Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Dehydration, Disturbance in attention, Dizziness, Injection site pain
Clinical narrative: attack of Crohn's; Lack of focus; light headedness/dizziness; Dehydration; burning at the injection site; whelp at the injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (attack of Crohn's) in an elderly male 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) solution for injection for Crohn's disease and Rheumatoid arthritis.    Concurrent medical conditions included Crohn's disease and Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (attack of Crohn's) (seriousness criterion medically significant), DISTURBANCE IN ATTENTION (Lack of focus), DIZZINESS (light headedness/dizziness), DEHYDRATION (Dehydration), INJECTION SITE PAIN (burning at the injection site), INJECTION SITE URTICARIA (whelp at the injection site) and PRURITUS (Itching). At the time of the report, CROHN'S DISEASE (attack of Crohn's) was resolving, DISTURBANCE IN ATTENTION (Lack of focus) and DEHYDRATION (Dehydration) outcome was unknown, DIZZINESS (light headedness/dizziness), INJECTION SITE PAIN (burning at the injection site) and INJECTION SITE URTICARIA (whelp at the injection site) had resolved and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event(s) of lack of focus, dehydration, burning at the injection site and whelp at the injection site with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of light headedness/dizziness and attack of Crohn's with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of itching was not provided. The reporter's causality for event attack of Crohn's with Humira (adalimumab) with Moderna Covid-19 vaccine was reported as possible.  No treatment details were 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.  CC: This spontaneous case concerns an elderly, male patient with concurrent conditions of Crohn's disease and Rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Crohn's disease in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event Crohn's disease relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Patient also reported burning and whelp at the injection site, itching, as well as dehydration, which may have led to lack of focus and dizziness on unknown dates. Outcome of the event Crohn's disease was reported as resolving. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an elderly, male patient with concurrent conditions of Crohn's disease and Rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Crohn's disease in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event Crohn's disease relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Patient also reported burning and whelp at the injection site, itching, as well as dehydration, which may have led to lack of focus and dizziness on unknown dates. Outcome of the event Crohn's disease was reported as resolving. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying Crohn's disease remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.