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Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes
Write-up: Information has been received from a Health Authority (reference # ADR20657398) concerning a 13 year old female patient with unreported medical history who on 14-OCT-2009 was vaccinated intramuscularly with the first dose of GARDASIL (manufacturer, batch # not reported and site not reported). On 13-NOV-2009, the patient was vaccinated intramuscularly with the second dose of GARDASIL (manufacturer, batch # not reported and site not reported) and experienced N-Methyl-D-Aspartate Receptor (NDA) encephalitis and was hospitalized. On an unreported date, the patient became symptomatic either in the same month as the patient received the first dose and onwards or three days prior to admission to the hospital. The patient was confirmed to have N-Methyl-D-Aspartate Receptor (NDA) encephalitis. A third dose of GARDASIL was not given. The patient was recovering at the time of reporting. According to the reporter and the agency the event was considered serious as it was life-threatening, hospitalization and disabling/incapacity. The agency coded the event of encephalitis. This case is medically confirmed. Other business partner numbers include E2010-05321. No further information is available.
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