Sex: M
Vaccine: FLUX
Symptoms: Gene sequencing, Live birth, Prenatal screening test, Ultrasound foetal abnormal
Clinical narrative: Fused toes-webbing; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 03-May-2021, with additional information received on 04-May-2021 (being processed together), concerning a male neonate whose mother was a 33-year-old pregnant female subject of body weight: 130 lbs, height: 63 inches and body mass index (BMI): 23, who was enrolled in CSLCT-OBS-17-15, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The maternal concurrent conditions included nausea. The mother had both genetic markers for celiac disease but, had not been tested or diagnosed with celiac disease. The maternal concomitant medications included Zofran (ondansetron) for nausea, Prenatal vitamins (unspecified minerals and vitamins) for pregnancy.  The neonate's mother obstetrical history included three previous pregnancies, with three full term live births. The neonate's mother had no history of offspring with major congenital malformation (MCM). The mother had no maternal history with MCM and paternal medical history with MCM included congenital heart issues in father's brother and sister. The neonate's mother did not use tobacco, alcohol or illicit drugs, during pregnancy.   The neonate's mother last menstrual period (LMP) was on 21-Jul-2020. The type of pregnancy was singleton. The neonate's mother estimated delivery date (EDD) was reported as 26-Apr-2021 and corrected estimated date of delivery (CEDD) was not reported. The neonate's father was a 34-year-old.  On 05-Oct-2020, the blood draw for maternal cell free deoxyribonucleic acid (DNA) screening was performed and no MCM was noted.  On 07-Dec-2020, at 19 weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, route of administration, indication and anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy'). The batch number was reported as P100255599.  On the same day, the ultrasound at 19 weeks of gestation (as reported) revealed shadow, risk for Down syndrome. No MCM was noted.  On 01-Mar-2021, the neonate's mother developed heartburn and commenced treatment with oral Tums (calcium carbonate), up to six tablets, as needed.   At 39 weeks of gestation (as reported), the subject delivered a live birth male neonate, by caesarean method of delivery. The neonate's birth weight was 3770 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes and at ten minutes were not provided. MCM identified at birth included fused toes-webbing.    Per MCM evaluation for webbed toesm etiology was attributed to failure of programmed cell death to release the digits from the limb plate. This problem was seen in some genetic syndromes or as an isolated autosomal dominant or recessive trait. It was also seen with pregnancy exposure to prostaglandins or amniotic band sequence. In this case, there were no information supporting these causes, so the cause was unknown. The family history of congenital heart disease appeared to be unrelated. Exact gestational age range for origin of the defect was 6-7 weeks after conception, or 8-9 weeks after last menses. There were no confounding factors reported.  Per MCM temporal assessment the exposure was after origin of defect. Scientific advisory committee (SAC) temporal assessment was not reported.  At the time of this report, the outcome of the event 'toes webbed' was not reported.   The event of 'toes webbed' was considered to be serious due to congenital anomaly and medical significance by a Physician.  The reporter considered the event of 'toes webbed' as not related to Afluria QIV, since exposure was after origin of defect per MCM temporal assessment.   This case is linked to case 202102254 (the corresponding mother case).  Company comment: A male neonate whose mother was a 33-year-old pregnant female subject, was exposed to Afluria QIV at 19 weeks of gestation. On the same day, the ultrasound at 19 weeks of gestation (as reported) revealed shadow, risk for Down syndrome. No MCM was noted. On the 19-Apr-2021, at 39 weeks of gestation (as reported), the subject delivered a live birth male neonate, by caesarean method of delivery. MCM identified at birth included fused toes-webbing. Exact gestational age range for origin of the defect was 6-7 weeks after conception. The reporter considered the event of 'toes webbed' as not related to Afluria QIV, since exposure was after origin of defect per MCM temporal assessment. Causality is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A male neonate whose mother was a 33-year-old pregnant female subject, was exposed to Afluria QIV at 19 weeks of gestation. On the same day, the ultrasound at 19 weeks of gestation (as reported) revealed shadow, risk for Down syndrome. No MCM was noted. On the 19-Apr-2021, at 39 weeks of gestation (as reported), the subject delivered a live birth male neonate, by caesarean method of delivery. MCM identified at birth included fused toes-webbing. Exact gestational age range for origin of the defect was 6-7 weeks after conception. The reporter considered the event of 'toes webbed' as not related to Afluria QIV, since exposure was after origin of defect per MCM temporal assessment. Causality is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company conventions.