Sex: M
Vaccine: UNK
Symptoms: Apgar score low, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 2 and at five minutes was 2; This is an observational study case, initially reported by other health professional on 20-Feb-2020, concerning a male, neonate subject whose mother was 23-year-old, female subject of body weight 136 lbs, height 63 inches and body mass index (BMI) 24.1, enrolled in a prospective observational safety study.  The subject's mother's medical history included postpartum gastrointestinal haemorrhage, anxiety, depression and acute sinusitis.   The subject's mother's concomitant medications included prenatal vitamins (unspecified minerals and vitamins), TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine, promethazine-codeine syrup (codeine phosphate, promethazine hydrochloride) and Zithromax Z-pack (azithromycin) both used for sinusitis.  The subject's mother's obstetrical history noted that the mother had one previous full term, live birth pregnancy with no birth defects. The subject's mother had no history of offspring with major congenital malformation (MCM). The mother's second cousin had spina bifida. The subject's mother used e-cigarettes during pregnancy. The subject's mother did not use alcohol or illicit drugs during pregnancy.   The subject's mother last menstrual period (LMP) date was 16-May-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 20-Feb-2020. The type of pregnancy was singleton. The subject's father was a 23-year-old.  On 13-Aug-2019, the subject's mother underwent first trimester screen and nuchal translucency. No MCMs were noted.  On 12-Sep-2019, the subject's mother underwent maternal serum alpha fetoprotein screening (MSAFP) and second trimester screen. No MCMs were noted.  On 03-Oct-2019, at approximately 20 weeks of gestation, the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number reported as 269809 (Seqirus batch number: 259809), dose: 0.5 mL, 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 anatomy ultrasound and no MCMs were noted.  At approximately 38.9 weeks of gestation, the mother vaginally delivered a live male neonate. The neonate's birth weight was 3402 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 2, at five minutes was 2 and no data was provided at ten minutes. No MCMs were identified at the time of birth.   At the time of initial reporting, the outcome for the event of 'APGAR score low' was not reported.  The event of 'APGAR score low' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.   This case is linked to the case 201906325, the corresponding mother case.  Company comment: A male neonate subject experienced apgar score low after maternal receipt of Flucelvax QIVc vaccine at approximately 20 weeks of gestation (considered as foetal exposure during pregnancy). Chronology seems plausible. Mother's medical history of e-cigarettes use may provide alternative aetiology for the event. Non-company vaccine Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) also confounds causality in significant way. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event apgar score low is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: A male neonate subject experienced apgar score low after maternal receipt of Flucelvax QIVc vaccine at approximately 20 weeks of gestation (considered as foetal exposure during pregnancy). Chronology seems plausible. Mother's medical history of e-cigarettes use may provide alternative aetiology for the event. Non-company vaccine Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) also confounds causality in significant way. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event apgar score low is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).