Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Premature delivery, Twin pregnancy
Clinical narrative: Delivery at 33.6 weeks of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a 28-year-old pregnant, female subject, of body weight 148.8 lbs, height 63 inches and body mass index (BMI) 26.4, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's medical history included increased BMI.  The subject's concomitant medications included Prometrium (progesterone) and Prenatal (unspecified vitamins and minerals), both indicated as neonatal care.  The subject's obstetrical history included three previous pregnancies, one full time live birth and two spontaneous abortions. 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-Jul-2019. The type of pregnancy was multiple (twins). The subject's estimated delivery date (EDD) was reported as 12-Apr-2020 and corrected estimated delivery date (CEDD) was reported as 13-Apr-2020.   On 26-Aug-2019, the subject underwent ultrasound scan and no MCMs were noted.  On 25-Sep-2019, the subject underwent first trimester screen and no MCMs were noted.  On 12-Nov-2019, at approximately 18 weeks of gestation (calculated per LMP), the subject 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 expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  At 33.6 weeks of gestation (as reported), the subject delivered two live male neonates by caesarean method of delivery. The characteristics of the first neonate included: birth weight 1720 grams, length: 45.1 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores 7 (at one minute) and 8 (at five minutes). The characteristics of the second neonate included: birth weight 2290 grams, length: 44.7 cm and APGAR scores 7 (at one minute) and 8 (at five minutes). There was no APGAR score data for 10 minutes and head circumference for both neonates. No MCMs were identified at birth.  At the time of this report, the outcome of event premature delivery' was not reported.  The event of premature delivery' was considered as serious due to criterion of medical significance.  The reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to cases 202003315 and 202003316 (the corresponding babies cases).  Company comment: At approximately 18 weeks of gestation, the patient was administered Flucelvax QIVc (explicitly coded as Vaccine exposure during pregnancy'). Reportedly, at 33.6 weeks of gestation, the patient delivered two live male neonates by caesarean method of delivery. (coded as premature delivery). Chronology seems unsuggestive. Medical history of high body mass index confounds causality. Causal relationship for the event of vaccine exposure during pregnancy is assessed as not related to suspect vaccine per company's conventions, while causal relationship between the suspect product and event of premature delivery is assessed as not related due to unsuggestive temporal relationship and confounding factor provided.; Sender's Comments: At approximately 18 weeks of gestation, the patient was administered Flucelvax QIVc (explicitly coded as Vaccine exposure during pregnancy'). Reportedly, at 33.6 weeks of gestation, the patient delivered two live male neonates by caesarean method of delivery. (coded as premature delivery). Chronology seems unsuggestive. Medical history of high body mass index confounds causality. Causal relationship for the event of vaccine exposure during pregnancy is assessed as not related to suspect vaccine per company's conventions, while causal relationship between the suspect product and event of premature delivery is assessed as not related due to unsuggestive temporal relationship and confounding factor provided.