Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
pain and soreness he is experiencing in the left shoulder where the vaccine was injected; soreness left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and soreness he is experiencing in the left shoulder where the vaccine was injected) and ARTHRALGIA (soreness left shoulder) in a 64-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 COVID-19 prophylaxis: SPIKEVAX NOS (The patient received Moderna for his first series of COVID shots.). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 01-Dec-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced VACCINATION SITE PAIN (pain and soreness he is experiencing in the left shoulder where the vaccine was injected) and ARTHRALGIA (soreness left shoulder). At the time of the report, VACCINATION SITE PAIN (pain and soreness he is experiencing in the left shoulder where the vaccine was injected) and ARTHRALGIA (soreness left shoulder) had not resolved. No concomitant medications provided by the reporter. It was reported that the patient received a dose of the Spikevax on 01-Dec-2025. The patients doctor told to take Tylenol if the patient experienced event of headaches and pain. The patient enquired whether it was ok to take Ibuprofen for the pain and soreness which the patient experienced in the left shoulder where the vaccine was injected.