Sex: U
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal growth restriction
Clinical narrative: Intrauterine growth restriction; Foetal exposure during pregnancy; This is an observational study case from, initially received from other health professional on 27-Feb-2020, concerning a foetus subject of unknown gender, whose mother was a 21-year-old female, of body weight 154 lbs, height 61 inches and body mass index (BMI) 29.1, enrolled in, a prospective observational safety study.  The subject's mother's past medical history included chlamydia infection. The subject's mother's current medical history included Rh negative, body mass index hight (29.1), nausea and vomiting and gastroesophageal reflux disease (GERD).   The subject's mother's concomitant medications included Prenatal gummy (unspecified vitamins and minerals) for pregnancy, Zantac (ranitidine hydrochloride) for GERD, Unisom (doxylamine succinate) and pyridoxine for nausea and vomiting and Rhogam (anti-d immunoglobulin) for Rh negative.   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 06-Aug-2019. Type of pregnancy was singleton. The estimated delivery date (EDD) of subject's mother was reported as 18-May-2020 and corrected estimated date of delivery (CEDD) was reported as 18-Apr-2020. The subject's father age were not reported.  On 15-Oct-2019, the subject's mother underwent ultrasound and non-invasive prenatal testing (NIPT), and no MCM was noted.   On 21-Nov-2019, the subject's mother underwent maternal serum alpha-fetoprotein screening, and no MCM was noted.   On 03-Dec-2019, the subject's mother underwent 20 week anatomy ultrasound, and no MCM was noted.  On 31-Dec-2019, at approximately 21 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 an influenza immunization.   On an unknown date, the pregnancy status was collected and intrauterine growth restriction (IUGR) was noted.  At the time of initial reporting, the outcome of the event fetal growth restriction' was not reported.  The event of  fetal growth restriction' was considered serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to 202001962 (the corresponding mother case).  Company comment: Foetal growth restriction was noted in neonate subject with foetal exposure Afluria QIV. Subject's mother was administered vaccine at approximately 21 weeks of gestation. The event was noted on an unknown date, therefore chronology needs more clarification. With information available, 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 are assessed as unrelated per company's conventions.; Sender's Comments: Foetal growth restriction was noted in neonate subject with foetal exposure Afluria QIV. Subject's mother was administered vaccine at approximately 21 weeks of gestation. The event was noted on an unknown date, therefore chronology needs more clarification. With information available, 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 are assessed as unrelated per company's conventions.