eVAERS regulation updates

In May 2019 and June 2020, the FDA published revised technical specifications to accommodate the submission of Postmarketing Safety Reporting for Combination Products.

Note:

Regulations from June 2020 are partially implemented due to late availability. Remaining regulation updates will be available in the future release.

The following are the list of changes made in the application to be compliant with the latest regulations.

• The new field Pregnant at time of Vaccination is available under Case Form > Patient Tab > Patient Details.
• Factory data changes have been made to the following codelists and flexible codelists:
  • Console > Codelist > Routes of Administration
  • Console > Codelist > Anatomical Location
  • Console > Codelist > Flexible re-categorization > Route
  • Console > Codelist > Flexible re-categorization > Location
• Null flavor set assignments have been changed for the following case form elements under Console > System Configuration > Field Properties:
  • Patient Title
  • Patient Middle Name
  • Patient Last Name
  • Patient Address 1
  • Patient City
  • Patient State
• Element numbers are provided for all the existing FDA regional elements and for the new elements in eVAERS profile. The element numbers are displayed in the decoded view of the ICSR viewer and as inline comments in the XML file.
• The following changes have been made to the eVAERS profile:
  • New elements have been added.
  • Elements related to the Parent have been deleted.
  • Mapping logic has changed for elements.
  • Conformance rules have changed for elements.
  • Data length has changed for elements.
  • Data element descriptions have changed for elements.
  • Allowed null flavors have changed for elements.
  • Allowed values have changed for elements.