Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 29-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 27th January 2014. Co-suspect products included INFLUENZA vaccine (Non-GSK). The subject's past medical history included no adverse event (The current pregnancy ws form normal conception with no in-vitro fertilization utilized). The subject's last menstrual period was on 26th June 2013 and estimated date of delivery was 2nd April 2014. The subject received BOOSTRIX at week 30 of the pregnancy and during the third trimester of pregnancy. On 4th April 2014, 67 days after receiving BOOSTRIX the subject developed live birth (Non-serious). Additional event(s) included vaccine exposure during pregnancy and expired vaccine used. The outcome of live birth was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown) and expired vaccine used (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 4th April 2014 after 40 weeks and 2 days, the subject gave birth to a male neonate via vaginal delivery. It was unknown if the investigator considered the live birth, vaccine exposure during pregnancy and expired vaccine used to be related to BOOSTRIX. Additional information received: This prospective pregnancy case was reported by a healthcare professional (certified medical assistant) and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm) and experienced expired vaccine used and vaccine exposure during an unknown trimester of pregnancy. The gestational age at the time of vaccination was not reported. The date of last menstrual period was reported as 26 June 2013. The estimated date of delivery was reported as 2 April 2014. The lot number was reported as AC52B080A from the reporter, however, based on a safety lot number review, the lot number was updated to AC52B080AA. The lot number had an expiry date of 15 December 2013. Per the reporter, administration of BOOSTRIX to the pregnant subject was intentional. At the time of reporting, the pregnancy was ongoing. 04 September 2014- No further information was provided; patient lost to follow-up. Follow up was received from the healthcare professional (medical assistant) on 22 September 2014. The healthcare professional documented (signed on 3 march 2014) that the 29-year-old subject had a pregnancy from normal conception without the use of in-vitro infertilization. On 27 January 2014 (previously not reported), the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm) and experienced expired vaccine used and vaccine (non-GSK, Sanofi-Pasteur) and experienced vaccine exposure during the second trimester of pregnancy. The gestational age at the time of vaccination with BOOSTRIX was 30 weeks and at the time of vaccination with seasonal influenza vaccine (non-GSK)(unknown route, 0.5mL) was 20 weeks. The date of last menstrual period was confirmed as 26 June 2013. The estimated date of delivery was confirmed as 2 April 2014. Per the reporter, there were no applicable adverse events. No further details were reported. At the time od reporting (signed on 3 March 2014 but provided to GSK on 22 September 2014) the pregnancy was ongoing. For this reason, the case was reopened to attempt to obtaining details regarding the pregnancy outcome. The current pregnancy was from normal conception with no in-vitro fertilization utilized.