Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
severe arthralgia (joint pain)/which made her "barely able to walk"; myalgia (muscle pain), which made her "barely able to walk"; exacerbated her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (exacerbated her arthritis), ARTHRALGIA (severe arthralgia (joint pain)/which made her "barely able to walk") and MYALGIA (myalgia (muscle pain), which made her "barely able to walk") in a 75-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Hypertension and Osteoarthritis. On 03-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced ARTHRITIS (exacerbated her arthritis). On 03-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced ARTHRALGIA (severe arthralgia (joint pain)/which made her "barely able to walk") and MYALGIA (myalgia (muscle pain), which made her "barely able to walk"). The patient was treated with Paracetamol (Tylenol) in 2025 at an unspecified dose and frequency and Ibuprofen (Advil) in 2025 at an unspecified dose and frequency. On 05-Nov-2025, ARTHRALGIA (severe arthralgia (joint pain)/which made her "barely able to walk") and MYALGIA (myalgia (muscle pain), which made her "barely able to walk") had resolved. At the time of the report, ARTHRITIS (exacerbated her arthritis) was resolving. Patient had no vaccines within the past 4 weeks. No concomitant medications were provided. The patient was experiencing severe arthralgia (joint pain) and myalgia (muscle pain), because of which the patient was barely able to walk. These side effects began within a day of receiving the vaccine and lasted for almost a month, from 03-Oct-2025 to 05-Nov-2025. She still did not feel back to her baseline health level even after the symptoms subsided. The patient had never experienced anything similar to this before, it was scary, and she was afraid that it was going to be a permanent thing. The hypertension and osteoarthritis were pre-existing, but the mNEXSPIKE definitely exacerbated her arthritis. She briefly talked about this with the HCP but never discussed it at length with them. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol and Advil to help with her symptoms. This case was linked to MOD-2025-791148 (Patient Link).; Reporter's Comments: Concurrent medical conditions of osteoarthritis remains as a confounding factor for the events. The benefit-risk relationship of the product is not affected by this report.
Hypertension; Osteoarthritis