Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Dyspnoea, Exposure during pregnancy, Feeding disorder neonatal, Foetal heart rate deceleration
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient, with codeine allergy, who on 14-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # and expire date not reported), 0.5 ml, intramuscularly. On 07-OCT-2010 the patient was vaccinated with the second dose of GARDASIL (Lot # 666929/0331Z and expire date 20-NOV-2012), 0.5 ml, intramuscularly. Concomitant therapy included unspecified birth control pills hormonal. The patient became pregnant "sometime around 01-NOV-2010" and on 01-NOV-2010 a pregnancy test was given to the patient in the office. The patient's last menstrual period was on 20-SEP-2010 and the estimated delivery date is on 27-JUN-2011. Follow up information has been received from the registered nurse concerning the female patient with no previous pregnancies. The estimated conception date was 04-OCT-2010. It was reported that other medications used during this pregnancy included LOESTRIN 24 FE, daily for oral contraception and was discontinued on 01-NOV-2010. On 16-NOV-2010 an ultrasound was performed and the result showed a viable pregnancy and a EDD (reported as EDC): 27-JUN-2011. Follow up information has been received via telephone call from a registered nurse who reported that the patient delivered a full term infant "with no problems" on 26-JUN-2011. She confirmed that the baby had no congenital anomalies. Also, it was reported that the patient had a C-section because the baby "just did not want to come out" and that it was "nothing related to GARDASIL". At the time of the report, the patient recovered from the C-section. Follow up information has been received from a pediatric medical center. They stated that the mother was not one of their patients. They saw the child but not the mother. Upon internal review, C-section was determined to be an other important medical event. Follow up information has been received. The patient agree to participate in the Pregnancy Registry for GARDASIL. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products. The following experience was identified: on 26-JUN-2011, at a gestational age of 39.6 weeks the baby male was born via C-section for fetal decelerations with a weight of 4.040 kg, length of 52.07 cm, OFC of 34.93 cm, APGAR 1 minute was 7 and 5 minutes was 9. The baby was given aqueous vitamin K 1mg, erythromycin 0.5% in each eye and dose 1 of HepB (manufacturer unknown) vaccine 0.5 ml was given. The baby's oxygen saturation was 100/98; SBP/DBP/MEAN was 69/41/52. The baby was hospitalized for 3 days following birth because he had initial difficulty breathing and feeding. On 27-JUN-2011, the baby underwent a circumcision procedure. Baby's initial exam was normal except for irregular heart beat. Subsequently, he had a normal heartbeat and a normal ECHO. On 28-JUN-2011, discharge exam was normal. On 01-AUG-2011, a month exam was performed. The patient experienced laryngomalacia. The patient was referred to speech therapy for possible aspiration. Preventive medicine was discussed with his parents. The patient's vital signs, review of systems and general examination were normal. On 29-AUG-2011, the patient was vaccinated with dose 2 of HepB (manufacturer unknown) in the left thigh, dose 1 of PENTACEL in the right thigh, dose 1 of PREVNAR 13 in the left thigh and dose 1 of ROTATEQ. On 02-SEP-2011, the patient was admitted to hospital for feeding intolerance. Video-feeding study was performed which showed aspiration with thin and semi-thickened liquids. The patient was hospitalized for training of NG feeds due to failed video feeding. On 03-SEP-2011, the patient was discharged from hospital with a normal discharge physical examination and was prescribed simethicone 20 mg p.o and a diet with SIMILAC. The patient's discharge weight was 6.04 kg. On 20-OCT-2011, the patient had a doctor visit. The patient's development was normal. Review of systems was normal excepted for a stuffy nose at night and diarrhea and constipation that they treated with diet. The patient's weight was 8.3 kg, height was 65.3 cm and OFC was 42.5 cm. The patient was not given any medication. Family history: mom's sister and brother have ADD. The patient's mom and dad had seasonal allergies and had allergy shots as children. There was adult onset diabetes and heart disease on grandmother's side of the mother, hypertension in maternal grandmother and learning disabilities, ADD, ADHD. Maternal grandmother was bipolar and mom's brother was bipolar. There were thyroid problems with maternal grandmother and pseudoseizures with bipolar in maternal grandmother. On 25-OCT-2011, the patient was vaccinated with dose 2 of PENTACEL in the right thigh, dose 2 of PREVNAR 13 in the left thigh, and dose 2 of ROTATEQ. On 28-NOV-2011, the patient had an appointment for weight check. The patient's review of systems, vital signs and physical examination were normal. The patient was feeding well now that the NG tube was out. On 27-DEC-2011, the patient was vaccinated with dose 3 of HepB (manufacturer unknown) in the right thigh, a dose of FLUZONE in the left thigh, dose 3 of PENTACEL in the left thigh, dose 3 of PREVNAR 13 in the right thigh and dose 2 of ROTATEQ. On 02-JUL-2012, the patient was vaccinated with dose 1 of HepA (unspecified) in the right thigh, dose 1 of M-M-R II in the left thigh and dose 1 of VARIVAX (Merck) (manufacturer unknown). On 02-OCT-2012, the patient was vaccinated with dose 4 of DTP in the right thigh, dose 4 of Hib in the left thigh, dose 4 of PREVNAR 13 in the left thigh and a dose of FLUZONE in the right thigh. On 07-JAN-2013, the patient was vaccinated with dose 2 of HepA (unspecified) in the left thigh. On 10-JAN-2013, the patient experienced speech delay. The patient's physical status was healthy. On 06-FEB-2013, the patient's fine motor score was 12, gross motor score was 15, adaptive score was 6, cognitive score was 17, social communication score was 4 and social score was 4. According to the AEPs, the patient showed -2SD delay in adaptive, social communication and social skills. The patient was placed on strategies. On 01-JUL-2013, the patient went to a 24 month exam. The patient's review of systems, vital signs and physical examination were normal. All available medical records will be provided upon request. Additional information is not expected.