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-Oct-2019, concerning a female, neonate subject, whose mother was a 28-year-old female of body weight 115 lbs, height 63 inches and body mass index (BMI) 20.4 and father 56-year-old, enrolled in a prospective observational safety study.   The mother's medical history included schizophrenia bipolar and trichomonas. The mother's past medication included Metrogel (metronidazole) for trichomonas. Concomitant medication included Prenatal vitamins (minerals not specified (nos), vitamins nos) for pregnancy and Zoloft (sertraline hydrochloride) for bipolar.   The mother's obstetrical history included two previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother used tobacco during pregnancy and the amount of consumption was reported as half pack per day. The mother did not use alcohol and illicit drugs during pregnancy.  The mother's last menstrual period (LMP) was on 14-May-2018 and type of pregnancy was singleton. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother was reported as 18-Feb-2019.   On 21-Aug-2018, the mother underwent spinal muscular atrophy and cystic fibrosis mutation analysis and no MCMs were noted.   On 06-Sep-2018, the mother underwent ultrasound scan and Qnatal test and no MCMs were noted.  On 09-Oct-2018, at approximately 21 weeks of gestation, the mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-subunit, batch number: 252664, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On 06-Dec-2018 and 17-Jan-2019, the mother underwent ultrasound scan and no MCMs were noted.   At gestational age of 37.3 weeks, the mother vaginally delivered live female neonate. The characteristics of neonate included birth weight: 2155 grams, head circumference: 30.5 cm and length: 45.7 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. The neonate had no MCMs identified at birth.  At the time of initial reporting, the outcome of the event of low birth weight was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.  This case is linked to the case 201905078 (the corresponding maternal pregnancy report).; Sender's Comments: Reportedly, the female neonate subject was delivered as low birth weight baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of trichomonas and tobacco use may provide alternative aetiology for the event. Causality was also confounded by use of concomitant drug, Zoloft (sertraline hydrochloride). Foetal exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event low birth weight baby is assessed as unlikely related.