcome of frequent near syncope, dizziness, weakness when standing/feeling of muscle weakness, cognitive symptoms, burning/tingling discomfort in the soles/palms, nausea, increased sweating and muscle pain was unknown.


VAERS ID: 502765 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-17
Entered: 2013-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose decreased, Headache, Influenza like illness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: Blood test (unknown date) Low blood sugar
CDC Split Type: WAES1309DNK006737

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 10-Sep-2013 under the reference DK-DKMA-ADR 22225974. Case is not medically confirmed. A female patient had received an injection of GARDASIL (batch number not reported) on an unspecified date 3-4 years ago. On an unspecified date, the patient developed fainting episodes. She had many sick days due to headache and flu-like symptoms. The patient was examined at hospital due to suspicion of epilepsy and presented at the physician countless times. The only diagnosis was low blood sugar, although the patient also had experienced fainting after repeated eating. At the time of reporting, the outcome was unknown.


VAERS ID: 502885 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-01
Onset:0000-00-00
Submitted: 2013-09-17
Entered: 2013-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Grand mal convulsion, Incomplete course of vaccination, Syncope
SMQs:, Torsade de pointes/QT prolongation (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309BGR006396

Write-up: This spontaneous report as received from a physician through a company sales representative refers to a 12 year old female patient. In December 2012 and in February 2013 the patient was vaccinated with the first dose and second dose of SILGARD (lot #, expiration date and dose unspecified), 20/40/40/20 mcg/ 0.5ml, suspension for injection, frequency report as 0, 2, 6 months, intramuscular. In February 2013 (two weeks after the second dose) the patient experienced tonic-clonic seizure and syncope. No medication was administered. From that moment on the patient had experienced recurring seizures with increasing frequency. On 12-SEP-2013 the physician reported that the next the patient would be hospitalized for undergoing examinations (electroencephalograph (EEG), nuclear magnetic resonance (NMR), and consultation with neurologist) and diagnosis. The reporting physician did not wish to be contacted by company representative in order to provide follow-up information until results from diagnostic tests were ready and she was persuaded in causality relation. Third dose of the vaccine would not be administered. The outcome of tonic-clonic seizure was unknown. The outcome of syncope was reported as recovered/resolved on an unknown date in 2013. The reporter considered tonic-clonic seizure and syncope to be related to SILGARD. The reporting physician was not aware of any concurrent conditions, concomitant therapy and allergies of the patient. There was no medical history of similar reactions after administration of other vaccines in the past. Lot/batch of the administered vaccines was requested via the sales representative. The reporter considered the tonic-clonic seizure to be medical significant. Upon internal review, tonic-clonic seizure was also considered as medical significant. Additional information has been requested.


VAERS ID: 502886 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-04
Onset:2013-09-04
   Days after vaccination:0
Submitted: 2013-09-17
   Days after onset:13
Entered: 2013-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Dysarthria, Dyskinesia, Fall, Hypotonia, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? 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: WAES1309SWE006913

Write-up: Case received from school nurse in a foreign country on 06-Sep-2013. Case medically confirmed. A 11-year-old female patient had received an injection of GARDASIL (dose 1, batch/lot number H022294) on 04-Sep-2013. Immediately after the injection she faints. When she wakes up after fainting (timing not rep) her body is still flaccid and she cannot control her muscles. She could not speak as she could not articulate. When the nurse helped her to sit up she just fell down again. After an hour and a half, she was better and was helped into a car. Three hours after the incident, the father was contacted, and he reported that the girl was fully recovered. The company considered the report serious due to medically important event (aphasia). At the time of reporting, the outcome was recovered.


VAERS ID: 502889 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-12
Onset:2009-01-15
   Days after vaccination:34
Submitted: 2013-09-18
   Days after onset:1706
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blister, Blood test, Cystitis, Depersonalisation, Depression, Diarrhoea, Disturbance in attention, Dizziness, Dysmenorrhoea, Ear pain, Ear, nose and throat examination, Enuresis, Fatigue, Feeling cold, Hot flush, Hyperacusis, Infection, Inflammation, Influenza, Insomnia, Joint swelling, Lymphadenopathy, Memory impairment, Migraine, Myalgia, Nausea, Nocturia, Nuclear magnetic resonance imaging brain, Ophthalmological examination, Oral herpes, Pain in jaw, Photosensitivity reaction, Presyncope, Restlessness, Sensory disturbance, Skin papilloma, Speech disorder, Tonsillar hypertrophy, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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: Repeated blood sampling performed (blood tests not specified) on unspecified dates. Ear, nose and throat examination performed on an unspecified date. Investigation at an Infectious Diseases clinic on an unspecified date. Ophthalmological examination performed by ophthalmologist on an unspecified date. MR-scan of head on an unspecified date. Investigated at a dizziness clinic on an unspecified date. Investigated by a rheumatologist on an unspecified date. Has been extensively examined, however without diagnosis.
CDC Split Type: WAES1309DNK001386

