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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients'' pertinent medical history, concomitant medication and drug reactions or allergies was reported. The physician reported that she reviewed an unspecified article that described the patients, who, on unknown dates, were vaccinated with doses of GARDASIL (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided). On unknown dates, an unspecified amount of time after the doses were administered, the patients were diagnosed with Guillain-Barre Syndrome and there were 44 deaths associated with GARDASIL. The outcome of Guillain-Barre syndrome was reported as unknown. The reporter considered death to be related to GARDASIL. The relatedness between Guillain-Barre syndrome and GARDASIL was not reported. Upon internal review, the events of Guillain-Barre syndrome and death were considered to be medically significant. Additional information has been requested.
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