Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
polymyalgia rheumatica/stiff shoulders / everything was stiff; Patient reported the temporal arteritis and GCA they are all the same field; felt like Covid; legs hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff) in a 63-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. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (Patient reported the temporal arteritis and GCA they are all the same field). In 2021, the patient experienced SUSPECTED COVID-19 (felt like Covid) and PAIN IN EXTREMITY (legs hurt). The patient was treated with Tocilizumab (Actemra) at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff), GIANT CELL ARTERITIS (Patient reported the temporal arteritis and GCA they are all the same field), SUSPECTED COVID-19 (felt like Covid) and PAIN IN EXTREMITY (legs hurt) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient reported that it had all started after getting the Covid shot on 11-Jan-2021 (Moderna), with the second one on 08-Feb-2021 (Moderna), before taking Actemra. The patient reported that she hadn't been taking anything and had been perfectly healthy, but within 6 months of getting the second Moderna Covid shot, her shoulders and legs had become stiff, everything had felt stiff, and it had felt like Covid.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.