Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, Skin ulcer
Clinical narrative: Leg ulcer; Rheumatoid arthritis flare up on shoulders/arm/legs; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ULCER (Leg ulcer) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up on shoulders/arm/legs) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced SKIN ULCER (Leg ulcer) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up on shoulders/arm/legs). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, SKIN ULCER (Leg ulcer) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up on shoulders/arm/legs) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  Company Comment: This spontaneous case concerns an elderly (in the 6th decade of life) male patient with pre-existing rheumatoid arthritis being treated with Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis, described as flare episode of the pre-existing condition, affecting the shoulders and extremities. The non-serious event of Skin ulcer, reported as appearance of sores on the legs, was also reported. The events occurred on an unknown date after receiving a dose of mRNA-1273, reported as booster dose. Description of the symptoms and clinical course were not provided in the case. The patient was prescribed with hydrocortisone and the reported outcome is resolving. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Adalimumab (Humira) was cited as co-suspect in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly (in the 6th decade of life) male patient with pre-existing rheumatoid arthritis being treated with Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis, described as flare episode of the pre-existing condition, affecting the shoulders and extremities. The non-serious event of Skin ulcer, reported as appearance of sores on the legs, was also reported. The events occurred on an unknown date after receiving a dose of mRNA-1273, reported as booster dose. Description of the symptoms and clinical course were not provided in the case. The patient was prescribed with hydrocortisone and the reported outcome is resolving. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Adalimumab (Humira) was cited as co-suspect in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.