Since 1994, health care providers who administer any vaccine to adults or children, covered by the National Childhood Vaccine Injury Act (NCVIA) are required to provide a copy of the relevant Vaccine Information Statement (VIS) before administering certain vaccinations. These CDC statements contain information on risks and benefits of each specific vaccine. Additional information may be provided but the VIS is the minimum required by federal law. VISs are information sheets produced by CDC that explain to vaccine recipients both the benefits and risks of a vaccine. If the patient is a minor, the VIS must be given to the parent or legal representative. VISs are available in fifty languages from the IAC website, or by calling the CDC’s information hotline at 1-800-232-4636 (1-800-CDC-INFO). When ACIP publishes new or revised vaccine recommendations, a new or revised VIS is also posted. The person administering vaccine is responsible for giving the correct VIS statement to the patient. The patient should be given a VIS for as well as a record of the vaccination she just received. If the patient has an adult or adolescent immunization record, simply update the record. If not, this would be the appropriate time to begin a record for the patient.
The National Childhood Vaccine Injury Act (NCVIA) was enacted to compensate individuals of all ages who have been injured by vaccines that are listed in the vaccine injury table. The vaccines adults receive that are covered by this law include diphtheria, hepatitis A, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis B, varicella, trivalent inactivated influenza vaccine and any new vaccine recommended by CDC for routine administration to children and published by HHS Secretary. This includes meningococcal and HPV vaccines.
The vaccinator must record certain information about the vaccine(s) administered in the patient’s medical record or in a permanent office log. The information required includes the date the vaccination was given, the route used, the vaccine manufacturer and lot number of the vaccine, the name, and title of the individual who administers the vaccine, the VIS publication date, and the date the VIS was given to the patient or legal representative.
Any adverse event the patient experiences following the vaccination must be reported, even if it is suspected the events were not caused by the vaccine. Events must be reported if they are listed on the Vaccine Injury Compensation Table, part of the Vaccine Injury Compensation Program: a no-fault system which allows persons thought to have suffered from injury or death from known adverse reactions to seek compensation. The Vaccine Adverse Events Reporting System (VAERS) serves as a national database of events that occur following immunizations. Both the CDC and Food and Drug Administration review data reported to VAERS. Of note, anyone, including the vaccine recipient, may submit a report. Providers and patients should fill out a VAERS report to document adverse reactions. Copies of the VAERS reporting form can be found on the VAERS website or by calling 1-800-822-7967.
The National Vaccine Injury Compensation Program (VICP) is a no-fault alternative to the traditional tort system for resolving vaccine injury claims.
Click here for ACIP's updated recommendations on reporting adverse events published January 28, 2011.