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Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes
Write-up: Information has been received from a physician as part of the GARDASIL Access Program concerning a female who entered a HPV vaccine pilot project. On 15-FEB-2011 was vaccinated with 3rd dose of GARDASIL (lot # 666987/1016Z). The patient was admitted to hospital with abdominal pain and distension on 03-APR-2011. The patient died on hospital on 07-APR-2011. The cause of death was abdominal pain and abdominal distension. The reporting physician felt that abdominal pain (grade 5) and abdominal distension (grade 5) were not related to GARDASIL. Abdominal pain (grade 5) and abdominal distension (grade 5) were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.
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