Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Normal newborn
Clinical narrative: Information has been received from a pediatrician via medical records for the pregnancy registry of GARDASIL concerning a 2 days old male patient whose mother was vaccinated on 28-JUL-2009 with the first dose of GARDASIL (lot number 661046/0381X) while she was maybe pregnant (WAES # 0910USA01764). Concomitant vaccinations for the mother included prenatal vitamins and a 0.5 mL dose of H1N1 vaccine (manufacturer unspecified). The patient was born on 08-APR-2010 via vaginal delivery at 14:55 hrs at gestational age of 39.5 weeks, his birth weight was 8 pounds and 8 ounces (3855 gr), the APGAR score was 9. Initially the patient was breast feed. Upon admission to maternal unity on 09-APR-2010, his temperature was 98.6; he had a pulse rate of 144 and respiratory rate of 48. All the physical examination was normal, he was considered a term normal male with possible THC, a tox urine was performed which was negative. A hearing screening was done, the patient failed right and passed left. All the physical examination was normal except by jaundice. Diagnostic laboratory tests performed on 10-APR-2010 included: Cystic fibrosis, biotinidase deficiency, galactosemia, primary congenital hypothyroidism, congenital adrenal hyperplasia, MS/, MS Acylcarnitine panel, MS/MS Aminoacid panel and hemoglobinopathies which were all negative. The patient was determined to have a usual hemoglobin pattern. The patient was given a dose of HepB vaccine (manufacturer unspecified). On 10-APR-2010, the patient was discharged home with his mother, his temperature at discharge was 98.6, pulse rate was 128, weight was 3.684 gm and respiratory rate 38. No medications were prescribed. On 15-APR-2010, a 7 day follow up visit was made, which was reported as a new born well visit. The patient's weight at that time was 9 pounds, his height was 20 inches, his head circumference was 14 and Temperature was 97.6. There were no known drug allergies. On 26-APR-2010, a 2 weeks follow up visit was performed, the patient's weight was 9 pound sand 5 ounces (weight gain adequate), his height was 20 inches and head circumference was 15, temperature was 98.2, there were no known drug allergies or pediatrician concerns. The patient's physical examination was normal and the visit was considered a 2 week well child visit. The patient's mom was wondering when belly button was going to fall off. The patient was being breast feed. On 08-JUN-2010, at the age of two months, the patient had a follow up visit, his weight was 12 pounds 12 ounces, his height was 23 inches. The head circumference was 16 and temperature was 97.5. There were no known drug allergies. The physical examination was normal except by an small umbilical hernia. On that visit, the patient was given the first doses of PENTACEL, PREVNAR and ROTATEQ and the second dose of HepB (manufacturer unspecified). It was reported that the patient slept from 12 to 4 A.M. The patient was being breast feed. On 10-AUG-2010, the patient was seen in a 4 months follow up visit. The patient's weight was 16 pounds and 8 ounces. His height was 26 inches, head circumference was 17 and temperature 98.0. There were no known drug allergies. The patient's growth development was normal and physical examination was normal (good). The patient was given the second dose of PENTACEL, PREVNAR and ROTATEQ. At the time of the report, the patient's outcome was not reported. A follow up information was received from a physician who stated that she did not consider the patient's small umbilical hernia to be a congenital anomaly. She stated that she did not put it in her documentation but at 4 months old the patient's small umbilical hernia had resolved. Additional information has been requested.