Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Foetal growth restriction, Low birth weight baby
Clinical narrative: Low birth weight of 2235 g; Vaccine foetal exposure during pregnancy; Intrauterine growth restriction; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a female foetal subject whose mother was 26-year-old, pregnant, female subject of body weight: 205 lbs, height: 62 inches and body mass index (BMI): 37.5 enrolled in a prospective observational safety study.  The mother's past medical history included bacterial vaginosis, while the mother's current medical history included acid reflux and high BMI.  The mother's past medication included Metrogel (metronidazole) for bacterial vaginosis, while the mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Zantac (ranitidine hydrochloride) for acid reflux.  The mother's obstetrical history included two previous full term live births. The subject's mother had no history of offspring with major congenital malformation (MCM) nor relevant maternal or paternal history. The subject's mother did not consume alcohol and illicit drugs during pregnancy, but consumed cigarettes (a half of a pack per day).  The mother's last menstrual period (LMP) date was 23-Mar-2019. The type of pregnancy was singleton. The mother's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both 20-Dec-2019. The father's age was 29.  On 05-Sep-2019, the subject's mother underwent horizon test and no MCM was noted.  On 17-Oct-019, at gestational age of 29 weeks (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: reported as 262218', dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.  On an unknown date in 2019, an unknown amount of time after vaccination, the pregnancy was complicated with intrauterine growth restriction (IUGR).  At gestational age of 37.6 weeks (as reported), the subject's mother delivered a female neonate via caesarean method of delivery. The birth weight of subject was 2235 g. The neonate's head circumference was 33 cm and length were 47 cm.  Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 9. APGAR score for 10 minutes was not provided. The outcome of IUGR was resolved. No MCM was identified at birth.  At the time of initial reporting, the outcome of low birth weight baby' was not reported.  The events of foetal growth restriction and low birth weight baby' were considered serious due to the criterion of medical significance.  This reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to case 202002628 (the corresponding mother's case).  Company Comment: A neonate subject experienced foetal growth restriction an unknown amount of time after vaccination and low birth weight 1 month 16 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 29 weeks. Chronology is plausible. The mother's past medical history included bacterial vaginosis, while the mother's current medical history included acid reflux and high BMI. Causality was highly confounded since subject's mother consumed cigarettes (a half of a pack per day). However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A neonate subject experienced foetal growth restriction an unknown amount of time after vaccination and low birth weight 1 month 16 days after foetal exposure to Flucelvax QIVc. Vaccine was administered at gestation age of 29 weeks. Chronology is plausible. The mother's past medical history included bacterial vaginosis, while the mother's current medical history included acid reflux and high BMI. Causality was highly confounded since subject's mother consumed cigarettes (a half of a pack per day). However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.