Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight of 2410 g; This is an observational study case, initially reported by other health professional on 06-Apr-2020, concerning a female, neonate subject whose mother was 30-year-old, female of body weight 161 lbs, height 64 inches and body mass index (BMI) 27.6, enrolled in a prospective observational safety study.   The subject's mother's current condition included increased BMI.  The subject's mother's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother's obstetrical history noted that the mother had one previous pregnancy of full-term live birth with no birth defects. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). 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 last menstrual period (LMP) date was 07-Jul-2019, while the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 12-Apr-2020. The type of pregnancy was singleton. The subject's father was a 32-year-old.  On 04-Sep-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 07-Oct-2019, the subject's mother underwent first trimester screen and no MCMs were noted.  On 05-Nov-2019, at approximately 17 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 reported as 261226, 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.   At approximately 37.1 weeks of gestation (as reported), the mother delivered a live female neonate via caesarean method. The neonate's birth weight was 2410 grams, body length was 48.9 cm and head circumference was 33 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was provided at ten minutes. No MCMs were identified at the time of birth.   At the time of initial reporting, the outcome for the event of 'low birth weight baby' was not reported.  The event of 'low birth weight baby' was considered as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  This case is linked to the case 202002765 (the corresponding mother's case).  Company comment: A female neonate subject, whose mother was 30-year-old female, developed  low birth weight baby after her mother was vaccinated with the suspect product Flucelvax QIVc for influenza immunisation. Reportedly, at approximately 37.1 weeks of gestation the subject was born. Chronology seems compatible. The subject's mother's current condition included increased BMI. The subject's mother's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy. With information presented, causality is assessed as not related to the product due to reported increased BMI of the mother. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A female neonate subject, whose mother was 30-year-old female, developed  low birth weight baby after her mother was vaccinated with the suspect product Flucelvax QIVc for influenza immunisation. Reportedly, at approximately 37.1 weeks of gestation the subject was born. Chronology seems compatible. The subject's mother's current condition included increased BMI. The subject's mother's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy. With information presented, causality is assessed as not related to the product due to reported increased BMI of the mother. Foetal exposure during pregnancy is assessed as unrelated per company conventions.