Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: diagnosed with primary polymyalgia rheumatica; This spontaneous case was reported by a patient and describes the occurrence of POLYMYALGIA RHEUMATICA (diagnosed with primary polymyalgia rheumatica) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     Previously administered products included for Shingles: Shingles (Route given was intramuscular) in October 2021. Past adverse reactions to the above products included No adverse event with Shingles. Concurrent medical conditions included Drug allergy and Spinal stenosis (Spinal stenosis of lower and upper back and neck. Recent change in status was reported as worsening.). Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Spinal stenosis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POLYMYALGIA RHEUMATICA (diagnosed with primary polymyalgia rheumatica) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (diagnosed with primary polymyalgia rheumatica) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that after receiving the 2nd dose of the Moderna vaccine, he started experiencing a lot of shoulder, groin, and knee pain, around the middle of Jun-2021. Within a couple of weeks of that, it started becoming hard for him to get out of bed. He was having a lot of shoulder pain and it became hard for him to move around. He was used to walking 1-2 miles daily, but after starting to experience the pain, he could barely walk a quarter mile. He saw his healthcare provider on 21-Jul-2021 and was diagnosed with primary polymyalgia rheumatica. He was put on steroids for about 6 months. The joint pain started to subside when he was put on high dose steroids. He says that he was able to taper off the steroids quicker than most people because he was also on a ketogenic diet to reduce the inflammation.  Company Comment: This spontaneous case concerns a 57-year-old, male patient with no relevant medical history who experienced the unexpected, serious (medically significant) event of Polymyalgia rheumatica which occurred 14 weeks after receiving the second dose of mRNA-1273 vaccine. The first dose of mRNA-1273 was administered 28 days prior to the second dose with no information on adverse event. Patient experienced multiple joint pains involving the shoulder, groin, and knee. The pain has worsened over the weeks and has affected his usual daily activities prompting consultation with a healthcare provider. A diagnosis of primary polymyalgia rheumatica was made and patient was started on chronic steroid therapy for 6 months. Joint pain subsided after treatment with high dose steroids. He was then advised to start diet modification. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-587021 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old, male patient with no relevant medical history who experienced the unexpected, serious (medically significant) event of Polymyalgia rheumatica which occurred 14 weeks after receiving the second dose of mRNA-1273 vaccine. The first dose of mRNA-1273 was administered 28 days prior to the second dose with no information on adverse event. Patient experienced multiple joint pains involving the shoulder, groin, and knee. The pain has worsened over the weeks and has affected his usual daily activities prompting consultation with a healthcare provider. A diagnosis of primary polymyalgia rheumatica was made and patient was started on chronic steroid therapy for 6 months. Joint pain subsided after treatment with high dose steroids. He was then advised to start diet modification. The benefit-risk relationship of mRNA-1273 is not affected by this report.