Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: Intrauterine growth restriction; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 09-Jun-2020, concerning a male foetus, whose mother was 22-year-old pregnant female subject of body weight: 112 Ibs, height: 63 in and body mass index (BMI) 19.8, enrolled in a prospective observational safety study.  The foetus' mother's medical history was not provided.  The foetus' mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The foetus' mother's obstetrical history included one previous pregnancy, with one full term live birth. The foetus' mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The foetus' mother's last menstrual period (LMP) date was 09-Mar-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported both as 15-Dec-2019. The type of pregnancy was singleton. The foetus' father was 30-year-old.  On 15-Jul-2019, the foetus' mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and there were no MCMs noted.  On 27-Sep-2019, at approximately 29 weeks of gestation (calculated per LMP), the foetus' mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5 mL, 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 foetus' mother underwent ultrasound, and there were no MCMs noted.  On 15-Oct-2019 and 18-Oct-2019, the foetus' mother underwent ultrasound and there were no MCMs noted.  On 25-Oct-2019, 28 days after vaccination, the intrauterine growth restriction (IUGR) was noted in foetus.  On the same day, the foetus' mother underwent ultrasound and there were no MCMs noted.  On 01-Nov-2019, after vaccination, the foetus' mother developed anaemia and was treated with ferrous sulfate, at dose of 325 mg, twice a day (BID), orally.  On 15-Nov-2019, 25-Nov-2019, 02-Dec-2019 and 03-Dec-2020, the foetus' mother underwent ultrasound and there were no MCMs noted.   At 38.4 weeks of gestation (as reported), the subject delivered live birth, male neonate via caesarean method of delivery. The neonate's birth weight was 2800 g, his head circumference was reported as 34.3 cm, and length was reported as 46.4 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were for 8 (one minute), 9 (five minutes) and for ten minutes was not provided. No MCM was noted on birth.  On the same day, the subject recovered from the anaemia and the treatment with ferrous sulfate was stopped. The neonate recovered from the event foetal growth restriction'.  Per company, the event of foetal growth restriction' was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202003791, the corresponding mother case.  Company Comment: The event of foetal growth restriction was noted in foetus 28 days after foetal exposure to the suspect product Flucelvax QIV. The foetus' mother was administered vaccine at approximately 29 weeks of gestation. No MCM was noted after vaccine administration. More information regarding mother's medical history is needed. No alternative aetiology was provided. With information available, causal role of the suspect product 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 conventions.; Sender's Comments: The event of foetal growth restriction was noted in foetus 28 days after foetal exposure to the suspect product Flucelvax QIV. The foetus' mother was administered vaccine at approximately 29 weeks of gestation. No MCM was noted after vaccine administration. More information regarding mother's medical history is needed. No alternative aetiology was provided. With information available, causal role of the suspect product 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 conventions.