Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, 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 18-Dec-2019, concerning a female, neonatal subject. The subject's mother was 29-year-old  pregnant female of body weight: 191 Ibs, height: 64 in and body mass index (BMI) 32.8 enrolled in a prospective observational safety study.  The mother's current medical condition included hypertension and seasonal allergies.  The mother's  concomitant medications included Prenatal multivitamin + DHA (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, unspecified vitamin B12, zinc oxide) for pregnancy, labetalol for hypertension, iron as supplement and Zyrtec (cetirizine hydrochloride) for allergies. The subject's father was 29-year-old.  The subject's mother had one previous pregnancy with full term live birth with no birth defects. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring 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 11-Mar-2019. Estimated delivery date (EDD) was reported as 18-Dec-2020 and corrected estimated delivery date (CEDD) was reported as 23-Dec-2019. The type of pregnancy was singleton.   On 02-May-2019 and 09-Aug-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 01-Oct-2019, at approximately 29 weeks of gestation, the subject's mother was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On 15-Oct-2019, the subject's mother underwent ultrasound and no MCMs were noted.  At approximately 37.1 weeks of gestation, the mother delivered a live female neonate via caesarean method. The characteristics of the neonate included weight: 2490 grams, head circumference: 31 cm and length: 48.3 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and at ten minutes was not reported. No MCMs were identified at the time of birth.   The event of low birth weight baby was considered as serious due to criterion of medical significance.  At the time of this report, the outcome for the event of low birth weight baby was not reported.  The reporter did not provide causality assessment to Afluria QIV.  This case is linked to case 201907398 (the corresponding mother case).  Company comment: The subject experienced low birth weight, 2 months after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 29 weeks of gestation. Chronology is plausible. No plausible alternative aetiology was provided. Causal role of the suspect vaccine cannot be excluded and is assessed as related. The event foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender's Comments: The subject experienced low birth weight, 2 months after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 29 weeks of gestation. Chronology is plausible. No plausible alternative aetiology was provided. Causal role of the suspect vaccine cannot be excluded and is assessed as related. The event foetal exposure during pregnancy is assessed as not related to the suspect vaccine.