Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight of 4252 g; This is an observational study case, initially received from other health professional on 07-Jul-2020, concerning a male neonate, whose mother was 23-year-old, female pregnant subject of body weight: 261 lbs, height: 70.5 inches and body mass index (BMI) 36.9, 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 obesity and high BMI.  The neonate's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) for vaccination.  The neonate's mother had no previous pregnancies. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The neonate's mother's last menstrual period (LMP) date was on 16-Jul-2019, the estimated delivery date (EDD) was reported as 21-Apr-2020 and corrected estimated delivery date (CEDD) was reported as 14-Apr-2020. The type of pregnancy was singleton. The neonate's father was 31-year-old.  On 14-Oct-2019, the neonate's mother underwent first trimester screen and ultrasound, no MCMs were noted.  On 29-Oct-2019, at approximately 15 weeks of gestation (calculated per LMP), the neonate's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On the same day, the neonate's mother underwent second trimester screen and and maternal serum alpha-fetoprotein (MSAFP)/serum markers, no MCMs were noted.  On 20-Nov-2019, the neonate's mother underwent anatomy ultrasound and no MCMs were noted.   On 20-Mar-2020, 2 months and 20 days after vaccination, the neonate's mother developed bacterial infection due to streptococcus, group B (reported as group B strep').  On 08-Apr-2020, the neonate's mother underwent growth scan and no MCMs were noted.  At 41.1 weeks of gestation (as reported), the mother vaginally delivered a live, male neonate. The neonate's birth weight was 4252 g, while head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score for 10 minutes was not reported. No MCMs were identified at the time of birth.  At the time of initial report, the outcome of event high birthweight baby' was not reported.  The event of high birthweight baby' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to 202003845 (the corresponding mother case).  Company comment: The neonate's mother was administered the suspect product, Flucelvax QIVc at approximately 15 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 41.1 weeks of gestation, the subject vaginally delivered male neonate whose birth weight was 4252 grams (coded as large for dates baby). Medical history of obesity and high BMI confound causality. For the event large for dates baby, causal role of the suspect product is assessed as not related due to biological implausibility. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: The neonate's mother was administered the suspect product, Flucelvax QIVc at approximately 15 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 41.1 weeks of gestation, the subject vaginally delivered male neonate whose birth weight was 4252 grams (coded as large for dates baby). Medical history of obesity and high BMI confound causality. For the event large for dates baby, causal role of the suspect product is assessed as not related due to biological implausibility. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. Foetal exposure during pregnancy is assessed as not related per company conventions.