Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Muscle disorder, Myalgia
Clinical narrative: Whenever took any of the covid-19 vaccine, it rattled Crohn's disease; Muscles were sore and could not bend down like used to; Muscles were sore and could not bend down like used to; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 4782590) 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 an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, 40MG/0.4ML. On an unknown date, the patient experienced CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) (seriousness criterion medically significant), MUSCLE DISORDER (Muscles were sore and could not bend down like used to) and MYALGIA (Muscles were sore and could not bend down like used to). At the time of the report, CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) had resolved, MUSCLE DISORDER (Muscles were sore and could not bend down like used to) outcome was unknown and MYALGIA (Muscles were sore and could not bend down like used to) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information provided. It was unknown if patient was enrolled in COVID-19-Vaccine trial. No treatment information provided.  Company comment: This spontaneous case concerns an elderly female patient with relevant medical history of Moderate to Severe Adult Crohn's Disease on HUMIRA reported, who experienced the unexpected, serious (medically significant) event of CROHN'S DISEASE (reported as "covid-19 vaccine, it rattled Crohn's disease"), among other non-serious events after first dose of mRNA-1273 vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported as whenever took any of the covid-19 vaccine, it rattled Crohn's disease. No further clinical information was provided for medical reviewing. Outcome of the event was resolved at the time of report. The relevant medical history could be confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-675610 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly female patient with relevant medical history of Moderate to Severe Adult Crohn's Disease on HUMIRA reported, who experienced the unexpected, serious (medically significant) event of CROHN'S DISEASE (reported as "covid-19 vaccine, it rattled Crohn's disease"), among other non-serious events after first dose of mRNA-1273 vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported as whenever took any of the covid-19 vaccine, it rattled Crohn's disease. No further clinical information was provided for medical reviewing. Outcome of the event was resolved at the time of report. The relevant medical history could be confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.