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Life Threatening? No
Write-up: This is in follow-up to report (s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 24 year old female with no medical history of drug reactions/allergies who on 25, Jan 2007 was vaccinated with the first IM 0.5 ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 04, Feb 2007 (1 1/2 weeks after the first injection), the patient experienced lesions/"vaginal bumps" on the external vaginal area. The patient contacted the physician on 26, Feb 2007 regarding the "rash" and ''vaginal bumps" . A vulvar biopsy of the left labia and posterior fourchette revealed condyloma. No treatment was provided at the time of reporting. Cultures were obtained ad HPR, Hep B, Hep C, HSV 1 and 2 HIV tests were performed and were all negative. The patient had not recovered. It was noted in follow-up tht the patient ws vaccinated intramuscularly into the right deltoid with a second dose of GARDASIL on 27-MAR-2007 (Lot # "00844"). As of 05-MAY-2007, there was no report of an adverse experienced with this second dose. No further information is available.
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