Frequently asked questions

The Vaccine Adverse Event Reporting System (VAERS) is a national early warning system. It looks for possible safety problems in vaccines licensed in the United States. It accepts and reviews reports of health problems that happen after vaccination.

VAERS cannot show that a vaccine caused a health problem. It can show unusual or unexpected patterns in reports that need a closer look.

VAERS is run jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Both are part of the Department of Health and Human Services (HHS).

Every report adds to the VAERS database. Reports that are accurate, complete, and sent soon after the event give staff the information they need to monitor vaccine safety and decide what to study further.

No. The National Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP) are run by the Health Resources and Services Administration (HRSA). They are separate from VAERS.

Sending a VAERS report does not start a compensation claim. To check whether you are eligible, contact VICP on 800-338-2382 or CICP on 855-266-2427.

Anyone. Patients, parents, caregivers, and healthcare providers are all encouraged to report, even when it is not clear that the vaccine caused the problem. Healthcare providers must report some events by law.

Report any health problem that matters to you and that happened after a vaccination. Report it even if you are not sure the vaccine caused it. Also report a mistake made while giving the vaccine, such as the wrong dose or the wrong vaccine.

The law requires providers to report:

• Any event in the VAERS Table of Reportable Events that happens within the time period the table sets out
• Any event the manufacturer lists as a reason not to give another dose

Providers are strongly encouraged to also report:

• Any event after a vaccine licensed in the United States, whether or not the vaccine appears to be the cause
• Mistakes made while giving a vaccine

Manufacturers must report every event that comes to their attention.

An event is serious if it involves any of the following:

• Death
• A life-threatening event
• A stay in hospital, or a longer stay than planned
• Lasting or significant disability, or a major disruption to normal daily life
• A birth defect
• Another important medical event that, in clinical judgement, may need treatment to prevent one of the outcomes above

No. Some events are caused by vaccination and others happen at the same time by coincidence. VAERS accepts reports without judging the cause. A report is a signal to look, not a finding.

No. Speak to a doctor or another healthcare professional about your case. Clinicians with complex cases can request a consultation through the CDC Clinical Immunization Safety Assessment (CISA) project.

Use the online form. Start at report an adverse event. The form asks one set of related questions per screen and takes about 10 minutes.

Yes, if you give your contact details. You will get a confirmation number on screen, or an identification number by post, depending on how you reported.

If you have your VAERS identification number you can find your report on the CDC WONDER website. If you need help, contact the VAERS help desk on 1-800-555-0199 or at info@vaers.example.gov.

VAERS will contact you if it needs medical records or other documents. Send anything you add through submit follow-up information and include your E-number or VAERS identification number. Do not post or email medical records.

Yes. Patient identity is kept confidential. VAERS follows US government security standards for health information. Read the privacy notice for detail.

Reports are public with identifying details removed. Start on the data page, which also links to CDC WONDER.

Strengths:

• Covers every US state and territory
• Accepts reports from anyone
• Collects details of the vaccine, the person, and the event
• Is published for anyone to read
• Can pick up rare events early

Limits:

• The data usually cannot show whether a vaccine caused an event
• Reports are often incomplete and sometimes contain errors
• Serious events are reported more often than minor ones
• Report numbers rise when a subject is in the news
• The data cannot be used to work out rates

Counting reports of death as deaths caused by vaccines is a common misreading of this data.

Routine maintenance usually runs from 8:30 p.m. to 12:30 a.m. on the third Thursday of each month. The site is occasionally down at other times for urgent security work.

No. You can send a report only while the website is online. Data on CDC WONDER stays available.

Contact the help desk on 1-800-555-0199 or at info@vaers.example.gov, Monday to Friday, 9 a.m. to 5 p.m. Eastern Time. Messages sent later are usually answered the next working day.