Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a physician and a certified medical assistant, for GARDASIL, a Pregnancy Registry Product, concerning her 17 year old niece no pertinent medical history and no known allergies who on 14-NOV-2007 was vaccinated (injection) with a first dose of GARDASIL (lot# (lot# 659437/1266U) a second dose on 16-JAN-2008 (lot# 659439/1267U), and a third dose was administered on 21-MAY-2008 (lot# 660389/1968U). There was no concomitant medication. In June 2008 the patient found out she was pregnant. The patient then had her baby in March 2009 and the baby was born with brain swelling. The baby then had surgery (name of hospital, address and phone number unspecified) to have the fluid around the brain drained and once the fluid was drained the physician noticed that the baby's brain was not fully developed in the frontal cortex. The certified medical assistant reported that the patient and baby were under care with the patient's Obstetrician/Gynecologist (OBGYN). The patient's last menstrual period (LMP) was reported as "around June 2008". The patient was determined to be pregnant in December 2008 when she was 6 months gestation. The patient delivered a male infant on 23-MAR-2009. The infant was diagnosed with hydranencephaly at birth (also reported by the physician as 2 months after birth). Unspecified medical attention was sought. At the time of the report, the patient had not recovered. The physician reported that she was unsure about the patient's prenatal care. Follow up information was received on 28-JUL-2009 via telephone call from a registered nurse who reported that concomitant therapy included MENACTRA (lot# U2538AA) and influenza virus vaccine (unspecified) (lot# U2475KA). The nurse confirmed that there was no pertinent medical history and no known drug allergies (NKDA) and the only therapy taken by the patient was pm naproxen for menses. The nurse was not certain, but believed it was the patient's first pregnancy. LMP date and length of gestation were not available from the nurse's office. Follow up information was received on 28-JUL-2009 via another telephone call from the same registered nurse from the office of the patient's pediatrician who confirmed that they were the pediatrician's office for the baby with the hydranencephaly. The nurse reported that with each office visit, the physician was concerned about the baby's increasing head circumferences. The grandmother was reported as saying that "everyone in the family had a big head." On 18-JUN -2009, both an ultrasound and a computed axial tomography (CT) scan of the head were performed showing "vastly abnormal" results. The baby was then admitted to hospital, where shunts were placed (hospital name was reported). The baby was seen in the office on 20-JUL-2009, where it was noted that the baby was feeding well. Follow up information was received on 28-JUL-2009 via telephone call from a registered nurse who was from the office of the patient's obstetrician indicating that the patient was 25 weeks along when they first saw her. The patient delivered at over 41 weeks on 23-MAR-2009. This was the first pregnancy. The office was not aware of any problems with the baby. Additional information has been requested.