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Life Threatening? No
Write-up: Information has been received from a health professional concerning a 16 year old female who was vaccinated with Gardasil (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, felt cold and was shaking. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from an other health professional and a physician concerning a 16 year old female who was vaccinated IM into the deltoid with an entire second 0.5ml dose of GARDASIL (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, was cold and shaking. The physician reported that the patient experienced a syncopal episode with approximately 30 seconds of clonic activity and urinary incontinence. The physician mentioned there was no post ictal confusion. The patient did well with Trendelenburg and rest. The physician reported that the patient was ok for discharge after approximately 10 minutes of monitoring. Subsequently, the patient recovered from syncopal episode, urinary incontinence and clonic activity. No product quality complaint was involved. Upon internal review, clonic activity was considered to be an other important medical event. Additional information is not expected.
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