Sex: U
Vaccine: FLUX
Symptoms: Bacterial disease carrier, Cervical dysplasia, Chromosome analysis normal, Exposure during pregnancy, Foetal disorder
Clinical narrative: Anterior abdominal wall defect; Foetal exposure during pregnancy; This is an observational study case, received from other health professional on 07-Dec-2020 and concerned a foetus, whose mother was 33-year-old, pregnant subject of body weight: 178 lbs, height: 67 inches and body mass index (BMI): 27.9, enrolled, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.   The foetus' mother's concurrent condition included body mass index increased. The foetus' mother's past medical history included urinary tract Infection with group B Streptococcus. The foetus' mother's concomitant medication included Prenatal DHA vitamin (unspecified vitamins and docosahexaenoic acid) for pregnancy, Flintstones (unspecified vitamins) for pregnancy and amoxicillin for urinary tract infection with group B Streptococcus.  The mother's obstetrical history included five previous pregnancies with two full term live births, two spontaneous abortions and one preterm live birth. The foetus' mother had no history of offspring with major congenital malformation (MCM). The foetus' mother had no maternal or paternal history with MCM. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) date was 25-Jun-2020, estimated delivery date (EDD) was reported as 01-Apr-2021 and corrected estimated date of delivery (CEDD) was reported as 02-Apr-2021. The type of pregnancy was singleton. The foetus' father was 33-year-old.    On 11-Sep-2020, at gestational age of 11 weeks (calculated per LMP), the foetus' mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and  anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100230203.   On the same day, after receiving Afluria QIV, it was determined that the mother was group B Streptococcus carrier. Also, ultrasound, Counsyl fundamental panel with fragile X and Counsyl chromosomes 13, 18, 21 and sex chromosome analysis revealed no MCMs.  On 28-Sep-2020, 17 days after receiving Afluria QIV, the foetus' mother developed human papilloma virus (HPV) infection with cervical intraepithelial neoplasia I (CIN 1).  02-Nov-2020, ultrasound revealed MCM anterior abdominal wall defect in foetus.  The outcome of the event 'abdominal wall anomaly' was not reported.  The reporter did not provide a causality assessment to Afluria QIV.  The event 'abdominal wall anomaly' was considered serious due to criterion of congenital anomaly and medical significance by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked to a case 202005412 (the corresponding mother case).  Company comment: A 33-year-old, pregnant subject experienced abdominal wall anomaly almost 2 months after administration of Afluria QIV. Causality is assessed as not related to vaccine due to biological implausibility and more likely related to the mother's medical history of BMI increased. More information regarding adnominal wall anomaly is needed for a more precise causality assessment. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A 33-year-old, pregnant subject experienced abdominal wall anomaly almost 2 months after administration of Afluria QIV. Causality is assessed as not related to vaccine due to biological implausibility and more likely related to the mother's medical history of BMI increased. More information regarding adnominal wall anomaly is needed for a more precise causality assessment. Foetal exposure during pregnancy is assessed as unrelated per company conventions.