Announcement: Implementation of the Vaccine Adverse Event Reporting System 2.0 Reporting Form

Article Metrics
Altmetric:
Citations:
Views:

Views equals page views plus PDF downloads

Related Materials

The Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and the Food and Drug Administration (FDA), is the national postmarketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines (1,2). On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. Persons 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.

Transition to the VAERS 2.0 form is expected to be completed by the end of December 2017. Accommodations will be made for persons unable to submit reports electronically. The revised VAERS reporting form and system is intended for health care professionals, patients, parents, guardians, caregivers and other nonmanufacturers. Vaccine manufacturers will submit reports to VAERS by a separate process through the FDA Electronic Submissions Gateway (3). Instructions for reporting to VAERS are available at https://vaers.hhs.gov/reportevent.htmlexternal icon. Additional assistance is available via email at info@vaers.org or by telephone at 1-800-822-7967.


References

  1. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine 2015;33:4398–405. CrossRefexternal icon PubMedexternal icon
  2. US Department of Health and Human Services. Vaccine Adverse Event Reporting System. Washington, DC: US Department of Health and Human Services, CDC, Food and Drug Administration; 2017. https://vaers.hhs.gov/index.htmlexternal icon
  3. Food and Drug Administration. Electronic Submissions Gateway. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2017. https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/external icon

Suggested citation for this article: Announcement: Implementation of the Vaccine Adverse Event Reporting System 2.0 Reporting Form. MMWR Morb Mortal Wkly Rep 2017;66:738. DOI: http://dx.doi.org/10.15585/mmwr.mm6627a5external icon.

MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.

All HTML versions of MMWR articles are generated from final proofs through an automated process. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version (https://www.cdc.gov/mmwr) and/or the original MMWR paper copy for printable versions of official text, figures, and tables.

Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

View Page In:pdf icon
Page last reviewed: July 12, 2017