Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Premature delivery, Retained placenta or membranes, Ultrasound antenatal screen normal
Clinical narrative: Pre-term delivery; Retained placenta with postpartum hemorrhage; Retained placenta with postpartum hemorrhage; Eclampsia; Mild pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Dec-2019, concerning a 32-year-old pregnant, female subject of body weight 150 lbs, height 66 inches and body mass index (BMI) 24.2,  enrolled in, a prospective observational safety study.  The subject's medical history included anxiety, depression and gestational diabetes.   The subject's concomitant medications included trazodone and sertraline, both used for anxiety and depression and Prenatal vitamins (unspecified vitamins) as supplement.  The subject had one previous pregnancy that ended as elective abortion.  The subject had no maternal/paternal history with major congenital malformation (MCM).  The subject's last menstrual period (LMP) date was 03-Mar-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both 08-Dec-2019. The subject did not consume tobacco, alcohol and illicit-drugs during pregnancy.  On 02-Jul-2019, the subject performed Inheritest and maternal serum alpha-fetoprotein (MSAFP/serum markers) no and no MCM was noted.  On 10-Jul-2019 and on 10-Sep-2019, the subject underwent ultrasound and no MCM was noted.  On 16-Oct-2019, at gestational age of 32 weeks, the patient was administered Afluria QIV [influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] for influenza immunisation (explicitly coded as 'Vaccine exposure during pregnancy').  On 25-Oct-2019, nine days after vaccination, the subject developed mild pre-eclampsia. On the same day, the subject underwent ultrasound and no MCM was noted.  On 31-Oct-2019, the subject started treatment with betamethasone for pre-eclampsia at a dose of 12.5 mg, twice a day via intramuscular route of administration.  On an unspecified date in Nov-2019, the patient developed eclampsia.  On 10-Nov-2019, at gestational age of 36 weeks, the subject vaginally delivered female neonate. The subject had retained placenta and experienced postpartum hemorrhage. The birth weight of the neonate was 2183 g, there were no data for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 4, at five minutes was 7 and no data was reported for APGAR score at ten minutes. No MCM was identified at birth.  At the time of initial report, the outcome of all events, except vaccine exposure during pregnancy, was not reported.  This case is linked to case 201907460 (the corresponding child case).  The events of eclampsia, pre-eclampsia, preterm delivery and retained placenta with haemorrhage were considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Afluria QIV.  Company comment: The subject experienced eclampsia, pre-eclampsia, premature delivery, postpartum haemorrhage and retained placenta associated with administration of Afluria QIV. The patient was administered vaccine at approximately 32 weeks of gestation. Chronology is plausible. However, causality was highly confounded by medical history of gestational diabetes. Regarding the events postpartum haemorrhage and retained placenta, risk factors (age over 30 and premature delivery) may have contributed to development of the events. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The subject experienced eclampsia, pre-eclampsia, premature delivery, postpartum haemorrhage and retained placenta associated with administration of Afluria QIV. The patient was administered vaccine at approximately 32 weeks of gestation. Chronology is plausible. However, causality was highly confounded by medical history of gestational diabetes. Regarding the events postpartum haemorrhage and retained placenta, risk factors (age over 30 and premature delivery) may have contributed to development of the events. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.