S Vaccine Adverse Event Reporting System (Page 4 of 4) in pdf

y Item 16: Select the single best answer for the type of facility where the vaccine(s) was given.

y Item 17: Include only vaccines given on the date listed in no. 4. For vaccines given as a series (i.e., 2 or more doses of the

same vaccine given to complete a series), list the dose number for the vaccine in the last column named “Dose no. in series”

(e.g., if this is the second time you are getting the same vaccine, write “2”).

y Item 18: Describe the adverse event(s), treatment and outcome(s). Include signs and symptoms, when the symptoms occurred,

diagnosis, and treatment. Provide specific information if you can (e.g., if patient had a fever, provide the temperature).

y Item 19: List any medical tests and laboratory results related to the adverse event(s). Include abnormal findings as well as

normal or negative findings.

y Item 20: Select “Yes” if the patient’s health is the same as it was prior to the vaccine or “No” if the patient has not returned

to the same state of health as before the vaccine, and provide details in no. 18. Select “Unknown” if the patient’s present

condition is not known.

y Item 21: Select the result(s) or outcome(s) for the patient. If the patient did not have any of the outcomes listed, select “None

of the above.” Prolongation of existing hospitalization means the patient was hospitalized and received a vaccine during their

hospital stay. An adverse event following vaccination occurred and resulted in the patient spending extra time in the hospital.

Life threatening illness means you believe this event could have resulted in the death of the patient.

y Item 22: List any other vaccines the patient received within one month prior to the vaccination date listed in no. 4.

y Item 23: List adverse events following any previous vaccine(s). Include patient age at vaccination, dates of vaccination, vaccine

type and brand name.

y Item 24: Check all races that apply.

y Item 25: Check the single best answer for ethnicity.

y Item 26: This is for health department use only.

y Items 27 and 28: These items should only be completed if the patient is associated with the U.S. Military or Department of

Defense.

GENERAL INFORMATION

y VAERS ( ) is a national vaccine safety monitoring system that collects information about adverse events

(possible reactions or problems) that occur after administration of vaccines licensed in the United States.

y VAERS protects patient identity and keeps patient identifying information confidential.

y The HIPAA Privacy Rule permits reporting of protected health information to public health authorities including CDC and FDA

(45 CFR § 164.512(b)).

y VAERS accepts all reports without judging the importance of the adverse event or whether a vaccine caused the adverse event.

y Acceptance of a VAERS report by CDC and FDA does not constitute admission that the vaccine or healthcare personnel caused

or contributed to the reported event.

y VAERS is primarily concerned with monitoring adverse health events. Using clinical judgment, healthcare professionals can

decide whether or not to report a medical error at their own discretion.

y The Vaccine Injury Compensation Program (VICP) is administered by the Health Resources and Services Administration

(HRSA). The VICP is separate from the VAERS program and reporting an event to VAERS does not constitute filing a claim for

compensation to the VICP (see ).

y Knowingly filing a false VAERS report with the intent to mislead the Department of Health and Human Services is a violation of

Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.

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