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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a 13 year old female with no pertinent medical history and no drug reactions or allergies who on 17-MAR-2007 was vaccinated IM into the left deltoid with Gardasil (Lot #655619/1427F). The nurse reported the patient was administered an incomplete dose of Gardasil and soon after fainted. The nurse also reported that while she was administering the patient''s first dose of Gardasil she experienced some resistance in the plunger of the syringe. Before finishing the injection, some of the vaccine leaked out around the injection site. When the patient was informed of the problem and possibly of another injection she fainted. The patient fainted 3-5 minutes after the vaccine was administered. On 17-MAR-2007, she recovered quickly. The patient''s vital signs were taken and she was monitored for twenty minutes. The office received an e-mail from the patient''s father one hour after she left the office which stated that she had fully recovered. There were no laboratory diagnostic studies performed. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No additional information is expected.
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