Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Premature labour
Clinical narrative: Delivery at 36 weeks of gestation; Vaccine exposure during pregnancy; Pre-eclampsia; This is an observational study case, initially received on 17-Jan-2020, concerning a 28-year-old, pregnant female subject of body weight 193 lbs, height 60 inches and body mass index (BMI) 37.7, enrolled in a prospective observational safety study.  The subject's current medical conditions included hypertensive disorder, diabetes mellitus and obesity. It was reported that the subject was non-immune to rubella.  The subject's concomitant medication included unspecified vitamins with iron as obstetrical (OB) supplement, nifedipine and labetalol, both for hypertensive disorder, Novolog (insulin aspart) and Lantus (insulin glargine), both for diabetes mellitus and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular and tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history included one previous pregnancy with spontaneous abortion. 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 06-Apr-2019, estimated delivery date (EDD) was reported as 11-Jan-2020, while corrected estimated date of delivery (CEDD) was reported as 17-Jan-2020. The type of pregnancy was singleton.   On 07-Jun-2019, the subject underwent initial ultrasound and no MCMs were noted.  On 05-Jul-2019, the subject underwent first trimester screen and no MCMs were noted.  On 05-Aug-2019, the subject underwent maternal serum alpha fetoprotein screening (MSAFP) and second trimester screen and no MCMs were noted.  On 04-Sep-2019, the subject underwent anatomy ultrasound and short arm/leg measurements were noted. No MCMs were noted.  On 01-Oct-2019, at gestational age of 25 weeks, 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: 216200, 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 in 2019, the subject developed pre-eclampsia.  At approximately 36 weeks of gestation, the subject gave live birth to a male neonate via caesarean method. The characteristics of the neonate included birth weight: 2200 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the events of preterm labour and pre-eclampsia was not reported.  The events of preterm labour and pre-eclampsia were considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202000489 (the corresponding baby case).  Company comment: The subject experienced pre-eclampsia and premature labour associated with administration of Flucelvax QIV. The patient was administered vaccine at approximately 25 weeks of gestation. Chronology is plausible. Causality was highly confounded by medical history of hypertensive disorder, diabetes mellitus, obesity and treatment with concomitant medications. Therefore, causality is assessed as not related for the event pre-eclampsia. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related to the event premature labour. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The subject experienced pre-eclampsia and premature labour associated with administration of Flucelvax QIV. The patient was administered vaccine at approximately 25 weeks of gestation. Chronology is plausible. Causality was highly confounded by medical history of hypertensive disorder, diabetes mellitus, obesity and treatment with concomitant medications. Therefore, causality is assessed as not related for the event pre-eclampsia. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related to the event premature labour. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.