Write-up: Case received from a patient/consumer via Health Authority in a foreign country on 22-Aug-2013 under reference numbers EFO6602 and 22216740. Case not confirmed. A 15 year old female patient had received an injection of GARDASIL (dose, batch number, route and site not reported) on 18-Dec-2008 and later on 15-Jan-2009 she developed infections, migrainous headache, dizziness, near fainting, nausea, severe tiredness, sleeplessness, restlessness in the body, concentration problems, memory problems, visual disturbance, speech disorder, self-estrangement, feeling cold, hot flashes, chronic muscle pain and joint pain in neck, shoulder, back, lower back, hips and knees, swelling in the knee, jaw pain, swollen tonsils, swollen lymph, cold sores, warts on legs, inflammation, pain in ears, significant menstrual pain, flu symptoms, nighttime urination 2-5 per night, permanent diarrhea, bladder infection, depressed, sensitive to sound, photosensitive, blisters on the eye and pain in ears. The patient has earlier always been healthy and active and performed sport at a very high level, which she not has been able to during the last couple of years and she has not been/is able to take an education at prescribed time. It is mentioned by HA that neither former doctor or the patient herself has been aware of the relationship, despite the fact that especially after the second vaccination the patient suddenly got health problems. As it is reported by HA that patient''s health problems started especially after vaccination no. 2 (all events started 15-Jan-2009) it is considered that the vaccination date (19-Jun-2009) mentioned by HA is vaccination 3. The patient was previously probably vaccinated with GARDASIL (batch number, route and site not reported) on an unspecified date. The patient has not earlier had any health problems in general. Several examinations have been performed. No results provided. Repeat blood sampling performed (blood tests not specified) on unspecified dates. Ear, nose and throat examination performed on an unspecified date. Investigation at an Infectious Diseases clinic on an unspecified date. Ophthalmological examination performed by ophthalmologist on an unspecified date. MR-scan of head on an unspecified date. Investigated at a dizziness clinic on an unspecified date. Investigated by a rheumatologist on an unspecified date. At the time of reporting, the outcome was not recovered. Follow-up information received from health care professional via Health Authority in a foreign country on 10-Sep-2013. The side effects sensory disturbance was added, the side effect infection has been changed to recurrent infection and adverse reaction urination involuntary changed to nocturnal enuresis. The case has changed from not serious to serious and is not medically confirmed. The patient''s doctor has reported side effects: dizziness, joint pain, severe tiredness, sensory disturbances, vision and speech disturbances, concentration problems, nausea, headache, sleeplessness, restlessness, tendency to infection, flu symptoms, nocturia, depression and photosensitivity. The patient''s physician reported that the patient after 2 doses of GARDASIL experienced multiple symptoms and she has been extensively examined, however without diagnosis. Previously, the patient was very active soccer player at a high level and now she can barely cope with everyday life and school. The patient''s doctor has reported that the side effects resulted in disability or significant loss of function. The doctor reports that the patient was first shot on 12-Dec-2008 and second vaccine on 13-Feb-2009. Batch numbers of the vaccines are unknown. The vaccines are given intramuscularly. The patient had no other vaccines or other medicines used as side effects occurred. Based on the information reported, the date of first dose GARDASIL was changed from 18-Dec-2008 to 12-Dec-2008. The latency is changed to 34 days for all events (previously 28 days). The outcome is not recovered for all events. Contradictory in HA report: The doctor reported first vaccination date as 12-Dec-2008 and second vaccination date as 13-Feb-2009. Onset of AE was reported as 15-Jan-2009 but HA also mentioned that AE onset was after second vaccination.


