Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Low birth weight; Preterm birth; This is an observational study case, initially received from other health professional on 08-Oct-2019, concerning a female, neonate subject, whose mother was a 34-year-old female of body weight 294 lbs, height 62 inches and body mass index (BMI) 53.8 and father 35-year-old, enrolled in a prospective observational safety study.  The mother's medical history included obesity. Concomitant medication included Prenatal vitamins (minerals not specified (nos), vitamins nos) and Terazol (terconazol).  The mother's obstetrical history included three previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 13-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 17-Feb-2019. The pregnancy was complicated with gestational hypertension, yeast and placental abruption.  On 05-Nov-2018, the mother underwent spinal muscular atrophy test and cystic fibrosis mutation analysis and no MCM was noted.   On 06-Nov-2018, at approximately 26 weeks of gestation, the mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 252664, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization. On the same day, the mother underwent Q-natal test and no MCM was noted.   On 13-Nov-2018 and 07-Jan-2019, the mother underwent ultrasound scan and no MCM was noted.   At gestational age of 34.7 weeks, the mother delivered live female neonate by caesarean method. The characteristics of neonate included birth weight: 2041 grams, head circumference: 31.1 cm and length: 45 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 events low birth baby and premature birth were not reported.   The case was assessed as serious and the reporter did not provide causality assessment.   This case is linked to the case 201905142 (the corresponding mother case).; Sender's Comments: The female neonate subject was delivered as premature baby and low birth weight baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. The mother's medical history of extreme obesity (BMI) 53.8, gestational hypertension, yeast and placental abruption may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant drug, Terazol (terconazol). Foetal exposure during pregnancy is assessed as not related per company conventions. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.