Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Delivery, Exposure during pregnancy, Foetal heart rate deceleration abnormality, Neonatal disorder
Clinical narrative: Marginal placenta abruption; Pre-term delivery; Spontaneous rupture of membranes (SROM), premature rupture of membranes (PROM); Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 13-Mar-2020, concerning a 39-year-old, pregnant, female subject of body weight: 177 lbs, height: 64 inches and body mass index (BMI): 30.4, enrolled in a prospective observational safety study.  The subject's medical history included advanced maternal age, BMI increased, genital herpes simplex virus and vaginal yeast.   The subject's concomitant medications included metronidazole for vaginal yeast, Makena (hydroxyprogesterone caproate) for history of preterm labor and Prenatal vitamins with iron (unspecified vitamins and minerals) as vitamin supplementations.   The subject's obstetrical history included four previous pregnancies with three full term live births and one preterm delivery. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 21-Jun-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 27-Mar-2020.   On 17-Sep-2019, the subject underwent nuchal translucency and Maternit 21 test and no MCM was noted.   On 03-Oct-2019, approximately at 15 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, batch number: 261207, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy').  On 18-Oct-2019, the subject underwent second trimester screen and maternal serum alpha fetoprotein screening (MSAFP/ serum markers) and no MCM was noted.   On 01-Nov-2019, the subject underwent anatomy ultrasound scan and no MCM was noted.  On an unspecified date, the subject experienced marginal placental abruption.    The subject experienced spontaneous rupture of membranes (SROM) and premature rupture of membranes (PROM).   On the same day, at gestational age of 32.9 weeks (as reported), the subject gave a vaginal birth after caesarean (VABC) to live, female neonate of birth weight 2013 grams. The neonate's head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 at one minute and 8 at five minutes. APGAR score for 10 minutes was not reported. Pregnancy was complicated by fetal heart decelerations affecting management of mother. Baby was sent to neonate intensive care unit (NICU).  At the time of this report, the outcome of events was not reported.  The subject's date of completion of registry was 13-Mar-2020.   The events of premature delivery', abruptio placentae' and premature rupture of membranes were considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.   This case is linked to 202002410 (the corresponding fetal case).  Company comment: A pregnant patient was administered Flucelvax QIV at 15 weeks of gestation. The patient experienced premature rupture of membranes and premature delivery four months later. The patient also developed premature separation of placenta (marginal placental abruption) on an unspecified date. Temporal relationship is unsuggestive. Causality was confounded by advanced maternal age. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A pregnant patient was administered Flucelvax QIV at 15 weeks of gestation. The patient experienced premature rupture of membranes and premature delivery four months later. The patient also developed premature separation of placenta (marginal placental abruption) on an unspecified date. Temporal relationship is unsuggestive. Causality was confounded by advanced maternal age. Causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.