Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Chorioamnionitis, Drug exposure before pregnancy, Foetal heart rate disorder
Clinical narrative: Information has been received from a medical assistant for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with type O Rh(D) negative blood and a history of 1 pregnancy and 1 elective termination who on 05-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662404/0312Y). Concomitant therapy included prenatal vitamins (unspecified). Subsequently, the patient became pregnant. Her LMP was 15-SEP-2009. On 11-NOV-2009, ultrasound done for viability and dates, result showed intrauterine pregnancy (IUP) seen approximately 13 weeks. The patient's estimated date of delivery was 19-MAY-2010 and the baby was normal. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a medical assistant who reported that on 09-DEC-2009 serum alpha-fetoprotein screening was performed for routine pregnancy test, with normal result. It was also reported that the patient's blood type is O negative. The patient also had one previous pregnancy which she electively terminated at 11 weeks gestation. At the time of the report, the patient's outcome was unknown. Follow-up information has been received which reported that the patient did not agree to participate in the Pregnancy Registry for GARDASIL. Follow up information has been received from the physician who reported that the patient was admitted to the hospital with the pre-operative diagnosis: Intrauterine pregnancy at: 40w 6d, chorioamnionitis, protracted labor, nonreassuring fetal heart rate tracing (NRFHT); Post-operative Diagnosis: status post delivery of VMI, normal pelvic anatomy, same. The patient was seen prior to surgery (Primary Low Transverse Cesarean Section). The risks, benefits, complications, treatment options, and expected outcomes were discussed with the patient. The patient concurred with the proposed plan, giving informed consent. The site of surgery properly noted/marked. A Time Out was held and the above information confirmed. While the patient was being prepped, the FHT were continuously monitored via FSE. The FHT were in the 110s, and then decreased to 60s for approximately one minute, then returned to 110s. During this time, the decision was made to proceed in a stat format. The patient had already been dosed and tested, but when she was rechecked, she complained of pain with the Allis pinching her. Thus she was placed under general anesthesia, as it was felt there was no further time to dose her further. A Pfannenstiel incision was made and carried down through the subcutaneous tissue to the fascia. Fascial incision was made and extended transversely. The fascia was separated from the underlying rectus tissue superiorly and inferiorly. The peritoneum was identified and entered. Peritoneal incision was extended longitudinally. The utero-vesical peritoneal reflection was incised transversely and the bladder flap was bluntly freed from the lower uterine segment. A low transverse uterine incision was made bluntly extended. The infant was delivered from vertex presentation, ROP position. The infant's mouth and nares were bulb suctioned on the abdomen, and the infant was then handed to the neonatology team. The placenta was manually extracted and cleared of all clots and debris. After the umbilical cord was clamped and cut, cord blood was obtained for evaluation. The uterus was exteriorized. Adequate fundal tone was obtained with bimanual fundal massage, IV PITOCIN. The uterine incision was primarily closed with a running interlocking suture of #1 chromic. A secondary imbricating Lembert stitch of #1 chromic was placed for support of the incision. Hemostasis was observed. The posterior cui de sac and pericolic gutters were cleared of clot and debris with a moist laparotomy pad and suction. The uterus was then returned to its normal anatomic position. The parietal peritoneum was closed with 3-0 Vicryl. The fascia was then reapproximated with a running suture 0 Vicryl. The subcutaneous layer was irrigated. The skin was reapproximated with staples. Hemostasis of each layer was obtained prior to the closure. The patient tolerated the procedure well. Infant cord pH (arterial) 7.11. Instrument, sponge, and needle counts were correct prior to abdominal closure and at the conclusion of the case. On 25-MAY-2010, at 16:38, the patient delivered a normal male infant, weight 3845 grams. Findings were normal uterus, bilateral ovaries and bilateral fallopian tubes. The patient's estimated blood loss was 900cc. Intrapartum Maternal Complications included maternal fever and chorioamnionitis. On 26-MAY-2010, the patient was administered Rho(D) immune globulin. On 28-MAY-2010, the patient discharged from the hospital. Additional information is not expected. All available medical records will be provided upon request.