Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Gestational diabetes, Nausea, Ultrasound antenatal screen normal
Clinical narrative: Nausea; Gestational diabetes; Vaccine exposure during pregnancy; This is a observational study case, reported by other health professional and initially received on 26-Mar-2020, concerning a 25-year-old, pregnant female subject, of body weight: 277.5 lbs, height: 65.3 inches and body mass index (BMI): 45.8, who was enrolled in in , a prospective observational safety study.  The subject's medical history included rhesus factor negative (RhD), history of pregnancy induced hypertension and high body mass index.  The subject's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) and folic acid for pregnancy, Vitamin D3 as health supplementation and Aspirin (acetylsalicylic acid) for history of pregnancy induced hypertension.  The subject's obstetrical history noted that the subject had two previous pregnancies which included one full-term live birth and one spontaneous abortion. 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 use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 24-Sep-2019, the estimated delivery date (EDD) was 30-Jun-2020 and corrected estimated date of delivery (CEDD) was reported as 05-Jul-2020. The type of pregnancy was singleton.   On 11-Nov-2019, the subject underwent ultrasound scan, and no MCM was noted.  On 20-Nov-2019, the subject received Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100126099, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On an unspecified date, an unknown amount of time after vaccination, the subject experienced nausea.   On 30-Jan-2020 and 17-Feb-2020, the subject underwent ultrasound scans, and no MCM was noted.  On 27-Feb-2020, the subject started treatment with Zofran (ondansetron hydrochloride), at a dose of 8 mg, administered via oral route, every eight hours per needed, for nausea.   On 02-Mar-2020, approximately three months after vaccination, the subject developed gestational diabetes.   On 16-Mar-2020, the subject underwent ultrasound scan, and no MCM was noted.  At the time of initial reporting, the subject had not recovered from the event of gestational diabetes, while the outcome for the event of nausea was not reported.  The event of gestational diabetes mellitus' was assessed as serious due to criteria of medically significance, per company.  The reporter did not provide causality assessment.  Company comment: A pregnant subject was administered Afluria QIV and experienced gestational diabetes three months later. The patient also developed nausea an unknown amount of time after vaccination. Chronology is needs more clarification for nausea. Causality is highly confounded by pregnant state and medical history of pregnancy induced hypertension and high body mass index. However, causal role of vaccine is not excluded and is assessed as unlikely related for both events (defaults to related for reporting purposes). Vaccine exposure during pregnancy was assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Afluria QIV and experienced gestational diabetes three months later. The patient also developed nausea an unknown amount of time after vaccination. Chronology is needs more clarification for nausea. Causality is highly confounded by pregnant state and medical history of pregnancy induced hypertension and high body mass index. However, causal role of vaccine is not excluded and is assessed as unlikely related for both events (defaults to related for reporting purposes). Vaccine exposure during pregnancy was assessed as not related per company's conventions.