Sex: M
Vaccine: FLU4
Symptoms: Apgar score low, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Apgar score 5 at one minute; Large for gestational age; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 11-May-2020, concerning male foetus, whose mother was a 32-year-old pregnant female of body weight: 186 lbs, height: 62 inches and body mass index (BMI): 34, who was enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's mother medical history included anaemia and increased BMI.   The subject's mother concomitant medications included ferrous sulfate for anemia and docusate sodium for an unknown indication.   The subject's mother had no previous pregnancies. The mother had no maternal or paternal history of major congenital malformation (MCM). The mother did not consume tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was on 18-Jun-2019. The subject's estimated delivery date (EDD) was 24-Mar-2020 and corrected estimated date of delivery (CEDD) was not provided. The type of pregnancy was singleton.   On 21-Oct-2019, at gestational age of 17 weeks (calculated per LMP), 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') as influenza immunisation.   On the same day, the mother underwent prenatal panel test and no MCM was noted.  On 06-Nov-2019, the mother underwent targeted ultrasound and no MCM was noted.  On 27-Dec-2019, two months and six days after vaccination, the subject's mother developed gestational diabetes mellitus diet-controlled type 2 (GDMA2), as pregnancy complication.   On 25-Feb-2020, four months and four days after vaccination, it was noted that the foetus was large for gestational age, which was reported as pregnancy complication.  On 03-Mar-2020, four months and 11 days after vaccination, the subject's mother developed pre-eclampsia, as pregnancy complication.  On, at 38 weeks of gestation (as reported), the mother vaginally delivered a live birth male neonate. The characteristics of the neonate included birth weight of 3700 grams, while head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 at one minute and 8 at five minutes. APGAR score was not reported for 10 minutes. No MCMs were identified at birth.  On the same day, the foetus recovered from the events large for gestational age and Apgar score low' and the subject's mother also recovered from gestational diabetes mellitus diet-controlled type 2 (GDMA2) and pre-eclampsia.   Per company, the events large for gestational age and Apgar score low' were considered serious due to criterion of medical significance.  The reporter did provide not provide causality assessment to Afluria QIV.  This case is linked to the case 201907397, the corresponding mother case.  Company comment: A male neonate was born at gestational age of 39,7 weeks, after foetal exposure to the suspect product Afluria QIV. Subject's mother was vaccinated approximately 17 weeks of gestation age. The subject experienced the events large for dates baby and Apgar score low more than four months later. Chronology is unsuggestive. The subject's mother developed gestational diabetes mellitus which highly confounded causality. The subject's mother medical history included anaemia and increased BMI. Causality between suspect product and the events is assessed as not related. Foetal exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A male neonate was born at gestational age of 39,7 weeks, after foetal exposure to the suspect product Afluria QIV. Subject's mother was vaccinated approximately 17 weeks of gestation age. The subject experienced the events large for dates baby and Apgar score low more than four months later. Chronology is unsuggestive. The subject's mother developed gestational diabetes mellitus which highly confounded causality. The subject's mother medical history included anaemia and increased BMI. Causality between suspect product and the events is assessed as not related. Foetal exposure during pregnancy assessed as not related per company's conventions.