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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
3,326 total reports4.9% serious outcomes
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3,326
Total Reports
22
Deaths
142
Hospitalizations
4.9
Severity Rate
% serious outcomes
About Off label use Reports
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%.
Understanding Off label use in VAERS
•Temporal association only: These reports show Off label use occurred after vaccination, not necessarily because of vaccination.
•Background rates matter: Many symptoms occur naturally at baseline rates in the population, unrelated to vaccination.
•Reporting variability: Medical terminology may be used differently by various healthcare providers and over time.
•Investigation needed: High-frequency reports may trigger further epidemiological studies to determine causation.
What This Data Shows
Most Associated Vaccines: The vaccines most frequently mentioned in reports with Off label use. This may reflect usage patterns, not causation.
Severity Patterns: The percentage of reports that involve serious outcomes can help prioritize safety investigations.
Reporting Trends: Changes in reporting frequency over time may reflect increased awareness, media attention, or actual safety signals.
Most Associated Vaccines
View all vaccines →Detailed Breakdowns
Quick Facts
Reports:3,326
Deaths:22
Hospitalizations:142
Mortality Rate:0.66%
Severity Rate:4.9%
Related Analysis
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Data Source
This data comes from the Vaccine Adverse Event Reporting System (VAERS), jointly managed by CDC and FDA.