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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a Licensed practical nurse, via a company representative, concerning a 15 year old female patient. On 29-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (lot # AE0131; Expiration date was not reported). On 13-SEP-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (lot # AE0131; Expiration date was not reported), and on 29-MAR-2013, the patient received the third dose of GARDASIL (dose, route and frequency were not reported) (lot #: H015555; Expiration date was not reported). It was reported that in April 2013, shortly after receiving the third dose of GARDASIL, the patient experienced significantly abdominal pain and nausea. The patient sought medical attention through doctor''s appointment, and it was determined that the patient would need to have her gallbladder removed. It was reported that surgery was planned at an unspecified time. Also it was reported that the patient discontinued GARDASIL therapy on 29-MAR-2013. It was also reported that the events did not cause significant disability or incapacity. In April 2013, the patient died. It was unknown if autopsy was performed. Cause of death was unknown. At the time of the report, the patient''s outcome for abdominal pain, gallbladder disorder and nausea was unknown. Additional information has been requested.
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