Vaccine Information Statements

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What are VISs?
Vaccine Information Statements (VISs) are statements describing vaccines that are covered by the National Childhood Vaccine Injury Act (NCVIA). By Federal law, VISs must be produced by the Centers for Disease Control and Prevention (CDC) and cannot be altered. Pediatricians may add the name, address, etc, of their practice, but substantive changes are not acceptable.

What VISs must be used?
NCVIA requires that all US health care providers administering any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus
influenzae type b (Hib), varicella (chickenpox), influenza, or pneumococcal conjugate vaccine, provide a copy of the relevant VIS to the adult vaccinee or parent or legal representative. The relevant VIS must be given prior to administration of every dose of the vaccine. The VISs should be supplemented with visual presentations or verbal explanations, as appropriate.

A VIS must be given with every vaccination, including each dose of a multidose series. This is done for several reasons - the statement might have been updated between visits, or the health status of the child may have changed (eg, he or she may have an evolving neurological disorder).

VISs are also available for human papillomavirus (HPV), meningococcal, pneumococcal polysaccharide, and rotavirus, as well as various vaccines used primarily for international travelers. The use of these VISs is recommended but not currently required by federal law.

To whom must the VISs be given?
Federal law states that VISs must go to:

  1. Any adult receiving one of the vaccines; or
  2. The parent or legal representative of any child receiving one of the covered vaccines. ("Legal representative" is defined as a person who is qualified to consent to immunization of a minor under State law.)

What VISs currently are available?
All public and private providers who administer vaccines covered by the NCVIA are required to use the CDC-developed materials. Click here for all VISs available from CDC.

What is the most current issue date on each of the VISs?

DTaP/DT/DTP: 5/17/07
Hepatitis A: 3/21/06
Hepatitis B: 7/11/01
Hib: 12/16/98
HPV: 2/2/07
Influenza (LAIV): 6/30/06
Influenza (TIV): 6/30/06
Meningococcal: 11/16/06
MMR: 1/15/03



PCV: 9/30/02
PPV: 7/29/97
Polio: 1/1/00
Rabies: 1/12/06
Rotavirus: 4/12/06
Td: 6/10/94
Tdap: 7/12/06
Typhoid: 5/19/04
Varicella: 1/10/07
Yellow Fever: 11/9/04

How can physicians get VISs?
Camera-ready copies (clear, easy to read copies made from a master copy) and explanatory information are sent to all Immunization Projects. The Immunization Projects are then responsible for printing and distributing VISs to their public health clinics. Immunization Projects also are asked to print and distribute camera-ready copies to all providers in their state or metro area who administer vaccines.

The VISs are available on the CDC Web page. These copies are identical to the printed VISs and may be downloaded and printed by Immunization Projects or providers for use as camera-ready copies. The CDC updates VISs regularly, and it is important to ensure that the most recent version is being used.

How do physicians keep track of VISs that have been distributed?
Health care providers may be required to obtain the signature of the patient, parent, or legal representative acknowledging receipt of a VIS based on the state in which they practice. Whether a signature is required or not, at the time a VIS is given, health care providers must note in the patient's permanent medical record:

  • the specific VIS that was given (eg, polio);
  • the VIS date of publication (on the back, bottom right);
  • the date the VIS was provided;
  • the name, address, and title of the person who administered the vaccine;
  • the date the vaccine was administered;
  • the vaccine manufacturer used; and
  • the lot number of the vaccine used.

Are VISs considered "informed consent"?
Informed consent requirements are determined by State law. The VISs were written to fulfill information requirements of the amendment to the NCVIA and are not designated as informed consent documents. However, because the materials cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed.

Health care providers should consult their legal counsel to determine if there are specific "informed consent" requirements related to immunization. Such requirements could be procedural (eg, whether informed consent is required prior to vaccination, whether it may be oral or must be in writing, whether State law requires a signature prior to vaccination) or substantive (eg, the types of information the State requires be included in any informed consent). In addition to State law requirements, all health care providers are still required to provide VISs whenever vaccines are given.

The Federal requirement to provide VISs is in addition to any applicable State law, and no State law can negate this requirement.

What if physicians need more information?
For more information about VISs, contact the CDC at 800/232-4636 or the Immunization Action Coalition at 651/647-9009. In addition VISs are translated into a number of languages by the California and Minnesota immunization programs and can also be downloaded from the IAC Web site at: www.immunize.org/vis/.

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