Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Inflammatory bowel disease (IBD) flare; Inflammatory bowel disease (IBD) flare; This literature-non-study case was reported in a literature article and describes the occurrence of INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease (IBD) flare) and CONDITION AGGRAVATED (Inflammatory bowel disease (IBD) flare) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included IBD. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease (IBD) flare) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Inflammatory bowel disease (IBD) flare) (seriousness criterion medically significant). At the time of the report, INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease (IBD) flare) and CONDITION AGGRAVATED (Inflammatory bowel disease (IBD) flare) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFLAMMATORY BOWEL DISEASE (Inflammatory bowel disease (IBD) flare) and CONDITION AGGRAVATED (Inflammatory bowel disease (IBD) flare) to be related. This case was identified during a retrospective clean-up activity initiated under [withheld] in response to a Health Inspection Observation. Specific concomitant and treatment medications were not reported. This case was referred to patient 3 out of 4 patients who received mRNA-1273. There were seven patients with Crohn disease and three with ulcerative colitis, who complained of gastrointestinal symptoms highly suspicious of an IBD flare, which were temporally associated with an administration of SARS-CoV-2 mRNA vaccine. In this cohort were 7 men and 3 women with a median age of 38 yrs. Four patients received mRNA-1273, and 6 received BNT162b2 and BioNTech vaccine for SARS-CoV-2. Six patients developed gastrointestinal complaints after the first dose of the SARS CoV-2 vaccine (median 9.5 days), and4 patients after the second dose of the vaccine (median 5.5 days). Based on clinical evaluation, 7 patients had moderate to severe flare symptoms, and 3 patients had mild symptoms. Fifty percent of patients had bloody diarrhea associated with abdominal pain, and the rest had abdominal pain along with nausea/ vomiting and bloating. Eighty percent of the patients had a resolution of their gastrointestinal complaints within a few days. Two patients received a CT scan of the abdomen/ pelvis within 48 hours of symptom onset, revealing new active inflammation in the ileum and was associated with an elevated CRP. One patient underwent colonoscopy for persistent complaints 4 weeks after onset and was found to have active proctitis. One patient required escalation of adalimumab dose by decreasing frequency to the weekly regime, and another patient required hospitalization for intravenous steroids with good response. Author stated that more extensive studies were necessary to confirm an association between the SARS-CoV-2 vaccine and disease flare. Even if we accept that these patients were all experiencing a true exacerbation of their IBD, it was important to remember that most recovered spontaneously, without the need for abrupt changes in therapy. This case was linked to MOD-2022-537619 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: MOD-2022-537619:Master case (Patient 1 out of 04)
IBD