Sex: U
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy
Clinical narrative: Echogenic intracardiac focus; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Jan-2020, concerning a foetus of unknown gender, whose mother was a 30-year-old, female subject of body weight 163 lbs, height 64 inches and body mass index (BMI) 28, enrolled in a prospective observational safety study.   The mother's current condition included anemia and increased BMI.   The subject's mother concomitant medications included Prenatal vitamin (vitamin nos, mineral nos) for pregnancy and ferrous sulfate for anemia.  The subject 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 last menstrual period (LMP) date was 06-Jul-2019, estimated delivery date (EDD) was 11-Apr-2020 and corrected estimated date of delivery (CEDD) was not reported. The pregnancy was singleton.  On 28-Aug-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 02-Oct-2019, the subject's mother underwent sequential 1 test and no MCM was noted.  On 30-Oct-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 sequential 2 test and no MCM was noted.  On 26-Nov-2019, the subject's mother underwent anatomy scan at 20 weeks of gestation, and ecogenic intracardiac focus was noted.  At the time of initial reporting, the subject had not recovered from the event.   The event of ecogenic intracardiac focus was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  The case is linked to case 202000270, the corresponding mother case.  Company comment: Reportedly, echogenic intracardiac focus (EIF, coded as foetal disorder and because of that assessed as serious) was associated with Afluria QIV. The subject's mother was administered vaccine at approximately 16 weeks of gestation and the event was noted 27 days after. Chronology is plausible. Researchers have noted an association between an EIF and chromosome problems, such as Patau syndrome and Down syndrome. If there are no problems or chromosome abnormalities, EIFs are considered normal changes found in about 35% of normal pregnancies and cause no health problems. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, echogenic intracardiac focus (EIF, coded as foetal disorder and because of that assessed as serious) was associated with Afluria QIV. The subject's mother was administered vaccine at approximately 16 weeks of gestation and the event was noted 27 days after. Chronology is plausible. Researchers have noted an association between an EIF and chromosome problems, such as Patau syndrome and Down syndrome. If there are no problems or chromosome abnormalities, EIFs are considered normal changes found in about 35% of normal pregnancies and cause no health problems. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.