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; Born at 33.6 weeks of gestation; Birth weight 1720 g; Birth lenght 41.3 cm; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a male neonate subject, whose mother was 28-year-old, female subject, of body weight 148.8 lbs, height 63 inches and body mass index (BMI) 26.4 enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's mother's current condition included increased BMI.  The subject's mother's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) and Prometrium (progesterone) both for neonatal care.  The subject's mother's obstetrical history included three previous pregnancy which included one full term live birth and two spontaneous abortions. The subject's mother had no history of offspring with major congenital malformations (MCMs), nor relevant maternal and paternal medical history with MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was 07-Jul-2019. The subject's mother's estimated delivery date (EDD) was reported as 12-Apr-2020 and corrected estimated date of delivery (CEDD) was reported 13-Apr-2020. The type of pregnancy was multiple (twins). The subject's father was 29-years-old.  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, approximately at 18 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD)  [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunization.  At 33.6 weeks of gestation (as reported), the subject's mother delivered two premature live male neonates by Caesarean method. The characteristics of neonate subject included weight of 1720 grams, length of 41.3 cm head circumference was not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score was 7 at one minute and 8 at five minutes. No APGAR score data for 10 minutes was reported. No MCM was identified at birth.  At the time of this report, the outcome of events 'low birth weight', 'small for gestational age' and 'premature baby 33 to 36 weeks' was not reported.  Per company, the events of 'low birth weight', 'small for gestational age' and 'premature baby 33 to 36 weeks' were considered as serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to 202003314 (the corresponding mother case) and 202003316 (the corresponding baby brother case).  Company comment: A male neonate subject, whose mother was 28-year-old female subject, developed premature baby, low birth weight baby and small for dates baby after vaccination with the suspect product Flucelvax QIV for influenza immunization. Reportedly, at 33.6 weeks of gestation, the subject's mother delivered two premature live male neonates by Caesarean method. Chronology seems compatible. The subject's mother's current condition included increased BMI, while concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) and Prometrium (progesterone) both for neonatal care. The subject's mother's obstetrical history included three previous pregnancy which included one full term live birth and two spontaneous abortions. The subject's mother had no history of offspring with major congenital malformations (MCMs). With information presented, causality is assessed as unlikely related for all 3 events considering increased BMI and twin pregnancy. 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 28-year-old female subject, developed premature baby, low birth weight baby and small for dates baby after vaccination with the suspect product Flucelvax QIV for influenza immunization. Reportedly, at 33.6 weeks of gestation, the subject's mother delivered two premature live male neonates by Caesarean method. Chronology seems compatible. The subject's mother's current condition included increased BMI, while concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) and Prometrium (progesterone) both for neonatal care. The subject's mother's obstetrical history included three previous pregnancy which included one full term live birth and two spontaneous abortions. The subject's mother had no history of offspring with major congenital malformations (MCMs). With information presented, causality is assessed as unlikely related for all 3 events considering increased BMI and twin pregnancy. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)