Post date: September 29, 2017

Alert: Online Report to the Vaccine Adverse Event Reporting System (VAERS)

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The Vaccine Adverse Event Reporting System (VAERS), co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), is the national post-marketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines. On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. People reporting adverse events are now able to use the VAERS 2.0 online reporting tool to submit reports directly online; alternatively, they may download and complete the writable and savable VAERS 2.0 form and submit it using an electronic document upload feature.

Data elements that have been added to the new writable form include pregnancy status, race, and ethnicity. The original VAERS reporting form will be phased out after December 2017.

The revised VAERS reporting form and system is intended for health care professionals, patients, parents, guardians, caregivers, and other non-manufacturers. Complete reporting instructions are available at the Report an Adverse Event web page located on the VAERS website. Additional assistance is available via email at info@vaers.org or by telephone at 1-800-822-7967.

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