Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Rheumatoid arthritis flare up; Stiffness; Injection site bruising; Pain; Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 30-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.    Previously administered products included for Drug use for unknown indication: SUDAFED. Past adverse reactions to the above products included No adverse event with SUDAFED. Concurrent medical conditions included Drug allergy (Allergic to SUDAFED). Concomitant products included MAGNESIUM, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]), VITAMIN D3, AZELASTINE HCL, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LEVOTHYROXINE SODIUM (SYNTHROID), IBUPROFEN and FISH OIL for an unknown indication.   In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness), INJECTION SITE BRUISING (Injection site bruising), PAIN (Pain), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), MUSCULOSKELETAL STIFFNESS (Stiffness), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown and PAIN (Pain) was resolving.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was 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 30-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), among other non-serious events. The event Rheumatoid arthritis occurred on an unknown date in 2021 in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 30-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), among other non-serious events. The event Rheumatoid arthritis occurred on an unknown date in 2021 in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.