Sex: M
Vaccine: UNK
Symptoms: Premature baby
Clinical narrative: Non-reassuring fetal heart tones; Fetus intrauterine growth restrictions and failure to progress; Hypospadias; Foetal exposure during pregnancy; Neonate's birth weight was 2013 g; This is an observational study case, initially received from other health professional on 21-Nov-2019 and with additional information received on 25-Nov-2019 (being processed together), concerning a male neonatal subject whose mother was 27-year-old pregnant, female subject, of body weight: 210 Ibs, height: 68 in and body mass index (BMI) 31.9  enrolled in, a prospective observational safety study. The subject's father was 30-year-old.  The subject's mother had three previous pregnancies with three spontaneous abortions. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's current condition include obesity with BMI 30+ and hypertension. The mother's historical vaccine included TDap (diphtheria vaccine toxoid, pertussis vaccine acellular and tetanus vaccine toxoid) as vaccine. The mother's concomitant medications included Baby Aspirin (acetylsalicylic acid) and labetalol, both used for hypertension and prenatal vitamins (unspecified vitamins and minerals) for obstetrical (OB) care.   The mother's last menstrual period (LMP) date was on an unspecified date in 2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 25-Nov-2019. The type of pregnancy was singleton.   On 22-May-2019, the subject's mother underwent first trimester screen and it was noted that the foetus was positive for Down Syndrome. However, later the mother underwent MaterniT 21 and it was within normal limits. No MCMs noted.  On 29-May-2019, the subject's mother underwent MaterniT 21 and no MCMs were noted.  On 09-Oct-2019, at approximately 33 weeks of gestation, the subject's mother was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On an unspecified date, pregnancy status of subject's mother was collected and non-reassuring fetal heart tones (FHT), failure to progress (FTP) and fetus intrauterine growth restrictions (IUGR) were reported as pregnancy complications.   On 06-Nov-2019, at approximately 37.3 weeks of gestation, the mother delivered a live male neonate via caesarean method. The neonate's birth weight was 2013 grams, body length and head circumference were not reported. The reported appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was provided at 10 minutes. MCM identified at birth was hypospadias. As reported, contributing factor to neonate's hypospadias was hypertension in mother. Etiology was unknown, however, it was reported that it was possibly genetic as possible anti-androgenic exposures. It was reported that gestational age for origin of the defect was 7 to 12 weeks and that the origin of the defect was prior the mother's vaccination. Other factors contributing to the MCM were unknown.  At the time of initial reporting, the outcome of the events of low birth weight baby, hypospadias, non-reassuring fetal heart tones and fetus intrauterine growth restrictions and failure to progress was not reported.  The events of 'low birth weight baby', 'hypospadias', 'non-reassuring fetal heart tones' and 'fetus intrauterine growth restrictions and failure to progress' were assessed as serious (medically significant).   The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case number 201906264 (corresponding mother case).  Company Comment: The male neonatal subject was delivered as low birth weight baby with nonreassuring foetal heart rate pattern, foetal growth restriction and hypospadias after foetal exposure during pregnancy (at approximately 33 weeks of gestation) with the suspect product, Flucelvax QIV. Chronology is plausible for all events except for hypospadias. Gestational age for origin of hypospadias was 7 to 12 weeks, making temporal relationship incompatible. Mother's medical history of three spontaneous abortions, hypertension and obesity (body mass index 31.9) may provide alternative aetiology for the events. Causality was also confounded with concomitant medications, Baby Aspirin (acetylsalicylic acid) and labetalol. Foetal exposure during pregnancy is assessed as not related per company's conventions. For the events low birth weight baby nonreassuring foetal heart rate pattern and foetal growth restriction, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. Causality for the event hypospadias is assessed as not related.; Sender's Comments: The male neonatal subject was delivered as low birth weight baby with nonreassuring foetal heart rate pattern, foetal growth restriction and hypospadias after foetal exposure during pregnancy (at approximately 33 weeks of gestation) with the suspect product, Flucelvax QIV. Chronology is plausible for all events except for hypospadias. Gestational age for origin of hypospadias was 7 to 12 weeks, making temporal relationship incompatible. Mother's medical history of three spontaneous abortions, hypertension and obesity (body mass index 31.9) may provide alternative aetiology for the events. Causality was also confounded with concomitant medications, Baby Aspirin (acetylsalicylic acid) and labetalol. Foetal exposure during pregnancy is assessed as not related per company's conventions. For the events low birth weight baby nonreassuring foetal heart rate pattern and foetal growth restriction, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. Causality for the event hypospadias is assessed as not related.