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Life Threatening? No
Write-up: Information has been received from a licensed practical nurse concerning a female "teenager" (exact age unspecified) who in March 2007, was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil. Shortly after administration of the vaccine, the patient fainted. It was noted that the patient received allergy shots often and had never fainted prior to this event. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The patient recovered the same day and did not have to go to the emergency room. No product quality complaint was noted. 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 a licensed practical nurse concerning a 25 year old female with allergies to amoxicillin and BIAXIN who on 27-MAR-2007 at approximately 08:30 was vaccinated intramuscularly into the right deltoid with a first 0.5 mL dose of GARDASIL (Lot #656051/0244U). Shortly after administration of the vaccine (approximately 08:45), the patient fainted (also reported as "while at the check out window, the patient passed out"). The patient never lost consciousness and was immediately alert and oriented (x3) and neuro was grossly intact. The patient was clammy and pallor and was given a granola bar and orange juice. The patient reported feeling better after resting for 10 minutes. The patient''s blood pressure was 120/70. It was noted that the patient received allergy shots often and had never fainted prior to this event. The patient recovered the same day and did not have to go to the emergency room. The patient left the office in good condition. No product quality complaint was noted. No further information is available.
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