Sex: U
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Foetal growth restriction, Ultrasound antenatal screen abnormal
Clinical narrative: Growth 26%; Foetal exposure during pregnancy; This is an observational study case initially received from other health professional on 16-Jan-2020, concerning a foetus subject of unknown gender, whose mother was a 24-year-old female of body weight 164 lbs, height 63 inches and body mass index (BMI) 29, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The mother's medical history included increased BMI, asthma, anxiety and depression.  The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin supplementation, escitalopram for anxiety and depression and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation.   The mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 21-May-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) of subject's mother were reported as 25-Feb-2020. The subject's father was a 27-year-old.  On 16-Aug-2019, the subject's mother underwent first trimester screen and no MCM was noted.   On 13-Sep-2019, the subject's mother underwent maternal serum alpha-fetoprotein screening (MSAFP)/ serum markers and no MCM was noted.  On 26-Sep-2019, at approximately 18 weeks of gestation, the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On 02-Oct-2019, the subject's mother underwent anatomy ultrasound and no MCM was noted.   On 27-Nov-2019, the subject's mother underwent growth ultrasound and it was noted that foetal growth was 26% (as reported).   At the time of initial reporting, the outcome of the event was not reported.   The event of 'foetal growth restriction' was considered serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202000161 (the corresponding mother case).  Company Comment: The neonate subject experienced foetal growth restriction after foetal exposure during pregnancy, at gestation age of 18 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 29), asthma, anxiety and depression may provide alternative aetiology for the event. Causality is also confounded by therapy with concomitant medication, escitalopram and concomitant product, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event foetal growth restriction is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The neonate subject experienced foetal growth restriction after foetal exposure during pregnancy, at gestation age of 18 weeks with the suspect product Flucelvax QIV. Chronology is plausible. Mother's medical history of obesity (body mass index 29), asthma, anxiety and depression may provide alternative aetiology for the event. Causality is also confounded by therapy with concomitant medication, escitalopram and concomitant product, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). Foetal exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event foetal growth restriction is assessed as unlikely related (defaults to related for reporting purposes).