VAERS ID: 502927 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-24
Onset:0000-00-00
Submitted: 2013-09-18
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H017056 / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Drug hypersensitivity, Erythema, Headache, Hyperthermia, Incomplete course of vaccination, Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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? 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: WAES1306FRA000732

Write-up: A 15-year-old female patient, related to the reporter, had received the first dose of GARDASIL (batch number not reported) on 24-Apr-2013. Thirty minutes post-vaccination, she experienced pain in the vaccinated arm. Less than hour post-vaccination, she experienced diffuse arthralgia, nausea, headache and myalgia in the region of the nee and elbow. She also presented with neck stiffness. On an unspecified time to onset, the reporter suspected fever as the patient experienced erythema of the face. She did not have skin eruption nor bronchospasm. At the time of reporting, the patient had not recovered. Follow-up information received on 11-Sep-2013: The case was upgraded to serious as the reporter considered it serious. The patient had no relevant medical history. She had received the dose of GARDASIL (batch number H017056) in the arm. Three or four hours post-vaccination, the patient experienced hyperthermia, tremor and cephalgia, which resolved in 24 hours. These adverse reactions were reported to be severe. No corrective treatment was administered. The patient was diagnosed with drug allergy. Vaccination was discontinued.


VAERS ID: 502951 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:0000-00-00
Submitted: 2013-09-18
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Asthma, Back pain, Confusional state, Convulsion, Disorientation, Dizziness, Dyspnoea, Fatigue, Headache, Hypoaesthesia, Impaired work ability, Paraesthesia, Pulmonary function test decreased, Sensory disturbance, Speech disorder, Stress
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (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: Asthma; Immunisation
Preexisting Conditions: 01/2013, GARDASIL, Fatigue; 01/2013, GARDASIL, Dizziness; 01/2013, GARDASIL, Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK007393

Write-up: Case about a patient received from an article on 06-Sep-2013. Case not medically confirmed. A 27 year old female patient (initials unknown) had received an injection of GARDASIL (dose 2, batch number not reported, site and route of administration not reported) on 12-Mar-2013 and later on, the same day, she developed exhaustion, dizzy and confused. A few days later she had orientation disturbed (she could barely orientate herself). She went to work but her condition became worse, on an unspecified date she developed breathing difficulties, convulsion, pricking feeling in face, no feeling of hands. She was transported with an ambulance to hospital where the doctor treated breathing difficulties and got it under control. She went home to her parents where she can be supervised. And then the day after (date not specified) she developed lung function decreased and her asthma medicine (not specified) had no effect. This time the patient was hospitalized at a pulmonary medicine ward for a week. She found out that asthma was caused by stress. She was convinced it was related to the HPV-vaccine but the physician thought otherwise and she was released from the hospital. But she can not work and she had asthma aggravated (3-4 attacks a week), can not get words out of her mouth (know the words but cannot say them, persistent headache, persistent pain in joint and back, sensory disturbance, stress and tiredness. The third acute hospitalization (date not specified) gave her some kind of clarification. The physician concluded a possible relatedness between the patients problems and the vaccine. The situation has only become worse for the patient. She has been fired from her job as a florist, and her social life is narrowed because she never knows when she will have an attack. According to the patient she is afraid that her body would not hold a pregnancy. Medical history: The patient has well controlled asthma. No further information specified. After first dose of GARDASIL on unspecified date in January 2013 (batch number not reported, site and route of administration not reported) she developed dizziness and tiredness and an asthmatic attack (onset date not reported). At the time of reporting, the outcome was not recovered for asthma aggravated, lung function decreased, 3-4 days of attacks per week, tiredness, persistent headache, persistent pain in joint and back and not reported for exhaustion, dizzy, confused, breathing difficulties, convulsion, prickling feeling in face, no feeling of hands, can not get words out of her mouth, stress, orientation disturbed and sensory disturbance. According to the reporter, the reaction was possibly related to vaccination.


VAERS ID: 502994 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-30
Onset:2011-04-02
   Days after vaccination:3
Submitted: 2013-09-18
   Days after onset:900
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), 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? 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: WAES1108USA00268

