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Life Threatening? No
Write-up: Information has been received from a Certified Medical Assistant concerning a 22 year old female patient with genital warts and history of abnormal Pap smears who on 21 Nov 2006 was vaccinated IM in the left deltoid with her first dose of Gardasil (yeast), lot #653736/0868F. Concomitant therapy included Ortho Tri-Cyclen Lo. The patient called to report that prior to the vaccination she had 2 undiagnosed "bumps" in the vulva area. Two weeks after the vaccination, on 05 Dec 2006, the patient had an increase in amount of genital warts (3 more "bumps" appeared in the surrounding area). Medical attention was sought. The patient had undergone a Pap smear and cervical biopsy on 21 Nov 2006 (results were not reported). At the time of the report the patient had not recovered. Additional information has been requested. Follow-up information has been received concerning the female student with genital warts who on 21-NOV-2006 at 2:00 p.m. had received her first dose of GRDASIL, lot # 653736/0868F. The patient stated she had a history of bumps in vaginal area, and was never diagnosed with any disease. On 05-DEC-2006 the bumps increased in size and number. The patient was positive for HPV 6. On 15-JAN-2007 at 3:00 p.m. she was vaccinated IM in left deltoid with her second dose of GRDASIL, lot # 655617/1447F. Her outcome was unknown. Additional information is not expected.
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