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Frequently
Asked Questions |
What is VAERS?
The Vaccine Adverse Event Reporting
System (VAERS)
is a national vaccine safety surveillance program co-sponsored
by the Centers for Disease Control and Prevention
(CDC) and the Food and Drug Administration (FDA).
VAERS collects and analyzes information from reports of adverse
events following immunization. Since 1990, VAERS
has received over 123,000 reports, most of which describe mild
side effects such as fever. Very rarely, people experience serious
adverse events following immunization. By monitoring such events,
VAERS
helps to identify any important new safety concerns and thereby
assists in ensuring that the benefits of vaccines continue to
be far greater than the risks. |
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Who can report
to VAERS?
Anyone can report to VAERS. The majority
of VAERS reports are sent in by vaccine manufacturers (42%) and
health care providers (30%). The remaining reports are obtained
from state immunization programs (12%), vaccine recipients or
their parent/guardians, (7%) and other sources (9%). Vaccine recipients
or their parents or guardians are encouraged to seek the help
of their health care professional in filling out the VAERS form.
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Why should
I report to VAERS?
Each report provides valuable information
that is added to the VAERS
database. Accurate and complete reporting of post-vaccination
events supplies the information needed for evaluation of vaccine
safety. The CDC
and FDA
use VAERS
information to ensure the safest strategies of vaccine use and
to further reduce the rare risks associated with vaccines. |
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How do I report
to VAERS?
You should use a VAERS
report form to report any adverse event. You can obtain pre-addressed
postage paid report forms by calling VAERS
at 1-800-822-7967. You may use photocopies of the form to submit
reports. You may also download printable copies of the VAERS
form as well as other information about the VAERS
Program from the following Internet sites:
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What events
should I report to VAERS?
VAERS
encourages the reporting of any clinically significant adverse
event that occurs after the administration of any vaccine licensed
in the United States. You should report clinically significant
adverse events even if you are unsure whether a vaccine caused
the event.
The National Childhood Vaccine Injury Act (NCVIA) requires health
care providers to report:
- Any event listed
by the vaccine manufacturer as a contraindication to subsequent
doses of the vaccine.
- Any event listed
in the Reportable Events Table that occurs within the specified
time period after vaccination.
A copy of the Reportable Events Table
can be obtained by calling VAERS at 1-800-822-7967 or by downloading
it from http://vaers.hhs.gov/reportable.htm.
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How are VAERS
reports analyzed?
Both the CDC
and the FDA
review data reported to VAERS.
The FDA reviews reports to assess whether a reported event is
adequately reflected in product labeling, and closely monitors
reporting trends for individual vaccine lots. Copies of published
reviews are available from VAERS. Many different types of events
occur after vaccination. Approximately 85% of the reports describe
mild events such as fever, local reactions, episodes of crying
or mild irritability, and other less serious experiences. The
remaining 15% of the reports reflect serious adverse events involving
life-threatening conditions, hospitalization, permanent disability,
or death, which may or may not have been truly caused by an immunization. |
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Are all events
reported to VAERS
caused by vaccinations?
No. VAERS
receives reports of many events that occur after immunization.
Some of these events may occur coincidentally following vaccination,
while others may truly be caused by vaccination. Studies help
determine if there is more than a temporal (time) association
between immunization and adverse events. The fact that an adverse
event occurred following immunization is not conclusive evidence
that the event was caused by a vaccine. Factors such as medical
history and other medications given near the time of the vaccination
must be examined to determine if they could have caused the adverse
event. It is important to remember that many adverse events reported
to VAERS
may not be caused by vaccines. |
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How do I find
out if a vaccine adverse event has been reported?
You can request information
about adverse events reported to VAERS by faxing requests to
(301) 443-1726, or by sending requests to:
Food and Drug
Administration | Freedom of Information Staff (HFI-35)
5600 Fishers Lane | Rockville, MD 20857
(301) 827-6500 |
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