Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Vaccine exposure during pregnancy; Pre-eclampsia; This is an observational study case, initially received from other health professional on 17-Jan-2020, concerning a 24-year-old, female pregnant of body weight: 189 lbs, height: 64.8 inches and body mass index (BMI): 31.6 enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's past drug included methylprednisolone for migraine.  The subject's current conditions included obesity, migraine, urinary tract infection, polycystic ovaries, low back pain and gastroesophageal reflux disease (GERD). The subject was rubella and varicella non-immune.  The subject's concomitant medications included cyclobenzaprine for migraine, vitamins nos as supplement, Protonix (omeprazole), pantoprazole, metoclopramide, omeprazole and ranitidine, all for GERD.  The subject's obstetrical history noted that subject had one previous pregnancy with one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal and paternal medical history. The subject did not use tobacco, illicit drug or alcohol during pregnancy.  The subject's last menstrual period (LMP) date was 10-Apr-2019. The subject's estimated delivery date (EDD) was 15-Jan-2020 and corrected estimated date of delivery (CEDD) was 23-Jan-2020. The type of pregnancy was singleton.   On 02-Jul-2019, the subject initial ultrasound test and no MCM was noted.  On 16-Jul-2019, the subject underwent ultrasound  nuchal translucency (NT) and first trimester screen and no MCM was noted.  On 20-Aug-2019, the subject underwent second trimester screen and maternal serum alpha fetoprotein (MSAFP) / serum markers and no MCM was noted.  On 27-Aug-2019, the subject underwent ultrasound - anatomy and no MCM was noted.  On 05-Nov-2019, at gestational age of 29 weeks, the subject was administered with Flucelvax (Flu Vaccine Cell Subunit) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On the same day, the subject was administered with non-company co-suspect TDAP vaccine [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; dose: 0.5 ml, route of administration: intramuscular, batch number, anatomical location and expiration date: not reported] as vaccine.  On an unspecified day in 2019, an unknown amount of time after vaccination, the subject developed pre-eclampsia.  At gestation age of 37 weeks, the subject delivered live birth, male neonate by caesarean delivery. The neonate's birth weight was 2339 g, his head circumference and length were not provided. 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 the subject was recovered from the event of pre-eclampsia.  The event of pre-eclampsia was assessed as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  The case is linked to case 202000475, the corresponding mother case.  Company comment: The subject experienced pre-eclampsia associated with administration of Flucelvax. The patient was administered vaccine at approximately 29 weeks of gestation. Chronology is plausible. Causality was confounded by medical history of obesity and migraine treated with methylprednisolone, as well as co-suspect TDAP vaccine administered on the same day as Flucelvax. 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 Flucelvax. The patient was administered vaccine at approximately 29 weeks of gestation. Chronology is plausible. Causality was confounded by medical history of obesity and migraine treated with methylprednisolone, as well as co-suspect TDAP vaccine administered on the same day as Flucelvax. 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.