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FDA VAERS - Vaccine Adverse Event Reporting System

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents and patients.

Healthcare providers are required by law to report to VAERS:

Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations

An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine

Healthcare providers are strongly encouraged to report to VAERS:

Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event.

Vaccine administration errors

Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.

Online reporting is strongly encouraged. Please report clinically important adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event.

The Vaccine Adverse Event Reporting System (VAERS) accepts all reports, including reports of vaccination errors. Guidance on reporting vaccination errors is available if you have additional questions.

Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.

How to Report Online?

Online Form: https://vaers.hhs.gov/esub/index.jsp

What events should be reported to VAERS?

VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in the United States. You should report any significant adverse event even if you are unsure whether a vaccine caused the event.

The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report:

  • Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine.

  • Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination.

The Reportable Events Table specifically outlines the reportable post-vaccination events and the time frames in which they must occur in order to qualify as being reportable. To obtain a copy of the Reportable Events Table, call 1-800-822-7967 or go to http://www.vaers.hhs.gov/reportable.htm

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VAERS Table of Reportable Events Following Vaccination

 

Source: https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/vaccine-adverse-events

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HIPAA VAERS LETTER

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