Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Malaise, Musculoskeletal disorder, Osteoarthritis, Pain
Clinical narrative: Rheumatoid arthritis flare up/Grip strength decreased/Musculoskeletal stiffness/Arthralgia; Lower extremity dysfunction/CHRONIC FOOT ISSUES ON LEFT SIDE; Hips osteoarthritis/OSTEOARTHRITIS IN HIPS; Swelling of feet/LEFT FOOT SWELLING AND OCCASIONAL ON RIGHT FOOT; Pain in arm/ SORE ARM; Injection site redness/RED SPOT ON LEFT LEG AT INJECTION SITE; Feeling sick; General body pain/BODY ACHES/ENITRE BODY HURT; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Grip strength decreased/Musculoskeletal stiffness/Arthralgia) in a 47-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.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Dec-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF. On 02-May-2022, received third 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) CF. In 2021, the patient experienced MALAISE (Feeling sick) and PAIN (General body pain/BODY ACHES/ENITRE BODY HURT). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Grip strength decreased/Musculoskeletal stiffness/Arthralgia) (seriousness criterion medically significant), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction/CHRONIC FOOT ISSUES ON LEFT SIDE), OSTEOARTHRITIS (Hips osteoarthritis/OSTEOARTHRITIS IN HIPS), PERIPHERAL SWELLING (Swelling of feet/LEFT FOOT SWELLING AND OCCASIONAL ON RIGHT FOOT), PAIN IN EXTREMITY (Pain in arm/ SORE ARM) and INJECTION SITE ERYTHEMA (Injection site redness/RED SPOT ON LEFT LEG AT INJECTION SITE). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Grip strength decreased/Musculoskeletal stiffness/Arthralgia), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction/CHRONIC FOOT ISSUES ON LEFT SIDE), OSTEOARTHRITIS (Hips osteoarthritis/OSTEOARTHRITIS IN HIPS) and PERIPHERAL SWELLING (Swelling of feet/LEFT FOOT SWELLING AND OCCASIONAL ON RIGHT FOOT) had not resolved, MALAISE (Feeling sick), PAIN (General body pain/BODY ACHES/ENITRE BODY HURT) and PAIN IN EXTREMITY (Pain in arm/ SORE ARM) outcome was unknown and INJECTION SITE ERYTHEMA (Injection site redness/RED SPOT ON LEFT LEG AT INJECTION SITE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.  Company comment-This spontaneous case concerns a female patient aged 47 years with relevant medical history of MODERATE TO SEVERE RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient also experienced non serious events of Musculoskeletal disorder, Osteoarthritis, Peripheral swelling, Malaise, Pain, Pain in extremity and Injection site erythema on unknown dates.  Patient had received 1st and 2nd dose of mRNA-1273 at an interval of 28 days and 3rd dose approximately 15 months later. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event Rheumatoid arthritis was not resolved at the time of report. Relevant medical history remains a confounder to the event Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient aged 47 years with relevant medical history of MODERATE TO SEVERE RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient also experienced non serious events of Musculoskeletal disorder, Osteoarthritis, Peripheral swelling, Malaise, Pain, Pain in extremity and Injection site erythema on unknown dates.  Patient had received 1st and 2nd dose of mRNA-1273 at an interval of 28 days and 3rd dose approximately 15 months later. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event Rheumatoid arthritis was not resolved at the time of report. Relevant medical history remains a confounder to the event Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.