Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby, Macrosomia
Clinical narrative: Birth weight 4525 g; Suspected macrosomia; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jun-2020, concerning a male foetus, whose mother was 26-year-old pregnant female subject of body weight: 170 Ibs, height: 64 in and body mass index (BMI) 29.2, enrolled in, a prospective observational safety study on pregnancy outcomes in woman immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The foetus' mother's medical history included BMI high and history of gestational diabetes.  The foetus' mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Aspirin (acetylsalicylic acid) for history of gestational hypertension.  The foetus' mother's obstetrical history included one previous pregnancy with one full term live birth. The foetus' mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The foetus' mother's last menstrual period (LMP) date was 22-Jun-2019, the estimated delivery date (EDD) was reported as 28-Mar-2020 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The foetus' father's age was not provided.  On 26-Sep-2019, the foetus' mother underwent prenatal panel and no MCM was noted.  On 22-Oct-2019, at gestational age of 17 weeks (calculated per LMP), the foetus' mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.  On an unspecified date in 2019, an unknown amount of time after vaccination, the foetus' mother developed seasonal allergies and was treated with oral, Claritin (loratadine), at dose 10 mg administered once daily.  On 02-Feb-2020, suspected macrosomia was noted in foetus as pregnancy complication.  At gestational age of 39.3 weeks (reported as), the foetus' mother delivered live birth, male neonate via unknown delivery method. The neonate's birth weight was 4525 g, his head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (one minute) and 9 (five minutes) and for ten minutes not reported. No MCM was noted on birth.  On the same day, the outcome of the event suspected macrosomia was resolved.  At the time of this report, the outcome of the event high birthweight baby' was not reported.  The events of high birthweight baby' and macrosomia' were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202000099, the corresponding mother case.  Company Comment: A male neonate was delivered as large for dates baby (Birth weight 4525 g) approximately five months after foetal exposure to the suspect product, Afluria QIV. Suspected macrosomia was noted in foetus as pregnancy complication. Chronology is unsuggestive. Causality is highly confounded by maternal underlying BMI high and history of gestational diabetes. Causal role of the suspect vaccine is assessed as not related for both events, due to presented confounders, unsuggestive chronology and biological/ pharmacological implausibility. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A male neonate was delivered as large for dates baby (Birth weight 4525 g) approximately five months after foetal exposure to the suspect product, Afluria QIV. Suspected macrosomia was noted in foetus as pregnancy complication. Chronology is unsuggestive. Causality is highly confounded by maternal underlying BMI high and history of gestational diabetes. Causal role of the suspect vaccine is assessed as not related for both events, due to presented confounders, unsuggestive chronology and biological/ pharmacological implausibility. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.