Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Exposure during pregnancy, Foetal gastrointestinal tract imaging abnormal, Gestational hypertension, Pre-eclampsia
Clinical narrative: Pre-eclampsia; Gestational hypertension; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-Feb-2020, concerning a 25-year-old, pregnant, female subject of body weight: 168 lbs, height: 70 inches and body mass index (BMI): 24.1, enrolled in a prospective observational safety study.  The subject's relevant medical history was not reported.   The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's obstetrical history noted that the subject had two previous pregnancies with one full term live birth and one preterm live birth at 35 weeks. The subject had one twin pregnancy with the outcome with birth defect including gastroschisis of first baby. The subject had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject used 10 cigarettes per day during pregnancy. The subject did not use alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 02-Jul-2019. The subject's estimated delivery date (EDD) was reported as 07-Apr-2020, while corrected estimated delivery date (CEDD) was not reported. The type of pregnancy was multiple (twin gestation).   On 27-Aug-2019, the subject underwent ultrasound and no MCMs were noted.   On 25-Sep-2019, the subject underwent non-invasive prenatal testing (NIPT) and nuchal translucency, and no MCMs were noted.  On 23-Oct-2019, the subject underwent maternal serum alpha fetoprotein screening (MSAFP) and no MCMs were noted.  On 19-Nov-2019, at approximately 20 weeks of gestation, the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.   On the same day, after vaccination, the subject developed anaemia and received treatment medication ferrous sulphate at the dose of 325 mg, administered via oral route, once per day.   On the same day, the subject underwent 20-week anatomy ultrasound scan and echogenic bowel in twin A was noted and reported as ongoing. No MCMs were noted.   On an unspecified date, it was noted that the subject had pregnancy complications which included pre-eclampsia and gestational hypertension.  At the time of initial reporting, the subject had not recovered from the event of anaemia, while the outcome for the events of pre-eclampsia and gestational hypertension was not reported.  The event of pre-eclampsia' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202001669, the corresponding child case.  Company Comment: A pregnant subject experienced anaemia on the same day after vaccination with the suspect product Afluria QIV. Chronology is implausible. Pregnant state may provide alternative aetiology for anaemia, therefore causality is assessed as not related for this event. It was noted that the subject had pregnancy complications which included pre-eclampsia and gestational hypertension. Due to lack of information regarding onset date for this events and medical history, causality is unassessable for pre-eclampsia and gestational hypertension. Vaccine exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A pregnant subject experienced anaemia on the same day after vaccination with the suspect product Afluria QIV. Chronology is implausible. Pregnant state may provide alternative aetiology for anaemia, therefore causality is assessed as not related for this event. It was noted that the subject had pregnancy complications which included pre-eclampsia and gestational hypertension. Due to lack of information regarding onset date for this events and medical history, causality is unassessable for pre-eclampsia and gestational hypertension. Vaccine exposure during pregnancy is assessed as not related per company conventions.