Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Premature delivery, Ultrasound antenatal screen normal
Clinical narrative: Pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 12-Mar-2020, concerning a 38-year-old, pregnant, female subject of body weight: 230 lbs, height: 66.8 inches and body mass index (BMI) 36.2, enrolled in a prospective observational safety study.  The subject's current conditions included increased BMI, genital herpes simplex, anxiety, depression, asthma and pregnancy with advanced maternal age.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Singulair (montelukast sodium), Advair (fluticasone propionate, salmeterol xinafoate) and Proair (salbutamol sulfate), all three used for asthma, and Vibryd (vilazodone hydrochloride) for anxiety and depression.  The subject's obstetrical history noted that the subject had no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 24-May-2019. The subject's estimated delivery date (EDD) was reported as 28-Feb-2020, while corrected estimated delivery date (CEDD) was reported as 20-Mar-2020. The type of pregnancy was singleton.   On 30-Jul-2019, the subject underwent ultrasound and no MCMs were noted.   On 23-Sep-2019, at approximately 17 weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.   On an unspecified date, an unknown amount of time after vaccination, the pregnancy status was collected and it was noted that the pregnancy was complicated with pre-eclampsia.  On 23-Oct-2019, the subject underwent ultrasound and no MCMs were noted.   On 13-Nov-2019, the subject underwent ultrasound and no MCMs were noted.   At approximately 37.1 weeks of gestation (as reported), the subject gave live birth to a female neonate via caesarean method. The characteristics of the neonate included birth weight: 3544 grams, head circumference: 34.5 cm and length: 53.3. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes, while APGAR score for ten minutes was not reported. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the event of pre-eclampsia' was not reported.  The event of pre-eclampsia' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment. Company comment:The pregnant patient developed pre-eclampsia on an unspecified date, an unknown amount of time after vaccination with the suspect product, Afluria QIV. (explicitly coded as Vaccine exposure during pregnancy'). Chronology is unclear. Reportedly, the patient was given the vaccine at approximately 17 weeks of gestation. Causality may have been confounded by medical history of increased BMI and advanced age. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy is assessed as not related.; Sender's Comments: The pregnant patient developed pre-eclampsia on an unspecified date, an unknown amount of time after vaccination with the suspect product, Afluria QIV. (explicitly coded as Vaccine exposure during pregnancy'). Chronology is unclear. Reportedly, the patient was given the vaccine at approximately 17 weeks of gestation. Causality may have been confounded by medical history of increased BMI and advanced age. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Vaccine exposure during pregnancy is assessed as not related.