Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Preterm birth; Vaccine fetal exposure during pregnancy; This is an observational study case, initially received on 16-Jan-2020, concerning a male neonate subject, whose mother was 36-year-old, pregnant subject of body weight: 234 lbs, height: 64 inches and body mass index (BMI): 40.2,  enrolled in a prospective observational safety study.  The mother's medical history included migraines, high body mass index (BMI) and advanced maternal age.  The mother's concomitant medications included CitraNatal 90 DHA (vitamin C, calcium, iron, vitamin D3, vitamin E, thiamin, riboflavin, niacinamide, vitamin B6, folic acid, iodine, zinc, copper, docusate sodium, docosahexaenoic acid) as obstetrical (OB) vitamin.  The mother's obstetrical history included two previous pregnancies of full-term live birth. The mother did not have history of offspring with major congenital malformation (MCM), nor relevant maternal and paternal history. The mother did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The mother's last menstrual period (LMP) date was 10-Apr-2019, estimated delivery date (EDD) was reported as 15-Feb-2020, while corrected estimated date of delivery (CEDD) was reported as 03-Feb-2020. The type of pregnancy was singleton. The father's age was 39.  On 29-Jul-2019, the subject's mother underwent Maternit 21 and no MCM was noted.  On 22-Aug-2019, the subject' mother underwent second trimester screen - alfa-fetoprotein test (AFP) and no MCM was noted.  On 13-Sep-2019, at gestational age of 22 weeks, 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: 26100, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the subject underwent anatomy scan and no MCM was noted.  At gestational age of 36.6 weeks, the mother vaginally delivered live male neonate. The neonate's birth weight, head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score was 8 at one minute and 9 at five minutes. No data was reported for APGAR score at ten minutes. No pregnancy complications were noted. No MCM was identified at birth.  At the time of this report, the outcome of premature birth was not reported.  Per company, the event of premature birth was considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment.  This case is linked to the case 202000170 (corresponding mother case).  Company Comment: The male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 22 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of advanced maternal age (36 years) and obesity (body mass index 40.2) may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event premature baby is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The male neonate subject was delivered as premature baby after foetal exposure during pregnancy, at gestation age of 22 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of advanced maternal age (36 years) and obesity (body mass index 40.2) may provide alternative aetiology for the event. Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event premature baby is assessed as unlikely related (defaults to related for reporting purposes).