What is a Vaccine Information Statement?

A Vaccine Information Statement (VIS) is a one-page (two-sided) information sheet, produced by CDC. VISs inform vaccine recipients — or their parents or legal representatives — about the benefits and risks of a vaccine. The law requires that VISs given out whenever certain vaccinations are given.

Who must give out VISs?
All provider of vaccines, both public and private sector.

Why must VISs be used?

It is a requirement of the National Childhood Vaccine Injury Act of 1986. Their purpose is to inform vaccine recipients, or parents of children getting vaccines, about the benefits and risks of vaccines.

When must VISs be given out?

They must be given out at the time of each vaccination — prior to administration of the vaccine.

Which VISs must I use?

A VIS must be provided for any vaccine that is covered by the Vaccine Injury Compensation Program (i.e., appears on the Vaccine Injury Table). As of August 2007, VISs that must be used are: DTaP, Td, MMR, Polio, Hepatitis A, Hepatitis B, Hib, Varicella, Influenza, and Pneumococcal Conjugate.

Other VISs that are available are Pneumococcal Polysaccharide, Meningococcal*, Tdap*, Rabies, Rotavirus*, HPV*, Shingles, Yellow Fever, Typhoid, Japanese Encephalitis, Anthrax, and Smallpox. Their use is not required by the National Childhood Injury Act, but is strongly encouraged – and they must be used when giving vaccines purchased through a CDC contract.

*Rotavirus Tdap, HPV, and meningococcal vaccines are covered by the Vaccine Injury Compensation Program, but the VISs for these recently-licensed, or recently-covered vaccines have not yet been published in "final" (i.e., non-interim) versions.

Provider Responsibilities

Providers Should

• Give the appropriate VIS to the recipient or to the recipient’s parent or legal representative with each dose of vaccine. A VIS must be given out prior to administration of the vaccine, and it must be given out each time the vaccine is given.
• Record the following information in the patient’s permanent medical record:
  
  • Which VIS was given.
  • Date of publication of the VIS.
  • Date the VIS was given.
    and record the following information in either the patient’s permanent medical record or in a permanent office log (the record should be both permanent and accessible):
    
    • The name, address, and title of the person who administered the vaccine.
    • The date of administration.
    • The vaccine manufacturer.
    • The vaccine lot number
• As needed, supplement VISs orally, with videotapes, with additional printed material, or in any other way that will help recipients understand the disease and vaccine.

Providers Should Not

• Change a VIS or make your own VIS. The law requires providers to use those developed by CDC.

Providers May

Add a practice’s name, address, or phone number to an existing VIS. If the publication date is cut off during downloading, add the date.

• Give out VISs at other times, in addition to prior to vaccine administration, (e.g., pre-natal visits).
• Have a recipient or their parent or legal representative sign a separate “informed consent” form if it is required by your state. There is no Federal requirement for written informed consent for vaccinations, and VISs are not informed consent forms, but some states have such requirements.

Current Vaccine Information Statements

For current Vaccine Information Statements, please link to the CDC, National Immunization Program website.