Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Delivery, Exposure during pregnancy, Gestational hypertension, Oligohydramnios
Clinical narrative: Vaccine exposure during pregnancy; Oligohydramnios in 3rd trimester; Gestational hypertension; This is an observational study case, initially received from other health professional on 04-Dec-2019, concerning a 27-year-old, female pregnant subject of body weight: 188 lbs, height: 65.5 inches and body mass index (BMI): 30.8) enrolled in a prospective observational safety study on pregnancy outcome in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's current medical history included body mass index high.   The subject's concomitant medication included Prenatal vitamin (unspecified minerals and vitamins) as supplement and Tums (calcium carbonate, magnesium carbonate) as antacid.  The subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 21-Feb-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 28-Nov-2019. The type of pregnancy was singleton.   On 22-Apr-2019 and 26-Jun-2019, the subject underwent ultrasound and no MCM was noted.  On 27-Sep-2019, at gestational age at 31 weeks, the subject was administered Afluria QIV[flu vaccine egg split QIV CSL, batch number: P100118566, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.  On an unspecified day in 2019, after an unknown amount of time after vaccination, the subject developed oligohydramnios in third trimester and gestational hypertension, but the details were not specified.  at gestational age of 37.7 weeks, the mother vaginally delivered live birth, female neonate. The neonate's birth weight was 2110 g, her head circumference was 31 cm and length was 47 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes). There was no MCM identified at birth.   At the time of this report, the outcome of the events oligohydramnios and gestational hypertension was not reported.  The event of oligohydramnios was assessed as serious due to criterion of medical significance per company.  The reporter did not provide causality assessment to Afluria QIV.  The case was linked with 201907093, the corresponding child case.  Company Comment: The subject experienced oligohydramnios and gestational hypertension after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at 31 weeks of gestation. Chronology is plausible. Pregnant state may provide alternative aetiology for both events. Medical history of obesity (body mass index 30.8) may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events oligohydramnios and gestational hypertension is assessed as unlikely related.; Sender's Comments: The subject experienced oligohydramnios and gestational hypertension after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at 31 weeks of gestation. Chronology is plausible. Pregnant state may provide alternative aetiology for both events. Medical history of obesity (body mass index 30.8) may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events oligohydramnios and gestational hypertension is assessed as unlikely related.