evidence: The Vaccine Adverse Event Reporting System (VAERS) is the nation's early warning system that monitors the safety of FDA-approved vaccines and vaccines authorized for use for public health emergencies. The system accepts and analyzes reports of possible adverse events after vaccination and is co-managed by CDC and FDA. The number of reports submitted varies each year. VAERS accepts reports regardless of seriousness or how likely the vaccine may have caused the adverse event. A report to VAERS does not mean the vaccine caused the event. [...] - VAERS data alone cannot determine if the vaccine caused the reported adverse event. Establishing a causal relationship requires rigorous scientific assessment and consideration of multiple factors beyond just VAERS reports alone.