2001 07 VAERS-2 Front - fda-2025

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What is VAERS? VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).
VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.
Please report any adverse events related to any of our products by calling us at 1-800-438-1985 (United States only). If you prefer, you may contact the U.S. Food Drug Administration (FDA) directly. .fda.gov/Safety/MedWatch or call 1-800-FDA-1088.
CDC and FDA use VAERS reports to: Assess the safety of newly licensed or authorized vaccines. Detect new, unusual or rare adverse events that happen after vaccination. Monitor increases in known side effects, like arm soreness where a shot was given.
VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Reports vary in quality and completeness.
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CDC and FDA monitor the safety of vaccines after their approval or authorization. If they find a problem with a vaccine, CDC and FDA inform health officials, healthcare providers and the public. VAERS accepts and analyzes reports of possible health problems that happen after vaccination.
In response to NCVIA, CDC and FDA established VAERS in 1990. NCVIA was enacted to compensate individuals of all ages who have been injured by vaccines that are listed in the vaccine injury table.

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