Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain, Alpha 1 foetoprotein normal, Cervical dysplasia, Colposcopy, Drug exposure during pregnancy
Clinical narrative: Information has been received for the Merck Pregnancy Registry for Gardasil via a registered nurse concerning a 23 year old female with a sulfonamide allergy and drug hypersensitivity to erythromycin, BACTRIM and ZITHROMAX who on 22-JAN-2007 was vaccinated with the first dose of Gardasil (lot # 655619/1427F). Concomitant therapy included pre-natal vitamins. It was reported that the patient may have been pregnant when she received the vaccination on 22-JAN-2007. The patient reported the date of her last menstrual period as approximately 20-JAN-2007. The patient's estimated date of delivery is 27-OCT-2007. The patient sought unspecified medical attention. In February 2007, a "pap smear" revealed cervical intraepithelial neoplasia 3 and the patient underwent colposcopy (results not provided). The reporter indicated that the pregnancy has been normal to date. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007, 04/07/2008. Initial and follow up information has been received for the Merck Pregnancy Registry for GARDASIL via a registered nurse concerning a 23 year old female smoker of 1 pack per day with hypoglycemia, cervical intraepithelial neoplasia, excessive weight gain, a sulfonamide allergy and drug hypersensitivity to erythromycin, BACTRIM and ZITHROMAX, and with a history of 2 previous pregnancies (1 full term delivery and 1 spontaneous abortion, anxiety, colposcopy, and attention deficit/hyperactivity disorder, a maternal mother (grandmother) that had platelets with a defective release mechanism, a maternal father (grandfather) with high blood pressure before 50 and a fraternal father (grandfather) with diabetes, who on 22-JAN-2007 was vaccinated with the first dose of GARDASIL (lot # 655639/1427F). Concomitant therapy included pre-natal vitamins starting in February 2007, once a day. It was reported that the patient may have been pregnant when she received the vaccination on 22-JAN-2007. The patient reported the date of her last menstrual period as approximately 20-JAN-2007. The patient's estimated date of delivery is 27-OCT-2007. The patient quit smoking with a positive urine pregnancy test. The patient sought unspecified medical attention. In February 2007, a "pap smear" revealed cervical intraepithelial neoplasia 1 and the patient underwent colposcopy. The colposcopy showed cervical intraepithelial neoplasia 1. The reporter indicated that the pregnancy has been normal to date. On 04-APR-2007 an ultrasound was performed for "NT and screen" and the results were normal. On 02-MAY-2007 a Maternal Serum Alpha-Fetoprotein Screening was performed and the results were negative. On 01-OCT-2007 an ultrasound was performed and the results indicated bilateral pyelectasis with comments to "follow-up for size greater than dates". Follow-up indicated that on 10-OCT-2007 the patient gave birth to a normal female infant (39 weeks LMP). The infant weighted 7 pounds 4 ounces, was 19 1/3 inches long, and her apgar score was 8/9. There were no congenital anomalies. As previously reported an ultrasound performed on 01-OCT-2007 showed the baby to have moderate bilateral pyelectasis. Postnatal antibiotics and a possible renal sonogram were recommended. It was reported that complications during pregnancy were hypoglycemia and excessive weight gain. There were no complications during labor and delivery. There were no birth defects and no infant complications in previous pregnancies. Follow-up information that on 11-OCT-2007 a renal sonogram was performed on the baby and the results were normal. On 12-DEC-2007 the patient was seen in the office for a postpartum exam. The patient was prescribed YAZ for twelve months and the Loop Electrosurgical Excision Procedure (LEEP) procedure was scheduled. In regards to the patient's cervical intraepithelial neoplasia 3, it was reported that on 10-JAN-2008 the patient came back to the office for a Loop Electrosurgical Excision Procedure (LEEP) procedure and was doing fine. On 12-DEC-2007 the patient was seen in the office for a postpartum exam. Additional information is not expected.