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; Delivery at 33.6 weeks of gestation; Low birth weight of 2290 g; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a male neonate subject, whose mother was a 28-year-old adult female pregnant subject of body weight: 148.8 lbs, height: 63 inches and body mass index (BMI): 26.4, enrolled in a prospective observational safety study.  The subject's mother medical history included increased BMI.  The subject's mother concomitant medications included Prometrium (progesterone) and Prenatal vitamins (unspecified vitamins and minerals), both for neonatal care.   The subject's mother obstetrical history included three previous pregnancies with two spontaneous abortions and one full term live birth. The mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was 07-Jul-2019, the estimated delivery date (EDD) was 12-Apr-2020 and corrected estimated date of delivery (CEDD) was 13-Apr-2020. The type of pregnancy was multiple.  On 26-Aug-2019, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 25-Sep-2019, the subject's mother underwent first trimester screen and no MCMs were noted.  On 12-Nov-2019, at gestation age of 18 weeks (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261207; route of administration, anatomical location and expiry date: not reported) (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  At gestational age of 33.6 weeks (as reported) the subject's mother gave birth to a two-premature live male neonates via caesarean method. The characteristics of neonate subject included birth weight: 2290 grams, length: 45.7 cm; head circumference was not provided. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 7, at five minutes was 8 and no data was reported for APGAR score at ten minutes. No MCM was identified at birth.  At the time of this report, the outcome of 'low birth weight baby' and 'premature baby 33 to 36 weeks' was not reported.   Per company, the events of 'low birth weight baby' and 'premature baby 33 to 36 weeks' were considered serious due to criterion of medical significance.   The reporter did not provide causality assessment.  This case is linked to cases 202003314 (corresponding mother case) and 202003315 (corresponding baby twin case).  Company comment: A male neonate subject, whose mother was a 28-year-old adult female pregnant subject, developed premature baby and low birth weight baby after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, the subject's mother was administered with the vaccine at gestation age of 18 weeks. At gestational age of 33.6 weeks (as reported) the subject's mother gave birth to a two-premature live male neonates via caesarean method Chronology seems plausible. The subject's mother medical history included increased BMI. The subject's mother concomitant medications included Prometrium (progesterone) and Prenatal vitamins (unspecified vitamins and minerals), both for neonatal care. The subject's mother obstetrical history included three previous pregnancies with two spontaneous abortions and one full term live birth. With information presented, causality is assessed as unlikely related for premature baby considering med. history of the mother while for other event is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A male neonate subject, whose mother was a 28-year-old adult female pregnant subject, developed premature baby and low birth weight baby after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, the subject's mother was administered with the vaccine at gestation age of 18 weeks. At gestational age of 33.6 weeks (as reported) the subject's mother gave birth to a two-premature live male neonates via caesarean method Chronology seems plausible. The subject's mother medical history included increased BMI. The subject's mother concomitant medications included Prometrium (progesterone) and Prenatal vitamins (unspecified vitamins and minerals), both for neonatal care. The subject's mother obstetrical history included three previous pregnancies with two spontaneous abortions and one full term live birth. With information presented, causality is assessed as unlikely related for premature baby considering med. history of the mother while for other event is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)