Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Alpha 1 foetoprotein abnormal, Exposure during pregnancy, Foetal disorder, Placenta praevia, Ultrasound antenatal screen abnormal
Clinical narrative: Vaccine exposure during pregnancy; Partial placenta previa; This observational study case, received on 30-Oct-2020 from other health professional and concerned a 28-year-old, female, pregnant subject of body weight: 133 lbs, height: 63.3 inches and body mass index (BMI): 23.3, enrolled in a prospective observational safety study.  The subject's concurrent conditions included anxiety, acid reflux and morning sickness. The subject's past medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness, nexium and famotidine both for acid reflux. The subject's concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy.  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). The subject had no maternal or paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 24-Jun-2020. The subject's estimated delivery date (EDD) was reported as 31-Mar-2021 and corrected estimated date of delivery (CEDD) was reported as 01-Apr-2021. The type of pregnancy was singleton.   On 25-Aug-2020, the ultrasound revealed no MCM.  On 02-Sep-2020, the counsyl chromosome 13, 18, 21 plus sex chromosome analysis and ultrasound revealed no MCM.  On 12-Oct-2020, at approximately 15 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100253284.   On the same day, the maternal serum alpha fetoprotein screening (MSAFP/Serum marker) revealed borderline elevation for spina bifida and it was unknown if MCM was noted.  On 20-Oct-2020, the MSAFP/Serum marker - repeat revealed no MCM.  On 03-Nov-2020, the ultrasound revealed partial placenta praevia and fluid collection near left kidney related to baby.  On 01-Dec-2020, the ultrasound revealed MCM: lymphangioma of foetus.  The outcome of the event 'placenta praevia' was not reported.  The reporter did not provide a causality assessment.  The event of 'placenta praevia' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with case 202008416, due to the corresponding baby case.  Additional information received from other health professional on 21-Dec-2020 with additional document received on 29-Dec-2020: Two additional lab tests added. Placenta praevia added as event and case was upgraded from non-serious to serious. Fluid collection near left kidney related to baby and lymphangioma noted as baby case opened. The narrative was amended accordingly.  Company comment: A 28-year-old, female, pregnant subject  experienced placenta praevia approximately 28 days after administration of Afluria QIV. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. Concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. Causality is assessed as  not related due to chronological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: Company comment: A 28-year-old, female, pregnant subject  experienced placenta praevia approximately 28 days after administration of Afluria QIV. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. Concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. Causality is assessed as  not related due to chronological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.