Write-up: Case received from the Health Authorities on 18-Jul-2011 under the reference number L201105-1066, initially reported by a nurse, via the local site Sanofi Pasteur MSD. Case medically confirmed. Case of misuse (corrected). A 17-year-old female patient had received an injection of GARDASIL (batch number not reported) on an unspecified date and presented a generalised urticarial rash after vaccination. The outcome was unknown. Follow-up information received on 23-Feb-2012: Case initially reported as non-serious and then upgraded to serious by the Health Authorities on 21-Jun-2011. It was specified that the generalised urticarial rash occurred after the administration of the third dose of GARDASIL (batch number NM30560), which had been administered via intramuscular route on 30-Mar-2011. The reaction''s time to onset was three days post-vaccination, on 02-Apr-2011. The duration of the symptom, which was not reported, motivated the patient''s visit to the hospital''s emergency room on an unspecified date. The patient received an unknown corrective treatment, and the symptom improved. It was reported that there was no suspicion of interaction between drugs, and that the same drug was not reintroduced. On 16-Jun-2011, the symptom was persisting without recovery. On 21-Jun-2011 the symptom was still persisting and the HA upgraded the case to serious after clinical review. Finally, on 03-Jan-2012, the Health Authorities were informed that the patient had recovered on an unknown date in 2011. The patient had received the first dose of GARDASIL on 29-Sep-2010 and the second dose on 19-Jan-2011. Both injections were performed via intramuscular route. The patient had no known clinical history and no known previous reactions to this vaccine or to any other drug. The patient''s initials and date of birth were provided. Corrective version created on 01-Mar-2012: Upon internal review the company decided to add the following misuse coding "drug dose administration interval too short" since the period between the second dose and the third dose of GARDASIL was shorter than recommended. Follow-up information received on 09-Sep-2013: The Health Authorities added the MedDRA code ''intentional drug misuse'' due to the too short interval between the second and third dose of GARDASIL. The Health Authorities assessed the causal relationship according to the global introspection: between the reported reaction and vaccination as possible; between the reported misuse and vaccination as unknown. The reporter assessed the causal relationship according to an unknown assessment method: between the reported reaction and vaccination as probable; between the reported misuse and vaccination as unknown.


VAERS ID: 503046 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-02-01
Onset:2011-05-01
   Days after vaccination:89
Submitted: 2013-09-18
   Days after onset:871
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ37720 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Migraine
SMQs:

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: 1992, Migraine without aura; Immunisation
Preexisting Conditions: 09/08/2010, GARDASIL, Immunisation; 06/22/2010, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK007247

Write-up: Case received from a health care professional via our partner via the Health Authorities on 10-Sep-2013 under the references DK-DKMA-ADR 22228790 and DK-DKMA EFO6714. Case is medically confirmed. A 23-year-old female patient (weight 75 kg, height 170 cm) with a medial history of migraine with out aura periodically and of modest scale since 1992, had received a complete vaccination series with three doses of GARDASIL IM on 22-Jun-2010 (D1, batch-no. NL37230, lot no 1334X), on 08-Sep-2010 (D2, batch-no. NK51040, lot no. NJ37720) and on 01-Feb-2011 (D3, batch-no. NK38860, lot no NJ37720). 3 months after the third vaccination, on 01-May-2011, the patient developed aggravation of migraine and chronic headache. The patient was examined by several neurologists and at a headache center. At the time of reporting, the patient had not recovered.


VAERS ID: 503058 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-12-19
Onset:2007-12-25
   Days after vaccination:6
Submitted: 2013-09-18
   Days after onset:2093
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Multiple sclerosis, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (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: Investigation, results of spinal test was not provided; Nuclear magnetic resonance imaging, multiple sclerosis
CDC Split Type: WAES1309DNK006738

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 22234959 and DK-DKMA-EFO6774. Case is not medically confirmed. A 23-year-old female patient (weight 80 kg, height 164 cm) had received the first dose of GARDASIL (batch number not reported) on 19-Dec-2007. On 25-Dec-2007, the patient developed pricking in the left arm, hand, foot and heel. The left arm, hand, foot and heel felt dead. The patient was hospitalised. The symptoms got worse and worse by hour. After 2-3 days of hospitalization, the patient only felt her head and right arm. MRI scan performed on an unspecified date revealed multiple sclerosis. In addition a spinal test was done on an unspecified date. Results were not provided. At the time of reporting, the patient had not recovered. The outcome of multiple sclerosis was unknown. D2 of GARDASIL was administered on 24-Jan-2008. Due to neurological symptoms, the patient did not receive the third dose.


VAERS ID: 503061 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-27
Onset:0000-00-00
Submitted: 2013-09-18
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy skin abnormal, Chillblains, Culture positive, Cutaneous lupus erythematosus, Erythema, Pain, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Accidents and injuries (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Skin tumours of unspecified malignancy (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: Biopsy, Chilblain lupus not provided; Culture, Chilblain lupus not provided
CDC Split Type: WAES1309DNK007468

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 22231082 and DK-DKMA-EFO6739. Case is not medically confirmed. A 26-year-old female patient (weight 61 kg, height 162 cm) had received the first dose of GARDASIL (batch number unknown) IM on 25-Sep-2012. On 01-Nov-2012, the patient developed painful bumps/dots which felt like stones under the skin. The bumps could be felt by inserting a finger gently over the area. The area was red and swollen. The bumps lasted around 2 and 10 days and then disappeared. The bumps had appeared both inside and outside of the hand. Biopsy and cell samples were compatible with chilblain lupus. The patient was treated (not specified). The patient felt more tired than usual. Although the patient was in good shape, exercised every day, eat a healthy diet, switched gloves, tried to work with gloves, changed alcohol and oil, the symptoms did not change. At the time of reporting, the patient had not recovered. The patient received D2 of GARDASIL (lot-no. not reported) on 28-Nov-2012 and on 27-Feb-2013 (D3, lot-no. not reported). Noteworthy: Despite it was reported that the bumps disappeared, all events were reported as not recovered.


