Since March 21, 1988, the National
Childhood Vaccine Injury Act of 1986 (NCVIA)has required
health care providers and vaccine manufacturers to report
certain serious adverse events, following specific vaccinations
to the Secretary of the Department of Health and Human
Services. The NCVIA
stipulates the vaccines, the adverse events, and the time
of occurrence after vaccination for which reporting is
required.
The Reportable
Events Table (RET),
which lists conditions reportable by law (42USC 300aa-25)
to the Vaccine Adverse Event Reporting System (VAERS),
including conditions found in the manufacturers package
insert, and on the VAERS website.
Parents, guardians or other third parties representing
the patient can report adverse events following vaccine
administration.
VAERS is a reporting system created by the FDA and the
CDC to receive and analyze reports about adverse events
that may be associated with vaccines under the National
Childhood Vaccine Injury Act of 1986.
VAERS encourages the reporting of all clinically significant
adverse events following any vaccine, whether of not vaccine
is believed to be the cause of the event. Both CDC and
the FDA routinely review data reported to VAERS. The FDA
monitors reports to determine whether any vaccine lot
has a higher than expected reporting rate of adverse events.
The report of an adverse event to VAERS is not documentation
that a vaccine has caused the event and does not enter
a person into the vaccine injury compensation process.
Although certain events must be reported in accordance
with the law, healthcare providers are encouraged to report
all suspected or actual vaccine adverse events. Anyone
can report an adverse event 24 hours a day, by calling
(800) 822-7967 or using the 
VAERS
FORM. Call the Center for Immunization, 410-767-6679,
if you have questions.
Do not report events associated with TB screening tests
or immune globulins to VAERS.
