Sex: U
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy
Clinical narrative: Echogenic intra cardiac focus; Fetal exposure during pregnanay; This is an observational study case, initially received from other health professional on 30-Mar-2020, concerning a foetal subject, whose mother was a 25-year-old female of body weight 291 lbs, height 67 inches and body mass index (BMI) 45.6, enrolled in a prospective observational safety study.  The subject's mother's medical history included obesity, nausea and vomiting. The subject's mother was rubella non-immune.  The subject's mother's concomitant medications included Unisom (doxylamine succinate), ondansetron and pyridoxine for nausea and vomiting and Prenatal vitamins (vitamin not specified (nos), minerals nos) for pregnancy.   The subject's mother had no previous pregnancies. 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 26-Oct-2019. Type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 01-Aug-2020 and corrected estimated date of delivery (CEDD) was not reported. The subject's father age was not reported.  On 17-Dec-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 08-Jan-2020, the subject's mother underwent non-invasive prenatal testing (NIPT) and no MCM was noted.  On 22-Jan-2020, at approximately 12 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 19-Feb-2020, the subject's mother underwent maternal serum alpha-fetoprotein screening (MSAFP)/serum marker and no MCM was noted.  On an unspecified date, after vaccination, the subject's mother experienced allergy.  On 19-Mar-2020, the subject's mother started treatment with Zyrtec (cetirizine hydrochloride), 10 mg, every day, orally for allergy. On the same day, the subject's mother experienced heartburn and started treatment with Protonix (omeprazole), 20 mg, every day, orally.   On the same day, the subject's mother underwent 20-week-anatomy ultrasound and echogenic intracardiac focus and normal echo of subject was noted. No MCM was noted.  At the time of this report, the outcome of the event echogenic intracardiac focus was not reported.  The event of echogenic intracardiac focus was considered serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to 202002671 (the corresponding mother case).  Company comment: Reportedly, foetal disorder (echogenic intracardiac focus - EIF) was noted in neonate subject, 1 month 26 days 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 (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) was noted in neonate subject, 1 month 26 days 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 (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.