Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Complication of pregnancy, Eclampsia, Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; Eclampsia; This is an observational study case, initially received on 14-Jan-2020, concerning a 23-year-old, pregnant female subject, of body weight 184 lbs, height 62 inches and body mass index (BMI) 33.7, 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 historical condition included urinary tract infection (UTI) and kidney stones. The subject's current medical condition included increased BMI and nausea.   The subject's historical medications included cefpodoxime for UTI and hydrocodone acetaminophen for kidney stones. The subject's concomitant medication included promethazine for nausea.  The subject's obstetrical history noted that the subject had no previous pregnancies. 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 09-Jan-2019, estimated delivery date (EDD) was reported as 16-Oct-2019, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 15-Apr-2019, the subject underwent first trimester screen and no MCMs were noted.  On 06-Sep-2019, at gestational age of 34 weeks, the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 2612000, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.   On an unspecified date in 2019, the subject developed eclampsia, reported as pregnancy complication.  At gestational age of 40 weeks, the subject delivered a live birth, female neonate via caesarean method. The neonate's birth weight was 2835 g, while the head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. It was reported that there were no MCM identified at birth.  At the time of initial report, the outcome for the event of eclampsia was not reported.  The event of eclampsia was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  Company comment: The subject experienced eclampsia associated with administration of Flucelvax QIV. The subject was administered vaccine at approximately 34 weeks of gestation and developed event on an unspecified date in 2019. Chronology needs more clarification. Causality was confounded by medical history of increased BMI and treatment with concomitant medications. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The subject experienced eclampsia associated with administration of Flucelvax QIV. The subject was administered vaccine at approximately 34 weeks of gestation and developed event on an unspecified date in 2019. Chronology needs more clarification. Causality was confounded by medical history of increased BMI and treatment with concomitant medications. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.