Vaccine Adverse Event Reporting System

VAERS is the Vaccine Adverse Event Reporting System. It is a passive collection of reports of vaccine side effects that may be filed by doctors or patients. It is generally considered to only contain about 10% of the actual side effects that occur, since there is no requirement to make a report and many patients don’t know that it exists. It is also not necessarily a representative sample of vaccine injuries. However, it is the system that is monitored for side effects that may not have shown up in clinical trials before a vaccine was licensed. You may access the website at vaers.hhs.gov/index. If you would like to find information on actual reports, click on the “data” tab.

How To File a VAERS Report

If you believe that you or your child has experienced a vaccine injury, you or your doctor may report it at vaers.hhs.gov/esub/index. It is best to get information together before filing which would include the name of the vaccine and the lot number as well as specifics of the adverse event, dates and times.

Vaccine Licensure and Package Inserts

Vaccines are licensed by the Food and Drug Administration which has primary responsibility for ensuring that they are safe and effective. See listing of all vaccines licensed in the United States.

Within this list, if you click on an individual vaccine, you can access the package insert. Each vaccine’s package insert typically contains a summary of its uses, the populations it is approved for, a summary of the safety and efficacy studies that have been done on it, its ingredients and a list of contraindications for use.

Vaccine Information Statements

A Vaccine Information Statement (VIS) is a one-page (two-sided) information sheet, produced by CDC. VISs inform vaccine recipients — or their parents or legal representatives — about the benefits and risks of a vaccine. They do not include as much information as the package inserts. The law requires that VISs given out whenever certain vaccinations are given. All providers of vaccines, both public and private sector, must give them out. It is a requirement of the National Childhood Vaccine Injury Act of 1986 that they must be given out at the time of each vaccination — prior to administration of the vaccine. 

More information about VIS

Download actual forms