Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 4340 g, birth lenght 57.2 cm; This is an observational study case, initially received from other health professional on 06-Apr-2020, concerning a male neonate subject, whose mother was 24-year-old, female subject (Ethnicity: Not reported), of body weight 154 lbs, height 63 inches and body mass index (BMI) 27.1 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 subject's mother's current conditions included increased BMI.  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, 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's last menstrual period (LMP) date was 28-Feb-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 01-Jan-2020. The type of pregnancy was singleton.   On 22-Apr-2019, the subject's mother underwent horizon, cystic fibrosis mutation analysis and spinal muscular atrophy and no MCMs were noted.   On 24-May-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On 07-Jun-2019, the subject's mother underwent panorama and no MCMs were noted  On 19-Jun-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On 28-Oct-2019, at approximately 34 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: 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 13-Nov-2019, the subject's mother underwent ultrasound and no MCMs were noted.   On 09-Dec-2020, month 11 days after vaccination, the subject's mother developed anaemia and started treatment with oral ferrous sulfate at dose of 325 mg, administered via oral route twice a day.  26-Dec-2019, the subject's mother underwent ultrasound and no MCMs were noted.   at gestational age of 39.7 weeks (as reported), the subject's mother vaginally delivered a live birth, male neonate. The neonate's birth weight was 4340 grams. The neonate's head circumference were 35.6 cm and body length were 57.2 cm. 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.  On the same day, the subject's mother recovered from anaemia and treatment was finished.  At the time of this report, the outcome of event Large for dates baby' was not reported.  The event of Large for dates baby' was considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202002768 (the corresponding mother case).  Company comment: The patient's mother was administered the suspect product, Flucelvax QIVc at approximately 34 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 39.7 weeks of gestation, the patient's mother vaginally delivered male neonate whose birth weight was 4030 grams (coded as large for dates baby). Medical history of body mass index high confounds causality. Causal relationship for foetal exposure during pregnancy is assessed as not related, while for the event large for dates baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to related for reporting purposes).; Sender's Comments: The patient's mother was administered the suspect product, Flucelvax QIVc at approximately 34 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 39.7 weeks of gestation, the patient's mother vaginally delivered male neonate whose birth weight was 4030 grams (coded as large for dates baby). Medical history of body mass index high confounds causality. Causal relationship for foetal exposure during pregnancy is assessed as not related, while for the event large for dates baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to related for reporting purposes).