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Administered by: Other Purchased by: Unknown
Life Threatening? No
Write-up: This solicited, social-media report was received as a part of patient support program from on-line article and refers to unspecified number of female patients. There was no information about the patients'' concomitant medications, concurrent conditions and medical history reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, route of administration, lot# and expiry date were not reported). On unknown dates, the patients experienced overimmunization, anaphylaxis and mental disorder. The patients were permanently and temporarily disordered due to "disorderly" immunization. The outcome of the events was unknown. The events were considered to be related to GARDASIL. Upon internal review the event of anaphylaxis was considered to be medically significant. This is one of several reports from the same reporter. Additional information is not expected as further contact is not possible. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational therapy and the reported events cannot be established. Lack of medical substantiation, concomitant drugs, and lab workup performed preclude a proper causality assessment of this report. The non-serious event of mental disorder was also reported. Company Comment- No changes to the investigational vaccine safety information are warranted at this time. Merck and Co., Inc. continues to monitor the safety profile of the investigational vaccine.; Sender''s Comments: VN-009507513-1612VNM006398:
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