Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Premature delivery, Premature separation of placenta, Preterm premature rupture of membranes
Clinical narrative: Placental abruption; Preterm premature rupture of membranes; Delivery at 31.9 weeks of the gestational age; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-Apr-2020, concerning a 40-year-old, female pregnant subject of body weight: 219 lbs, height: 60 inches and body mass index (BMI): 42.8, enrolled in a prospective observational safety study.  The subject's medical history included high body mass index and pregnancy with advanced maternal age.  The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject had no obstetrical history. 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 07-Jul-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was reported as 09-Apr-2020 and corrected estimated date of delivery (CEDD) was reported as 07-Apr-2020.  On 06-Sep-2019, the subject underwent maternit 21 test, no MCM was noted.  On 18-Sep-2019, the subject underwent ultrasound scan, no MCM was noted.  On 16-Oct-2019, approximately at 14 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: 261226, 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 an unknown date, an unknown amount of time after vaccination, the subject experienced placental abruption and preterm premature rupture of membranes.  Approximately at 31.9 weeks of gestation (as reported), the subject delivered an female neonate by caesarean method of delivery. The neonate's birth weight was 1616 grams, body length: 39.4 cm, head circumference: not reported and the appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute, five minutes and ten minutes were not reported. There was no MCM identified at birth.  At the time of this report, the outcome of the events abruptio placentae', premature delivery' and 'preterm premature rupture of membranes' was not reported.  The events of abruptio placentae', premature delivery' and  'preterm premature rupture of membranes' were assessed as serious due to criteria of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  The case is linked to the case 202002762 (baby case).  Company comment: A 40-year-old female pregnant subject developed premature separation of placenta, preterm premature rupture of membranes and premature delivery after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, an unknown amount of time after vaccination the events occurred. Chronology needs more clarification however, considering reported dates and date of delivery it seems compatible. The subject's medical history included high body mass index and pregnancy with advanced maternal age. The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy. With information presented, causality is assessed as possibly related for premature separation of placenta and preterm premature rupture of membranes. The subject's medical history may have an influence on reported events, but this is not medically confirmed. The subject did not used tobacco, infections were not noted, illicit drug use was not mentioned or any other factor which could develop this separation and rupture. For the event premature delivery, causality is assessed as not related due to reported event of rupture. Exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A 40-year-old female pregnant subject developed premature separation of placenta, preterm premature rupture of membranes and premature delivery after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, an unknown amount of time after vaccination the events occurred. Chronology needs more clarification however, considering reported dates and date of delivery it seems compatible. The subject's medical history included high body mass index and pregnancy with advanced maternal age. The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy. With information presented, causality is assessed as possibly related for premature separation of placenta and preterm premature rupture of membranes. The subject's medical history may have an influence on reported events, but this is not medically confirmed. The subject did not used tobacco, infections were not noted, illicit drug use was not mentioned or any other factor which could develop this separation and rupture. For the event premature delivery, causality is assessed as not related due to reported event of rupture. Exposure during pregnancy is assessed as unrelated per company conventions.