Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: Asymmetric fetal growth; Foetal exposure during pregnancy; Intrauterine growth restrictions; This is an observational study case, initially received from other health professional on 15-Apr-2020, concerning a female, foetal subject whose mother was 30-year-old female subject of body weight 164 lbs, height 62 inches and body mass index (BMI) 30, enrolled in a prospective observational study.  The medical history of subject's mother included increased BMI, depressive disorder, and gastroesophageal reflux disease (GERD).    Concomitant medications of subject's mother included TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine, Citranatal B-calm (ascorbic acid, calcium citrate, colecalciferol, folic acid, iron pentacarbonyl, pyridoxine hydrochloride) as vitamin, sertraline for depression, Tamiflu (oseltamivir phosphate) for exposure to influenza, and Prevacid (lansoprazole) for gastroesophageal reflux disease (GERD)  The obstetrical history of subject's mother included three previous pregnancies with three previous full-term live births. The subject's mother did not have a history of offspring with major congenital malformation (MCM). The subject's mother had no maternal or paternal history with MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was 28-Jun-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 03-Apr-2020. The type of pregnancy was singleton. It was reported that the subject's mother had late entry prenatal care. The subject's father was a 29-year-old.  On 22-Oct-2019, at approximately 16 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunization.  On the same day, the subject's mother underwent second trimester quad screen and no MCMs were noted.   On 19-Nov-2019, the subject's mother underwent anatomy ultrasound and no MCMs were noted.  On 04-Feb-2020, the subject's mother underwent ultrasound follow-up intrauterine growth restriction and no MCMs were noted. On the same day, foetal growth restrictions were noted.  On 25-Feb-2020 and 17-Mar-2020, the subject's mother underwent ultrasound follow-up intrauterine growth restriction and no MCMs were noted.   At 39 weeks of gestation (as reported), labour was induced due to asymmetric fetal growth and the mother delivered live birth female neonate, by vaginal method of delivery. The neonate's birth weight was 2778 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 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 27-Mar-2020, the outcome of all events was resolved.   Per company, the events of foetal growth restriction' and asymmetric foetal growth' were assessed as serious due to the criterion of medical significance.  The reporter did not provide causality assessment.  This case is linked to 202001698 (the corresponding mother case).  Company comment: A foetal subject experienced foetal growth restriction and foetal growth abnormality (reported as asymmetric foetal growth) after foetal exposure to Flucelvax QIV. The subject's mother was administered vaccine at 16 weeks of gestation and the event was noted 3 months and 13 days later. Chronology is compatible. The medical history of subject's mother included increased BMI, depressive disorder, and gastroesophageal reflux disease (GERD). Causal role of the suspect vaccine cannot be totally excluded and 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 foetal subject experienced foetal growth restriction and foetal growth abnormality (reported as asymmetric foetal growth) after foetal exposure to Flucelvax QIV. The subject's mother was administered vaccine at 16 weeks of gestation and the event was noted 3 months and 13 days later. Chronology is compatible. The medical history of subject's mother included increased BMI, depressive disorder, and gastroesophageal reflux disease (GERD). Causal role of the suspect vaccine cannot be totally excluded and 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.