Information for Healthcare Professionals

Information for Healthcare Professionals
VAERS relies on receiving adverse event reports from healthcare professionals. The following information has been prepared to provide healthcare professionals with guidance regarding the accurate and timely submission of adverse event reports to VAERS.
-Guidance on Reportable Events
-Submit a Report of an Adverse Event Following a Vaccination
-Follow-up Requests for Information from VAERS
-Request VAERS Materials
-Vaccine Safety
-Frequently Asked Questions (FAQs)
-Training (Coming soon!)
-Guidance on Reportable Events
You may report any adverse event that occurs after the administration of a vaccine licensed in the United States. You may report adverse events even if you are unsure whether a vaccine caused them.

The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report:

.Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine; or
.Any adverse event listed in the Vaccine Injury Table that occurs within the specified time period after vaccination.


Follow-up Requests for Information from VAERS
It is very important that submitted reports are complete and accurate as possible. You may be asked to provide follow-up information in response to a VAERS acknowledgment or follow-up letter from our office. If necessary, our nurse researchers may also contact you (or the individuals involved in the case) to obtain additional information, including medical records, that may help us understand the circumstances surrounding the adverse event. Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), VAERS is considered part of a public health entity, thus individual authorization is not necessary before releasing information. If you have questions about how the HIPAA applies to VAERS, please visit our VAERS Privacy Policies and Disclaimers section.

You may also provide additional information about a report you filed via fax, mail, or telephone by calling our Information Line at (800) 822-7967. Be sure to include your E-number or VAERS identification number. (We do not recommend you send e-mail, as the confidentiality of your information cannot be assured.)

Request VAERS Materials
Hard-copies of the VAERS report form and brochures are available for distribution upon request. Contact VAERS for specifics on quantity limits and availability. Please note that materials may also be photocopied and downloaded from the website.


Vaccine Safety
CDC's Immunization Safety Office provides information about vaccine safety, including how vaccines are tested and monitored, answers to common questions, and information about vaccine safety concerns.


Frequently Asked Questions
The following information has been provided to respond to questions frequently received by the VAERS office.

Does VAERS have reporting deadlines?
Do we need to fax AND mail a copy of the report?
Will we receive confirmation that the report we filed was received?
Given prior adverse events to vaccines how should we handle future immunizations?
We would like to order more Vaccine Information Statements (VIS) or laminated vaccine schedules?
We have questions about vaccine storage
Is VAERS Involved in the Vaccine Injury Compensation Program?


Does VAERS have reporting deadlines?
There are no deadlines for the submission of an adverse event report. You are encourage to submit a report promptly after an adverse event occurs to facilitate surveillance and review.


Do we need to fax AND mail a copy?
The report should only be submitted once either online, via fax, or by mail. Please note that online submission is the preferred method of submission.


Will we receive confirmation that the report we filed was received?
A confirmation number, called an "E-number," is automatically generated for reports submitted online. Individuals who submit a paper report will receive an acknowledgement letter within a few days after receipt by the VAERS office. This letter will include the case number and the VAERS ID number. It is important to include your contact information, located in the reporter section of the form, since this information is used to generate the acknowledgement letter.

Given prior adverse events to vaccines how should we handle future immunizations?
For assistance and information contact the CDC-Info Contact Center by calling (800) 232-4636 or visit the CDC's Vaccines and Immunizations website.

We would like to order more Vaccine Information Statements (VIS) or laminated vaccine schedules
For information contact the CDC-Info Contact Center by calling (800) 232-4636, visit the CDC's Vaccines and Immunizations website or contact the vaccine manufacturer directly.


We have questions about vaccine storage
For information contact the CDC-Info Contact Center by calling (800) 232-4636, visit the CDC's Vaccines and Immunizations website or contact the vaccine manufacturer directly.


Is VAERS Involved in the Vaccine Injury Compensation Program?
The Vaccine Injury Compensation Program (VICP), which compensates people whose injuries may have been caused by vaccines recommended by CDC for routine use, is administered by the Health Resources and Services Administration. The VICP is separate from the VAERS program, and reporting an event to VAERS does not file a claim for compensation to the VICP.

For more information about the VICP, call (800) 338-2382 or visit the VICP Web site.

abrir aquí para acceder al documento HHS-FDA completo:
Information for Healthcare Professionals