Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Gestational hypertension, Premature delivery, Ultrasound antenatal screen normal
Clinical narrative: Pregnancy induced hypertension; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 27-Sep-2019, concerning a 34-year-old, pregnant, female subject of body weight: 135 lbs, height: 65 inches and body mass index (BMI): 22.5, enrolled in a prospective observational safety study on pregnancy outcomes.  The subject's obstetrical history included two previous spontaneous abortions. The subject did not have history of offspring with major congenital malformation (MCM) and did not have maternal and paternal history with MCM. The subject did not consume tobacco, alcohol or illicit drugs. The subject's current condition included headaches and anemia. Concomitant medications included Prenatal vitamins (minerals NOS, vitamins NOS), butalbital/acetaminophen and ferrous sulphate.  The subject's last menstrual period (LMP) date was 12-May-2018, the estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were 16-Feb-2019. The type of pregnancy was singleton.  On an unspecified date, at 7 weeks of gestational period, the pregnancy status was collected and small subchorionic hematoma (SCH) was noted.  On 25-Jun-2018, 02-Jul-2018 and 16-Jul-2018, the subject underwent ultrasound and no MCM was noted.  On 13-Aug-2018, the subject performed Q natal and no MCM was noted.  On 06-Sep-2018, the subject performed MSAFP/serum markers and no MCM was noted.  On 03-Oct-2018, approximately at gestational age of 20 weeks, the subject was administered Flu Vaccine Egg Split QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 252664, dose: 0.5 ml, route of administration, anatomical location and expiration: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On 05-Dec-2018, 10-Jan-2019 and 14-Jan-2019, the subject underwent ultrasound and no MCM was noted.  On 14-Jan-2019, approximately three months after vaccination, the subject developed pregnancy induced hypertension.   On 25-Jan-2019, the subject underwent ultrasound and no MCM was noted.  At gestational age of 37.4 weeks, the subject vaginally delivered male neonate. The neonate's birth weight was 2778 g, head circumference was 31.8 cm and length was 49.5 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes) and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  On the same day, the subject recovered from the event of 'pregnancy induced hypertension'.  Company comment: The patient developed gestational hypertension, approximately three months after vaccination with Flu Vaccine Cell Subunit QIV NVD. Vaccine was administered at 20 weeks of gestation, which was coded as vaccine exposure during pregnancy. Chronology is plausible. More information regarding medical history is needed. However, causal role of the suspect vaccine cannot be totally excluded and it is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Reporter's Comments: The patient developed gestational hypertension, approximately three months after vaccination with Flu Vaccine Cell Subunit QIV NVD. Vaccine was administered at 20 weeks of gestation, which was coded as vaccine exposure during pregnancy. Chronology is plausible. More information regarding medical history is needed. However, causal role of the suspect vaccine cannot be totally excluded and it is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.