Sex: F
Vaccine: UNK
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: Fetal intolerance of labor; Apgar score at one minut was one; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 07-Jul-2020, concerning a female foetus, whose mother was 35-year-old pregnant female subject of body weight: 161 Ibs, height: 66 inches and body mass index (BMI) 26, was enrolled in a prospective observational study.  The foetus' mother medical history included advanced maternal age, BMI high, nausea and vomiting.  The foetus' mother concomitant medications included Prenatal (unspecified vitamins and minerals) as vitamin and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea.  The foetus' mother had two previous pregnancies with one full term live birth and one molar pregnancy. The foetus' mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The foetus' mother last menstrual period (LMP) date was 10-Sep-2019, the estimated delivery date (EDD) was reported as 16-Jun-2020 and corrected estimated date of delivery (CEDD) was reported as 23-Jun-2020. The type of pregnancy was singleton. The foetus' father was 40-year-old.  On 03-Dec-2019, the foetus' mother underwent ultrasound and no MCMs were noted.  On 16-Dec-2019, at approximately 13 weeks of gestation (calculated per LMP), the foetus' mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the foetus' mother underwent nuchal translucency ultrasound and no MCMs were noted.  On 09-Jan-2020, the foetus' mother underwent maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and second trimester screen. No MCMs were noted.  On 30-Jan-2020, the foetus' mother underwent anatomy ultrasound and no MCMs were noted.  At gestational age of 39 weeks (as reported), during delivery, the mother had arrest of dilation and the foetus experienced fetal intolerance of labour. Therefore, the mother delivered a live female neonate by caesarean method. The neonate's birth weight was 3260 grams, head circumference and body length were not reported. Appearance, pulse, grimace response, activity, respiration (APGAR) score in one minute was 1, in five minutes was 8 and in ten minutes was 9. No MCMs noted at birth.  On the same day, the neonate recovered from the event of APGAR score low'.  At the time of initial report, the outcome of event foetal distress' was not reported.  The events of APGAR score low' and foetal distress' were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202003842, the corresponding mother case.  Company comment: A 35-year-old pregnant subject was administered Flucelvax QIVc at gestational age of 13 weeks. The subject experienced arrested labour and delivered a live female neonate by caesarean method. The foetus developed Foetal distress syndrome and Apgar score low six months after vaccination. Considering implausible temporal relationship, causality between suspect product and the events is assessed as not related. The foetus' mother medical history included advanced maternal age and BMI high may have contributed to development of the events. 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 13 weeks. The subject experienced arrested labour and delivered a live female neonate by caesarean method. The foetus developed Foetal distress syndrome and Apgar score low six months after vaccination. Considering implausible temporal relationship, causality between suspect product and the events is assessed as not related. The foetus' mother medical history included advanced maternal age and BMI high may have contributed to development of the events. Foetal exposure during pregnancy is not related per company's conventions.