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Life Threatening? No
Write-up: This spontaneous report as received from nurse refers to a 14 year old female patient with attention deficit disorder and anxiety and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated with first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided), on 25-JUL-2012 patient received second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot number: J007354, expiration date 20-FEB-2016) (dose and route of administration were not provided). Secondary suspect therapy included FLUMIST which was given on 21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported that patient complained of headache on 04-JAN-2014 and she went to bed early that night. It was reported that "she never woke up". Patient died on 04-JAN-2014. Nurse has not been informed of the autopsy result so she could not determinate cause of death. Lab diagnostic studies were not performed. It was also reported that approximately 27 doses of the recalled lot of GARDASIL were also administered at reporter''s facility but she has not heard of any other adverse effects. The outcome of headache was unknown. The relatedness between death, headache and GARDASIL was unknown. Additional information has been requested.
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