Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: symptoms of Rheumatoid Arthritis; Toes and Feet Swelling; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (symptoms of Rheumatoid Arthritis) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   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 RHEUMATOID ARTHRITIS (symptoms of Rheumatoid Arthritis) (seriousness criterion medically significant), PERIPHERAL SWELLING (Toes and Feet Swelling) and PAIN (Pain). At the time of the report, RHEUMATOID ARTHRITIS (symptoms of Rheumatoid Arthritis) outcome was unknown and PERIPHERAL SWELLING (Toes and Feet Swelling) and PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for an events PERIPHERAL SWELLING and PAIN with Humira was no reasonable possibility and not provided for RHEUMATOID ARTHRITIS.  No treatment information was provided.  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 is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of ankylosing spondylitis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ankylosing spondylitis. Non-serious events of Pain and Peripheral swelling could be related to Rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Underlying ankylosing spondylitis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of ankylosing spondylitis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ankylosing spondylitis. Non-serious events of Pain and Peripheral swelling could be related to Rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Underlying ankylosing spondylitis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.