Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: HELLP syndrome, Premature delivery
Clinical narrative: Preterm delivery; Vaccine exposure during pregnancy; Eclampsia in third trimester; HELLP syndrome; This is an observational study case, initially received by other health professional on 20-Jan-2020, concerning a 34-year-old, pregnant female subject of body weight 127.8 lbs, height 63 inches and body mass index (BMI) 22.6, enrolled in a prospective observational safety study.   The subject's current medical conditions included nausea, uterine leiomyoma, and history of positive human papilloma virus (HPV) test.  The subject's past medication included progesterone intramuscular oil for IVF.  The subject's concomitant medication included prenatal vitamins (unspecified vitamins and minerals) as obstetrical (OB) care vitamin, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for nausea 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 had an in vitro fertilisation (IVF) on unspecified date.  The subject's last menstrual period (LMP) date was 12-Apr-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 17-Jan-2020. The type of pregnancy was singleton.   On 02-Aug-2019, the subject underwent maternal serum alpha fetoprotein screening (MSAFP) and second trimester scan and no MCMs were noted.  On 23-Aug-2019, the subject underwent anatomy ultrasound and no MCMs were noted.  On 20-Sep-2019, at gestational age of 22 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: 261200, 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 hypertension associated disorders of pregnancy (HELLP), reported as pregnancy complication.  On an unspecified date in 2019, reported as in third trimester, the subject developed eclampsia.  At approximately 30 weeks of gestation, the subject gave live birth to a female neonate via caesarean method in breech position. The characteristics of the neonate included birth weight: 1219 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 2 at one minute and 7 at five minutes. It was not reported if MCMs were identified at the time of birth.   At the time of this report, the outcome for the events of premature delivery, eclampsia, HELLP syndrome was not reported.  Per company, the events of premature delivery, eclampsia and HELLP syndrome 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 202000551 (the corresponding baby case).  Company Comment: The subject experienced premature delivery, eclampsia and HELLP syndrome after vaccination with the suspect product, Flucelvax QIV. The patient was administered vaccine at approximately 22 weeks of gestation. Chronology is plausible. Medical history of uterine leiomyoma, human papilloma virus and in vitro fertilisation may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and non-company co-suspect TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid).  Causality between suspect product and the events premature delivery, eclampsia and HELLP syndrome is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.; Sender's Comments: The subject experienced premature delivery, eclampsia and HELLP syndrome after vaccination with the suspect product, Flucelvax QIV. The patient was administered vaccine at approximately 22 weeks of gestation. Chronology is plausible. Medical history of uterine leiomyoma, human papilloma virus and in vitro fertilisation may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and non-company co-suspect TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid).  Causality between suspect product and the events premature delivery, eclampsia and HELLP syndrome is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.