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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report as received from a pharmacist (also reported as Company''s employee) refers to a female patient of unknown age. On 02-OCT-2014, the patient was vaccinated with a dose of GARDASIL strength reported as: 0.5 ml, frequency reported as: at month 0, 2, 6, intramuscular (lot number was not reported). On 02-OCT-2014, 20 minutes after the vaccination, the patient fainted and then experienced headache and vomiting. The outcome of fainting was reported as recovered (date unspecified in October 2014). The outcome of headache and vomiting was reported as not resolved. The relatedness between events and GARDASIL was not reported. Follow-up information has been received from the reporting pharmacist regarding a 9 year old female patient. It was reported that three hours after GARDASIL administration (on 02-OCT-2014), the patient experienced headaches and stomach ache, followed by vomiting. These symptoms continued for about 6 hours. The patient had to be treated with IZOFRAN ZYDIS, one tablet 4 mg, once. Vomiting could only be stopped with IZOFRAN ZYDIS. About 2 hours after IZOFRAN ZYDIS intake, the patient recovered (on approximately 02-OCT-2014). The patient did not had to be hospitalized. However the events caused significant disability. The reporter associated the events with GARDASIL. Additional information is not expected as all requested information has been received.
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