Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Born at 34.1 weeks of gestation; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a neonate male subject, whose mother was a 20-year-old female of body weight 309 lbs, height 67 inches and body mass index (BMI) 48.4, enrolled in a prospective observational safety study.  The subject's mother's historical conditions included history of severe pre-eclampsia in G1 (gravidity) and G3 and infection due to Escherichia coli (from 24-Sep-2019 to 01-Oct-2019).  The subject's mother's current condition included severe obesity (body mass index 48.4).  The subject's mother concomitant medication included TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.     The subject's mother's obstetrical history included three previous pregnancies with two preterm live births and one spontaneous abortion. The subject's mother had no history of offspring with major congenital malformations (MCMs). Also, the mother had no maternal or paternal history with MCMs.   The mother's last menstrual period (LMP) date was 23-Jul-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 28-Apr-2020. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's father was 24 years old.   On 21-Oct-2019, the mother underwent first trimester screen and initial ultrasound and no MCM was noted.   On 18-Nov-2019, at 16 weeks of gestation (calculated per LMP), the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunization.   On the same date, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and no MCM was noted.  On 26-Dec-2019, the mother underwent anatomy ultrasound and no MCM was noted.   On an unknown date, the mother developed hypertension and was treated with ASA (acetylsalicylic acid).   On 29-Jan-2020, the mother developed gestational diabetes mellitus and was treated with metformin.   On 11-Feb-2020 and 05-Mar-2020, the mother underwent follow up growth ultrasound scans and no MCM was noted.   On 16-Mar-2020, the subject's mother developed pre-eclampsia.   At 34.1 weeks of gestation (as reported), the subject's mother gave a live birth to a male neonate, delivered by caesarean method of delivery. The neonate's birth weight was 2552 grams, head circumference was 34 centimetres and body length were 47.5 centimetres. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (at one minute) and 7 (at five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   At the time of this report, the outcome of event premature baby 33 to 36 weeks' was not reported.  The of event of premature baby 33 to 36 weeks' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202002625 (the corresponding mother case).  Company comment: The patient's mother was administered the suspect product, Flucelvax QIV at approximately 16 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 34.1 weeks of gestation the subject's mother gave a live birth to a male neonate, delivered by caesarean method of delivery (coded as premature baby). Medical history of severe obesity, spontaneous abortion and treatment with concomitant vaccine TDAP confound causality. Causal relationship for the event of  foetal exposure during pregnancy is assessed as not related, while for the event premature baby causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to related for reporting purposes).; Sender's Comments: The patient's mother was administered the suspect product, Flucelvax QIV at approximately 16 weeks of gestation (explicitly coded as Foetal exposure during pregnancy'). Reportedly, at 34.1 weeks of gestation the subject's mother gave a live birth to a male neonate, delivered by caesarean method of delivery (coded as premature baby). Medical history of severe obesity, spontaneous abortion and treatment with concomitant vaccine TDAP confound causality. Causal relationship for the event of  foetal exposure during pregnancy is assessed as not related, while for the event premature baby causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to related for reporting purposes).