Sex: U
Vaccine: UNK
Symptoms: Exposure during pregnancy, Foetal cardiac disorder, Pyelocaliectasis, Ultrasound antenatal screen abnormal
Clinical narrative: Echogenic intracardiac focus; Left pyelectasis; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 27-Feb-2020, concerning a fetal subject of unreported gender, whose mother was a 21-year-old, pregnant, female subject of body weight 152 lbs, height 67 inches and body mass index (BMI) 23.8, enrolled in a prospective observational safety study.  The subject's mother's current condition included nausea.   The subject's mother's concomitant medications included Prenatal Gummies (unspecified vitamins and minerals) for pregnancy and ondansetron for nausea.  The subject's mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. 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 04-Sep-2019, the estimated delivery date (EDD) was 10-Jun-2020, while the corrected estimated date of delivery (CEDD) was not reported. The pregnancy was singleton. The subject's father's age was not reported.   On 02-Dec-2019, the subject's mother underwent first sequential and nuchal translucency tests, and no MCMs were noted.  On 30-Dec-2019, at approximately 16 weeks of gestation, the subject's mother was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On the same day, the subject's mother underwent ultrasound and second sequential test. No MCM was noted.  On 28-Jan-2020, the subject's mother underwent anatomy scan at 20 weeks of gestation, and echogenic intracardiac focus and left pyelectasis were noted.  At the time of initial reporting, the outcome of the events was not reported.  The events of echogenic intracardiac focus' and pyelectasia' were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  The case is linked to case 202001966, the corresponding mother's case.  Company comment: Reportedly, foetal disorder (echogenic intracardiac focus - EIF) and pyelocaliectasis were noted in neonate subject a month after subject's mother received Afluria QIV. EIFs are considered normal changes found in about 35% of normal pregnancies and cause no health problems. However, considering plausible temporal relationship, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for both events (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: Reportedly, foetal disorder (echogenic intracardiac focus - EIF) and pyelocaliectasis were noted in neonate subject a month after subject's mother received Afluria QIV. EIFs are considered normal changes found in about 35% of normal pregnancies and cause no health problems. However, considering plausible temporal relationship, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for both events (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.