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Administered by: Unknown Purchased by: ?
Life Threatening? Yes
Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 879 patients experienced disability (from an unspecified adverse event), 99 patients died, 5352 patients did not recover (from an unspecified adverse event), 500 patients had abnormal papsmear, 202 patients experienced cervical dysplasia, 57 patients experienced cervix carcinoma, 502 patients had adverse event which was life threatening, 9545 patients had to visit emergency room (from an unspecified adverse event), 2717 patients were hospitalized and 218 patients extended the hospital stay (from an unspecified adverse event), 3625 experienced serious adverse events (from an unspecified medically significant adverse event), 25636 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)", abnormal papsmear, cervical dysplasia, cervix carcinoma, "adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. Upon internal review, the events cervix carcinoma was determined to be medically significant. This is one of the multiple reports from the same reporter.
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