Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Oligomenorrhoea, Polycystic ovaries, Ultrasound pelvis normal, Uterine cervical squamous metaplasia
Clinical narrative: Information has been received from the mother of a 26 year old female who, on an unspecified date was vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot #, site and route not reported). Concomitant therapy included hormonal contraceptives (unspecified). The date of the patient's first vaccination with GARDASIL vaccine (yeast) was not reported. The mother reported that "her daughter received her second dose of GARDASIL vaccine (yeast) and her monthly cycle has not ended". No additional information was reported. The patient outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008.  Initial and follow-up information has been received from the mother of a 25 year old female with breakthrough bleeding at the time of vaccination and no known drug allergies and history of 3 prior pregnancies, 2 abortions and 2 living children (twins) who on 30-NOV-2007 received her first dose of GARDASIL (lot # 658556/1060U) in the left deltoid.  Concomitant therapy included ORTHO TRI-CYCLEN).  Follow-up information was received via medical records.  On 12-FEB-2008 the patient was administered with her second dose of GARDASIL (lot # 658556/1060U) in the right deltoid.  The mother reported that "her daughter received her second dose of GARDASIL and her monthly cycle has not ended".  The patient outcome was not reported.  On 12-FEB-2008 a pap smear 1gG was negative; CT NO was negative and rfx HPV all was negative.  Diagnosis was negative for intraepithelial lesion and malignancy.  Cellular changes associated with inflammation were present.  Endocervical and/or aquamous metaplastic cells (endocervical component) are present.  Chlamydia and gonococcus results were negative.  Blood pressure measurement was 124/60.  On 30-APR-2008 the patient called the doctor to report she was having breakthrough bleeding for 2 months (February 2008).  The patient was given SPRINTEC.  On 30-MAY-2008 the patient received her third dose of GARDASIL (lot# 660387/1967U) at 4:00 PM in the right deltoid.  The patient had complaints of bloding for 3 months (february 2008).  On 30-MAY-2008 a pelvic ultrasound with transvaq non ob was performed for dysfunctional uterine bleeding, nine months postpartum and the impression was normal pelvic ultrasound.  Minimal free fluid in the cul-de-sac was presumed physiological.  The monocytes were 31.  On 29-JUL-2008 the patient had irregular nausea occurring too many times and heavy (2 weeks on 2 weeks off).  Impression was intrauterine bleeding:  breakthrough bleeding.  On 29-JUL-2008 the patient had a ultrasound perlvic with transvaq non  OB exam performed for dysfunctional uterine bleeding.  The impression was grossly unremarkable apprearance of the uterus.  Endometrium measures 4.6 mm in thickness.  Multiple small follicles in both ovaries,left greater than right, many of which have a somewhat peripheral distribution.  This is non-specific and may be normal, though can be seen in setting of polycystic ovarian syndrome.  Correlate clinically.  There is slightly larger 1.4 cm anechoic focus in the left ovary, most likely a prominent/dominant follicle or follicular cyst.  No abnormal fluid collections or free fluid.  Plan was to discontinue birth control pills, observe and dilation and curettage.  Conflicting information reported that the patient's breakthrough bleeding was reported prior to the first vaccination with GARDASIL.  30-JUL-2008 the physician discontinued birth control pills.  Additional information is not expected.