Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Exposure during pregnancy, Premature delivery
Clinical narrative: Preterm delivery at 36.7 weeks of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received on 11-Feb-2020, concerning a 35-year-old, pregnant, female subject, 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 current conditions included obsessive compulsive disorder (OCD) and anxiety. It was noted that the subject had a pregnancy in advanced age.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's obstetrical history noted that the subject had two previous full-term, live birth pregnancies with no birth defects. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 07-Feb-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 02-Dec-2019. The type of pregnancy was singleton.   On 01-Apr-2019, the subject underwent haemoglobin electrophoresis and no MCMs were noted.  On 16-Apr-2019, the subject underwent ultrasound and no MCMs were noted.  On 20-Jun-2019, the subject underwent ultrasound and no MCMs were noted.  On 03-Oct-2019, the subject underwent ultrasound and no MCMs were noted.  On 17-Oct-2019, at approximately 33 weeks of gestation, the subject 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 'Vaccine exposure during pregnancy') for influenza immunisation.  On 09-Nov-2019, at approximately 36.7 weeks of gestation, the subject gave live birth to a male neonate via caesarean section method. The neonate's birth weight was 2750 grams, length was 50.2 cm and head circumference was 33 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). The APGAR score for ten minutes was not reported. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the event of 'premature delivery' was not reported.  The event of premature delivery' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202001701 (the corresponding baby 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 delivery was considered unassessable. Vaccine 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 delivery was considered unassessable. Vaccine exposure during pregnancy was assessed as unrelated to the vaccine in line with internal conventions.