Sex: U
Vaccine: FLUX
Symptoms: Anxiety, Exposure during pregnancy, Foetal malformation, Prenatal screening test, Ultrasound antenatal screen
Clinical narrative: Bilateral club foot; Foetal exposure during pregnancy; is an observational study case, initially received from other health professional on 07-Feb-2020, concerning a foetal subject whose mother was 26-year-old, female pregnant subject of body weight: 148.6 lbs, height: 64 inches and body mass index (BMI): 25.5, enrolled in, a prospective observational safety study.  The subject's mother's current conditions included increased BMI, anxiety depression, genital herpes and nausea.   The mother's concomitant medications included Lexapro (escitalopram oxalate) for anxiety depression, Diclegis (doxylamine succinate and pyridoxine hydrochloride) for nausea and Vistaril (hydroxyzine embonate) for anxiety.  The mother's obstetrical history included two previous pregnancies with one full term live birth and one preterm live birth. Also, the subject's mother had history of twin's preterm rupture of membranes in gravida 1. The subject's mother had no history of offspring with major congenital malformations (MCMs) and no relevant paternal or maternal medical history with MCMs. The subject's father had club feet. The subject's mother did not use alcohol or illicit drugs during pregnancy, but she was using cigarettes, one fourth of a pack per day.   The mother's last menstrual period (LMP) date was 06-Aug-2019. The mother's estimated delivery date (EDD) was reported as 12-May-2020, while corrected estimated date of delivery (CEDD) was reported as 27-May-2020. The type of pregnancy was singleton. The pregnancy was complicated by anxiety.  On 30-Oct-2019, the subject's mother underwent ultrasound scan and no MCMs were noted.  On 04-Nov-2019, approximately at 13 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.  On 13-Nov-2019, the subject's mother underwent first trimester screen and nuchal translucency ans no MCMs were noted.   On 11-Dec-2019, the subject's mother underwent second trimester screen and no MCMs were noted.   On 02-Jan-2020, approximately two months after vaccination, the subject's mother underwent anatomy ultrasound and probable bilateral club foot was noted. It was reported that the cardiac was not seen.  On 30-Jan-2020, the subject's mother underwent follow up ultrasound and bilateral club foot was reported as MCM.  At the time of this report, the outcome for the event of clubfoot was not reported.  The event of clubfoot' was considered as serious due to criterion of medical significance and congenital anomaly.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked with case 202001217 (the corresponding mother case).  Company comment: A foetal subject developed talipes after vaccination with the suspect product Flucelvax QIV for an influenza immuniza. Reportedly, approximately two months after vaccination, the event was noted via ultrasound. Chronology seems plausible. The mother's obstetrical history included two previous pregnancies with one full term live birth and one preterm live birth. Also, the subject's mother had history of twin's preterm rupture of membranes in gravida 1. The subject's mother's current conditions included increased BMI, anxiety depression, genital herpes and nausea. The mother's concomitant medications included Lexapro (escitalopram oxalate) for anxiety depression, Diclegis (doxylamine succinate and pyridoxine hydrochloride) for nausea and Vistaril (hydroxyzine embonate) for anxiety. With information presented, causality is assessed as unlikely related considering presented confounders (previous pregnancies, medical history of the subject's mother and concomitant drugs). Foetal exposure during pregnancy is assessed as not related per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)