Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Colonoscopy, Crohn's disease, Liver function test, Liver function test increased
Clinical narrative: Crohn's disease aggravated; Back pain; Liver function test increased; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Fractured vertebra in 2020, Fall in 2020 and Dental implant user. Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant), BACK PAIN (Back pain) and LIVER FUNCTION TEST INCREASED (Liver function test increased). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated), BACK PAIN (Back pain) and LIVER FUNCTION TEST INCREASED (Liver function test increased) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Crohns active. On an unknown date, Liver function test: LIVER LEVELS Up.         It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 64-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease. The patient reported to have Crohn's disease active again on unknown date after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease. The patient reported to have Crohn's disease active again on unknown date after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.