Received May 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Polymyalgia rheumatica; Body aches; Severe headaches; Disabling fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in an 8-decade-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 24-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant), PAIN (Body aches), HEADACHE (Severe headaches) and FATIGUE (Disabling fatigue). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), PAIN (Body aches), HEADACHE (Severe headaches) and FATIGUE (Disabling fatigue) outcome was unknown. Concomitant medication use information was not provided by reporter. Shortly after vaccination, the patient experienced severe headaches, followed by disabling fatigue and body aches. In April, the patient was diagnosed with polymyalgia rheumatica by a primary care physician and referred to a rheumatologist. The pharmacy indicated that the dose was 1/2 cc, but they could not provide more specific details. Given that the patient was in her late 70s, the reporter was asking for more detailed information regarding the specific dosing of the vaccine that was received. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of the product is not affected by this report