Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Born at 36.9 weeks of gestation; Oligohydramnios; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a male neonate whose mother was 29-year-old, female pregnant subject of body weight: 286 lbs, height: 60 inches and body mass index (BMI): 55.8 enrolled in a prospective observational safety study.  The subject's mother's historical condition included vaginitis, treated with Metrogel(metronidazole).  The subject's mother's current conditions included anaemia and obesity (body mass index 55.8).  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and ferrous sulfate for anemia.  The subject' mother had two previous pregnancies with full term live births, with no birth defects. The subject' mother had no maternal or paternal history with major congenital malformation (MCM).    The subject's mother's last menstrual period (LMP) date was 14-Mar-2019. The type of pregnancy was singleton. The subject's mother's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both 19-Dec-2020. The subject' mother did not consume tobacco, alcohol or illicit drugs during pregnancy. The subject's father age was not reported.  On 25-Jun-2019, the subject' mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy, no major congenital malformations (MCM) was noted.  On 22-Jul-2019, the subject's mother started Ferrous sulafte as treatment for anaemia, 325 mg twice a day, orally.  On 24-Jul-2019, the subject's mother underwent ultrasound scan and panorama, and no MCM was noted.   On 24-Oct-2019, at gestational age of 32 weeks(calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 262218, dose:0,5mL, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On the same day, the subject's mother underwent ultrasound scan and no major congenital malformations (MCM) was noted.  On 13-Nov-2019, the subject's mother underwent ultrasound scan and no major congenital malformations (MCM) was noted.  On 26-Nov-2019, the subject's mother underwent ultrasound scan and no major congenital malformations (MCM) was noted.  At gestational age of 36.9 weeks, the subject's mother delivered male neonate by caesarean method. The birth weight of the neonate was 2552 g. Head circumference was 33 cm and length 45.7 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9. No data was reported for APGAR score at ten minutes. No MCM was identified at birth. On the same day the pregnancy complication of oligohydramnios was noted and was resolved. On the same day the subject's mother stopped taking treatment for anaemia.  The outcome of event premature baby' was not reported.  The event of premature delivery' and oligohydramnios' was considered serious due to the criterion of medical significance, per company.  The reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to 202002627 corresponding mother case.