Sex: M
Vaccine: FLUC4
Symptoms: Respiratory disorder neonatal
Clinical narrative: Poor respiratory effort; Transverse arrest of descent; Apgar score 1 at one minute and 6 at five minutes; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Jul-2020, concerning a male foetus whose mother was 35-year-old, pregnant, female subject of body weight 137.6 lbs, height 68.4 inches and body mass index (BMI) 20.7, enrolled in a prospective observational study.  The foetus' mother current conditions included pregnancy with advanced maternal age, herpes simplex and Rhesus antigen negative (RhD negative).  The foetus' mother concomitant medications included Prenatal gummies (unspecified minerals and vitamins) and Prenate pixie with iron (ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, alpha-tocopherol acetate, dl-, docusate sodium and blueberry) both for obstetrical supplementation, Rophylac (anti D-immunoglobulin) for RhD negative.  The foetus' mother obstetrical history noted that she had no previous pregnancies. The foetus' mother had no history of offspring with major congenital malformations (MCMs). The foetus' mother's maternal history included great aunt with malignant breast tumour. The foetus' mother's paternal history included aunt with malignant breast tumour. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy. The foetus' father was a 35-year-old.   The foetus' mother last menstrual period (LMP) date was 25-Jul-2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 30-Apr-2020. The type of pregnancy was singleton.   On 07-Oct-2019, at gestational age of 10 weeks (calculated per LMP), the foetus' mother was administered FLUCELVAX QIV [dose: 0.5 ml, batch number: 261207, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On the same date, the foetus' mother underwent maternit 21 and first trimester ultrasound and no MCMs were noted.  On 14-Nov-2019, the foetus' mother underwent second trimester screen and maternal serum alpha-fetoprotein screening (MSAFP)/serum markers and no MCMs were noted.  On 05-Dec-2019, the foetus' mother underwent ultrasound anatomy and fetal maternal evaluation and no MCMs were noted.  On 13-Feb-2020, the foetus' mother developed influenza and received treatment medication Tamiflu (oseltamivir phosphate) at a dose of one capsule, two times a day, administered orally.  On an unspecified date, unknown amount of time after the vaccination, transverse arrest of descent was noted.  At 40 weeks of gestation (as reported), the foetus' mother delivered a live birth male neonate, by caesarean method of delivery. The neonate's birth weight was 3714 grams, while head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 1 at one minute, 6 at five minutes and 8 at ten minutes. There was no major congenital malformation identified at birth. The neonate had poor respiratory effort. Infant was sent to neonate intensive care unite (NICU) due to poor respiratory effort.  The neonate recovered from the events of Apgar score low' and deep transverse arrest'.    At the time of this report, the outcome of the event labored respiration' was not reported.   The events of Apgar score low' and deep transverse arrest' were considered as serious due to criterion of medical significance, per company. The event of labored respiration' was considered serious due to hospitalization.   The reporter did not provide causality assessment.  This case is linked to 202001885, the corresponding mother case.  Company comment: A 35-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 10 weeks. On an unspecified date, unknown amount of time after the vaccination, transverse arrest of descent was noted. The subject delivered a live birth male neonate, by caesarean method of delivery, six months after vaccination. The neonate experienced Apgar score low and was sent to neonate intensive care unite (NICU) due to poor respiratory effort. Causality was confounded by advanced maternal age. All events are assessed as not related to the suspect vaccine due to biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy is not related per company's conventions.; Sender's Comments: A 35-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 10 weeks. On an unspecified date, unknown amount of time after the vaccination, transverse arrest of descent was noted. The subject delivered a live birth male neonate, by caesarean method of delivery, six months after vaccination. The neonate experienced Apgar score low and was sent to neonate intensive care unite (NICU) due to poor respiratory effort. Causality was confounded by advanced maternal age. All events are assessed as not related to the suspect vaccine due to biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy is not related per company's conventions.