Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Streptococcal identification test positive
Clinical narrative: Information has been received through the Pregnancy registry concerning a 19 year old female patient, who on 19-MAY-2007 was vaccinated with a second dose of Gardasil. It was reported that the patient was 20 weeks pregnant. The patients last menstrual period was 16-APR-2007 and her estimated delivery date was 21-JAN-2008. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information was received on 24-MAR-2008 and 02-APR-2008. The patient delivered a baby boy on 28-JAN-2008 (weeks from LMP-40). The baby was born with pneumonia. He weighed 9 lbs. 2 oz. The baby's pediatrician was called on 02-APR-2008. The nurse confirmed the patient had well visits and was seen multiple times during the month of February for pneumonia and what looked like abdominal pain. A request for Medical Records was faxed to the nurse to obtain the baby's records. Follow up information received in the form of physician's notes, indicated that on 28-JAN-2008, the infant first had a "vacuum attempt without success and positive meconium." The physician noted the infant was status post "C-section for failure to progress," and added that the mother was group B strep positive. After birth, the infant had an increased respiratory rate and "was on oxyhood overnight." The chest X-ray revealed right lower lobe pneumonia. Treatment in the hospital included IV ampicillin and gentamycin, and the infant "continued to do well with respiratory rate decreasing and 99% spO2 room air, feeding well." The infant was discharged on 02-FEB-2008 ("two days ago"). On 04-FEB-2008, the infant was seen in follow up at the physician's office, and was "improving clinically" the physician's assessment was pneumonia due to streptococcus, group B. Mild facial jaundice was documented. He was also diagnosed with diaper rash-candida, also noted as etoxicum rash; nystatin was prescribed, with follow up in 2 days. The infant was continued on AUGMENTIN. On 06-FEB-2008, the infant was seen by the physician and was improved clinically, with no jaundice noted and only mild etoxicum rash. On 14-FEB-2008, the infant visited the physician for a recheck, with notes of visiting the emergency department, 4 days earlier (10-FEB-2008), because he was "wheezing and crying uncontrollably." Treatment at the ED included Vaponeb, and he improved. At home, the mother used a nebulizer a few times. The physician indicated the infant had "cephalohematoma right posterior scalp." and also noted "well baby. Pneumonia resolved." On 22-FEB-2008, the infant was brought to the physician with "purple feet," and was also noted as being inconsolable, with pulling his legs up and crying. The physician indicated that infant had a "little color change with cold reassurance," and colic was diagnosed. Treatment included nutramagen movement, tight swaddle and white noise. The physician also noted the head had no abnormalities, lesions or masses. On 24-MAR-2008, the infant was brought to the physician with a runny nose and congestion, and reports that "he spits up almost every feeding." The diagnosis was "well baby" The infant was vaccinated with DTaP (+) poliovirus vaccine inactivated (+) tetanus toxoid (manufacturer not specified), HIB (manfacturer not specified), PREVNAR and ROTATEQ. The physician noted that the infant had no previous immunization reaction. Upon internal review, "C-section for failure to progress" was determined to be serious as an other important medical event. Additional information is not expected.