Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | 3052734 | — |
Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 67-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052734) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (Dose 7) in December 2024; for Product used for unknown indication: COMIRNATY (6 Pfizer vaccines). Past adverse reactions to the above products included No adverse effect with COMIRNATY; and Vaccination site pain with SPIKEVAX 2024-2025 PFS. On 25-Sep-2025, the patient received eighth dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) .2 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had resolved. No concomitant medication was reported. It was reported that patient had received 8 doses of covid-19 vaccine since 2020 , 6 Pfizer doses and 7th dose of Moderna was in Dec 2024. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-789741 (Patient Link).