Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm delivery at 36.7 weeks of gestation; This is an observational study case initially received from other health professional on 11-Feb-2020, concerning a neonate male subject whose  mother was 35-year-old female pregnant  of body weight 108 lbs, height 62 inches and body mass index (BMI) 19.8, enrolled in a prospective observational safety study.   The subject's mother current conditions included advanced maternal age, obsessive compulsive disorder (OCD) and anxiety.  The subject's mother concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother obstetrical history noted that the mother had two 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 07-Feb-2019. The subject's mother estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 02-Dec-2019. The type of pregnancy was singleton. The subject's father was 37 years old.  On 01-Apr-2019, the subject's mother underwent haemoglobin electrophoresis and no MCMs were noted.  On 16-Apr-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 20-Jun-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 03-Oct-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 17-Oct-2019, at approximately 33 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: 261218, 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 36.7 weeks of gestation, the mother delivered a live male neonate via caesarean method. The characteristics of the neonate included birth weight: 2750 grams, length: 50.2 cm and head circumference: 33 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five 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 202001700 (corresponding mother case).  Company comment: It was reported that the male neonate was delivered via Caesarean section several weeks after vaccination. A Caesarean section in general, and in particular if conducted prior to the term, would suggest an underlying cause prompting this method over vaginal delivery. No other pregnancy complications were reported which precludes thorough assessment of causality. Based on the available information, causality for the event of premature baby was considered unassessable. Foetal exposure during pregnancy was assessed as unrelated to the vaccine in line with internal conventions.; Sender's Comments: It was reported that the male neonate was delivered via Caesarean section several weeks after vaccination. A Caesarean section in general, and in particular if conducted prior to the term, would suggest an underlying cause prompting this method over vaginal delivery. No other pregnancy complications were reported which precludes thorough assessment of causality. Based on the available information, causality for the event of premature baby was considered unassessable. Foetal exposure during pregnancy was assessed as unrelated to the vaccine in line with internal conventions.