Workflow 7: Manage Adverse Event Reporting

General Description

This workflow describes how EHRs and other clinical software systems use information to assist with documenting, reporting, and storing adverse event information.  General User Workflow 7 also describes how systems make adverse event information available in settings where providers administer immunizations to patients.

Requirements Within this Workflow

7.1: Identify Adverse Event

7.2: Initiate and Submit a VAERS Report

7.3: Notify of Previous Adverse Event

7.4: Notify Public Health Immunization Registry (IIS) of Update from Adverse Event

Who Performs this Workflow

  • Clinicians (physicians, nurses, and other personnel who assist with providing immunizations)

Examples of Work Related to this Workflow

  • There are numerous reporting forms for various types of adverse events. In some cases there are standard forms for such reporting.
  • Providers voluntarily report adverse events to patient safety organizations, with protections for such reporting offered to providers through The Patient Safety and Quality Improvement Act of 2005. In accordance with the Patient Safety and Quality Improvement Final Rule.[1] The Agency for Healthcare Research and Quality (AHRQ) has developed Common Formats for such reporting.
  • The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the CDC and the Food and Drug Administration (FDA).  VAERS provides a nationwide mechanism by which adverse events following immunization may be reported, analyzed, and made available to the public. Providers can access the reporting form online and submit adverse event information either electronically through the VAERS website or via fax or mail.[2]
  • MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program, enables clinicians and consumers to report serious medical product problems, either through an online submission form or by completing a standard form and sending it to the FDA via fax or mail.[3]
  • Many EHRs provide a link for providers to access the VAERS or MedWatch sites.
  • The ONC Standards and Interoperability Framework initiative, Structured Data Capture, is developing standard mechanisms to report directly using information already captured in the EHR.[4]  VAERS is one of the reports addressed by the Structured Data Capture initiative (although listed as a low priority example).

[1] US Department of Health and Human Services. Health Information Privacy: Patient Safety and Quality Improvement Act of 2005 Statute and Rule. July 29, 2005. Available at: Accessed 9 December 2014.

[2]Centers for Disease Control and Prevention and the Food and Drug Administration.  Vaccine Adverse Event Reporting System.  Department of Health and Human Services, 21 March 2014. Web. 21 March 2014.

[3] Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  Food and Drug Administration. Web. 21 March 2014.

[4] Standards and Interoperability Framework. Structured Data Capture Initiative. 2014. Available at: Accessed 9 December 2014.

Leave a Reply

Your email address will not be published. Required fields are marked *