Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: Initial and follow-up information has been received via the Merck pregnancy registry, from a nurse practitioner (NP) and a registered nurse concerning her daughter, a 17 year old female, with no pertinent medical history, who on approximately 08-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of GARDASIL (Lot #0211U). On approximately 09-JUN-2007, the patient became pregnant. It was also reported that the vaccination was given "between the 3rd and 8th week of pregnancy." Concomitant therapy included TERAZOL. An ultrasound on 11-JUL-2007, reported the pregnancy duration as 6 weeks and 4 days, positive fetal heart tones and provided an estimated date of delivery was 01-MAR-2008. On an unspecified date the patient had a prenatal profile (results not reported) and a cystic fibrosis test reported within normal limits. On 16-JUL-2007, 7 1/2 weeks (previously reported as 7 weeks) from last menstrual period the patient had a spontaneous abortion and underwent a dilatation and curettage. On an unspecified date the patient tested positive for human papilloma virus. The mother reported that her daughter has been depressed, suicidal, and unable to get out of bed. The patient had to see a psychiatrist and was currently on medication to lift her depression. The patient's mother stated that "her daughter is already different since receiving GARDASIL." Also reported as "not the same person." The patient's mother reported that her daughter had loss of her "inner self and inability to carry on a normal life." She also reported that she needed to get her daughter "intensive therapy." At the time of the report the outcome of the patient was unknown. Upon internal review, abortion was considered to be other important medical event. Conflicting information has been received from the patients mother, a registered nurse. It was reported that the patient was vaccinated with the first dose of GARDASIL on 08-JUN-2007 (the mother previously reported as 18-JUN-2007) with a pregnancy test on 21-JUN-2007 estimating 7-10 days pregnant (the mother previously reported that the patient was two and a half months pregnant at the time of the vaccination). The patient first tested positive for pregnancy by the end of June 2007. On 19-JUL-2007 the patient went for a second ultrasound that reported the baby's heart beat had stopped. On 19-JUL-2007 the female had the "tissue surgically evacuated from her uterus". Follow-up information was received from the consumer regarding herself who had no drug reactions or allergies. Historic condition included polycystic ovarian disease. On an unknown date in 2007 (previously reported as 08-JUN-2007), the patient had received the first dose of GARDASIL (Lot number 0211U, expiry date was 22-NOV-2009). At that time, the patient did not realize that she was pregnant. She thought about suing her doctor for not giving her a pregnancy test before receiving GARDASIL. The patient stated that she found out that she was pregnant about a week after receiving GARDASIL injection. It was determined that she was 4 to 6 weeks pregnant at the time. During a follow up appointment with her doctor about a week later, the doctor found that the fetus no longer had a heartbeat. The patient went for an emergency D and C (Dilation and Curettage) procedure at a medical center. The patient stated that this was an outpatient procedure and she was not admitted to the hospital. The patient has not received any further GARDASIL injections, but asked about the efficacy of GARDASIL after only receiving a single injection. Legal issue was involved and the adverse event was sent to legal team. Additional information is not expected.