Sex: U
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal gastrointestinal tract imaging abnormal
Clinical narrative: Echogenic bowel; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a foetus subject of unknown gender, whose mother was a 32-year-old female, of body weight: 105 lbs, height: 59 inches and body mass index (BMI) 21.2, enrolled in, a prospective observational safety study.  The subject's mother medical history included nausea, vomiting and acid reflux.   The subject's mother concomitant medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea and vomiting, Zantac (ranitidine hydrochloride) for acid reflux, Prenatal vitamins (unspecified vitamins and minerals), folic acid and Prenatal probiotic (probiotic unspecified) all 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 15-Jul-2019, estimated delivery date (EDD) was reported as 20-Apr-2020 and corrected estimated date of delivery (CEDD) was not reported. Type of pregnancy was singleton. The age of subject's father were not reported.  On 10-Sep-2019, the subject's mother underwent ultrasound, and no MCM was noted.  On 09-Oct-2019, the subject's mother underwent first sequential and nuchal translucency, and no MCM was noted.   On 05-Nov-2019, at approximately 16 weeks of gestation, the 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 influenza immunization.   On 06-Nov-2019, the subject's mother underwent second sequential, and no MCM was noted.   On 05-Dec-2019, the subject's mother underwent anatomy ultrasound at 20 weeks, and echogenic bowel was noted.  At the time of initial reporting, the outcome of the event of echogenic bowel was not resolved.  The event of echogenic bowel was considered serious due to medically significance per company.   The reporter did not provide causality assessment to Afluria QIV.  This case is linked to the case 202000588 (the corresponding mother case).  Company comment: On a foetus subject of unknown gender foetal gastrointestinal tract imaging abnormal was noted after foetal exposure during pregnancy with the suspect product, Afluria QIV at approximately 16 weeks of gestation. Chronology is plausible. Pregnant state may provide alternative aetiology for the event since echogenic bowel can be a normal variant/isolated finding in up to ~70% of cases. The subject's mother medical history of nausea, vomiting and acid reflux may have contributed to development of the event. Causality is also confounded by therapy with mother's concomitant medications, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and Zantac (ranitidine hydrochloride). Causality between suspect product and the event foetal gastrointestinal tract imaging abnormal is assessed as unlikely related (defaults to related for reporting purposes) since it can't be totally excluded. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.; Sender's Comments: On a foetus subject of unknown gender foetal gastrointestinal tract imaging abnormal was noted after foetal exposure during pregnancy with the suspect product, Afluria QIV at approximately 16 weeks of gestation. Chronology is plausible. Pregnant state may provide alternative aetiology for the event since echogenic bowel can be a normal variant/isolated finding in up to ~70% of cases. The subject's mother medical history of nausea, vomiting and acid reflux may have contributed to development of the event. Causality is also confounded by therapy with mother's concomitant medications, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and Zantac (ranitidine hydrochloride). Causality between suspect product and the event foetal gastrointestinal tract imaging abnormal is assessed as unlikely related (defaults to related for reporting purposes) since it can't be totally excluded. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.