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Life Threatening? No
Write-up: Information has been received from a physician concerning a 14 year old female with no pertinent medial history or drug reactions/allergies, who on 17-AUG-2006 was vaccinated intramuscularly with HPV rLI 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). There was no concomitant medication. On 17-AUG-2006, 15 minutes after receiving the vaccination, the patient "passed out" in the car on her way home. The patient was driven back to the physician''s office, where she "woke up and was given soda and cold compresses". There was no reactions at the injection site and the patient had no additional reactions. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 at 10:00 AM was vaccinated intramuscularly in the arm with the first dose of GARDASIL (lot # 653650/0702F). There was no concomitant medication and no illnesses a time of vaccination. On 17-AUG-2006, at 10:10 AM, the patient "passed out" in the car on her way home. It was reported that following vaccination, the patient went to her car and as her mother was driving, the patient passed out. The mother drove right back to the physician''s office with the patient, and the patient was carried into the office by a physician at which time she was awake. The patient lied down and was given soda and a cold compress to her forehead. It was reported that the "patient was only out a matter of 2 minutes before coming to". There was no reaction at the injection site and the patient had no additional reactions. No further information is expected.
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