Information and resources

Background on what happens to reports, who is required to file, and where to go for other kinds of help. All content on this prototype is illustrative.

• How vaccine safety monitoring works

  Reports are reviewed for patterns. A single report cannot show causation, but clusters of similar reports can trigger deeper study in linked data systems.

• Provider reporting requirements

  Providers must report events listed in the reportable events table and any event listed as a contraindication in the package insert. Administration errors are strongly encouraged.

• For patients and caregivers

  You can report on your own behalf or for a family member. You do not need medical records or medical vocabulary to file a useful report.

• When to seek care instead

  This form is not a way to get medical help. For trouble breathing, swelling of the face or throat, chest pain, or fainting, call 911.

• Compensation programs

  Separate federal programs handle claims for injuries alleged to be caused by certain vaccines. Filing a safety report is not a claim and does not start that process.

• Privacy of your report

  In this prototype, personal details you enter are treated as sensitive and are kept separate from the illustrative public data files shown here. Refer to official CDC and FDA guidance for how the real system handles data.