Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Premature labour
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no known drug reactions/allergies and severe asthma who on 15-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 659964/1978U) and on 22-JAN-2009, was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 661531/1311X). Concomitant therapy included ADVAIR, FLOVENT, Prednisone, Albuterol and Influenza virus vaccine (unspecified) (given on 22-JAN-2009). The registered nurse reported that the patient became pregnant after receiving the second dose of GARDASIL. She also stated the patient delivered the baby on 11-SEP-2009; however, the baby was born with hydrocephalus. The patient sought unspecified medical attention. On 01-OCT-2009, through a telephone call, the registered nurse reported that the mother and baby were being treated by the same physician. The mother was seen in the office on 22-JAN-2009 for an appointment. She was a severe asthmatic who had been on ADVAIR for years (exact therapy dates not provided) and ADVAIR was not controlling her asthmas as well as the physician would have liked. The patient was also noted to be a smoker. On 22-JAN-2009, the patient was switched to FLOVENT, Prednisone and Albuterol for asthma management. The patient was also given a flu vaccine (manufacturer not specified) and her second dose of GARDASIL. The registered nurse further noted that on that date (22-JAN-2009) the patient had a negative urine HCG test. It was estimated that the patient was actually 3 weeks, pregnant at the time of the urine pregnancy screen because she soon found out she was pregnant and her last menstrual period was estimated to have been around 02-JAN-2009. The reporter did not have the mother OB/Gyn contact information or any specific information surrounding her labor and delivery. She reported that she thought that the baby's hydrocephalus was diagnosed by ultrasound prior to his birth, but she did not have the baby's chart available at the moment to consult. She did report that the baby was 36 weeks gestation at birth on 11-SEP-2009. She did not have any more details to provide. She reported that she thinks he spent time in the hospital and thought he had a stent placed to treat the hydrocephalus. The health care professional contacted during telephone follow-up could not supply the following information: healthcare provider name and contact information for mother's OB/Gyn care or specific information about the baby. Additional information has been requested.  11/06/09 Medical records recieved for DOS range 1/22/09-10/14/09. Pt seen for asthma check 1/22/09 with vax given. ED visit for fall on ice and lower back pain mid Feb 2009. Subsequently found (+) pregnant. LMP (1/28/09). EDD 10/7/09. Return to ED 2/15/09 with abd pain and persistent back pain. UTI (+).  Several ER visits for asthma exacerbations. Prenatal consults note fetus with moderate to severe hydrocephalus and club feet seen on U/S. Amnio notes normal chromosomal, male fetus. Subsequent PCP visit for exacerbation of asthma. Poor air movement. Neb and MDI tx. Improved.  Live male infant born at 36wks. Apgars8/9 .Severe hydrocephalus.