Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Delivery, Exposure during pregnancy, Foetal death, Foetal hypokinesia
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of stillbirth in a 30-year-old female patient who received BOOSTRIX. The patient's past medical history included pregnancy, cholecystectomy, genital herpes simplex, cystocele and rectocele. Concurrent medical conditions included female circumcision, anemia and high risk pregnancy. Concomitant products included ferrous sulfate, folic acid, docusate sodium, ranitidine hydrochloride and Prenatal vitamins. On 22nd January 2013, the patient received the 3rd dose of BOOSTRIX (intramuscular). The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received BOOSTRIX at week 28 of the pregnancy and during the third trimester of pregnancy. In January 2013, several days after receiving BOOSTRIX, the patient experienced chills, vomiting, appetite absent and epigastric pain. On 22nd January 2013, the patient experienced vaccine exposure during pregnancy and contraindicated drug administered. On 25th January 2013, the patient experienced fetal hypokinesia (serious criteria GSK medically significant). On an unknown date, the patient experienced stillbirth (serious criteria GSK medically significant). On an unknown date, the outcome of the stillbirth, fetal hypokinesia, chills, vomiting, appetite absent, epigastric pain, vaccine exposure during pregnancy and contraindicated drug administered were unknown. The pregnancy ended in a stillbirth at greater than 22 weeks gestation, and a congenital anomaly was present. On an unknown date after [weeks gestation], the patient gave birth to a [gender] neonate via vaginal delivery. The reporter considered the stillbirth and fetal hypokinesia to be related to BOOSTRIX. It was unknown if the reporter considered the chills, vomiting, appetite absent and epigastric pain to be related to BOOSTRIX. See case US2016GSK100204 for details regarding the baby case. Additional information was provided: This retrospective pregnancy case was reported in a literature article and described stillbirth in a 30-year-old female who was vaccinated with BOOSTRIX (GlaxoSmithKline). This case concerns to VAERS ID: 485632. The patient had a medical history of prior pregnancy, genital herpes simplex virus, midline cystocele, rectocele without prolapse, female circumcision, anaemia, haematoma complicating a procedure, cholecystectomy. The patient had insufficient prenatal care. The patient had not undergone 2nd trimester anatomic ultrasound or prenatal genetic testing. The patient had received ferrous sulfate 325mg orally BID, docusate 250mg orally QDay, ranitidine 150mg orally BID, prenatal vitamin orally QDay. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's family history was provided. On 22 January 2013, the patient received 3rd dose of BOOSTRIX intramuscularly on right arm (lot number AC52B103AA) during 3rd trimester, at 28 weeks and 3 days of pregnancy. On an unspecified date between 22 January 2013 and 25 January 2013, on routine obstetrics follow up, the patient presented with epigastric pain. The foetal movement was normal (data as per the obstetrics records received on 8 March 2013-service dates 22 January 2013 to 3 February 2013). On 25 January 2013, 3 days after the last dose of vaccination with BOOSTRIX, the patient felt decreased foetal movement. By approximately 27 January 2013, she was no longer feeling the baby movement. On 30 January 2013, the patient presented to the clinic with the feeling of no foetal movement for several days. The patient was diagnosed with high risk pregnancy, intrauterine foetal death (IUFD) with no cardiac activity or foetal movement (data as per the obstetrics records received on 8 March 2013-service dates 22 January 2013 to 3 February 2013). Subsequently, the patient was admitted to labour and delivery department for induction to evacuate the uterus. The patient had delivered breech foetus with hydrops, micrognathia and cord stricture via spontaneous vagina; delivery. Autopsy was not performed on the foetus due to religions reasons. The patient's laboratory and diagnostics included: abnormal ultrasound antenatal screen, complete blood count (low red blood cell count at 3.55 mil/mm3, low haemoglobin at 10.1 g/dL, low haematocrit at 31.2%, high red cell distribution width at 15.8% and high thrombin at 28.0 sec- normal values for all not provided). Urine culture was positive. The patient was discharged after 3 days of hospital stay and was advised pelvic rest for 6 weeks. The outcome of pregnancy was still birth. The authors did not comment of the relationship between the events and BOOSTRIX. However, it was reported that the patient 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.