Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Depression, Exposure during pregnancy, Polyhydramnios, Uterine rupture
Clinical narrative: Spontaneous uterine abruption; Depression; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 04-Nov-2019, concerning a 35-year-old female pregnant subject of body weight: 312 Ibs, height: 68 in and body mass index (BMI) 47.4 enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's past medical history included gastric bypass, while the subject's risk factors included advanced maternal age and high BMI.  The subject's concomitant medication included buspirone, ondansetron, Protonix (omeprazole), cyclobenzaprine, clonazepam and Zoloft (sertraline); all for an unknown indication.   The subject had three previous pregnancies, two with full term live births and one spontaneous abortion. The subject had a history of caesarean section. The subject had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 04-Feb-2019. Estimated delivery date (EDD) was reported as 11-Nov-2019 and corrected estimated delivery date (CEDD) was reported as 25-Nov-2019. The type of pregnancy was singleton.   On 01-May-2019, the subject underwent Maternit21 and there were no MCMs noted.  On 17-May-2019, the subject underwent gastric bypass panel and there were no MCMs noted.  On 21-Jun-2019, the subject underwent maternal serum alpha-fetoprotein /serum markers and there were no MCMs noted.  On 11-Jul-2019, the subject underwent targeted ultrasound and there were no MCMs noted.  On 10-Oct-2019, at approximately 35 weeks of gestation, the subject was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.  On 04-Nov-2019, the pregnancy status was collected and polyhydramnios, spontaneous uterine abruption and depression were noted.  At the time of initial reporting, the outcome for spontaneous uterine abruption and depression was not reported.  This case is linked to case number 201905906 (corresponding child case).  The case was assessed as serious and the reporter did not provide causality assessment to Afluria QIV.  Company comment: The subject experienced premature separation of placenta and depression after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 35 weeks. Chronology is plausible. Medical history of obesity (body mass index 47.4) and advanced maternal age (35 years) may provide alternative aetiology for the events. Causality was also confounded by therapy with multiple concomitant medications. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events premature separation of placenta and depression is assessed as unlikely related.; Sender's Comments: The subject experienced premature separation of placenta and depression after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 35 weeks. Chronology is plausible. Medical history of obesity (body mass index 47.4) and advanced maternal age (35 years) may provide alternative aetiology for the events. Causality was also confounded by therapy with multiple concomitant medications. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events premature separation of placenta and depression is assessed as unlikely related.