Important: VAERS reports alone cannot determine if a vaccine caused an adverse event. Reports may contain incomplete, inaccurate, or unverified information. Correlation does not equal causation.
Off label use appears in 3,326 VAERS reports across all vaccines. Of these, 22 reports also mentioned death and 142 involved hospitalization. The severity rate (deaths + hospitalizations as a percentage of reports) is 4.9%. The top vaccines associated with this symptom are COVID19, FLUX, VARZOS. Remember: VAERS reports show temporal association, not causation.
Off label use has been reported 3,326 times in VAERS from 1990 to 2026.
Of these reports, 22 were associated with death (0.66%) and 142 involved hospitalization.
The overall serious outcome rate (death or hospitalization) for reports mentioning Off label use is 4.9%.
This data comes from the Vaccine Adverse Event Reporting System (VAERS), jointly managed by CDC and FDA.