Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: CROHNS FLARE CAME UP; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS FLARE CAME UP) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced CROHN'S DISEASE (CROHNS FLARE CAME UP) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHNS FLARE CAME UP) had not resolved.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of vaccine including booster taken one in once.   No treatment information was provided.  The reporter's causality with Humira (Adalimumab) for the event of crohns flare came up was not provided.  Company comment  This spontaneous case reported by a consumer, concerns an elderly female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) event of Chron's Disease (chron's Disease Flare came up) unknown days after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received all the 3 previous doses with Moderna vaccine with no adverse events reported. Concurrent medical conditions included Chron's Disease. On an unknown date, the patient had received ADALIMUMAB for Chron's Disease, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an elderly female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) event of Chron's Disease (chron's Disease Flare came up) unknown days after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received all the 3 previous doses with Moderna vaccine with no adverse events reported. Concurrent medical conditions included Chron's Disease. On an unknown date, the patient had received ADALIMUMAB for Chron's Disease, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.