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1 1 (January 16, 2025)

handle is hein.crs/govesca0001 and id is 1 raw text is: The Vaccine Adverse Events Reporting System: Understanding the Data January 16, 2025 In general, vaccines undergo rigorous testing for safety through clinical trials before they are licensed (i.e., approved) or authorized for use by the Food and Drug Administration (FDA). These trials, which can involve thousands of patients, are designed to identify any major safety concerns with the vaccines. FDA licenses vaccines if they are determined safe for their intended use. Once a vaccine is on the market, federal agencies monitor vaccine safety through complementary systems such as the Vaccine Adverse Events Reporting System (VAERS) to help identify any rare or new safety issues that occur. VAERS is a monitoring system for reported adverse events following vaccination jointly operated by FDA and the Centers for Disease Control and Prevention (CDC). An adverse event is any health problem that happens after a vaccination. Using the VAERS system, anyone-including clinicians and the general public-can submit a report of an adverse event following vaccination. Under federal laws and regulations, health care providers and vaccine manufacturers are required to report certain adverse events that occur following vaccination. For Coronavirus Disease 2019 (COVID-19) vaccines, there have been additional VAERS reporting requirements through FDA and CDC that changed over time. CDC makes data on initial VAERS reports publicly available through its WONDER database. This CRS Insight provides an overview of how to understand publicly available VAERS data, its limitations, and the evidence usually required to determine whether a vaccine caused or contributed to a certain adverse health event. Understanding VAERS Data CDC and FDA monitor VAERS reports and use the information to determine whether to conduct further studies and investigations on the reported cases. VAERS serves as an early warning system to help detect possible new safety issues with vaccines, providing some of the earliest information on potential safety issues with newly introduced vaccines. VAERS is a passive reporting system, meaning it relies on individuals to send reports. VAERS is not designed to determine if a vaccine caused a specific adverse health event. Instead, VAERS is meant for detecting unusual or unexpected patterns of adverse event reporting that might indicate a potential safety problem with a vaccine that warrants further investigation. CDC and FDA can follow up on reported Congressional Research Service https://crsreports.congress.gov IN12486 CRS INSIGHT Prepared for Members and Committees of Congress

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