Sex: U
Vaccine: TDAP
Symptoms: Chills, Cytogenetic analysis abnormal, Foetal death, Foetal exposure during pregnancy, Hydrops foetalis
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of intra-uterine death in a patient exposed to BOOSTRIX in utero while the mother was treated. The parent's medical history included cholecystectomy, cystocele, genital herpes simplex, pregnancy and rectocele. Concomitant product exposures included ferrous sulfate, folic acid, docusate sodium , ranitidine hydrochloride and Prenatal vitamin. On 22nd January 2013, the 30-year-old mother received the 3rd dose of BOOSTRIX. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to BOOSTRIX at week 28 of gestation and during the third trimester of pregnancy. The patient was diagnosed with intra-uterine death (serious criteria death and GSK medically significant). On 22 January 2013, the patient experienced maternal exposure during pregnancy. On an unknown date, the patient experienced trisomy 12 (serious criteria and congenital anomaly), micrognathia (serious criteria death and congenital anomaly), hydrops fetalis (serious criteria death and GSK medically significant) and umbilical cord complication (serious criteria death). On an unknown date, the outcome of the intra-uterine death, trisomy 12, micrognathia, hydrops fetalis and umbilical cord complication were fatal and the outcome of the maternal exposure during pregnancy was unknown. An autopsy was not performed. The reporter considered the intra-uterine death, trisomy 12, micrognathia, hydrops fetalis and umbilical cord complication to be related to BOOSTRIX. See case US2016GSK100155 for details regarding the mother case. Additional information was provided: This retrospective pregnancy case was reported in a literature article and described the occurrence of trisomy 12 in a foetus of unspecified gender whose mother was vaccinated with BOOSTRIX during pregnancy. This case concerns VAERS ID: 485632. The patient's mother had a medical history of prior pregnancy, genital herpes simplex virus, midline cystocele, rectocele without prolapse, female circumcision, anaemia, haematoma complicating a procedure, cholecystectomy and had insufficient prenatal care. The patient's mother had not undergone 2nd trimester anatomic ultrasound or prenatal genetic testing. The foetus was also exposed to ferrous sulfate 325mg orally BID, docusate 250mg orally Qday, ranitidine 150mg orally BID, prenatal vitamin orally QDay which the mother took concurrently. No information on patient's medical history or concurrent condition or concomitant medication was provided. On 22 January 2013, the patient's mother had received 3rd dose of BOOSTRIX intramuscularly on right arm (lot number AC52B103AA). The foetus was exposed to the vaccine during the 3rd trimester at 28 weeks. On 25 January 2013, 3 days after the last dose of vaccination with BOOSTRIX, the patient's mother felt decreased foetal movement. By approximately 27 January 2013, she no longer felt the baby movement. On 30 January 2013, the patient's mother presented to the clinic with chills, vomiting, no appetite and the feeling of no foetal movement for several days. On presentation, the foetus had no movement or cardiac activity and was subsequently diagnosed with intrauterine foetal death (IUFD) (data as per the obstetrics records received on 8 March 2013-service dates 22 January 2013 to 3 February 2013). The patient was delivered with hydrops, micrognathia and cord stricture via spontaneous vaginal delivery (still birth). The case of death was unknown. Autopsy was not performed due to religious reasons. The pathology cytogenetic analysis revealed abnormal results: trisomy 12 identified through chromosomal analysis of the foetal tissue consistent with dysmorphic foetus at the time of delivery. This case was considered serious due to death and congenital abnormality. The authors did not comment of the relationship between trisomy 12 with BOOSTRIX. However, it was reported that the mother continued to believe that it was related to Tdap. The authors concluded that "We identified no safety concerns in this comprehensive review of VAERS reports after routine Tdap vaccination was recommended in pregnant women. Findings from our review are consistent with data from other monitoring systems and epidemiological studies which have found a favourable safety profile for Tdap vaccine use during pregnancy". This is 1 of the 2 valid cases from the same literature article.