VAERS ID: 503433 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-15
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: Fatigue, Mental disorder
SMQs:, Dementia (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: FYBOGEL; SANOMIGRAN; Terbinafine; TETRALYSAL
Current Illness: Dermatillomania; Immunisation; Irritable bowel syndrome; Headache; Fungal infection; Acne
Preexisting Conditions: Impetigo; 10/06/2010, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309IRL007357

Write-up: This case was received from the health authority on 10-Sep-2013. IMB ref 2013-018105. This case is medically confirmed as it was reported by a general practitioner. A 17 year old female patient, with a medical history of dermatillomania which is continuing and impetigo, received on 02-Dec-2010 a second dose of GARDASIL, (batch number not reported) intramuscularly, site of administration not reported and on 25-Feb-2010, an injection of PANDEMRIX, (batch number not reported) intramuscularly, dose number and site of administration not reported. The patient has since developed fatigue and has missed a lot of school. The fatigue was initially noted in Jan-2011. The patient has no symptoms of narcolepsy. The reporter indicated that she is not sure of the cause of the patient''s fatigue. The reporter got a second opinion and it was felt the reaction to be more psychological. It was reported the patient previously received the first dose of GARDASIL (batch number not reported), intramuscularly on 06-Oct-2010 and a third dose on 15-Mar-2011. The patient was concomitantly treated with FYBOGEL Citrus (Ispaghula husk) 1 tablet daily orally and mebeverine HCL (generic) orally since 10-Oct-2011 for irritable bowel syndrome, SANOMIGRAN (pizotifen) 1.5 mg daily orally since 06-Jan-2012 for headache, terbinafine (generic) 250 mg daily for fungal infection since 13-Apr-2012 and with TETRALYSAL (lymecycline) 300 mg daily orally for acne from 02-Jul-2012 to 17-Jan-2013. The reporter indicated that the patient has been prescribed various medications over the last few years for headaches and irritable bowel syndrome but the reporter is unsure if the patient took them. (As no information was provided on the onset for the events, the Company matched the IMB report regarding the coded AE). Upon internal review the Company judged relevant to code "reaction to be more psychological", LLT: psychological disorder NOS. At the time of reporting, the patient was recovering from fatigue. The IMB considered that case serious due to be medically significant.


VAERS ID: 503438 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-12-15
Onset:0000-00-00
Submitted: 2013-09-20
Entered: 2013-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Dizziness, Headache, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK008336

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 22236201 and DK-DKMA-EFO6794. Case is not medically confirmed. A 16-year-old female patient (weight 55 kg, height 172 cm) had received a dose of GARDASIL (batch number not reported) IM on 15-Dec-2009. On an unspecified date in Dec 2009, the patient developed headache and dizziness. In addition, the patient developed unconsciousness and convulsions on an unspecified date. The patient was hospitalised and examined at an pediatric outpatient clinic (not further specified). The patient received pain relievers and physiotherapy. At the time of reporting, the patient had not recovered from headache and dizziness. The outcome of unconsciousness and convulsions was unknown. The patient received D1 of GARDASIL on 13-May-2009 (batch no. not reported). Toleration was not reported.


VAERS ID: 503440 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-02
Onset:2013-02-01
   Days after vaccination:702
Submitted: 2013-09-20
   Days after onset:230
Entered: 2013-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Electromyogram, Immunoglobulin therapy, Myasthenia gravis, Nuclear magnetic resonance imaging
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: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK008974

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 22237499 and DK-DKMA-EFO6806. Case is not medically confirmed. A 14-year-old female patient (weight 65 kg, height 160 cm) had received a dose of GARDASIL (batch no. not reported) IM on 02-Mar-2011. On 01-Feb-2013, the patient developed myasthenia gravis. The patient was hospitalised. Blood test, EMG and MRI scan were performed. Results were not provided. The patient received medication (not specified) and immunoglobuline transfusion. No other medications were administered. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 10-Sep-2010. Toleration was not reported.


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), Dehydration (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), Dehydration (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), Dehydration (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 dur