On Jun. 30, 2017, the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) implemented a revised reporting form and a new process for submitting reports to the Vaccine Adverse Event Reporting System (VAERS).

Persons reporting adverse events were  able to use the VAERS 2.0 online reporting tool to submit reports directly online; alternatively, they downloaded and completed the writable and savable VAERS 2.0 form and submitted it using an electronic document upload feature.

The strengths of VAERS are that it is national in scope and can often quickly detect an early hint or warning of a safety problem with a vaccine. VAERS is one component of CDC’s and FDA’s multifaceted approach to monitoring safety after vaccines are licensed or authorized for use. There are multiple, complementary systems that CDC and FDA use to capture and validate data from different sources. VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also referred to as “safety signals.”

If a possible safety signal is found in VAERS, further analysis is performed with other safety systems, such as the CDC’s Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment(CISA) Project, or in the FDA BEST (Biologics Effectiveness and Safety) system. These systems are less impacted by the limitations of spontaneous and voluntary reporting in VAERS and can better assess possible links between vaccination and adverse events. Additionally, CDC and FDA cannot provide individual medical advice regarding any report to VAERS.

VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public. Additionally, reports to VAERS that appear to be false or fabricated with the intent to mislead CDC and FDA may be reviewed before they are added to the VAERS database. Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.