Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: AST/ALT ratio, Joint swelling, Product packaging issue, Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female 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 (Moderate to severe). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT SWELLING (Swelling of wrists) and PRODUCT PACKAGING ISSUE (Medication arrived with Ice packs melted/warm). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and JOINT SWELLING (Swelling of wrists) was resolving and PRODUCT PACKAGING ISSUE (Medication arrived with Ice packs melted/warm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, AST/ALT ratio: slightly elevated. Concomitant medication was not reported. In 2021, the patient experienced had rheumatoid arthritis flare up with second COVID-19 vaccination. On unknown date patient experienced wrist swelling, and slight elevation in liver enzymes. It was reported that medication was received with melted/warmth ice packs. Treatment details not 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 65 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She received the second dose after a month. On unknown date patient experienced wrist swelling and had slight elevation of liver enzymes. The event was resolving. No information on detailed clinical course, relevant investigations  and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Live follow up attached. Events added. Sender's Comments: This spontaneous case concerns a 65 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She received the second dose after a month. On unknown date patient experienced wrist swelling and had slight elevation of liver enzymes. The event was resolving. No information on detailed clinical course, relevant investigations  and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.