Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Pre-term birth; Birth weight 2495 g; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 23-Aug-2019, concerning a female, neonate subject, whose mother was 20-year-old, pregnant female subject of body weight 172 lbs, height 62 inches and body mass index 32.5, enrolled in a prospective observational safety study.  The mother's medical history included nausea, anxiety and polycystic ovarian syndrome. Concomitant medications included metformin ER, Lexapro (escitalopram oxalate), Bonjesta (doxylamine succinate, pyridoxine hydrochloride), TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) and Prenatal vitamins (mineral NOS, vitamins NOS).   The subject's mother had no previous pregnancies. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Also, the subject's mother had no maternal or paternal history with major congenital malformations. The mother's last menstrual period (LMP) date was 01-Nov-2018, and the expected delivery date was 08-Aug-2019. The type of pregnancy was singleton.   On 31-Dec-2018, at gestation age of 8 weeks, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252678, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 28-Jun-2019, at gestational age of 34.1 week, the mother delivered live birth, female neonate [explicitly coded as Premature baby'] via caesarean method. The neonate's birth weight was 2495 grams, head circumference and body length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute), 7 (five minutes) and 9 (ten minutes). There was no major congenital malformation identified at birth.   At the time of initial reporting, the outcome of the event low birth weight baby' was not reported.  This case is linked to 201903783 (corresponding mother case).  Company Comment: The neonate subject experienced low birth weight baby and premature baby 5 months 28 days after foetal exposure during pregnancy with the suspect product Flucelvax QIVc (Influenza vaccine). Chronology is plausible. Causality was confounded by mother's concomitant medications metformin ER, Lexapro (escitalopram oxalate), Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The neonate subject experienced low birth weight baby and premature baby 5 months 28 days after foetal exposure during pregnancy with the suspect product Flucelvax QIVc (Influenza vaccine). Chronology is plausible. Causality was confounded by mother's concomitant medications metformin ER, Lexapro (escitalopram oxalate), Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.