Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Complication of pregnancy, Delivery, Exposure during pregnancy, Placental disorder, Pre-eclampsia
Clinical narrative: Pre-eclampsia; Dysmature placenta; Vaccine exposure during pregnancy; This is an observational study case initially received on 27-Nov-2019, concerning a 33-year-old female pregnant subject of body weight 179 lbs, height 63 inches and body mass index (BMI) 31.7, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject's partner age was 34.  The subject's obstetrical history noted that the subject two previous pregnancies with one spontaneous abortion and one full term live birth with no birth defects. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 18-Feb-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 25-Nov-2019. The type of pregnancy was singleton.   The subject's historical condition included yeast since 30-Apr-2019 to 10-May-2019. The subject's current condition included hypertension since 13-Jun-2019. The subject's historical drug included Terazol (terconazole) for yeast. The subject's concomitant medications included prenatal vitamins (unspecified minerals and vitamins) for pregnancy and labetalol for hypertension.  On 19-Apr-2019, the subject haemoglobin (Hgb) electrophoresis and no MCMs were noted.  On 17-May-2019, the subject underwent ultrasound and panorama. No MCMs were noted.  On 11-Oct-2019, at approximately 33 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.  On an unspecified date, the patient experienced pre-eclampsia and dysmature placenta, reported as pregnancy complication.  at approximately 37 weeks of gestation, the subject gave live birth to a male neonate vaginally. The characteristics of the neonate included birth weight: 3070 grams, head circumference: 35.6 cm and length: 50.2 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. No major congenital malformations (MCMs) were identified at the time of birth.   At the time of the initial reporting, the outcome for the events of pre-eclampsia and dysmature placenta was not reported.  The events of pre-eclampsia and dysmature placenta were considered as serious due to criterion of medical significance per company.  The reporter did not provide causality assessment to Flucelvax QIVc.  Company Comment: The subject experienced pre-eclampsia and placental disorder after unknown amount of time after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 33 weeks of gestation. Chronology is unclear but plausible. Medical history of hypertension and obesity (body mass index 31.7) may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant medication, labetalol.  Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events pre-eclampsia and placental disorder is assessed as unlikely related.; Sender's Comments: The subject experienced pre-eclampsia and placental disorder after unknown amount of time after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 33 weeks of gestation. Chronology is unclear but plausible. Medical history of hypertension and obesity (body mass index 31.7) may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant medication, labetalol.  Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events pre-eclampsia and placental disorder is assessed as unlikely related.