Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 7+ | 3052549 | IM |
he had some fatigue/little bit tired; mild tenderness at the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (he had some fatigue/little bit tired) and VACCINATION SITE PAIN (mild tenderness at the vaccination site) in a 79-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (dose 12) in March 2025, SPIKEVAX 2024-2025 PFS (dose 12) in March 2025, Spikevax NOS (previous 11 doses) and Spikevax NOS (previous 11 doses). Past adverse reactions to the above products included Fatigue with SPIKEVAX 2024-2025 PFS; and Vaccination site tenderness with SPIKEVAX 2024-2025 PFS, Spikevax NOS and Spikevax NOS. On 02-Sep-2025, the patient received thirteenth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 50 microgram. In 2025, the patient experienced FATIGUE (he had some fatigue/little bit tired) and VACCINATION SITE PAIN (mild tenderness at the vaccination site). At the time of the report, FATIGUE (he had some fatigue/little bit tired) and VACCINATION SITE PAIN (mild tenderness at the vaccination site) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had some fatigue and mild tenderness at the vaccination site. His doctor did not want to prescribe him the vaccine for unknown reasons (even though he was already 69 years old, and he had 12 doses of Covid vaccines in the past with similar side effects) and he finally got vaccinated. He did not have an immunization card or any other numbers pertaining to the LOT and was unable to find out what the lot number was. He went to the pharmacist and collected the exact lot number. The patient was between various places that morning, and he was a little bit tired. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789115, MOD-2025-789158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2025: Live follow-up received: Age, lot number and event verbatim were updated and references added. On 09-Sep-2025: Live follow-up received: Reporter's details and reference numbers were added. Dose and unit updated.