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This is VAERS ID 578747

Case Details

VAERS ID: 578747 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
   Days after vaccination:9
Submitted: 2015-05-19
   Days after onset:230
Entered: 2015-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J015508 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Death, Encephalitis, Headache, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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:
Diagnostic Lab Data:
CDC Split Type: WAES1505BRA007659

Write-up: This spontaneous report was received via Business Partner: Institute (manufacturer control # was not provided so far) by a consumer (patient''s mother) and concerns a 14 years old non-pregnant female patient. Information about patient''s medical history was not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose: 0.5 ml, intramuscularly, lot# and anatomical location were unspecified). Then, on 22-SEP-2014, she was vaccinated with the second dose of GARDASIL (dose: 0.5 ml, intramuscularly, anatomical location reported as left deltoids) (lot # J015508, expiration date: 05-JUN-2016). On an unknown date in September 2014, the patient experienced vomiting, headache, agitation and generalized convulsion. These adverse events led patient to the emergency room on 24-SEP-2014. She was hospitalized since approximately the same day. On 01-OCT-2014, the patient was diagnosed with encephalitis. The patient died on an unknown date. It was unknown if autopsy was done. The outcome of encephalitis was reported as fatal. The outcome of agitation, vomiting, headache and generalized convulsion was unknown. The relatedness between the events and GARDASIL was not reported. Adverse event of generalized convulsion was considered to be medically significant event. Upon internal review, encephalitis was considered to be medically significant event. Additional information is not expected, as reporter could not provide patient''s physician contact details.

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