Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | — | — |
had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site; had 12 doses of 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 (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, eighth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, ninth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, tenth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and eleventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site). At the time of the report, FATIGUE (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) and VACCINATION SITE PAIN (had 12 doses of Covid vaccines in the past with similar side effects/fatigue and mild tenderness at the vaccination site) outcome was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had 12 doses of Covid vaccines in the past with similar side effect like some fatigue and mild tenderness at the vaccination site. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-789111 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2025: Live non-significant follow-up received: Reference added.