Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: Sometime after the second dose developed pain in her calves; gave chronic fatigue felt knocked out for several months; Got blood tests, rheumatologist diagnosed with polymyalgia rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Got blood tests, rheumatologist diagnosed with polymyalgia rheumatica) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced POLYMYALGIA RHEUMATICA (Got blood tests, rheumatologist diagnosed with polymyalgia rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sometime after the second dose developed pain in her calves) and FATIGUE (gave chronic fatigue felt knocked out for several months). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and CALCIUM for Adverse event, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Got blood tests, rheumatologist diagnosed with polymyalgia rheumatica) had not resolved and PAIN IN EXTREMITY (Sometime after the second dose developed pain in her calves) and FATIGUE (gave chronic fatigue felt knocked out for several months) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Company comment: This case concerns a 72-year old, female subject with no relevant medical history, who experienced the serious unexpected event of Polymyalgia rheumatica. The event occurred unknown number of days after the second dose of mRNA 1273 VACCINE. Approximately 7 months after the second dose of the mRNA 1273 vaccine, the patient got blood tests with unknown results and was diagnosed by a rheumatologist with Polymyalgia rheumatica. Treatment with Prednisone and Calcium was done. At the time of the report, outcome of the event was Not recovered/Not resolved. Rechallenge is Not applicable as no additional dose is expected to be given. Patient's age remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender's Comments: This case concerns a 72-year old, female subject with no relevant medical history, who experienced the serious unexpected event of Polymyalgia rheumatica. The event occurred unknown number of days after the second dose of mRNA 1273 VACCINE. Approximately 7 months after the second dose of the mRNA 1273 vaccine, the patient got blood tests with unknown results and was diagnosed by a rheumatologist with Polymyalgia rheumatica. Treatment with Prednisone and Calcium was done. At the time of the report, outcome of the event was Not recovered/Not resolved. Rechallenge is Not applicable as no additional dose is expected to be given. Patient's age remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.