Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Placenta praevia, Ultrasound antenatal screen normal
Clinical narrative: Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 16-Oct-2019, concerning a 35-year-old female, pregnant subject of body weight 200 lbs, height 68 in and body mass index (BMI) 30,4, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's current condition included anxiety, history of deep vein thrombosis (DVT) and allergies. The subject's concomitant medications included DHA Prenatal (docosahexaenoic acid) and Vitamin C (ascorbic acid) both as supplement; Singular (montelukast sodium) and nasal spray both for allergies and heparin porcine for DVT prophylaxis.  The subject's obstetrical history included one previous pregnancy with one full term live birth. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCMs. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period was on 08-Jan-2019 and estimated delivery date (EDD) was reported as 15-Oct-2019 and corrected estimated delivery date (CEDD) was reported as 28-Oct-2019. The type of pregnancy was singleton with risk factor reported as advanced maternal age.  Paternal age was 36-years old.  On 19-Mar-2019, the subject underwent ultrasound scan and no MCM was noted.  On 22-May-2019, the subject underwent ultrasound scan and it was established that the right kidney was located in pelvis.  On 27-Jun-2019, the subject underwent fetal echo and it was established that the right kidney was located in pelvis.  On 27-Sep-2019, at 37 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: P100118566, dose, expiration date, route of administration, anatomical location: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunization.  On the same day, the subject underwent ultrasound scan and no MCM was noted.  On an unspecified date, the subject developed low laying placenta.   The outcome of the event low laying placenta was not reported, at the time of initial reporting.  The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The subject experienced placenta praevia associated with the suspect product Flu Vaccine Egg Split QIV CSL. Reportedly, vaccination occurred during pregnancy at gestational age of approximately 37 weeks of gestation. Temporal relationship is implausible because the placenta is fully formed by 18 to 20 weeks. Causality was confounded by use of concomitant drugs, Singular (montelukast sodium) and heparin. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event placenta praevia is assessed as not related.