Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Caesarean section, Eclampsia, Exposure during pregnancy, Gestational diabetes, Pre-eclampsia
Clinical narrative: Pre-eclampsia; Eclampsia; Gestational diabetes; Vaccine exposure during pregnancy; This is an observational study case, initially received on 09-Jun-2020 concerning a 27-year-old, female pregnant subject of body weight: 129 lbs, height: 59 inches and body mass index (BMI): 26.1 Enrolled in, a prospective observational safety study.   The subject's medical history included chronic hypertension and increased BMI.  The subject's concomitant medications included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy.  The subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal and paternal history with MCMs. The subject did not consume tobacco, alcohol and illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 04-Apr-2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 09-Jan-2020. The type of pregnancy was singleton.  On 22-Jul-2019, the subject underwent ultrasound and panorama and no MCM was noted.  On 07-Aug-2019, the subject underwent ultrasound and no MCM was noted.  On 02-Oct-2019, at gestational age of 25 weeks (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.   On 30-Oct-2019, the subject underwent ultrasound and no MCM was noted.  On 13-Nov-2019, one month and 11 days after vaccination, the subject developed gestational diabetes.  On 21-Nov-2019, the subject underwent ultrasound and no MCM was noted.  On 12-Dec-2019, 20-Dec-2019 and 01-Jan-2020, the subject underwent ultrasound and no MCM was noted.  At gestational age of 38.9 weeks (as reported), the subject delivered a male neonate by Caesarean method. The birth weight of the neonate was 2404 g. Head circumference was 32.4 cm and length were 47 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 7 and at five minutes was 8. APGAR score at ten minutes was not provided. The pregnancy was complicated with pre-eclampsia and eclampsia. No MCM was identified at birth.  On the same day, the subject recovered from gestational diabetes, pre-eclampsia and eclampsia.  Per company, the events of gestational diabetes, pre-eclampsia and eclampsia were considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to case 202003789 (the corresponding baby case).  Company comment: A pregnant subject experienced pre-eclampsia and eclampsia approximately three months after receiving Flucelvax QIV. The subject also developed gestational diabetes 1 month and 11 days after vaccination, which may have contributed to development of eclampsia. The subject's current medical conditions included BMI high and chronic hypertension, therefore causality was highly confounded. Causal role of the suspect vaccine is assessed as not related for all events. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced pre-eclampsia and eclampsia approximately three months after receiving Flucelvax QIV. The subject also developed gestational diabetes 1 month and 11 days after vaccination, which may have contributed to development of eclampsia. The subject's current medical conditions included BMI high and chronic hypertension, therefore causality was highly confounded. Causal role of the suspect vaccine is assessed as not related for all events. Vaccine exposure during pregnancy assessed as not related per company's conventions.