by Sandra Douglas

Created on: September 17, 2010   Last Updated: September 21, 2010

All medications and vaccines, including flu shots, carry a risk of side effects, adverse reactions, and allergic reactions. VAERS, the Vaccine Adverse Event Reporting System, was created in 1990 as a central reporting system to gather information about the adverse effects from vaccines administered to children and adults.

VAERS is a national reporting system that accepts reports from health care providers, manufacturers, vaccine recipients, their caregivers, parents, or guardians. Anyone can file the report as a paper form by mail or fax or an online report.

The VAERS report requests the following information:

The type of vaccine received

Date and time of vaccination

The onset of the adverse event

Current illnesses or medication

Past history of adverse events following vaccination

Demographic information about the recipient

VAERS accepts a report of an allergic reaction as an adverse event though they are not the same thing.

Difference between Adverse Reactions and Allergic Reactions

An adverse event is the side effect or medical condition caused by the medication that was administered. An example is the dry mouth that is a common side effect associated with antihistamines. Side effects may be common and expected but they are not the desired effect of the medication. People don’t take an antihistamine because they want a dry mouth and the package label does not indicate “dry mouth” as a use of the medication.

An allergic reaction is the body’s immune system response to a foreign protein, also called an antigen. The person’s immune system is the cause of the reaction, not the drug.

A person that has an allergic reaction to a vaccine, medication, or any other substance, should avoid it in the future. For adverse reactions, a person can decide to continue to take a medication if the side effects are not severe.

What Happens to the Information?

The information received on the VAERS form is entered into a database. The information in the database can be used to monitor the safety of vaccines and in research studies. The data can even be accessed by the interested public; all personal information is removed to protect patient confidentiality.

Selected cases of more serious adverse reactions are subject to follow up after 60 days and one year post-vaccination to check the recovery status of the patient.  

One precaution about the data: Data is reported on the VAERS form but users of the information must be careful of assuming a cause

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