Sex: M
Vaccine: UNK
Symptoms: Apgar score low, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Apgar score 3 at one minute and 5 at five minutes; This is an observational study case, initially received from other health professional on 03-Apr-2020, concerning a male neonate subject whose mother was 34-year-old, female pregnant subject, of body weight: 183 lbs, height: 64 inches and body mass index (BMI): 31.4, enrolled a prospective observational safety study.  The subject's mother's medical history included high BMI.   The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins) for pregnancy.  The subject's mother had three previous pregnancies with full term live births. The subject's mother had no history of offspring with major congenital malformation (MCM). The subject's mother had no relevant maternal and paternal medical history with MCM. The subject's mother did not use tobacco, illicit drug or alcohol during pregnancy. The father was 28-year-old.  The subject's mother's last menstrual period (LMP) date was reported as 15-Jun-2019. The type of pregnancy was singleton. The subject's mother's estimated delivery date (EDD) was reported as 21-Mar-2020 and corrected estimated date of delivery (CEDD) was reported as 05-Mar-2020.  On 29-Jul-2019, the subject's mother underwent panorama test and no MCM was noted.  On 09-Aug-2019, the subject's mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCM was noted.  On 29-Aug-2020, 07-Sep-2020 and 19-Sep-2020, the subject's mother underwent ultrasound, no MCM was noted.  On 14-Nov-2019, at approximately 21 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261218, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On the same day, the subject's mother developed anaemia and started treatment with ferrous sulfate at a dose of 365 mg, twice daily (bid), orally.  On 12-Dec-2019 and 23-Jan-2020, the subject's mother underwent ultrasound, no MCM was noted.  At gestational age of 37.4 weeks (as reported), the subject's mother delivered live birth, male neonate via vaginal method of delivery. The neonate's birth weight was 2567 grams, head circumference 32.4 cm and length 45.7 cm. APGAR (appearance, pulse, grimace, activity and respiration) scores were 3 at one minute, 5 at five minutes and 8 at ten minutes. There were no MCMs identified at birth. On the same day, the subject recovered from the event 'APGAR score low'. The subject's mother recovered from the event anaemia and the treatment with ferrous sulfate was stopped.  The event of 'APGAR score low' was assessed as serious, due to criterion of medical significance.   The reporter did not provide causality assessment.  This case is linked to the case 202002744 (the corresponding mother's case).  Company comment: Apgar score low was reported in neonate subject, after foetal exposure Flucelvax QIV. Subject's mother was administered vaccine at approximately 21 weeks of gestation. Chronology is unsuggestive. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes) since no alternative aetiology was provided. Foetal exposure during pregnancy are assessed as unrelated per company's conventions.; Sender's Comments: Apgar score low was reported in neonate subject, after foetal exposure Flucelvax QIV. Subject's mother was administered vaccine at approximately 21 weeks of gestation. Chronology is unsuggestive. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes) since no alternative aetiology was provided. Foetal exposure during pregnancy are assessed as unrelated per company's conventions.