Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight; This is an observational study case, initially received from other health professional on 04-Dec-2019, concerning a female neonate, whose mother was a 27-year-old, pregnant, female subject of body weight 188 lbs, height 65.5 inches and body mass index (BMI) 30.8, enrolled in a prospective observational safety study. The subject's father was 28-year-old.   The mother's medical history included high body mass index.   The mother's concomitant medications included prenatal vitamin (unspecified vitamins and minerals) for pregnancy and Tums (calcium carbonate, magnesium carbonate) as antacid.  The mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother last menstrual period (LMP) date was 21-Feb-2019. Estimated delivery date (EDD) and corrected delivery date (CEDD) were 28-Nov-2019. The pregnancy was singleton and complicated with oligohydramnios in third trimester and gestational hypertension. The father was 28-year-old.  On 22-Apr-2019 and 26-Jun-2019, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 27-Sep-2019, at gestational age at 31 weeks, the subject's mother was administered Afluria QIV [influenza vaccine; batch number: P100118566, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On 12-Nov-2019, at gestational age of 37.7 weeks, the subject's mother vaginally delivered live birth, female neonate. The neonate's birth weight was 2110 g, her head circumference was 31 cm and length was 47 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes). There was no MCM identified at birth.   At the time of initial reporting, the outcome of the event low birth weight baby was not reported.   The event of low birth weight baby was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  The case is linked to case 201907092, the corresponding mother case.  Company Comment: The female neonate subject was delivered as low birth weight baby after foetal exposure during pregnancy with the suspect product Afluria QIV at gestation age of 31 weeks. Chronology is plausible. Mother's medical history of obesity (body mass index 30.8) and gestational hypertension may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event low birth weight baby is assessed as unlikely related.; Sender's Comments: The female neonate subject was delivered as low birth weight baby after foetal exposure during pregnancy with the suspect product Afluria QIV at gestation age of 31 weeks. Chronology is plausible. Mother's medical history of obesity (body mass index 30.8) and gestational hypertension may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event low birth weight baby is assessed as unlikely related.