Reporting Adverse Events

Under the Investigational New Drug Protocol, all adverse events following smallpox vaccination must be reported to the CDC through the designated principal investigators for each state.

To report adverse events or request consultation about an adverse event, please call:

For general vaccine questions (not adverse event reporting) please email the NIP at nipinfo@cdc.gov.

The FDA has recommended that the Vaccine Adverse Event Reporting System (VAERS) also be used to report adverse events. For that reason a brief overview of the VAERS system is provided.

The Vaccine Adverse Event Reporting System (VAERS)
The National Childhood Vaccine Injury Act (NCVIA-1986) requires health professionals and vaccine manufacturers to report to the Department of Health and Human Services (DHHS) specific adverse events following the administration of specific licensed vaccines.

Smallpox vaccine (vaccinia) is not currently licensed and is not included in the list of specific vaccines at present.

In 1990 the VAERS was established under the joint administration of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS accepts reports from health professionals, vaccine manufacturers and the general public. Reports may be submitted by mail, fax and the Internet. (See http://www.vaers.org for details). All reports enter the VAERS database.

Forms have been developed for consistent reporting and include identifying information about the patient, the vaccination given, the reported adverse event, and the person reporting the event. Please click here to open a PDF version of the VAERS form.

Serious reports include hospitalization, prolongation of hospitalization, death, life-threatening illness or permanent disability. All serious reports are followed up by a team of nurses to obtain additional information (such as medical records and autopsy reports) in order to provide as full a picture as possible. The data are subsequently analyzed.

All personal information is confidential. Medical records are protected by confidentiality requirements.