Vaccine Information Statement

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Vaccine Information Statement (VIS) is an important document designed to provide vaccine recipients, or their parents or caregivers, with essential information about the vaccines they are about to receive. This includes details about the benefits and risks associated with the vaccine, as well as what to expect during and after vaccination. The creation and distribution of VISs are mandated by the National Childhood Vaccine Injury Act of 1986 in the United States. This legislation requires that healthcare providers give a VIS to the patient, parent, or legal guardian before administering each dose of certain vaccines.

Purpose and Content

The primary purpose of the Vaccine Information Statement is to ensure that individuals are fully informed about the vaccines they receive. Each VIS contains standardized information, including:

• The diseases the vaccine protects against
• Who should get the vaccine and when
• The benefits of the vaccine
• Possible side effects and what to do about them
• Information on the risks of not getting the vaccine
• A section on what to do in case of a severe reaction

VISs are designed to support, but not replace, the conversation between a healthcare provider and the patient or their family. They serve as a starting point for a discussion about vaccination.

Distribution and Availability

VISs are available for all vaccines that are included in the vaccine injury compensation programs in the United States. They are produced by the Centers for Disease Control and Prevention (CDC) and are available in multiple languages to ensure broad accessibility. Healthcare providers are responsible for ensuring that they give the most current version of a VIS to their patients.

Legal Requirements

Under the National Childhood Vaccine Injury Act, healthcare providers must record specific information in the patient's medical record each time a vaccine is administered. This includes:

• The edition date of the VIS
• The date the VIS was given to the patient, parent, or guardian
• The name, address, and title of the person administering the vaccine
• The date of administration of the vaccine
• The vaccine manufacturer and lot number

Failure to provide and document the provision of a VIS can result in legal implications for healthcare providers.

Updates and Revisions

The CDC regularly updates VISs to reflect the most current information about vaccines. It is crucial for healthcare providers to use the latest version of a VIS when administering vaccines. The updated VISs are made available on the CDC's website, where they can be downloaded and printed.

Conclusion

Vaccine Information Statements are a critical tool in the vaccination process, ensuring that individuals are well-informed about the vaccines they receive. By providing standardized, factual information about the benefits and risks associated with vaccination, VISs help individuals make informed decisions about their health and the health of their families.