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This is VAERS ID 517245

Case Details

VAERS ID: 517245 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-03
Onset:2011-01-01
   Days after vaccination:120
Submitted: 2013-12-19
   Days after onset:1083
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy, Fatigue, Feeling abnormal, Foaming at mouth, Hallucination, Influenza like illness, Muscle spasms, Muscular weakness, Tongue biting, Urinary incontinence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312SWE008018

Write-up: Information has been received from Sanofi Pasteur MSD (E2013-10704) on 11-DEC-2013. Case was received from a non health care professional via the Health Authorities in a foreign country on 11-DEC-2013 under the reference MPA-2013-000265. Case is not medically confirmed. Primary source was a consumer. A 15-year-old female patient with no medical history reported, had received the unspecified dose number in series of GARDASIL (batch number not reported) via not reported route and site of administration on 15-Feb-2009. On 27-Apr-2009, the patient developed weakness of limbs. On 03-Nov-2009, the patient developed nightly hallucinations and cramps. The patient had also received the unspecified dose number in series of GARDASIL (batch number not reported) via not reported route and site of administration on 03-09-2010 (contradictory: HA mentioned 03-Sep-2013 in the narrative). On 01-Jan-2011, the patient additionally developed fully developed epileptic seizures. The patient was hospitalised. The patient reported "feels like I am falling. I try to scream but cannot open my mouth." "During the seizure I develop foaming at the mouth, has urine output, bite my tongue and hallucinate." The day after she was very tired and suffered from flu-like symptoms. She was treated with lamotrigine (Other MFR) due to the events. It was unknown how many doses of GARDASIL she had received. Upon medical review the company judged relevant to code the following adverse events: tiredness and flu-like symptoms which were not reported. According to the HA, the events were possibly related to the vaccination. The case was regarded serious by the consumer, because of hospitalization, life threatening reaction and continuing disability.


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