Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Caesarean section, Eclampsia, Exposure during pregnancy, Gene mutation identification test negative, Haemoglobin electrophoresis normal
Clinical narrative: Eclampsia at 34 weeks; Vaccine exposure during pregnancy; This is an observational study case, initially received on 27-Sep-2019, concerning a 24-year-old, pregnant, female subject [Ethnicity: Not reported] of body weight 158 lbs, height 64 inches and body mass index (BMI) 27.1, enrolled, a prospective observational safety study.  The subject's obstetrical history noted that the subject had two previous pregnancies including one previous full-term live birth and one preterm live birth pregnancy. 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 current conditions included anxiety, depression and hypertension. Concomitant medications included prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy and Zoloft (sertraline hydrochloride) for anxiety.  The subject's last menstrual period (LMP) date was 10-Nov-2018, the estimated date of delivery (EDD) and corrected estimated date of delivery was 17-Aug-2019. The type of pregnancy was singleton.   On 12-Mar-2019, the subject underwent spinal muscular atrophy, cystic fibrosis mutation analysis and hemoglobin electrophoresis and no MCM was noted.  On 19-Mar-2019, the subject underwent ultrasound and quad screen, and no MCM was noted.  On 15-May-2019, at approximately 26 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, 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 an unreported date, at 34 weeks of gestation, the subject experienced eclampsia, reported as pregnancy complication.  On 13-Aug-2019, at gestational age of 39.4 weeks, the subject delivered a live birth, male neonate via caesarean section. The neonate's birth weight was 3250 grams, head circumference was 35.6 cm and length was 50.8 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). There was no APGAR score data for 10 minutes reported. No MCM was identified at birth.   At the time of initial reporting, the outcome for the event of 'eclampsia' was not reported.  Company Comment: The subject experienced eclampsia after vaccination with the suspect product Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of hypertension and pregnant state may have contributed to development of the event. Causality was confounded by use of concomitant medication, Zoloft (sertraline hydrochloride). Causal relationship between the suspect product and exposure during pregnancy is assessed as not related. For the event eclampsia, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The subject experienced eclampsia after vaccination with the suspect product Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of hypertension and pregnant state may have contributed to development of the event. Causality was confounded by use of concomitant medication, Zoloft (sertraline hydrochloride). Causal relationship between the suspect product and exposure during pregnancy is assessed as not related. For the event eclampsia, causal role of the suspect product cannot be totally excluded and is assessed as related.