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Most people
experience normal, typically mild reactions to smallpox (vaccinia) vaccine.
However, some people may experience reactions that may require medical
attention and should be reported.
- Normal,
typically mild reactions include a sore arm, fever, swollen
glands, and body aches.
- Moderate
to severe reactions
include contact spread of the smallpox vaccine virus (vaccinia) to other
parts of the body or to other persons (inadvertent inoculation), spread
of vaccinia to other parts of the body through the blood (generalized
vaccinia), and a toxic or allergic reaction (erythema multiforme).
- Potentially
life threatening
include widespread infection of the skin (eczema vaccinatum), ongoing
tissue destruction (progressive vaccinia or vaccinia necrosum) and inflammation
of the brain (postvaccinal encephalitis). These reactions require immediate
medical attention.
- Other
severe events include events that result in hospitalization,
permanent disability, life-threatening illness, or death. These events
are temporally-associated with smallpox vaccination but have not been
documented to be causally associated.
What to do if vaccinees or close contacts experience
serious or life-threatening smallpox vaccine reactions
Healthcare providers may call the Clinician Information Line (CIL) at
1-877-554-4625 or their Health Department. If needed, the Centers for
Disease Control and Prevention (CDC) will be available to provide guidance
and consultation on clinical management issues, including use of Vaccine
Immune Globulin (VIG) and cidofovir.
When to use the Vaccine Adverse Event Reporting
System (VAERS) to report adverse events or reactions to smallpox vaccine
VAERS, the primary U.S. vaccine safety monitoring system, encourages reporting
of any unexpected or serious event occurring after smallpox
vaccination as well as adverse events occurring in persons following close
contact with a vaccine recipient. An adverse event is
any clinically significant medical event that occurs following administration
of a vaccine. A VAERS report should be submitted even if it is not certain
that the event was caused by the vaccine.
Adverse events that are serious or unexpected and require
expert consultation or IND (investigational new drug) therapeutics (VIG
or cidofovir) should be immediately reported by phone to the Health Department
or CDC, and should also be reported to VAERS as soon as possible. All
other smallpox vaccine adverse events judged to be serious should be reported
directly to VAERS within 48 hours of recognition. Other clinically significant
adverse events should be reported to VAERS within one week.
Anyone can report smallpox vaccine adverse events
Healthcare providers who clinically evaluate individuals having adverse
events are strongly encouraged to report to facilitate follow-up and medical
treatment. Health department personnel also can report or assist providers
reporting.
It is important to report smallpox vaccine adverse
events
Reporting to VAERS helps assure that smallpox vaccination will be conducted
as safely as possible. Data from VAERS reports are analyzed by the CDC
and the Food and Drug Administration (FDA) to identify
- new
and/or rare vaccine side effects
- increases
in rates of known side effects
-
patient risk factors for particular types of adverse events
Submitting a VAERS report
Electronic reporting of all smallpox vaccine adverse events is strongly
encouraged because it is the most timely and efficient method of providing
information. Secure web-based reporting is available at https://secure.vaers.org/VaersDataEntryintro.htm.
Detailed instructions for web-based reporting are provided on-line at
www.vaers.org.
Printable VAERS forms are available online at http://www.vaers.org/pdf/vaers_form.pdf.
Completed forms can be faxed toll-free to 1-877-721-0366 or mailed to
P.O. Box 1100; Rockville, MD 20894-1100. If further assistance is needed
to complete a form, please call 1-800-822-7967 or send an email to info@vaers.org.
Filling out a VAERS form
The VAERS form has not been changed for smallpox vaccination. Because
of limited knowledge about smallpox vaccine adverse events, it is particularly
important that the VAERS form be filled out as completely and accurately
as possible.
As with all VAERS reporting
-
when completing the form, boxes 3, 4, 7, 8, 10, 11, and 13 are considered
essential;
- when
reporting electronically, information from other electronic records
can be copied and pasted into boxes 7, 17, 18, and 19;
- when
submitting follow-up information (such as medical records) to VAERS
by fax or mail, use the VAERS E-report number, VAERS ID, PVN, or other
unique vaccination number. This number should be written in the upper
right hand corner of each page.
Sources
for more information about VAERS reporting
Vaccine Adverse Event Reporting System: www.vaers.org.
Centers for Disease Control and Prevention: www.cdc.gov/nip/vacsafe/#VAERS
Food and Drug Administration: www.fda.gov/cber/vaers/vaers.htm
CDC public response hotline: |
| • | English:
(888) 246-2675 |
| • | Español:
(888) 246-2857 |
| • | TTY:
(866) 874-2646 |
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Page last reviewed August 5, 2004
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