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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report was received from a pharmacist via a returned survey and refers to unspecified number of patients of unknown age and gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). On unknown dates, the patients experienced arrhythmogenic events, arrhythmogenic deaths or long QT episodes. The reporter found out about those events from a Food and Drug Administration (FDA) document from 2010. Since the pharmacist had a patient with congenital Long QT syndrome and the patient''s family was unsure if GARDASIL was safe to give, the pharmacist wanted the same information for the most recent 6 years to make an educated assessment for the patient. The pharmacist complained that these serious events were not mentioned in the package insert, while that information was needed for the patient. The outcome of arrhythmogenic events and long QT episodes was unknown. The outcome of arrhythmogenic deaths was fatal. The reporter considered the events to be associated with GARDASIL. Additional information has been requested.
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