Sex: U
Vaccine: FLUX
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Foetal cardiac disorder, Foetal gastrointestinal tract imaging abnormal, Ultrasound antenatal screen abnormal
Clinical narrative: Fetal ventricular septal defect; Foetal exposure during pregnancy; Echogenic bowel; This is an observational study case, initially received from other health professional on 06-Feb-2020, concerning a foetal subject whose mother was 20-year-old, female, pregnant subject, of body weight: 185 lbs, height: 67 inches and body mass index (BMI): 29, enrolled in, a prospective observational safety study.  The subject's mother current conditions included increased BMI, bundle branch block, seasonal allergies and acid reflux.  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Zantac (ranitidine hydrochloride) for acid reflux and Zyrtec (cetirizine hydrochloride) for allergies.  The subject's mother obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was on 30-Jul-2019. The subject's mother's estimated delivery date (EDD) was reported as 05-May-2020, while corrected estimated delivery date (CEDD) was reported as 12-May-2020. The type of pregnancy was singleton. The subject's father age was not reported.  On 25-Sep-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 23-Oct-2019, the subject's mother underwent non-invasive prenatal testing and nuchal translucency. No MCMs were noted.   On 20-Nov-2019, at approximately 16 weeks of gestation, the subject's mother 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 Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the subject's mother underwent maternal serum alpha fetoprotein screening (MSAFP) and no MCMs were noted.  On an unspecified date in 2019, echogenic bowel was noted.  On 30-Dec-2019, the subject's mother underwent 20-week anatomy ultrasound, foetal ventricular septal defect was noted as MCM and echogenic bowel was ongoing.  At the time of this report, the subject did not recover from the event of foetal gastrointestinal tract imaging abnormal', while the outcome for the event of foetal cardiac disorder' was not reported.  The events of foetal gastrointestinal tract imaging abnormal' was considered as serious due to criterion of medical significance, per company.  The events of foetal cardiac disorder' was considered as serious due to criterion of medical significance and congenital anomaly, per company.  The causality assessment was not provided.  This case is linked to case number 202001666, corresponding mother case.  Company comment: A foetal subject developed foetal cardiac disorder (reported as ventricular septal defect) and foetal gastrointestinal tract imaging abnormal after his mother was vaccinated (on 20-Nov-2019) with the suspect product Flu Vaccine Egg Split QIV CSL for an influenza immunisation. Reportedly, on an unspecified date in 2019, echogenic bowel was noted. Chronology needs more clarification. The subject's mother current conditions included increased BMI, bundle branch block, seasonal allergies and acid reflux. The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Zantac (ranitidine hydrochloride) for acid reflux and Zyrtec (cetirizine hydrochloride) for allergies. Both reported concomitant drugs are on B1 list. According to FDA regulations cetirizine should not be used during pregnancy unless the benefit outweighs the risk to the fetus. With information presented, causality is assessed as unlikely related for both events considering provided confounders (mothers medical history, reported concomitant drugs and unclarified temporal relationship) Foetal exposure during pregnancy is considered unrelated per labelling conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A foetal subject developed foetal cardiac disorder (reported as ventricular septal defect) and foetal gastrointestinal tract imaging abnormal after his mother was vaccinated (on 20-Nov-2019) with the suspect product Flu Vaccine Egg Split QIV CSL for an influenza immunisation. Reportedly, on an unspecified date in 2019, echogenic bowel was noted. Chronology needs more clarification. The subject's mother current conditions included increased BMI, bundle branch block, seasonal allergies and acid reflux. The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Zantac (ranitidine hydrochloride) for acid reflux and Zyrtec (cetirizine hydrochloride) for allergies. Both reported concomitant drugs are on B1 list. According to FDA regulations cetirizine should not be used during pregnancy unless the benefit outweighs the risk to the fetus. With information presented, causality is assessed as unlikely related for both events considering provided confounders (mothers medical history, reported concomitant drugs and unclarified temporal relationship) Foetal exposure during pregnancy is considered unrelated per labelling conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)