Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight; Pre-term birth; This is an observational study case, initially received from other health professional on 18-Dec-2019, concerning a male, neonatal subject. The subject's mother was 37-year-old  pregnant female of body weight: 121 Ibs, height: 61 in and body mass index (BMI) 22.9 enrolled in a prospective observational safety study.  The subject's mother current medical condition included acid reflux and advanced maternal age.   The subject's mother 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 and zinc oxide) for pregnancy, omeprazole for acid reflux, iron and Vitamin D3 (colecalciferol), both as supplement.  The subject's mother had one previous pregnancy with elective abortion. 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 06-Mar-2019. Estimated delivery date (EDD) was reported as 11-Dec-2019 and corrected estimated delivery date (CEDD) was reported as 31-Dec-2019. The type of pregnancy was singleton.   On 04-Jun-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 07-Aug-2019, the subject's mother underwent maternal serum alpha fetoprotein (MSAFP) screening and no MCMs were noted.  On 06-Sep-2019, the subject's mother underwent fetal echo and no MCMs were noted.  On 30-Sep-2019, at approximately 26 weeks of gestation, the subject's mother was administered Flu Vaccine Egg Split QIV CSL (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.  At approximately 35.3 weeks of gestation, mother delivered a live male neonate via caesarean method (explicitly coded as 'Premature birth'). The characteristics of the neonate included weight: 2410 grams (explicitly coded as Low birth weight baby'), head circumference: 33 cm and length: 45 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores 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 pregnancy complications were noted as severe pre-eclampsia and low-lying placenta. The events of 'low birth weight baby' and 'premature birth' are considered as serious due to criterion of medical significance.  At the time of this report, the outcome for the events of 'low birth weight baby' and 'premature birth' was not reported.   The causality assessment was not provided.  This case is linked to case 201905410 (corresponding mother case).  Company comment: The subject experienced preterm birth and low birth weight 2 months after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 26 weeks of gestation. Chronology is plausible. Advanced maternal age may have contributed to development of the events. No other alternative aetiology was provided. Causal role of the suspect vaccine cannot be excluded and is assessed as related. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender's Comments: The subject experienced preterm birth and low birth weight 2 months after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 26 weeks of gestation. Chronology is plausible. Advanced maternal age may have contributed to development of the events. No other alternative aetiology was provided. Causal role of the suspect vaccine cannot be excluded and is assessed as related. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.