Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Fungal infection, Gene mutation identification test negative, Gestational hypertension
Clinical narrative: Placental abruption; Premature delivery; Gestational hypertension; Yeast; Vaccine exposure during pregnancy; This is an observational study case initially received on 08-Oct-2019, concerning a 34-year-old female, pregnant subject of body weight 294 lbs, height 62 inches and body mass index (BMI) 53.8, enrolled in a prospective observational safety study. The subject's partner age was 35.  The subject's obstetrical history noted that the subject had three previous full-term, live birth pregnancies 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 13-May-2018. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 17-Feb-2019. The type of pregnancy was singleton.   The subject's current medical condition included obesity. The subject's concomitant medication included prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  On 05-Nov-2018, the subject underwent spinal muscular atrophy and cystic fibrosis mutation analysis. There was no MCM noted.  On 06-Nov-2018, at approximately 25 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit 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 date: not reported] (explicitly coded as ''Vaccine exposure during pregnancy'') for an influenza immunisation.   On the same day, the subject underwent Q natal and no MCM was noted.  On 13-Nov-2018 and 07-Jan-2019, ultrasound was performed, and no MCM was noted.  On 08-Jan-2019, the subject experienced gestational hypertension and yeast. On an unknown date, the subject experienced placental abruption, reported as pregnancy complication.  On 08-Jan-2019, the patient started treatment with Terazol (terconazole) for yeast, 1 applicator, daily, vaginally.  At gestational age of 34.7 weeks, the subject delivered a live birth, female neonate via Caesarean section. The characteristics of the neonate included birth weight: 2041 grams, head circumference: 31.1 cm, length: 45 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). There was no APGAR score data for 10 minutes reported. No MCM was identified at birth.   On the same day, the patient stopped treatment with Terazol.  The outcomes for the events of gestational hypertension and yeast were considered resolved on 11-Jan-2019. The outcome for the event of placental abruption was not reported.  This case is linked to case number 201905143 (corresponding child case).  The case was assessed as serious. The reporter did not provide causality assessment to Flucelvax QIVc.; Sender's Comments: The subject experienced premature separation of placenta, premature delivery, gestational hypertension and fungal infection after vaccination with the suspect product Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Medical history of extreme obesity (BMI) 53.8 may provide alternative aetiology for the events. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.