Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Colposcopy abnormal, Loop electrosurgical excision procedure, Mass
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female patient with a history of malignant hyperthermia, malignant hyperthermia in a family member, who bruised easily, with sinus issues and ringing ears, was vaccinated on 18-JAN-2007 with the first dose of GARDASIL, (lot # 654389/0961F), I.M., in the right arm, a second dose of 22-MAR-2007, (lot #655849/0263U), I.M, (site not reported) and a third dose on 26-JUL-2007, (lot # 658100/0525U, I.M, (site not reported). On 01-JUL-2007 the patient experienced: lump to vaginal area, LEEP procedure and severe cervical dysplasia. The patient had PAP smear after series of vaccines tested positive for Cervical Intraepithelial Neoplasia grade 3 (CIN III). The patient had to have a loop electrosurgical excision procedure (LEEP) to remove. The following information was obtained through follow-up and/or provided by the government. 27-JAN-2012 primary care physician (PCP) records received for day of service DOS 08-JAN-2007 - 06-JUL-2011 with impression: normal PAP smear. Patient (Pt) was seen for routine care. On 29-MAY-2008, lump to vaginal area was observed. On 27-JAN-2012 consultant record received for DOS 25-JUN-2008 with diagnosis (DX): Severe cervical dysplasia. Pt f/u to colposcopy with abnormal biopsy (bx's) of cervix. Scheduled for LEEP 27-JAN-2012, hospital record was received for DOS 21-JUL-2008 with impression: 1) cervical dysplasia; 2) CIN (cervical intraepithelial neoplasia) III; 3) high grade intra-epithelial lesion. Pt f/u to above. Repeated colposcopy: areas of acetowhite change to cervix. Given pre-op instructions for LEEP, plus f/u information. 27-JAN-2012, surgical record received for DOS 25-JUL-2008 with Dx: cervical intraepithelial neoplasia III of the cervix. Pt with severe cervical dysplasia, serial to parallel (s/p) colposcopy. LEEP procedure. Pt was discharged (d/c''d) home with f/u and care instructions. Laboratory test performed included: The patient had a PAP smear from another doctor and had tested negative for any of the cancer causing HPV strains. The following information was obtained through follow-up and/or provided by the government. 27-JAN-2012 lab/diagnostic records received for DOS 26-MAY-2006-29-MAY-2007. Pap: (-). 27-JAN-2012 lab/diagnostic records received for DOS 29-MAY-2008 to 25-JUL-2008. Pap smear: high grade squamous intraepithelial lesion. LEEP bx cervix: mildly dysplastic squamous epithelium. Patient's outcome was not reported. This report was considered serious and immediately life threatening. The original reporting source was not provided. A lot check has been initiated.. The VAERS ID # is 447896. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 658100/0525U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.