Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Endocrine test, Hepatitis B test negative, Human chorionic gonadotropin, Maternal exposure before pregnancy, Meconium in amniotic fluid
Clinical narrative: Information has been received from a other health professional, for the Pregnancy Registry for GARDASIL, concerning a female patient who on an unspecified date was vaccinated with GARDASIL (dose, route, and lot number not reported). Subsequently the patient became pregnant (date unspecified), last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. At the time of the report, the outcome of the patient's pregnancy had not been reported. It was unspecified if the patient sought medical attention. Follow up information has been received from the nurse who said that it was still "early" (not specified) in the patient's pregnancy and she was just waiting for the results of the Quad screen test. Follow up information has been received via a Pregnancy Questionnaire from the Registered Nurse practitioner concerning the female patient who on 04-DEC-2009 was vaccinated with a second dose of GARDASIL (lot number:659054/0311Y, expiration date 19-JUN-2010, route not reported). Concomitant vaccine included a dose of tetanus toxoid. Other concomitant therapies included pre-natal vitamins, and tuberculin purified protein derivative. On 06-DEC-2009 the patient had her LMP (estimated conception date approximately on 30-DEC-2009). The estimated delivery date 12-SEP-2010. On 11-FEB-2010, the patient had an ultrasound for checking the viability of pregnancy and the result revealed intrauterine pregnancy (IUP) positive. It was reported that the patient did not have previous pregnancies. Follow up information has been received from a registered nurse concerning the female patient who on 04-DEC-2009 was vaccinated with a second dose of GARDASIL. Additional concomitant therapies included globulin, RHOGAM for the treatment of Rhesus antibodies negative. On 10-MAR-2010 the patient was started on famotidine for the treatment of heartburn. The physician reported that on 13-SEP-2010 at 40 weeks from LMP, the patient delivered a male baby with 6 pounds and 2 ounces of weight and 20.5 inches of length, apgar score 8/9 and a head circumference: 33 (date unspecified). The infant was normal. There were no congenital anomalies. There were no other complications or abnormalities. It was also reported no complications during pregnancy or labor/delivery. During pregnancy the patient underwent diagnostic tests. On 11-FEB-2010, an ultrasound was performed and showed viability. On 20-APR-2010, an anomaly scan was performed. On 02-AUG-2010, a growth scan was performed showed weight within normal limits. Follow up information was received via medical records which reported that the 26 year old female patient who was reported to be non-immune for rubella, positive for Beta Streptococcus, negative for Hepatitis B screen, negative for GC and for Chlamydia, no alcohol nor tobacco user delivered a normal male baby on 13-SEP-2010, at 40 weeks of gestation, via vaginal (apgar score at 1 minute: 8 and 5 minute: 9; head circumference 33 cm; chest 32 cm; weight 2800 Kg (6 lb 2 oz) and height 70.30 inches). The patient had no history of diabetes, endocrine/hormonal problems, hypothyroidism/hyperthyroidism, bleeding disorders, no history of HSV or HSV active. The patient's ruptured membrane was on 13-SEP-2010, at 14.00. The patient's membranes were intact and the time from rupture to delivery was 7.7 hours. It was reported that there was moderate meconium in the membrane fluid. The baby's mother was taking vitamin D as a supplement for prevention of deficiency of vitamin D. All exams and laboratories performed on 13-SEP-2010 were within normal limits. On 14-SEP-2010, at 16:56, the baby underwent a hearing test (right and left) and the result was reported as Pass. On 16-SEP-2010, at 3 days of age, the baby's urine and stools were normal. All laboratory tests were normal, the reflexes (R L) were good and the baby had slight jaundice. The plan was re-visit at 1,2,4 and 8 week; call if decreased PO, pee or poop abnormal and if yellow color remained. The patient was referred to a lactation consultant. No further information is available.