Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Glucose tolerance test abnormal, HELLP syndrome, Premature delivery, Stillbirth
Clinical narrative: Preterm birth; HELLP syndrome; Vaccine exposure during pregnancy; This is a observational study case, initially received on 16-Dec-2019 and additional information (being processed together) received on 18-Dec-2019, concerning a 33-year-old female, pregnant subject, of body weight: 246 lbs, height: 67 inches and body mass index (BMI): 38.5, who was enrolled in, a prospective observational safety study during pregnancy.  The subject's past medical history was not provided, while the subjects current condition included obesity (body mass index 38.5), gestational hypertension, history of venous thromboembolism, nausea, vomiting and anxiety. The subject's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for pregnancy, Lexapro (escitalopram oxalate) for anxiety, Lovenox (enoxaparin sodium) for venous thromboembolism and Promethazine for nausea and vomiting.  The subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal history with MCMs. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. Paternal age was not reported.  The subject's last menstrual period (LMP) was on 24-Jun-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was reported as 30-Mar-2020 and corrected EDD (CEDD) was not reported.  On 18-Sep-2019, first sequential and nuchal translucency were performed, and no MCM was noted.  On 16-Oct-2019, second sequential was performed, and no MCM was noted.  On 16-Oct-2019, at approximately 22 weeks of gestation, the subject received Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On 30-Oct-2019, early glucose tolerance test was performed, per the reporter was failed, and no MCM was noted.  On 04-Nov-2019, three-hour glucose tolerance test was performed, and no MCM was noted.  At the gestational age of 22.7 weeks, the subject delivered non-viable male via vaginal delivery method (explicitly coded as Premature delivery'). Stillbirth baby birth weight was 417 grams, body length and head circumference were not reported and the appearance, pulse, grimace, activity and respiration (APGAR) score at one minute, five minutes and ten minutes were not reported. There was no MCM identified at birth. Factors that may have had an impact on the fetal loss were reported as, hypertension associated disorders of pregnancy (HELLP) diagnosed at 22.7 weeks gestational age.  On 18-Dec-2019, update history of deep vein thrombosis (DVT).  The events of hypertension associated disorders of pregnancy (HELLP) and premature delivery were considered as serious per medically significance via company. The reported did not provide causality assessment.  The case is linked to case 201907407, baby case.  Company comment: A 33-year-old pregnant subject experienced premature delivery 1 month 14 days post vaccination and HELLP syndrome, on an unspecified day after administration of Flu Vaccine Egg Split QIV CSL. The vaccine was administered at 22 weeks of gestation. Although causality was highly confounded by mother's medical history of obesity, gestational hypertension, history of venous thromboembolism, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related for both events. Vaccine exposure during pregnancy assessed as unrelated per company's conventions.; Sender's Comments: A 33-year-old pregnant subject experienced premature delivery 1 month 14 days post vaccination and HELLP syndrome, on an unspecified day after administration of Flu Vaccine Egg Split QIV CSL. The vaccine was administered at 22 weeks of gestation. Although causality was highly confounded by mother's medical history of obesity, gestational hypertension, history of venous thromboembolism, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related for both events. Vaccine exposure during pregnancy assessed as unrelated per company's conventions.