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Administered by: Other Purchased by: Other
Life Threatening? No
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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