Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Delivery, Drug exposure during pregnancy, Laboratory test normal, Pneumonia
Clinical narrative: Information has been received from a nurse, for the pregnancy Registry for GARDASIL, concerning a 21 year old female with a history of a "rash from PERCOCET" who was vaccinated with first (lot # 659182/1757U), second (lot # 660389/1968U) and third (lot # 660557/0072X) doses of GARDASIL on 24-MAR-2008, 28-MAR-2008 and 17-SEP-2008 respectively. There was no concomitant medication. Subsequently the patient was vaccinated with 3 doses of GARDASIL and was pregnant. The patient's last menstrual period was in question but may have been on 06-SEP-2008. The patient was not experiencing any problems. A urine pregnancy test was performed on 13-OCT-2008 and the result was positive. The patient sought medical attention. Follow up information has been received from a certified nurse midwife and a licensed practical nurse concerning a 21 year old  female with a history of a "rash from PERCOCET", asthma, appendectomy and no previous pregnancy who was vaccinated with first (lot# 659182/01757U), second (lot# 660389/1968U) and third (lot# 660557/0072X, IM in deltoid) doses of GARDASIL on 24-MAR-2008, 28-MAY-2008 and 17-SEP-2008 respectively. Concomitant therapy included prenatal vitamins (unspecified), daily. The patient did ultrasound on 20-Oct-2008 for dating and the result was 6.5 weeks intrauterine pregnancy. The patient did maternal serum alpha fetoprotein on 19-Dec-2008 and the results was within normal limits. The patient did first trimester screening on 01-Dec-2008 and the result was within normal limits. The patient did ultrasonography on 15-JAN-2009 and the result was 20 weeks intrauterine pregnancy. Follow up information has been received from a certified nurse midwife concerning a 21 year old female tobacco user who was pregnant. Subsequently, in approximately October 2008 the patient developed pneumonia and was treated with AVELOX, 400 mg daily, from 10-OCT-2008 to 17-OCT-2008. On 17-JUN-2009, the patient delivered a normal 5 pound 15 ounce male infant. There were no congenital anomalies or any complications during pregnancy or labor and delivery. It was noted that the patient did not have any previous pregnancies, spontaneous abortions or elective terminations. Follow-up information has been received from a medical record which indicated on 17-JUN-2009 the patient delivered a full term male newborn by normal spontaneous vaginal delivery. The baby's weight was 5 pound 15 ounce (also reported as 5 pound 13 ounce) , length (Ht) was 20cm, head circumference (HC) was 13cm, APGAR score at one minute was 8, at five minutes was 9. On 22-JUN-2009, cystic fibrosis screen (immuno reactive trypsinogen) was performed with a result of 39 ng/ml (normal range 0-69). On 20-Jul-2009, 1 month after birth, the baby's Wt was 9.13 pound, Ht was 21.75 cm, HC was 15.25cm. There were no known allergies. Physical examination found plagiocephaly. On the same day, skull X-ray of 2 views was performed which revealed that the baby's skull did have an elongated configuration. This would raise the question of fusion of the sagittal suture. The doctor believed that the normal sutures were faintly seen and were probably open. However, visualized by CT scanning. The exam was otherwise normal. The doctor's impression was probably normal suture anatomy. the baby would be followed up at 4-months visit. On 20-JUL-2009, the baby was vaccinated with the second dose of HEPATITIS B virus vaccine (manufacturer unspecified). There were no medications prescribed. On 24-AUG2009, 2 months after birth, the baby's wt was 12.9 pound, Ht was 23.5 cm, HC was 16 cm. Mild plagiocephaly was found during physical examination. The baby was fed Goodstart thickened with rice cereal and had some constipation, for which doctor suggested may give water and prune or peach juice. Well-child care was planned. On 24-AUG-2009, the baby was vaccinated with PENTACEL, ROTARIX, and PREVNAR. The baby would be followed up at 4-month visit. There were no medications prescribed. Additional information is not expected. All available medical records will be provided upon request.