Sex: F
Vaccine: UNK, FLUC3
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth; This is a serious spontaneous case, initially received from other health professional on 20-Nov-2019, concerning a female neonate patient.  The patient's mother was a 25-year-old, adult, female of body weight: 259.2 lbs, height: 66 inches and body mass index (BMI):41.8, whose obstetrical history included one previous pregnancy with one full term live birth. The mother had no history of offspring with major congenital malformation (MCM) and did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. Also, the mother had no maternal or paternal history with MCM.   The mother's current conditions included pregnancy induced hypertension and high BMI.  The mother's concomitant medication included labetalol for pregnancy induced hypertension and Prenatal vitamins (unspecified minerals and vitamins) as neonatal care.  The mother's last menstrual period date (LMP) was 18-Jan-2019. The estimated delivery date (EDD) was 25-Oct-2019 and corrected estimated delivery date (CEDD) was 29-Oct-2018. The type of pregnancy was multiple (twins). The pregnancy was complicated with high BMI and pregnancy induced hypertension.  On 14-Mar-2019, the patient's mother underwent ultrasound scan and no MCM was noted.  On 02-Apr-2019, the patient's mother underwent first trimester screen and no MCM was noted.  On 17-Jun-2019, the patient's mother underwent ultrasound scan and no MCM was noted.  On 23-Sep-2019, at approximately 35 weeks of gestation, the mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-subunit, batch number: 261207; dose, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for an unknown indication.   At 36.1 weeks of gestation, the mother delivered with vacuum assisted a premature female neonate. The characteristics of the neonate included birth weight: 2905 g, length: 50.8 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 at one minute and 9 at five minutes.). There was no APGAR score data for 10 minutes. No MCMs were identified at birth.    At the time of initial reporting, the outcome of the event of premature birth was not reported.   This case was assessed as serious (medically significant).  The reporter did not provide causality assessment.  This case is linked to cases 201906222 (mother case) and 201906224 (the same reporter).  Company Comment: The female neonate was delivered as premature baby after foetal exposure during pregnancy with the suspect product, Flucelvax QIV. Chronology is plausible. Mother's medical history of hypertension, obesity (body mass index 41.8) and twin pregnancy may provide more plausible alternative aetiology for the events. Causality was also confounded with concomitant medication, labetalol. Foetal exposure during pregnancy is assessed as not related per company's conventions. For the event premature baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The female neonate was delivered as premature baby after foetal exposure during pregnancy with the suspect product, Flucelvax QIV. Chronology is plausible. Mother's medical history of hypertension, obesity (body mass index 41.8) and twin pregnancy may provide more plausible alternative aetiology for the events. Causality was also confounded with concomitant medication, labetalol. Foetal exposure during pregnancy is assessed as not related per company's conventions. For the event premature baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.