Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Non reassuring fetal heart rate tracing; Oligohydramnios; Vaccine foetal exposure during pregnancy; This is an observational study case from, initially received from other health professional on 16-Jul-2020, concerning a male foetus, whose mother was 32-year-old, pregnant, female subject of body weight: 252 lbs, height: 62.4 inches and body mass index (BMI): 45.5 enrolled in, a prospective observational safety study.  The foetus' mother's medical history included Caesarean section (on 18-Oct-2014) and obesity.  The foetus' mother's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) and M-Natal plus iron (vitamin A, vitamin C, vitamin D, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folic acid, vitamin B12, calcium, iron, zinc, copper), both as obstetric (OB) supplements and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The foetus' mother's obstetrical history included one previous pregnancy with full term live birth. The foetus' mother had no history of offspring with major congenital malformation (MCM), nor relevant maternal or paternal history with major congenital malformations. The foetus' mother did not consume tobacco, alcohol or illicit drugs during pregnancy.  The foetus' mother's last menstrual period (LMP) was 12-Jul-2019, estimated delivery date (EDD) was reported as 17-Apr-2020 and corrected EDD (CEDD) was reported as 25-Apr-2020. The type of pregnancy was singleton. The father's age was 33.  On 26-Sep-2019, at gestational age of 10 weeks (calculated per LMP), the foetus' mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 15-Oct-2019, foetus' mother underwent nuchal translucency and first trimester screen. No MCM was noted.  On 12-Nov-2019, the foetus' mother underwent second trimester screen and maternal serum alpha-foetoprotein (MSAFP / serum markers). No MCM was noted.  On 04-Dec-2019, the foetus' mother underwent anatomy ultrasound and no MCM was noted.  On 12-Feb-2020, 4 months 17 days after vaccination, the foetus' mother developed gestational diabetes mellitus and started treatment for it with two tablets of metformin, administered orally twice a day and with Lantus U-100 (Insulin glargine) at a dose of 40 units administered subcutaneously.  On 06-Mar-2020, 5 months and 9 days after vaccination, oligohydramnios was noted.  On an unknown date, an unknown amount of time after vaccination, non-reassuring foetal heart rate tracing was noted.  On 16-Apr-2020, at gestational age of 38.7 weeks (as reported), the mother delivered a male neonate by caesarean method. The birth weight of the neonate was 3402 g. No data for head circumference and length were provided. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 9. APGAR score at ten minutes was not provided. No MCM was identified at birth.   On the same day, the outcome of oligohydramnios was resolved.  At the time of initial reporting, the outcome of fetal heart rate abnormal' was not reported.  The events of oligohydramnios and fetal heart rate abnormal' were considered as serious due to the criterion of medical significance, per company.  This reporter did not provide a causality assessment.  This case is linked to case 202003896 (the corresponding mother case).  Company comment: The event of oligohydramnios was noted in neonate subject 5 months 9 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 10 weeks (explicitly coded as Foetal exposure during pregnancy'). Chronology is implausible. The event of foetal heart rate abnormal developed on an unknown date. Concomitant vaccine TDAP may have contributed to development of the events. Causal role of the suspect vaccine is assessed as unrelated due to biological/ pharmacological implausibility for the events of oligohydramnios and foetal heart rate abnormal. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: The event of oligohydramnios was noted in neonate subject 5 months 9 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 10 weeks (explicitly coded as Foetal exposure during pregnancy'). Chronology is implausible. The event of foetal heart rate abnormal developed on an unknown date. Concomitant vaccine TDAP may have contributed to development of the events. Causal role of the suspect vaccine is assessed as unrelated due to biological/ pharmacological implausibility for the events of oligohydramnios and foetal heart rate abnormal. Foetal exposure during pregnancy is assessed as not related per company's conventions.