Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: Vaccine foetal exposure during pregnancy; Low birth weight of 2404 g; This is an observational study case, initially received on 09-Jun-2020 concerning a male neonate, whose mother was 27-year-old, pregnant subject of body weight: 129 lbs, height: 59 inches and body mass index (BMI): 26.1 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 neonate's mother's medical history included chronic hypertension and increased BMI.  The neonate's mother's concomitant medications included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy.  The neonate's mother had no previous pregnancies. The neonate's mother had no maternal and paternal history with major congenital malformations (MCMs). The neonate's mother did not consume tobacco, alcohol and illicit drugs during pregnancy.  The neonate's mother's last menstrual period (LMP) date was 04-Apr-2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 09-Jan-2020. The type of pregnancy was singleton. The father's age was 34.  On 22-Jul-2019, the neonate's mother underwent ultrasound and Panorama. No MCM was noted.  On 07-Aug-2019, the neonate's mother underwent ultrasound and no MCM was noted.  at gestational age of 25 weeks (calculated per LMP), the neonate's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.   On 30-Oct-2019, the neonate's mother underwent ultrasound and no MCM was noted.  On 13-Nov-2019, one month and 11 days after vaccination, the neonate's mother developed gestational diabetes.  On 21-Nov-2019, the neonate's mother underwent ultrasound and no MCM was noted.  On 12-Dec-2019, on 20-Dec-2019 and on 01-Jan-2020, the neonate's mother underwent ultrasound. No MCM was noted.  At gestational age of 38.9 weeks (as reported), the subject delivered a male neonate by caesarean method. The birth weight of the neonate was 2404 g. Head circumference was 32.4 cm and length were 47 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 7 and at five minutes was 8. APGAR score at ten minutes was not provided. On the same day, the pregnancy was complicated with pre-eclampsia and eclampsia in subject's mother from which the subject's mother recovered on the same day. Also, the subject's mother recovered from gestational diabetes. No MCM was identified at birth.   At the time of initial reporting, the outcome of 'low birth weight baby' was not reported.  Per company, the event of 'low birth weight baby' was considered serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to case 202003788 (the corresponding mother case).  Company Comment: A male neonate experienced the event of low birth weight baby (birth weight 2404 g) approximately three months after foetal exposure to the suspect product Flucelvax QIVc. The neonate's mother was administered Flucelvax QIVc at approximately 25 weeks of gestation. Causal role of the suspect product is assessed as not related, since was highly confounded by eclampsia. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A male neonate experienced the event of low birth weight baby (birth weight 2404 g) approximately three months after foetal exposure to the suspect product Flucelvax QIVc. The neonate's mother was administered Flucelvax QIVc at approximately 25 weeks of gestation. Causal role of the suspect product is assessed as not related, since was highly confounded by eclampsia. Foetal exposure during pregnancy is assessed as not related per company conventions.