Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
body ache; ARM TENDERNESS LASTED A COUPLE OF DAYS; fever; chills; fatigue; headache; NAUSEA AND VOMITING LASTING 2 DAYS; NAUSEA AND VOMITING LASTING 2 DAYS; Patient received dose 0.2 mL; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PAIN IN EXTREMITY (ARM TENDERNESS LASTED A COUPLE OF DAYS), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .2 milliliter. On 13-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced UNDERDOSE (Patient received dose 0.2 mL). On 14-Sep-2025, the patient experienced PAIN (body ache), PAIN IN EXTREMITY (ARM TENDERNESS LASTED A COUPLE OF DAYS), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), VOMITING (NAUSEA AND VOMITING LASTING 2 DAYS) and NAUSEA (NAUSEA AND VOMITING LASTING 2 DAYS). On 16-Sep-2025, PAIN (body ache), PAIN IN EXTREMITY (ARM TENDERNESS LASTED A COUPLE OF DAYS), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), VOMITING (NAUSEA AND VOMITING LASTING 2 DAYS) and NAUSEA (NAUSEA AND VOMITING LASTING 2 DAYS) had resolved. On 17-Sep-2025, FATIGUE (fatigue) had resolved. At the time of the report, UNDERDOSE (Patient received dose 0.2 mL) outcome was unknown. Concomitant medication was not reported. The fatigue event lasted one more day in comparison to other symptoms. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.