Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Maternal exposure during pregnancy, Papilloma viral infection, Premature labour, Ultrasound antenatal screen
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with no medical history and drug reactions/allergies, who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated with intramuscularly with the first, second and third doses of GARDASIL (lot# for the last dose was 662304/1013Y) respectively. There was no concomitant medication. On 25-MAR-2010 the patient discovered that she was pregnant and that the conception time was near the final injection time. The patient's LMP was approximately 22-FEB-2010 (currently about 5 weeks into the pregnancy). Unspecified medical attention was sought. There were no lab diagnostics studies performed. No known adverse reactions were available. Follow-up information was received from the registered nurse concerning a 15 year old pregnant female with a history of 0 pregnancies and 0 live births and with no other medical history who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated intramuscularly with the first, second and third doses of GARDASIL (lot# for the third dose was 662304/1013Y) respectively. Concomitant therapy included OTC prenatal vitamins (PNV) (25-MAR-2010 to present) which was used for pregnancy. The patient's LMP was approximately 22-FEB-2010 and her estimated delivery date was 15-NOV-2010. On 30-APR-2010 HPV test showed HPV positive. On 01-MAY-2010 (11 week 3 days) ultrasound was performed for testing size and date and it showed there were abnormal cranial vault, no normal cerebral, hemispheres or choroid and portion of baby "calictium" absent. Then on 11-MAY-2010 (12 week 2 days), ultrasound was performed again and showed results within normal limits. On an unspecified date the patient experienced anemia which was treated by ferrous sulfate (since late July 2010, 325 mg daily). In August 2010, at 28 weeks of gestation, the patient experienced preterm labor (PTL) which was treated by betamethasone (from 27-AUG-2010 to 28-AUG-2010, 12 mg x2). On 27-AUG-2010 the patient experienced bacterial vaginosis which was treated by cytarabine (+) fludarabine phosphate (+) granulocyte colony stimulating factor (unspecified) (from 27-AUG-2010, duration 1 week, 500 mg twice a day). It was reported that the baby also experience intrauterine growth regardation (IUGR) on an unspecified date. On 05-NOV-2010, at 38 1/2 weeks (also reported as 38 6/7 weeks) of gestation, the patient delivered a normal, healthy male baby weighing 5 pounds 7. Apgar score was 9/9. Baby's length was 19 inch and head circumference was 81.5. There were no congenital anomalies reported. There were no complications during labor. However, the reporter thought the baby was delivered at small gestation age (SGA). Other laboratory test included: fetal fibronectin test (FFN) which was performed on 27-AUG-2010 and showed positive result. Gestational Blood Sugar (GBS) which was performed on 12-OCT-2010 and showed negative. The baby's experience has been captured in WAES 1004USA00203B1. Additional information has been requested.