Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal distress syndrome, Foetal exposure during pregnancy, Maternal condition affecting foetus
Clinical narrative: Fetal intolerance of labor (FIOL); Vaccine foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 17-Aug-2020, concerning a male foetus, whose mother was a 27-year-old, pregnant, female subject whose body weight and height were not reported and body mass index (BMI) was above 30 enrolled in a prospective observational safety study.  The foetus' mother's past medical history included influenza like symptoms. The foetus' mother's current medical history included obesity and she was varicella non-immune.  The foetus' mother's past medication included Tamiflu (oseltamivir phosphate) for influenza like symptoms. The foetus' mother's concomitant medications included Prenatal vitamin (unspecified minerals and vitamins) as vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The foetus' mother's obstetrical history noted one previous pregnancy with spontaneous abortion. The foetus' mother had no history of offspring with major congenital malformation (MCM) nor relevant maternal history with MCM, but paternal history with MCM included that father of baby's second cousin had Down syndrome. The foetus' mother did not consume tobacco, alcohol or illicit drugs during pregnancy.  The foetus' mother's last menstrual period (LMP) was on 18-Oct-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 24-Jul-2020. The type of pregnancy was singleton. The foetus' father's age was 29.  On 09-Dec-2019, the foetus' mother underwent ultrasound dating scan and no MCM was noted.  On 18-Dec-2019, at gestational age of 8 weeks (calculated per LMP), the foetus' 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 expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 16-Jan-2020, the foetus' mother underwent nuchal translucency, first trimester screen and ultrasound. No MCM was noted.  On 12-Feb-2020, the foetus' mother underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers) test. No MCM was noted.  On 28-Feb-2020, the foetus' mother underwent anatomy ultrasound and no MCM was noted.  On 01-Jul-2020, the foetus' mother was group B streptococcus (Strep) positive.  On 10-Jul-2020, the foetus' mother developed pregnancy induced hypertension/gestational hypertension.  On an unknown date, an unknown amount of time after vaccination, the foetus' mother developed pre-eclampsia.  On an unknown day in Jul-2020, the foetus' mother experienced failure to progress in second stage and the foetus experienced foetal intolerance of labour.  At gestational age of 39.3 weeks (as reported), the mother delivered a male neonate by caesarean method. The birth weight of the neonate was 3345 g, head circumference and length were not reported. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8 and at five minutes was 9. APGAR score at ten minutes was not provided. No MCM was identified at birth. On the same day, the mother recovered from gestational hypertension.   At the time of initial reporting, the outcome of foetal distress' was not reported.  Per company, the event of foetal distress' was considered serious due to criterion of medical significance.  The reporter did not provide a causality assessment to Flucelvax QIV.  This case is linked to case 202004111 (the corresponding mother case).  Company comment: A pregnant subject was administered Flucelvax QIV. On an unknown day in Jul-2020, the subject experienced failure to progress in second stage and the foetus experienced foetal intolerance of labour. Chronology is unsuggestive. Causality is assessed as not related, due to biological/pharmacological implausibility. The event was likely attributed to prolonged labour. Foetal exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV. On an unknown day in Jul-2020, the subject experienced failure to progress in second stage and the foetus experienced foetal intolerance of labour. Chronology is unsuggestive. Causality is assessed as not related, due to biological/pharmacological implausibility. The event was likely attributed to prolonged labour. Foetal exposure during pregnancy assessed as not related per company's conventions.