Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Macrosomia
Clinical narrative: Macrosomia; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 11-May-2020, concerning a male, foetus subject whose mother was 24-year-old, pregnant, female of body weight: 135 lbs, height: 69 inches and body mass index (BMI): 19.9, 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's medical history included headache, asthma, gastroesophageal reflux disease (GERD), post-traumatic stress disorder (PTSD) and depression.  The subject's mother's concomitant medications included prenatal gummy (unspecified vitamins and minerals) and iron for pregnancy, Protonix (omeprazol) for GERD, Vistaril (hydroxyzine hydrochloride) and Zoloft (sertraline hydrochloride) for PTSD.  The subject's mother's obstetrical history included two previous pregnancies with two full term live births. The subject's mother did not have a history of offspring with major congenital malformation (MCM). Also, the subject's mother had no maternal or paternal history with MCMs. The subject's mother did not use alcohol or illicit drugs during pregnancy. The subject's mother was cigarette smoker with eight cigarettes per day.  The subject's mother's last menstrual period (LMP) date was 22-May-2019, estimated delivery date (EDD) was reported as 26-Feb-2020 and corrected estimated date of delivery (CEDD) was reported as 08-Mar-2020. The type of pregnancy was singleton.   On 17-Jul-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 14-Aug-2019, the subject's mother underwent non-invasive prenatal testing (NIPT) and nuchal translucency and no MCM was noted.  On 28-Oct-2019, the subject's mother underwent 20 week anatomy ultrasound and no MCM was noted.  On 14-Jan-2020, at gestational age of 33 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 expiry date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation.  On 28-Jan-2020, the subject developed macrosomia.  On, at 39,7 weeks of gestation (as reported), the mother delivered a live birth male neonate, via caesarean method of delivery. The neonate's birth weight was 3760 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   On the same day, the outcome for the event of macrosomia was resolved.  The event of macrosomia was assessed as serious due to criterium of medical significance, per company.  The reporter did not provide causality assessment for Afluria QIV.  This case is linked to 202003391, 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 33 weeks of gestation age and the event of foetal macrosomia was noted 14 days later. Chronology is compatible. The subject's mother's medical history included headache, asthma, gastroesophageal reflux disease (GERD), post-traumatic stress disorder (PTSD) and depression. Causality between suspect product and the event is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). 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 33 weeks of gestation age and the event of foetal macrosomia was noted 14 days later. Chronology is compatible. The subject's mother's medical history included headache, asthma, gastroesophageal reflux disease (GERD), post-traumatic stress disorder (PTSD) and depression. Causality between suspect product and the event is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy assessed as not related per company's conventions.