Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 13-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline) for prophylaxis while pregnant. Concurrent medical conditions included latex allergy, sulfa allergy and sulfonamide allergy.  Concurrent vaccination included GARDASIL, (Merck), MENVEO, (Novartis) and FLUMIST, (MedImmune) all given on 22 February 2012. There were no concurrent medications. On 22 February 2012 the pregnant subject received a dose of BOOSTRIX at 0.5 ml in the right arm. It was thought that the subject was one month pregnant at the time of vaccination. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period and estimated date of delivery were not provided. The pregnancy was ongoing at the time of reporting. It was noted that the subject was to see an obstetrician the week of reporting. Follow-up information was received on 11 May 2012 via healthcare professional. The subject's last menstrual period was on 26 January 2012 and estimated date of delivery is 02 November 2012. It was clarified that the subject received BOOSTRIX on 27 February 2012. The subject was exposed to BOOSTRIX at 2 to 4 weeks gestation during the first trimester. The pregnancy was by normal conception. At the time of the report the pregnancy was ongoing. Follow up received on 17 December 2012 from healthcare professional (nurse). In 2012, after 37-42 weeks gestation (full-term), the subject gave birth to a male live infant with no apparent congenital anomaly. The infant was delivered by normal vaginal delivery, weighed 7.75 pounds and was 50.8 centimeters long with a head circumference of 33.6 centimeters.  In 2012, the APGAR score was reported at 1 minute was 7 and at 5 minutes was 8. The neonate received no medications following delivery. The nurse documented that the vaccine exposure was not the result of a suspected transmission of an infectious agent via medicinal product. The nurse did not consider the vaccine exposure to be serious. Upon internal review following corrections were done on 5th June 2018: The case PHHY2013US140189 and PHEH2012US009267 was identified as duplicate of A0976042A. Case PHHY2013US140189 and PHEH2012US009267 will be deleted and all future correspondence will be submitted to A0976042A (which stands as case of record for this patient). The patient's medical history included myopia, attention deficit hyperactivity disorder. She had no prior pregnancies. Her concomitant medications were not reported. Her last menstrual period (LMP) was 26th January 2012. The patient was vaccinated with MENVEO (on left arm), FLUMIST, GARDASIL and BOOSTRIX on 27th February 2012. The patient went to emergency room for amenorrhea. Urine pregnancy test was performed on 27th April 2012 it was determined at this time that she was pregnant. Her estimated delivery date was 1st November 2012. She had no maternal complications. The patient sought medical attention by hospital visit. She delivered a healthy male infant on 9th October 2012 (at week 41 from LMP) without complications. His weight was 7 pounds (lb) and 12 ounces (oz) and length was 21. Apgar score was 7 and 8. No further information was provided.