Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Complication of pregnancy, Exposure during pregnancy, Pre-eclampsia, Premature delivery, Ultrasound antenatal screen normal
Clinical narrative: Pre-eclampsia; Premature delivery at 36.7 gestational weeks; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a 25-year-old, pregnant female subject of body weight: 102.6 lbs, height: 62 inches and body mass index (BMI): 18.8, enrolled in a prospective observational safety study.  The subject's current conditions and concomitant medications were not reported.  The subject's obstetrical history noted that subject had one previous full-term, live birth pregnancy. 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-Jun-2019, the estimated delivery date (EDD) was reported as 13-Mar-2020 and corrected estimated date of delivery (CEDD) was reported as 11-Mar-2020. The type of pregnancy was singleton.  On 07-Aug-2019, the subject underwent ultrasound scan, and no MCM was noted.  On 04-Sep-2019, the subject underwent first trimester screen, and no MCM was noted.  On 17-Oct-2019, at gestational age of 18 weeks (calculated per LMP), the subject was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) [Influenza Vaccine; batch number reported as: 100108765, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On 07-Nov-2019, the subject underwent ultrasound scan, and no MCM was noted.  On an unspecified date, the pregnancy status of the subject was collected, and it was noted that the pregnancy was complicated with pre-eclampsia.  At gestational age of 36.7 weeks (as reported), the subject vaginally delivered live birth female neonate. The neonate's birth weight was 2495 g, while head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 at one minute, 9 at five minutes and for ten minutes APGAR score was not reported. There were no major MCMs identified at birth.  At the time of this report, the outcome of the events pre-eclampsia and 'premature delivery' were not reported.  The events of pre-eclampsia and 'premature delivery' were assessed as serious due to the criteria of medically significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202003311 (the corresponding baby case).  Company comment: A 25-year-old pregnant female subject developed pre-eclampsia and premature delivery after vaccination with the suspect product Afluria QIV for immunisation. Reportedly, on an unspecified date, the pregnancy status of the subject was collected, and it was noted that the pregnancy was complicated with pre-eclampsia. At gestational age of 36.7 weeks (as reported), the subject vaginally delivered live birth female neonate. Chronology seems compatible. The subject's current conditions and concomitant medications were not reported. The subject's obstetrical history noted that subject had one previous full-term, live birth pregnancy. 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. With information presented, causality is assessed as possibly related for pre-eclampsia and unlikely related for premature delivery. Pre-eclampsia might have led to premature delivery. More information regarding occurrence of the event is needed in order to establish more precise causality. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 25-year-old pregnant female subject developed pre-eclampsia and premature delivery after vaccination with the suspect product Afluria QIV for immunisation. Reportedly, on an unspecified date, the pregnancy status of the subject was collected, and it was noted that the pregnancy was complicated with pre-eclampsia. At gestational age of 36.7 weeks (as reported), the subject vaginally delivered live birth female neonate. Chronology seems compatible. The subject's current conditions and concomitant medications were not reported. The subject's obstetrical history noted that subject had one previous full-term, live birth pregnancy. 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. With information presented, causality is assessed as possibly related for pre-eclampsia and unlikely related for premature delivery. Pre-eclampsia might have led to premature delivery. More information regarding occurrence of the event is needed in order to establish more precise causality. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)