Sex: F
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Foetal growth restriction, Low birth weight baby, Premature baby
Clinical narrative: Birth weight 1824 g; Born at 35.6 weeks of gestation; Intrauterine growth restriction (IUGR); Foetal exposure during pregnancy; This is an observational study case from, initially received from other health professional on 03-Apr-2020, concerning a foetal subject whose mother was 32-year-old, female, pregnant subject of body w,eight: 227 lbs, height: 62 inches and body mass index (BMI): 41.5, enrolled in, a prospective observational safety study.  The subject's mother's current conditions included increased BMI, herpes simplex virus 1 & 2, chlamydia and anaemia.  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, ferrous sulfate for anaemia and Zithromax (azithromycin) for chlamydia.  The subject's mother's obstetrical history noted that the mother had three previous pregnancies, one with two full term live births and one spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject's mother had no history of offspring with MCM. 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 on 04-Jul-2019. The subject's mother's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 09-Apr-2020. The type of pregnancy was singleton.   On 28-Aug-2019, the subject's mother underwent spinal muscular atrophy and cystic fibrosis mutation analysis. There were no MCMs noted.  On 16-Sep-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 30-Sep-2019, the subject's mother underwent panorama and no MCMs were noted.  On 22-Nov-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 27-Jan-2020, at approximately 16 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On 31-Jan-2020, 3 months 6 days after vaccination, intrauterine growth restriction (IUGR) was noted as pregnancy complication. On the same day, the subject's mother underwent ultrasound and no MCMs were noted.  On 14-Feb-2020, the subject's mother underwent ultrasound and no MCMs were noted.  On 28-Feb-2020, the subject's mother underwent ultrasound and no MCMs were noted.  On 01-Mar-2020, the subject's mother underwent ultrasound and no MCMs were noted.  At gestational age of 35.6 weeks (as reported), the subject's mother vaginally delivered a live birth female neonate. The neonate's birth weight was 1824 g, body length was 44.5 cm and head circumference was 30.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute), 9 (five minutes) and score was not provided for 10 minutes. No MCM was identified at birth.   At the time of this reporting, the outcome of the events 'foetal growth restriction', 'premature baby 33 to 36 weeks' and 'low birth weight baby' was not reported.  The events of 'foetal growth restriction', 'premature baby 33 to 36 weeks' and 'low birth weight baby' were considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202002746, corresponding mother case.  Company Comment: A foetal subject experienced premature birth, foetal growth restriction and low birth weight baby after foetal exposure to the suspect product, Flucelvax QIV. Foetal growth restriction was noted 3 months after vaccination and baby was born 4 months and 13 days after vaccination. Chronology is unsuggestive. The subject's mother's current conditions included increased BMI, herpes simplex virus 1 & 2, chlamydia and anaemia. Causality was highly confounded. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A foetal subject experienced premature birth, foetal growth restriction and low birth weight baby after foetal exposure to the suspect product, Flucelvax QIV. Foetal growth restriction was noted 3 months after vaccination and baby was born 4 months and 13 days after vaccination. Chronology is unsuggestive. The subject's mother's current conditions included increased BMI, herpes simplex virus 1 & 2, chlamydia and anaemia. Causality was highly confounded. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.