Vaccine Information Statements & Liability

Routinely recommended childhood vaccines are covered by the Vaccine Injury Compensation Program (VICP). Pediatricians and their clinic staff should follow good risk communication and documentation steps for vaccination, which includes providing parents with the appropriate Vaccine Information Statement (VIS) before a vaccine is administered. The VICP requires those who administer vaccines to use the latest version. Sign up to receive the IZ Express, a weekly newsletter from Immunize.org including new and updated VISs and immunization recommendations. VISs are available through AAP Pediatric Patient Education.

Vaccine Information Statements (VISs) are produced by the Centers for Disease Control and Prevention (CDC) as 1-page information sheets. They are designed to inform vaccine recipients and their parents or guardians about the benefits and risks of vaccines. Healthcare professionals are required by law to provide VISs before each vaccine administration.

An easy way to think about distribution of VISs in your practice is to follow the 5 D's.

• Double check to make sure the correct VIS is being used.
• Distribute the VIS before each vaccine dose is given. It is the law. There are many acceptable ways to provide patients and parents with VISs. The ways to give a VIS are detailed on the CDC website.
• Discuss the risks and benefits of the vaccine as well as the risks of not being immunized. VISs are intended to supplement, not replace, discussions about risks.
• Document in each patient's permanent medical record:
  • that the VIS was provided;
  • the office address, name, and title of the individual administering the vaccine;
  • the date of vaccine administration;
    the vaccine manufacturer and lot number of the vaccine administered;
  • the site (eg, deltoid area), route (eg, intramuscular) of administration; and
  • the expiration date of the vaccine are also recommended by the AAP.

• Dialogue with those who have questions or express hesitancy about vaccination. When parents refuse immunization, it is important to try to understand their reasoning and respond nonjudgmentally with facts about the safety and effectiveness of vaccines. If they still decline the recommended vaccine, it is prudent to have parents sign an informed refusal document. Here is the link to the AAP refusal form.

VISs are also available in additional languages.