Sex: U
Vaccine: UNK
Symptoms: Exposure during pregnancy, Foetal growth restriction
Clinical narrative: Intrauterine growth restriction; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 30-Mar-2020, concerning a foetal subject of unknown gender, whose mother was a 38-year-old female of body weight 237 lbs, height 62 inches and body mass index (BMI) 43.3, enrolled in a prospective observational safety study.  The mother's medical history included body mass index (BMI) high, advanced maternal age (AMA), polycystic ovarian syndrome (PCOS), hypothyroidism, Sjogren's syndrome, constipation and hypertension.  The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Colace (docusate sodium) for constipation, Synthroid (levothyroxine sodium) for hypothyroidism and Aspirin (acetylsalicylic acid) as prophylaxis for hypertension.   The subject's mother had one previous pregnancy with one spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) was on 05-Aug-2019. Type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) of subject's mother were reported as 12-May-2020. The subject's father age was not reported.  On 17-Oct-2019, the subject's mother underwent ultrasound scan and non-invasive prenatal testing (NIPT) and no MCM was noted.   On 25-Nov-2019, the subject's mother underwent maternal serum alpha-fetoprotein screening (MSAFP)/serum marker and no MCM was noted.  On 30-Dec-2019, the subject's mother underwent 20-week-anatomy ultrasound and no MCM was noted.  On 20-Jan-2020, at approximately 24 weeks of gestation (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 expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On 18-Feb-2020, the intrauterine growth restriction (IUGR) of subject was noted.  At the time of this report, the outcome of the event fetal growth restriction' was not reported.  Per company, the event of fetal growth restriction' was considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment.  This case is linked to 202002659 (the corresponding mother case).  Company comment: Foetal growth restriction was noted in a foetal subject of unknown gender. Subject's mother was administered Afluria QIV at approximately 24 weeks of gestation. The mentioned events were noted 29 days after vaccination. Chronology is plausible. The mother's medical history included body mass index (BMI) high, advanced maternal age (AMA), polycystic ovarian syndrome (PCOS), hypothyroidism, Sjogren's syndrome, constipation and hypertension. Treatment with concomitant medication also may have confounded causality for the event. Causal role of the suspect product cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Foetal growth restriction was noted in a foetal subject of unknown gender. Subject's mother was administered Afluria QIV at approximately 24 weeks of gestation. The mentioned events were noted 29 days after vaccination. Chronology is plausible. The mother's medical history included body mass index (BMI) high, advanced maternal age (AMA), polycystic ovarian syndrome (PCOS), hypothyroidism, Sjogren's syndrome, constipation and hypertension. Treatment with concomitant medication also may have confounded causality for the event. Causal role of the suspect product cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.