Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis pain; Feeling unwell /Felt poorly; Vaccination site pain; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain) in a 62-year-old 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In October 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain) (seriousness criterion medically significant), MALAISE (Feeling unwell /Felt poorly) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain) was resolving, COVID-19 (COVID-19) outcome was unknown and MALAISE (Feeling unwell /Felt poorly) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknow  It was unknown if patient was enrolled in a covid-19 vaccine trial. No concomitant medications were reported.  The reporter's causality for the event(s) of RHEUMATOID ARTHRITIS PAIN, FELT POORLY AND ARM LITTLE SORE AFTER MODERNA COVID 19 VACCINATION unknown onset and FELT POORLY AND ARM LITTLE SORE AFTER MODERNA COVID 19 VACCINATION unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of CONTRACTING COVID was not provided.  No treatment medications 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.  Company comment: This spontaneous case concerns a 62 year old male patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Rheumatoid arthritis (reported as Rheumatoid arthritis pain) and unexpected non serious AESI of COVID 19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the events, detailed clinical course, relevant investigations and treatment of the events was available in the report.  Concurrent condition of rheumatoid arthritis could be confounding for the event rheumatoid arthritis.  The ongoing COVID 19 pandemia could be confounding for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old male patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Rheumatoid arthritis (reported as Rheumatoid arthritis pain) and unexpected non serious AESI of COVID 19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the events, detailed clinical course, relevant investigations and treatment of the events was available in the report.  Concurrent condition of rheumatoid arthritis could be confounding for the event rheumatoid arthritis.  The ongoing COVID 19 pandemia could be confounding for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.