VACCINE INFORMATION STATEMENTS (VIS) &
Vaccine Adverse Event Reporting System (VAERS)

• VIS - Vaccine Information Statements
Vaccine Information Statements:
English / Other Languages

Required Use
As required under the National Childhood Vaccine Injury Act (42 U.S.C. § 300aa-26), all health care providers in the United States who administer any vaccine containing diphtheria*, tetanus*, pertussis*, measles*, mumps*, rubella*, polio*, hepatitis B§, Haemophilus infiuenzae type b (Hib)§, or varicella (chickenpox)§ vaccine shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC):
(a) to the parent or legal representative of any child to whom the provider intends to administer such vaccine, and
(b) to any adult to whom the provider intends to administer such vaccine.

The materials shall be supplemented with visual presentations or oral explanations, as appropriate.

"Legal representative" is defined as a parent or other individual who is qualified under State law to consent to the immunization of a minor.

Recordkeeping
Health care providers shall make a notation in each patient's permanent medical record at the time vaccine information materials are provided indicating (1) the edition date of the materials distributed and (2) the date these materials were provided.

This recordkeeping requirement supplements the requirement of 42 U.S.C. § 300aa-25 that all health care providers administering these vaccines must record in the patient's permanent medical record (or in a permanent office log) the name, address and title of the individual who administers the vaccine, the date of administration and the vaccine manufacturer and lot number of the vaccine used.

• VAERS - Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System is a Cooperative Program for Vaccine Safety of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (side effects) that occur after the administration of US licensed vaccines. Reports are welcome from all concerned individuals: patients, parents, health care providers, pharmacists, and vaccine manufacturers.

The VAERS form is available in PDF.

Mailing Instructions for VAERS

• For vaccine purchased with public funds, send to:

State of California
Department of Health Services
Immunization Branch
2151 Berkeley Way, Room 712
Berkeley, CA 94704
ATTN: VAERS Coordinator

• For vaccine purchased with private funds, send to:

VAERS
C/O ERC BioServices Corporation
A Division of Ogden Biomedical Services Group
1055 First Street, Suite 130
Rockville, MD 20850