Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Metabolic syndrome X; Vaccine exposure during pregnancy; Condition aggravated; Hypertension; This is an observational study case, initially received from other health professional on 20-Dec-2019, concerning a 34-year-old, pregnant, female subject of body weight: 276.6 lbs, height: 65 inches and body mass index (BMI): 46, enrolled in, a prospective observational safety study.   The subject's obstetrical history included two previous pregnancies with one full-term live birth and one spontaneous abortion. The subject had son with Chiari malformation, but no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's current medical history included metabolic syndrome X, morbid obesity, anxiety and depression.   The subject's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) as supplement, metformin for metabolic syndrome X and Zoloft (sertraline hydrochloride) for anxiety and depression.   The subject's last menstrual period (LMP) date was 30-Apr-2019. The subject's estimated date of delivery (EDD) was reported as 04-Feb-2020 and corrected estimated date of delivery (CEDD) was reported as 05-Apr-2020. The type of pregnancy was singleton.   On 05-Aug-2019, 23-Aug-2019, 11-Sep-2019 and 13-Sep-2019, the subject underwent ultrasound scan and no major congenital malformation (MCM) was noted.    On 23-Sep-2019, at 12 weeks of gestation, the subject was administered Afluria QIV [influenza vaccine, batch number: P100118562, dose; route of administration; anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. On the same day, the subject underwent ultrasound and no MCM was noted.  On 24-Sep-2019, the subject underwent MaterniT test, and no MCM was noted.  On 27-Sep-2019, the subject underwent ultrasound scan and no MCM was noted.  On an unknown date in 2019, metabolic syndrome X was aggravated and the subject experienced hypertension.  On 27-Nov-2019, the subject started treatment for aggravated metabolic syndrome X with NPH u100 Insulin (isophane insulin) at dose of 26 units, subcutaneous every night at bedtime (QHS).   At the time of initial reporting, the outcome of the events of metabolic syndrome X aggravated and hypertension was not reported.   The event of metabolic syndrome X aggravated was considered serious due to criterion of medical significance.    The reporter did not provide causality assessment to Afluria QIV.  Company comment: The subject experienced cardiometabolic syndrome/condition aggravated and hypertension associated with administration of Afluria QIV. The patient was administered vaccine at approximately 12 weeks of gestation. Chronology needs more clarification. Although, metabolic syndrome was reported as pregnancy complication, Metformin use prior to conception suggests that this is medical history. Causality was highly confounded by medical history of morbid obesity. Causal role of the suspect vaccine cannot be totally excluded and is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The subject experienced cardiometabolic syndrome/condition aggravated and hypertension associated with administration of Afluria QIV. The patient was administered vaccine at approximately 12 weeks of gestation. Chronology needs more clarification. Although, metabolic syndrome was reported as pregnancy complication, Metformin use prior to conception suggests that this is medical history. Causality was highly confounded by medical history of morbid obesity. Causal role of the suspect vaccine cannot be totally excluded and is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.