Received Apr 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | SC |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8820AA | SC |
Extreme effect on muscle/inability to walk correctly; Extreme effect on muscle/inability to walk correctly; extreme fatigue; Initial information received on 10-Apr-2026 regarding an unsolicited valid serious case received from a physician (healthcare professional). This case involves an 80-year-old female patient who experienced extreme effect on muscle /inability to walk correctly and extreme fatigue after receiving Fluzone High Dose. The patient's past medical history included chronic fatigue syndrome for 15 years, mild. On 30-Sep-2025, the patient received a 0.5 mg subcutaneous dose of Fluzone High Dose, Suspension for injection (batch/lot number: UT8820AA) (strength: unknown) via subcutaneous route in an unknown administration site for flu vaccine (Influenza immunisation). Relevant laboratory test results included: Protein electrophoresis - Gamma Globulin 0.7 (low); Kappa/Lambda Light Chain - Kappa 196, Lambda 77 (low); Musk Antibody Test - negative; Acetylcholine Receptor Blocking Antibody - 0.15; Acetylcholine Receptor Modulating Antibody - 31; Protein Total - 6.5; Immunofixation Electrophoresis - no monoclonal proteins detected; Immunoglobulin A - 70; Immunoglobulin G - 775; Immunoglobulin M - 233. The patient experienced extreme effect on muscle /inability to walk correctly (Gait disturbance, onset: 20-Oct-2025, latency: 20 days) and extreme effect on muscle /inability to walk correctly (Muscle disorder, onset: 20-Oct-2025, latency: 20 days). The patient also experienced extreme fatigue (Fatigue, onset: 20-Oct-2025, latency: 20 days). After the vaccine, the chronic fatigue syndrome worsened soon thereafter and has continued to worsen to the date of this report. The patient required the use of a cane and walker due to the inability to walk correctly. Action taken: Not applicable. Corrective treatment: Not reported. Event outcome: Gait disturbance, muscle disorder, and fatigue were not recovered/not resolved/ongoing. Seriousness criteria: Disabling/incapacitating for gait disturbance, muscle disorder, and fatigue.
Fatigue
Comments: NONE