Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 4030 g; This is an observational study case, initially received on 19-Mar-2020, concerning a male neonate whose mother was 34-year-old pregnant, female subject, of body weight: 223 lbs, height: 60 inches and body mass index (BMI): 43.5, enrolled in a prospective observational safety study.  The subject's mother's current conditions included Rubella non-immune, body mass index high, Crohn's disease, gastroesophageal reflux disease (GERD), anxiety, depression and attention deficit-hyperactivity disorder (ADHD).   The subject's mother's concomitant medications included Protonix (omeprazole) for GERD, prenatal vitamins (unspecified minerals and vitamins) for pregnancy, Prozac (fluoxetine) for anxiety and depression, Colace (docusate) for Crohn's disease and calcium citrate with Vitamin D3 (cholecalciferol) for an unknown indication.  The subject's mother had no previous pregnancies. 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 24-May-2019. The type of pregnancy was singleton. The subject's estimated date of delivery (EDD) was reported as 28-Feb-2020 while corrected estimated date of delivery (CEDD) was not reported. The paternal age was not reported.  On 19-Aug-2019, the subject's mother underwent nuchal translucency and sequential one tests, no MCMs were noted.  On 16-Sep-2019, the subject's mother underwent sequential two test, no MCM was noted.  On 14-Oct-2019, at approximately 20 weeks of gestation (calculate per LMP), the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [Influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, 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 the same day, the subject's mother underwent 20-week anatomy ultrasound, no MCMs were noted.  On 09-Dec-2019, the subject's mother underwent ultrasound, no MCMs were noted.  On 06-Jan-2020, the subject's mother underwent ultrasound, no MCMs were noted.  At 40.6 weeks of gestation (as reported), the subject's mother delivered live birth, male neonate via vaginal method of delivery. The neonate's birth weight was 4030 grams, body length and head circumference were not reported and APGAR (appearance, pulse, grimace, activity and respiration) scores were at one minute: 7, five minutes: 8 and ten minutes: not reported. There were no major MCMs identified at birth.  The event of high birthweight baby' was assessed as serious due to medically significance per the company.   The reporter did not provide causality assessment to Afluria QIV.  The case is linked to case 201905999 (mother case).  Company comment:The patient's mother was administered the suspect product, Afluria QIV at approximately 20 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 40.6 weeks of gestation, the patient's mother vaginally delivered male neonate whose birth weight was 4030 grams (coded as large for dates baby). Medical history of body mass index high and treatment with concomitant drug fluoxetine confound causality. Causal relationship for foetal exposure during pregnancy is assessed as not related, while for the event large for dates baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to related for reporting purposes).; Sender's Comments: The patient's mother was administered the suspect product, Afluria QIV at approximately 20 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 40.6 weeks of gestation, the patient's mother vaginally delivered male neonate whose birth weight was 4030 grams (coded as large for dates baby). Medical history of body mass index high and treatment with concomitant drug fluoxetine confound causality. Causal relationship for foetal exposure during pregnancy is assessed as not related, while for the event large for dates baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to related for reporting purposes).