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Life Threatening? No
Write-up: Information has been received from a physician concerning a female who was vaccinated with Gardasil (date and dose not provided). Subsequently at an unspecified time, the patient had a Pap smear that tested positive for HPV 6 and HPV 11. It was also reported that the patient experienced a break out of genital warts not long after vaccination with HPV. It was reported that the patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 22 year old female, with no known drug allergies, who on 07-NOV-2006 was vaccinated with IM with a dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included VALTREX. Subsequently on an unspecified date, the patient had a PAP smear that tested positive for HPV 6 and HPV 11. On 16-NOV-2006 the patient developed break out of genital warts. It was reported that the patient sought unspecified medical attention. The patient''s break out of genital warts persisted. Additional information is not expected.
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