Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Fatigue
Clinical narrative: CROHNS DISEASE FLARE UP OF TWO ULCER SORES; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS DISEASE FLARE UP OF TWO ULCER SORES) in a 56-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.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second 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) Citrate free,Solution for injection in pre-filled pen. In July 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced CROHN'S DISEASE (CROHNS DISEASE FLARE UP OF TWO ULCER SORES) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHNS DISEASE FLARE UP OF TWO ULCER SORES) had not resolved and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  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 reported by a consumer, concerning a 56-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease (reported as Crohn´s disease flare up of two ulcer sores), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Crohn´s disease can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 56-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease (reported as Crohn´s disease flare up of two ulcer sores), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Crohn´s disease can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.