Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Placenta praevia, Prenatal screening test, Rubella antibody positive, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed practical nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates in March 2015 and in May 2015, the patient was vaccinated with the first and second dose of GARDASIL (strength, dose, anatomical location, route of administration, lot # and expiration date were not reported), respectively. On 15-SEP-2015, the patient received intramuscularly a 0.5 ml dose of GARDASIL 9 (lot number K026246, expiration date 28-JAN-2017) as the third dose in the vaccination series. On 15-SEP-2015 (reported as now), the patient was pregnant with 7 weeks of gestation. The last menstrual period (LMP) date was 28-JUL-2015 (calculated from weeks of gestation) and the estimated due date was 04-MAY-2016. At the time of the report, the pregnancy outcome was pending. Follow-up information has been received from the nurse on 17-FEB-2016 referring to a 19 year old female patient. The patient's pertinent medical history included gastroschisis at birth which she had undergone 2 surgeries for repair. Concurrent conditions included asthma which was treated with albuterol as required (prn). No smoking, drug/alcohol use was reported. The patient had 2 previous pregnancies: 1 elective termination on 01-FEB-2013 and 1 full-term delivery (at 40 weeks 2 days, male baby with body weight 7 pounds and 2 ounces, no complications). There were no pre-term deliveries, spontaneous abortions or fetal deaths. There were no birth defects or infant complications in previous pregnancies. The patient became pregnant third time with the last menstrual period (LMP) date of 29-JUL-2015, estimated date of conception of 12-AUG-2015 and estimated date of delivery of 04-MAY-2016. On 08-SEP-2015 (sixth week of pregnancy), the patient underwent blood group antigens and the Rh antigen (ABO/RH) test which showed O positive. The patient was also placed on prenatal vitamins (1 tablet, qd (Frequency reported as "ipoqd"), orally, from 08-SEP-2015) for pregnancy. On 15-SEP-2015, the third dose of GARDASIL 9 was administered in the left deltoid. On 10-DEC-2015 (19 w1d), sequential screening was negative and ultrasound performed (as a fetus survey) showed low lying placenta with limited view (follow up visit had been book in). At the time of reporting, the pregnancy was ongoing. The outcome of placenta praevia was not reported. The relatedness between the event of low lying placenta and suspect therapies was not reported. This case is one of the two cases regarding the same patient (MARRS # 1509USA008658). Follow up information has been received from a registered nurse on 27-JUN-2016. The start date of therapy with prenatal vitamins was changed to an unknown date in October 2015 and the therapy was ongoing at the time of reporting. At 39 weeks gestation, the patient delivered a normal male infant weighing 6 pounds 1 ounce. The infant's APGAR scores were 8 at one minute and 9 at five minutes. There were no congenital anomalies and no other complications or abnormalities. There were no complications during pregnancy, labor or delivery and there were no infections or illnesses during pregnancy. The patient was Rubella and Varicella immune (hepatitis B and rapid plasma reagin test were not reported). The pregnancy outcome was live birth - full-term. Upon internal review the event of low lying placenta was considered to be medically significant. Additional information is not expected as all required correspondence was received. Patient, product, event and narrative was updated.