Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Complication of pregnancy, Delivery, Exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: Pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 09-Jun-2020, concerning a 38-year-old, pregnant female subject of body weight: 176 lbs, height: 69 inches and body mass index (BMI): 26, enrolled in, a prospective observational study on pregnancy outcomes in women immunized with Flucelvax, seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's historical medical condition included subchorionic hematoma (SCH). The subject's current medical conditions included BMI high and chronic hypertension.   The subject's concomitant medication included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy.   The subject's obstetrical history included three previous pregnancies with two full term live births and one spontaneous abortion. The subject did not have a history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCMs.   The subject's last menstrual period (LMP) date was 16-Jul-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 21-Apr-2020. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  On 27-Aug-2019, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no MCM was noted.  On 13-Sep-2019, the subject underwent ultrasound scan and SCH was noted. No MCM was noted.   On 04-Oct-2019, the subject underwent panorama test and no MCM was noted. On the same date, the subject underwent ultrasound scan and SCH was resolved. No MCM was noted.    On 07-Oct-2019, at approximately 11 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261218, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On 30-Jan-2020, 19-Mar-2020 and 09-Apr-2020, the subject underwent ultrasound scan and no MCM was noted.   On 10-Apr-2020, the subject's pregnancy status was collected, and pre-eclampsia was noted as pregnancy complication.   At 38.4 weeks of gestation (as reported), the subject delivered live birth male neonate, by vaginal method of delivery. The neonate's birth weight was 3385 grams, head circumference was 34.3 cm and body length 49.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   On the same date, the subject recovered from pre-eclampsia.   The event of pre-eclampsia was assessed as serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment.  Company comment: A pregnant subject experienced pre-eclampsia approximately six months after receiving Flucelvax QIV. The subject's current medical conditions included BMI high and chronic hypertension, therefore causality was highly confounded. Causal role of the suspect vaccine is assessed as not related, due to unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject experienced pre-eclampsia approximately six months after receiving Flucelvax QIV. The subject's current medical conditions included BMI high and chronic hypertension, therefore causality was highly confounded. Causal role of the suspect vaccine is assessed as not related, due to unsuggestive chronology. Vaccine exposure during pregnancy assessed as not related per company's conventions.