1. CBER eVAERS Best Practices
  2. Set up Reporting Rules

5 Set up Reporting Rules

We recommend you retain the existing expedited reporting rules (#1, #2) for 15-day and periodic report types, and create the other new expedited reporting rules. Below are the suggested reporting rules:

Country License Type Agency Rule Name Time Frame Report Form Condition
United States Marketed Vaccine CBER_VAERS 15 day 15 eVAERS Event Serious = Yes

Criteria using Advance conditions: Case Listedness = No

Any other condition as per your company’s business process
United States Marketed Vaccine CBER_VAERS Periodic 60 eVAERS Case Serious = No

OR

Case Serious = Yes

Criteria using Advance conditions:

Case Listedness = Yes

Any other condition as per your company’s business process
United States Marketed Vaccine CBER_VAERS 5-day 5 eVAERS Criteria using Advance conditions.
  • Remedial Action exists
  • Case Classification = Combination Product

Any other condition as per your company’s business process
United States Marketed Vaccine CBER_VAERS 30-day 30 eVAERS Case Serious = No
Criteria using Advance conditions:
  • Case Classification = Combination Product
  • Malfunction = Yes

Any other condition as per your company’s business process
World Marketed Vaccine CBER_VAERS 30-day 30 eVAERS Case Serious = No Criteria using Advance conditions
  • Classification=Combination
  • Product Malfunction=Yes
  • Product type=Treatment
  • Drug not administered=Yes
  • Similar Device=Yes
Any other condition as per your company’s business process