Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Delivery, Exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: Pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 17-Jan-2020, concerning a 20-year-old, pregnant female subject of body weight 211 lbs and height 63.5 inches and body mass index (BMI) 36.8, enrolled in a prospective observational safety study.  The subject's medical history included increased BMI, genital herpes and attention deficit hyperactivity disorder (ADHD).  The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Adderall (amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate and dexamphetamine sulphate) for ADHD.  The subject's obstetrical history included one previous pregnancy with elective abortion. 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 14-Apr-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 19-Jan-2020. The type of pregnancy was singleton.   On 08-Aug-2019, the subject underwent ultrasound and no MCMs were noted.  On 27-Aug-2019, the subject underwent ultrasound and no MCMs were noted.  On 17-Sep-2019, the subject underwent ultrasound and no MCMs were noted.  On 28-Oct-2019, at approximately 28 weeks of gestation, the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100126099, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.   At gestation age of 38.3 weeks, the subject vaginally delivered a live birth, female neonate. The neonate's birth weight was 3090 g, head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). It was reported that there were no MCM identified at birth.  On the same day, reported as a pregnancy complication, the subject developed pre-eclampsia.  On 13-Jan-2020, the subject recovered from the event of pre-eclampsia.  The event of pre-eclampsia was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Afluria QIV.  Company comment: The subject experienced pre-eclampsia, associated with administration of Afluria QIV. The patient was administered vaccine at approximately 28 weeks of gestation. Chronology is plausible. Causality was highly confounded by medical history of increased BMI and treatment with concomitant medication Adderall. However, 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 pre-eclampsia, associated with administration of Afluria QIV. The patient was administered vaccine at approximately 28 weeks of gestation. Chronology is plausible. Causality was highly confounded by medical history of increased BMI and treatment with concomitant medication Adderall. However, 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.