Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight was 4570 g; This is an observational study case from, initially received on 24-Feb-2020, concerning a male, neonate subject whose mother was 31-year-old pregnant, female subject, of body weight 231 lbs, height 68 inches and body mass index (BMI) 35.1, enrolled in, a prospective observational safety study.  The subject's mother's medical history included macrosomia, acid reflux and hard stool.   The subject's mother's concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for pregnancy, Zantac (ranitidine hydrochloride) for acid reflux and docusate sodium as stool softener.  The subject's mother's obstetrical history noted that the mother had three previous pregnancies, which included two full term live births and one spontaneous abortion. No birth defects were noted. The subject's mother had history of caesarean section. The subject's mother had no history of offspring with major congenital malformation (MCM). Also, the subject's mother had no maternal or paternal history 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 23-Mar-2019, the estimated delivery date (EDD) was reported as 28-Dec-2019, while the corrected estimated date of delivery (CEDD) was reported as 22-Dec-2019. The type of pregnancy was singleton.   On 10-Jun-2019, the subject's mother underwent first sequential and nuchal translucency tests, and no MCM was noted.  On 08-Jul-2019, the subject's mother underwent second sequential test, and no MCM was noted.  On 22-Oct-2019, at approximately 30 weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation.   On 30-Oct-2019, the subject's mother underwent targeted ultrasound scan, and no MCM was noted.  At approximately 38.3 weeks of gestation, the mother vaginally delivered a live male neonate. The neonate's birth weight was 4570 g, while body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes), while no data was provided for ten minutes. No MCMs were identified at the time of birth.   At the time of this report, the outcome of the event 'high birthweight baby' was not reported.  The event of 'high birthweight 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 202000100, the corresponding mother case.  Company comment: A male neonate was delivered as large for dates baby after maternal receipt of Afluria QIV vaccine at approximately 30 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible. Mother's medical history of macrosomia and obesity (body mass index 35.1) may provide alternative aetiology for the event. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event large for dates baby is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: A male neonate was delivered as large for dates baby after maternal receipt of Afluria QIV vaccine at approximately 30 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible. Mother's medical history of macrosomia and obesity (body mass index 35.1) may provide alternative aetiology for the event. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event large for dates baby is assessed as unlikely related (defaults to related for reporting purposes).