Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
weakness in the injected arm; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS (weakness in the injected arm) and VACCINATION SITE PAIN (pain at the injection site) in a 74-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 vaccine. Past adverse reactions to the above products included Pain with COVID-19 vaccine. On 05-Dec-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In December 2025, the patient experienced INJECTION SITE MUSCLE WEAKNESS (weakness in the injected arm) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE MUSCLE WEAKNESS (weakness in the injected arm) and VACCINATION SITE PAIN (pain at the injection site) had not resolved. No concomitant medication was reported. Patient had some pain at the injection site after the injection. He expected some soreness as he had many vaccination injections in the past. The patient went to do gym workout and found that there was weakness in the injected arm, particularly in his bicep. He had noticed that both the pain and the weakness in his arm were getting progressively worse. The patient did not experience any additional symptoms/events. No treatment medication was reported. Reporter causality not reported. This case was linked to MOD-2025-792512 (Patient Link).