Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Polymyalgia rheumatica, Pyrexia, Swelling
Clinical narrative: Polymyalgia rheumatica; joint pain due to weather; muscle pain due to weather; pain in joints; pain in muscles; Low grade fever; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 56-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 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-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) at an unspecified dose. In September 2021, the patient experienced SWELLING (Swelling), PYREXIA (Low grade fever), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant), ARTHRALGIA (joint pain due to weather) and MYALGIA (muscle pain due to weather). The patient was treated with METHOTREXATE at an unspecified dose and frequency. In September 2021, SWELLING (Swelling), PYREXIA (Low grade fever), ARTHRALGIA (pain in joints) and MYALGIA (pain in muscles) had resolved. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), ARTHRALGIA (joint pain due to weather) and MYALGIA (muscle pain due to weather) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant product reported by reporter.  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 56 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Polymyalgia rheumatica , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was treated with methotrexate. The event had not resolved. The patient received the second dose with the same vaccine about a month later. No information on exact date of the event, detailed clinical course, and relevant investigations 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.; Sender's Comments: This spontaneous case concerns a 56 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Polymyalgia rheumatica , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was treated with methotrexate. The event had not resolved. The patient received the second dose with the same vaccine about a month later. No information on exact date of the event, detailed clinical course, and relevant investigations 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.