Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | — | IM |
Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Previous 11 doses) and Spikevax NOS (Previous 11 doses). Past adverse reactions to the above products included Fatigue with Spikevax NOS; and Vaccination site tenderness with Spikevax NOS. In March 2025, the patient received twelfth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site). At the time of the report, FATIGUE (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (Patient had received Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were provided. The patient Doctor did not want to prescribe the vaccine for unknown reasons. Patient finally managed to get vaccinated at a pharmacy. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to MOD-2025-789111 (Patient Link).