Age: 19.0
Sex: F
Vaccine: HPV2
Symptoms: Blood test normal, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 19-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included possible hypothyroidism. No previous pregnancies. On 9 December 2013 the subject received unspecified dose of CERVARIX (.5 unknown, intramuscular, unknown deltoid). Her last menstrual period (LMP) occurred on 09 September 2013 and estimated date of delivery was reported as 22 June 2014. There was a discrepancy with the gestation age and due date based on the LMP of 09 September 2013. It was reported that the subject was 10 weeks pregnant on 09 December 2013 at the time of vaccination but pregnancy calculations show the subject was 13 weeks pregnant and estimated due date was 16 June 2014. The subject did not use contraception and the pregnancy was by normal conception. On 09 December 2014, at the time of vaccination with CERVARIX, the subject experienced vaccine exposure during pregnancy. No evidence of a defect from prenatal blood work testing, details not provided. At the time of reporting the pregnancy was ongoing, outcome was unknown. Follow-up information was received on 02 January 2014 via healthcare professional. The pregnancy was by normal conception, number of fetuses was unknown. The healthcare professional did not consider the vaccine exposure during pregnancy to be serious, but considered it related to vaccination with CERVARIX. At the time of the report the pregnancy was ongoing, outcome unknown. Follow-up information received on 01 October 2014: This prospective pregnancy case was reported by a other health professional and described the occurrence of live birth in a 19-year-old female patient who received CERVARIX (batch number AHPVA174BJ, expiry date 27th September 2014). The patient's past medical history included no adverse event (Maternal history included possible hypothyroid. Paternal history included ADHD (attention deficit hyperactivity disorder) and asthma). Concurrent medical conditions included acquired hypothyroidism. On 9th December 2013, the patient received CERVARIX (intramuscular) .5 unknown. The patient's last menstrual period was on 9th September 2013 and estimated date of delivery was 22nd June 2014. The patient received CERVARIX at week 13 of the pregnancy and during the first trimester of pregnancy. On 6th June 2014, 179 days after receiving CERVARIX, the patient experienced live birth. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the live birth and vaccine exposure during pregnancy were unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 6th June 2014 after 38 weeks and 4 days, the patient gave birth to a neonate via vaginal delivery. The neonate weighed 3185 grams (7lbs 0oz) at birth. APGAR scores were 8 and 9. It was unknown if the reporter considered the live birth and vaccine exposure during pregnancy to be related to CERVARIX. Additional information received on 01 October 2014: Full-term delivery. The length and the head circumference were unknown at time of reporting.