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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a female patient who on 13-Dec-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#654389/0961F). There was no concomitant medication. On 13-Dec-2006, shortly after vaccination, the patient fainted and her skin color was pale. The patient was aroused by shaking her right arm and with smelling salts. The patient''s vital signs were found to be normal upon discharge from the office. No further details were provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Follow up information received from the physician stated that on 13-DEC-2006 the injection of GARDASIL was administered by a medical assistant. It was reported that immediately after receiving the vaccination the patient had a syncopal episode. It was reported that the patient became hypotensive (actual blood pressure measurement not provided) and diaphoretic and responded to ammonia salts, being placed in the Trendelenburg and hydration, taken by mouth. It was reported that patient recovered from the event. Additional information has been requested.
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