Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Smear cervix abnormal
Clinical narrative: Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study. On 29-SEP-2006 the patient tested positive for high risk HPV. The patient's outcome was unknown. Upon internal request, the patient was unblinded on 25-OCT-2006, she received her first dose of HPV on 06-FEB-2003, her second dose in March 2003, and her third dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test (PCR) negative to all 4 vaccine types. In October 2003 she had been PCR negative to all 4 vaccine types. An April 2005 PCR result from a biopsy was negative for the 4 vaccine types. Additional study results: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 11/14/2006.  Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study.  On 29-SEP-2006 the patient tested positive for high risk HPV.  The patient's outcome was unknown.  Upon internal request the patient was unblinded on 25-OCT-2006, she received her first dose of HPV on 06-FEB-2003, her second dose in March 2003, and her third dose in September 2003.  She showed strong conversion to all 4 vaccine types.  At baseline the patient had been seronegative and polymerase chain reaction test (PCR) negative to all 4 vaccine types. In October 2003 she had been PCR negative to all 4 vaccine types. An April 2005 PCR result from a biopsy was negative for the 4 vaccine types. Additional study results: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type.  Follow up information has been received from a physician who provided laboratory tests regarding the patient's positive high risk HPV and abnormal PAP status post LEEP after receiving active vaccine # 3.  The cytology report indicated abnormal PAP/Biopsy within 3 years: narrative description was low grade squamous intraepithelial lesion.  An HPV DNA, low/high risk test was performed; result was positive for HPV high risk. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006; 1/5/2007. Information has been received spontaneously from a gynecologist concerning a 22-year-old female patient who had participated in an GARDASIL study, on 29-SEP-2006 the patient tested positive for high risk HPV. The patient's outcome was unknown. Upon internal request the patient was unblinded on 25-OCT-2006, she received her first dose of GARDASIL dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test negative to all 4 vaccine types. In October 2003 she had been PCR negative to all vaccine types. AN April 2005 PCR result from a biopsy was negative for the vaccine types. Additional study results: 07-DEC-2004 "ASC-H". 04-APR-2005 colposcopy biopsy vegative for lesion, descrepancy noted - biopsy was of less severity than the papanicolaou test result and repeat colposcopy, PAP, and endocervical curettage (among other choices) were needed per protocol. 21-SEP-2005 low-grade squamous intraepithelial lesions.; 13-OCT-2005 colposcopy cervical intracithelial neoplasia -1; 25-JAN-2006 atypical squamous cell of undetermined significance (HPV+); 30-MAR-2006 CIN-2; 12-MAY-2006 loop electrosurgical excision procedure = CIN-1 overall; 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Follow up information has been received from a physician at a student health center who provided laboratory test regarding the patient 's positive high risk HPV and abnormal PAP status post LEEP after receiving active vaccing x 3. The cytology report indicated abnormal PAP/Biopsy within 3 years; narrative description was low grade squamous intraepithelial lesion. An HPV DNA, low/high risk test was performed, result was positive for HPV high risk. This is a consolidation of 4 reports concerning the same patient. Additional information is not expected. It has been determined that WAES0704USA00327, 0704USA00561 and 0704USA00572 are duplicates of WAES0610USA04009, WAES #0601USA04009 was previously submitted on 14-NOV-2006 and on 05-JAN-2007.