Sex: M
Vaccine: UNK
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 07-Jul-2020, concerning a foetus whose mother was a 35-year-old, female pregnant subject of body weight: 185.8 lbs, height: 65 inches and body mass index (BMI): 30.9 enrolled in a prospective observational safety study.  The foetus' mother's past medical condition included female infertility, clomid pregnancy and intrauterine insemination procedure. The foetus' mother's current medical conditions included pregnancy with advanced maternal age and obesity.  The foetus' mother's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The foetus' mother had no previous pregnancies. The foetus' mother had no history of offspring with major congenital malformation (MCM). Also, the foetus' mother had no maternal or paternal history 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 reported as 16-Jul-2019.The foetus' mother's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both reported as 21-Apr-2020. The type of pregnancy was singleton. The father was 37-year-old.  On 04-Sep-2019, the foetus' mother underwent ultrasound and no MCM was noted.  On 30-Sep-2019, at gestational age of 11 weeks (calculated per LMP), the foetus' mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 259809, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 14-Oct-2019, the foetus' mother performed first trimester screen and increased risk of Down syndrome was noted. There was no MCM was noted.  On 18-Oct-2019, the foetus' mother underwent MaterniT21 test and no MCM was noted.  On 11-Nov-2019, the foetus' mother underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP) /serum markers test and no MCM was noted.  On 02-Dec-2019, the foetus' mother underwent anatomy ultrasound and no MCM was noted.  On 31-Jan-2020, the foetus' mother performed glucose tolerance test and result was abnormal.   On 10-Feb-2020, four months and 11 days after vaccination, the foetus' mother developed gestational diabetes mellitus (GDM).  On 12-Mar-2020, the foetus' mother underwent growth scan (growth 97%, as reported) and no MCM was noted.  On 06-Apr-2020, six months and seven days after vaccination, macrosomia was noted in foetus.  At gestational age of 39.1 weeks (as reported), the mother delivered a live birth, male neonate via caesarean method of delivery. The characteristics of the neonate included birth weight of 4621 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No date for APGAR score at 10 minutes was provided. No MCM was identified at birth.  At the time of this report, the outcome of the event of fetal macrosomia' was not reported.  The events of fetal macrosomia' was considered serious due to criterion of medical significance.  The reporter did not provide the causality assessment.  This case is linked to the case 201907199 (the corresponding mother's case).  Company comment: A 35-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 11 weeks. The subject's current medical conditions included pregnancy with advanced maternal age and obesity, which confound causality. The subject delivered a live birth, six months after vaccination. The characteristics of the neonate included birth weight of 4621 grams. Considering implausible temporal relationship and strong confounders, causality between suspect product and the event of fetal macrosomia is assessed as not related. Foetal exposure during pregnancy is not related per company's conventions.; Sender's Comments: A 35-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 11 weeks. The subject's current medical conditions included pregnancy with advanced maternal age and obesity, which confound causality. The subject delivered a live birth, six months after vaccination. The characteristics of the neonate included birth weight of 4621 grams. Considering implausible temporal relationship and strong confounders, causality between suspect product and the event of fetal macrosomia is assessed as not related. Foetal exposure during pregnancy is not related per company's conventions.