Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 4025 g; This is an observational study case from, initially received from other health professional on 25-Mar-2020, concerning male neonate subject, whose mother was  a 30-year-old pregnant female, of body weight: 211 lbs, height: 67 inches and body mass index (BMI): 33, who was enrolled in, a prospective observational safety study.  The subject's mother's medical history included anaemia, increased BMI and the subject's mother's was positive for chlamydia.  The subject's mother's concomitant medications included Prenatal vitamin (minerals nos, vitamins nos) for pregnancy and ferrous sulfate for anemia.  The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history of major congenital malformation (MCM). The subject's mother did not consume tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) was on 23-Mar-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both 28-Dec-2019.  On 02-Aug-2019, the subject's mother underwent panorama test, cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCM was noted.  On 05-Aug-2019 and on 28-Oct-2019, the mother underwent ultrasound and no MCM was noted.  On 04-Nov-2019, the mother underwent non-stress tests and the result was non-reactive, while no data for MCM was noted. Therefore, the subject's mother was instructed to get biophysical profiles. The mother underwent ultrasound for biophysical profile on the same day and no MCM was noted.  On the same day, at gestational age of 32 weeks (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: 262218, Seqirus batch number reported as: possibly 261218; dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On 18-Nov-2019, the subject's mother underwent ultrasound for biophysical profile and no MCM was noted.  On 25-Nov-2019, the mother underwent non-stress tests and the result was non-reactive, while no data for MCM was noted. Therefore, she was instructed to get biophysical profiles. The subject underwent ultrasound for biophysical profile on the same day and no MCM was noted.  On 12-Dec-2019, the subject's mother underwent non-stress tests and the result was non-reactive, while no data for MCM was noted, so she was instructed to get biophysical profiles. The mother underwent ultrasound for biophysical profile on the same day and no MCM was noted.  On 15-Dec-2019, the subject's mother underwent non-stress tests and the result was non-reactive, while no data for MCM was noted, so she was instructed to get biophysical profiles. The mother underwent ultrasound for biophysical profile on the same day and no MCM was noted.  At gestational age of 39.3 weeks (as reported), the subject's mother vaginally delivered a male neonate. The birth weight of the neonate was 4025 g, head circumference was 35.6 cm and length were 53.3 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 9. APGAR score at ten minutes was not provided. No pregnancy complications were noted. No MCM was identified at birth.  The event of high birthweight baby' was considered serious due to the criterion of medical significance.   The reporter did not provide a causality assessment to Flucelvax QIV.  This case is linked to case 202002632 (the corresponding mother case).  Company comment: Reportedly, large for dates baby was associated with Flucelvax QIVc. A subject's mother was vaccinated at 32 weeks of gestation. The baby was born 1 month 19 days later. It was reported that birth weight was 4025 grams. Chronology is plausible. Causality was confounded by increased BMI in mother, 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 unrelated per company's conventions.; Sender's Comments: Reportedly, large for dates baby was associated with Flucelvax QIVc. A subject's mother was vaccinated at 32 weeks of gestation. The baby was born 1 month 19 days later. It was reported that birth weight was 4025 grams. Chronology is plausible. Causality was confounded by increased BMI in mother, 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 unrelated per company's conventions.