Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby, Twin pregnancy
Clinical narrative: Foetal exposure during pregnancy; Brith at 36.9 weeks of gestation; This is an observational study case, initially received from other health professional on 11-Feb-2020, concerning a male neonate subject, whose mother was 20-year-old, female of body height 63 inches, weight and body mass index (BMI): not reported, enrolled in, a prospective observational safety study.  The subject's mother relevant medical history was not reported.  The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother obstetrical history noted that the subject had no previous pregnancies. 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 MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was 26-Mar-2019. Estimated delivery date (EDD) was reported as 31-Dec-2019, while corrected delivery date (CEDD) was not reported. The type of pregnancy was multiple. The subject's father age was 22-years.  On 06-Nov-2019, 13-Nov-2019 and 20-Nov-2019, the subject's mother underwent non-stress test and no MCMs were noted.  On 27-Nov-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 04-Dec-2019, the subject's mother underwent ultrasound and non-stress test. No MCMs were noted.  On 21-Oct-2019, at gestational age at 29 weeks, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine; batch number: 261218, dose: 0,5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On 09-Dec-2019, at gestational age of 36,9 weeks, the subject's mother delivered a live birth male neonate via caesarean method. Pregnancy complications were not reported. The neonate's birth weight: 2885 grams, head circumference: 34.3 cm and length: 48.3 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). There was no APGAR score for ten minutes reported. No major congenital malformations (MCMs) were identified at the time of birth.   At the time of this report, the outcome of the event 'premature baby' was not reported.  The event of premature baby was considered serious due to criterion of medical significance, per company.   The causality assessment was not provided.  This case is linked to 202001702 (corresponding mother case) and 202001704 (corresponding twin baby).  Company comment: Reportedly, a neonate subject was delivered as premature baby after foetal exposure to the suspect product Flucelvax QIVc. The vaccine was administered at 29 weeks of gestation. Temporal relationship is plausible. Although, early-onset of labor is common in multiple pregnancies such as this (twins), causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, a neonate subject was delivered as premature baby after foetal exposure to the suspect product Flucelvax QIVc. The vaccine was administered at 29 weeks of gestation. Temporal relationship is plausible. Although, early-onset of labor is common in multiple pregnancies such as this (twins), causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.