Vaccine Adverse Event Report System (VAERS)
VAERS Frequently
Asked Questions
What is VAERS?
The National Childhood Vaccine Injury Act (NCVIA) of 1986 mandated the
reporting of certain adverse events following vaccination to help ensure
the safety of vaccines distributed in the United States. This Act led to
the establishment of the Vaccine Adverse Event Reporting System (VAERS) in
November 1990 by the Department of Health and Human Services. VAERS
provides a database management system for the collection and analysis of
datafrom reports of adverse events following vaccination. VAERS is
operated jointly by the Centers for Disease Control and Prevention (CDC) and
the Food and Drug Administration (FDA). VAERS currently receives
approximately 800-1000 reports each month.
Who can report to VAERS?
Any one can report to VAERS.
VAERS reports are usually submitted by health care providers,
vaccine manufacturers,and vaccine recipients (or their parents/guardians).
Patients, parents, and guardians are encouraged to seek the help of
a health-care professional in reporting to VAERS.
Why should I report to VAERS?
Registries of disease or
injury work best when reporting is complete. Complete reporting of
post-vaccination events supplies public health professionals with the
information they need to ensure the safest strategies of vaccine
administration.
Does my reporting injuries (or deaths) to VAERS affect
personal liability?
No. The National Childhood Vaccine Injury Act
of 1986 provides liability protection through the Vaccine Injury
Compensation Program. In light of this protection, practitioner liability
is unaffected by the VAERS reporting requirement.
What events should be
reported to VAERS?
Although NCVIA only requires reporting of the
post-vaccination adverse events mentioned in the
Reportable Events Table,
VAERS encourages all reporting of any clinically
significant adverse event occurring after the administration of
any vaccine licensed in the United States. On average, about
17% of the reports reflect adverse events resulting in life-threatening
illness, hospitalization, permanent disability, extended hospital stay or
death. The remaining 83% of the reports primarily describe events such as
fever, local reactions transient crying or mild irritability, and other
less serious experiences.
The Reportable Events Table specifically
outlines the reportable post-vaccination events and the time frames in
whichthey must occur in order to qualify as being reportable. A copy of
the Table can be obtained by calling 1-800-822-7967.
The NCVIA
requires the following events be reported:
- Any event set forth in the Reportable Events Table that occurs
within the time period specified.
- Any event listed in the manufacturer's package insert as a
contraindication to subsequent doses of the vaccine.
How are VAERS reports analyzed?
Both the CDC and the FDA
review data reported to VAERS. The CDC focuses on collective reports,
attempting todetect unusual epidemiologic trends and associations. The
FDA reviews individual reports, assessing whether areported event is
adequately reflected in product labeling, and also closely monitors
reporting trends for individualvaccine manufacturers and vaccine lots.
Safety surveillance includes the analysis of reports by individual
epidemiologists, and weekly review meetings of serious VAERS reports to
detect potential risks which require further investigation.
Can
information reported to VAERS cause a recall of a vaccine?
The
FDA has the authority to recall a vaccine from use in the United States
if they feel it represents a risk to the American public. VAERS reports
may signal that there is the potential for a safety risk, which would
prompt a wider evaluation of the safety of the vaccine lot. If the
evaluation confirms a risk, the batch can be recalled.
Over the last
10 years, there have been only three vaccine recalls. One batch of
vaccine was recalled after the FDA detected impurities in the vaccine;
another was mislabeled. The third batch was recalled because an FDA
inspection found substandard conditions at the production plant which
had the potential to produce a substandard batch.
In the winter of
1996-97, a pharmaceutical company voluntarily withdrew a vaccine from
distribution because it did not retain its protective effect long enough
after manufacture to meet Federal standards. This vaccine was not a
safety threat, but did not work well enough to protect people from getting
the disease it was designed to protect them from.
Are all events
reported to VAERS caused by vaccinations?
Again, VAERS accepts all
reports of adverse events following vaccination, so not all events reported
to VAERS arecaused by vaccines. In fact, limitations such as differential
reporting rates, simultaneous administration of different vaccine antigens,
temporal reporting bias and lack of background vaccination rate data
generally prevent the determination of vaccine-event causal associations
using VAERS data. Without fully understanding its limitations, results
from VAERS can easily be misinterpreted.