Age: 30.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Premature separation of placenta
Clinical narrative: Vaccine exposure during pregnancy; 20% abruption; This is an observational study case, initially received on 14-Jan-2020, concerning a 30-year-old female pregnant subject of body weight 148 lbs, height 64 inches and body mass index (BMI) 25.4, enrolled in, a prospective observational safety study.  The subject's current condition included increased BMI.   The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) as vitamin (as reported).  The subject's last menstrual period (LMP) date was reported as 26-Mar-2019. The subject's estimated date of delivery (EDD) was reported as 31-Dec-2019, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   The subject's obstetrical history included two previous pregnancies, one full term live birth and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no paternal history with MCM. The subject's cousin had tetralogy of Fallot. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   On 04-Oct-2019, at approximately 27 weeks of gestation, the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261727, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.   On the same day, the subject was administered non-company co-suspect TDAP vaccine [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; dose: 0.5 mL, route of administration: intramuscular, anatomical location, batch number and expiration date: not reported] as vaccine.  On an unspecified date in 2019, the subject's pregnancy was complicated by 20 % abruption of placenta.  At approximately 39.3 weeks of gestation, the subject gave live birth to a female neonate via caesarean method of delivery. The characteristics of the neonate included birth weight of 2889 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. No data was provided for APGAR score at ten minutes. No major congenital malformations (MCMs) were identified at the time of birth. It was reported that pregnancy complication also included foetal intolerance of labour.  At the time of this report, the outcome for the event of placental abruption was not reported.  The event of placental abruption was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case number 202000133 (the corresponding baby case).  Company comment: The subject experienced premature separation of placenta associated with administration of Flucelvax QIV. The subject was administered vaccine at approximately 27 weeks of gestation and developed event on an unspecified date in 2019. Chronology needs more clarification. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related, since no alternate aetiologies was provided. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The subject experienced premature separation of placenta associated with administration of Flucelvax QIV. The subject was administered vaccine at approximately 27 weeks of gestation and developed event on an unspecified date in 2019. Chronology needs more clarification. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related, since no alternate aetiologies was provided. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.