Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Drug exposure during pregnancy, Full blood count normal, Heart rate increased, Immotile cilia syndrome
Clinical narrative: Initial and follow-up information has been received through the Merck Pregnancy Registry from a physician concerning a 20 year old female with bronchitis, Kartagener's syndrome, pregnancy and lung infection with a history of 1 pregnancy, 1 live birth and no birth defects in previous pregnancies who on 05-APR-2007 was vaccinated with GARDASIL (lot # 654535/0950F).  Concomitant therapy included albuterol 6.7 gm. QID as needed, salmeterol 50 mcg BID, and fluticasone propionate 10mcg BID for chronic bronchitis. Prenatal vitamins, iron (unspecified) and calcium (unspecified) taken once to twice daily for pregnancy and amoxicillin TID for lung infection. On 12-JUL-2007 the patient was vaccinated with a second dose of GARDASIL (lot# unknown). On 12-JUL-2007 the patient was found to be pregnant, in the first trimester. The patient's last date of menstrual period was 01-JUN-2007 and the estimated date of delivery is 10-MAR-2008. Unspecified medical attention was sought. An ultrasound was performed for dates and surveillance on 10-SEP-2007 and 25-OCT-2007 and was within normal limits: growth as expected. It was reported pregnancy was normal to date. Follow-up information was received from the physician. The physician reported that the patient delivered an 11 pound male on 11-MAR-2008 via vaginal delivery. The mother was formula feeding. There was no additional information on the baby at the time of reporting. Follow-up information was received via medical records. On 16-MAR-2008 the baby had neonatal physiologic jaundice in face only. On 16-MAR-2008 the baby's body temperature measurement was 99.2, respiratory rate measurement was 36, pulse oximetry was 94 and total heartbeat count was 142. Follow-up visit was scheduled for 2 weeks. On 27-MAR-2008 the baby had his 2 week old well child visit. The baby lost weight, was down to 5% from 10%. The baby had thrush and constipation issues, and changed formula to try to improve constipation and treat thrush. Try to increase daily formula amount to about 30 oz. day. Plan was to recheck weight in one week. The baby was administered nystatin oral pediatric suspension to treat thrush. The baby had a dry skin and was to be bathed every 3 days, use baby oil prior to baths on scalp, use lotions if desired on body. On 27-MAR-2008 the baby's complete blood cell count was normal. On 02-APR-2008 the baby had his evaluation and management of weight check. The baby was on formula feeding only. Denied bowel / bladder problem, denied rashes, sleeping well. Concern with stuffy nose in the morning. The baby is eating much better, no concerns of constipation and urine/stool. The mouth shows moist mucous membranes, small amount of white patches on hard palate with no surrounding erythema. The baby experienced oral candidiasis and was to continue with nystatin for another 5 days. On 12-MAY-2008 the patient had a visit and the mother stated the baby was doing well, has a good appetite, good elimination and sleeps thru the night. The baby was on formula only. It was also noted that the baby does have a small, easily reduced abdominal wall hernia and mild facial eczema. On 12-MAY-2008 the baby was vaccinated with ACTHIB (MSD) and developed diarrhea. (MSD WAES # 0810USA00559). Additional information is not expected. Medical records available upon request.