Age: 23.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Foetal disorder, Pre-eclampsia, Pregnancy test urine, Premature rupture of membranes, Streptococcus test negative
Clinical narrative: This spontaneous prospective pregnancy report has been received from a Registered Nurse referring to a 23 year old female patient with penicillin allergy and rhesus antibodies (RH) negative. On 31-MAR-2015, the patient inadvertently received a dose of GARDASIL (lot # K009482, expiration date: 06-MAR-2017, 0.5 ml, intramuscular) instead of TDAP, while pregnant at 27 weeks and 5 days (second trimester). The last menstrual period (LMP) was 18-SEP-2014 and the estimated date of delivery (EDD) was 25-JUN-2015. Foetus demographics and outcome were unknown. Concomitant therapies included RHOGAM and TDAP. The patient visited the office and it was determined that she was having contractions. Therefore she was sent to hospital on 31-MAR-2015. No lab diagnostics studies were performed. The patient was monitored and discharged to home on the same day. On 01-APR-2015, the patient was sent back to the hospital (reason unspecified) but was not admitted. At the time of the report, the outcome of adverse events was unknown. Relatedness between the events and suspect product was not specified. This is one of several reports received from the same reporter. Follow up information has been received from the nurse on 20-MAY-2015 referring to the female patient. Before injection of GARDASIL was given, the patient was already complaining of uterine cramping, and it was not related to the suspect medicine. Follow up information has been received from the nurse on 09-JUN-2015 referring to the patient with anaemia and a medical history of premature labour (date was not specified), urinary tract infection treated with Macrolid (not specified), orally, 100m, BID, from 05-JAN-2015 to 12-JAN-2015, rash in pregnancy treated with MEDROL, and pleurisy. She also reported that the patient is a tobacco user (a "few cigarettes daily"). The body mass index of the patient was 37+. Concomitant medication was reported as ZOTRAN 1mg bid oral (start date 14-NOV-2014) for nausea and vomiting. It was reported that the last menstrual period (LMP) was 01-SEP-2014, the estimated data of delivery (EDD) of 25-JUN-2015 and the estimated data of conception reported as 25-JUN-2015 by ultrasound (conflicting information). At 37 weeks gestation, the patient delivered a normal male infant weighing 3854.75 gms via cesarean delivery. The pregnancy outcome was live birth. The infant's APGAR scores were 8 at one minute and 9 at five minutes. The reporter stated that during the delivery, the patient experienced footling breech presentation, rupture of membranes and uterine atony, therefore she received CYTOTEC per rectum and later she received blood transfusion. It was also reported by the nurse, that the patient was at the borderline of pre-eclampsia. Laboratories test showed: Body mass index results: 37+; Pregnancy test urine serum results (28-OCT-2014): not reported, this lab test was performed at the 8 week 1/7 of pregnancy; ABO/rhesus antibodies (RH) results (28-OCT-2014): A negative, this lab test performed at 8 week 1/7 of pregnancy; B-Strep results (21-MAY-2015): negative, this lab test was performed at the 35 weeks 6/7 of pregnancy; Ultrasound results (04-NOV-2014): 6 weeks 5days/7days Changed estimated data of conception within normal limits changed Estimated data conception; Ultrasound results (03-FEB-2015): 19 weeks 5days/7days Changed estimated data of conception within normal limits changed Estimated data conception; Ultrasound results (27-MAY-2015): 35 weeks 6days/7days Changed estimated data of conception within normal limits changed Estimated data conception. At the time of reporting, the outcome of cesarean section, uterine atony, breech presentation and pre-eclampsia was unknown. It was also reported that the therapy with GARDASIL was discontinued. Upon internal review cesarean section was considered medically significant. Additional information has been requested. General, patient, products, events and narrative were updated.