Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Polymyalgia rheumatica
Clinical narrative: her symptoms worse again; covid 19; polymyalgia rheumatica/muscle pains; This spontaneous case was reported by a patient and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/muscle pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 016M20A and D32LZ0A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/muscle pains) (seriousness criterion medically significant). In May 2022, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced CONDITION AGGRAVATED (her symptoms worse again). The patient was treated with METHOTREXATE for Polymyalgia rheumatica, at an unspecified dose and frequency; PREDNISONE for Polymyalgia rheumatica, at an unspecified dose and frequency; FOLIC ACID for Polymyalgia rheumatica, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) in May 2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/muscle pains), COVID-19 (covid 19) and CONDITION AGGRAVATED (her symptoms worse again) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  She had received 3 doses of the moderna COVID-19 vaccines following the first dose of the vaccine she had muscle pains in her whole body starting after the first dose which got worse after the second dose.   On an unknown date of Mar-2021, the patient had polymyalgia rheumatica. Started taking methotrexate, prednisone, and folic acid which helped with her symptoms. She then received a booster dose which made her symptoms worse again.   On an unknown date of May-2022, the patient had COVID-19. Took paxlovid with that diagnosis. Her symptoms are fine now. She spoke to her two rheumatologists who gave her conflicting information on whether to receive an additional dose of the Moderna vaccine.  Company Comment: This is a Spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced the serious (per medically significant) unexpected event of polymyalgia rheumatica which occurred on the month after the second dose of mRNA-1273 and on an unknown date after the booster dose, received 9 months later, the condition aggravated. The patient was treated with methotrexate, prednisone, and folic acid. The events had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.