Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 36.9 gestational age; This is an observational study case  initially received on 03-Feb-2020, concerning a neonate female subject whose  mother was 33-year-old female pregnant, of body weight 243.4 lbs, height 64 inches and body mass index (BMI) 41.8, enrolled in, a prospective observational study.  The subject's mother current conditions included increased BMI, gestational diabetes mellitus (DM) and polycystic ovarian syndrome.  The subject's mother concomitant medications included prenatal vitamins (unspecified vitamins and minerals) as neonatal care and Metformin HCL ER (metformin hydrochloride) for gestational diabetes.   The subject's mother obstetrical history noted that the mother had four previous pregnancies of full-term live birth with no birth defects. 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 subject's mother last menstrual period (LMP) date was on 03-Jan-2019. The mother's estimated date of delivery (EDD) was reported as 10-Oct-2019, while corrected estimated date of delivery (CEDD) was reported as 07-Nov-2019. The type of pregnancy was singleton. The subject's father was 35 years old.  On 02-Apr-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 29-Apr-2019, the subject's mother underwent first trimester screen and no MCMs were noted.  On 24-Jun-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 12-Sep-2019, at approximately 32 weeks of gestation, the subject's mother was administered Flucelvax QIVc( Flu Vaccine Cell Subunit QIV NVD) [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.  At approximately (reported as) 36.9 weeks of gestation,, the mother delivered a live female neonate via caesarean method. The characteristics of the neonate included birth weight: 3062 grams, length: 48.3 cm, while head circumference was not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 at one minute, 8 at five minutes and 9 at ten minutes. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the event of premature baby was not reported.  The event of premature baby' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case number 202001630 (corresponding mother case).  Company Comment: A female neonate was delivered as premature baby after foetal exposure during pregnancy with Flucelvax QIVc, administered at approximately 32 weeks of gestation. Chronology is compatible. The subject's mother history of polycystic ovarian syndrome, gestational diabetes mellitus and obesity (body mass index 41.8) may provide alternative aetiology for the event. Causality was also confounded by subject's mother therapy with concomitant medication, Metformin HCL ER (metformin hydrochloride). Considering all the above mentioned, causality between suspect product and the event premature baby is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A female neonate was delivered as premature baby after foetal exposure during pregnancy with Flucelvax QIVc, administered at approximately 32 weeks of gestation. Chronology is compatible. The subject's mother history of polycystic ovarian syndrome, gestational diabetes mellitus and obesity (body mass index 41.8) may provide alternative aetiology for the event. Causality was also confounded by subject's mother therapy with concomitant medication, Metformin HCL ER (metformin hydrochloride). Considering all the above mentioned, causality between suspect product and the event premature baby is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as not related per company's conventions.