Vaccine Information Statement (VIS)
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 forty-two languages from the Immunization Action Coalition (IAC) website, or by calling the CDC’s information hotline at 1-800-232-4636 (1-800-CDC-INFO).
When the Advisory Committee on Immunization Practices (ACIP) publishes new or revised vaccine recommendations, a new or revised VIS is also posted. The person administering the vaccine is responsible for giving the correct VIS statement to the patient. The patient should be given a VIS form 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.
National Childhood Vaccine Injury Act (NCVIA)
The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires health professionals and vaccine manufacturers to report to the U.S. Department of Health and Human Services (HHS) specific adverse events that occur after the administration of routinely recommended vaccines. In response to NCVIA, CDC and FDA established VAERS in 1990.
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, 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.
Visit ACOG's Immunization for Women National Vaccine Childhood Vaccine Injury Act (NCVIA) webpage for more information.
National Vaccine Injury Compensation Program (VICP)
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 National Vaccine Injury Compensation Program (VICP) is a no-fault alternative to the traditional tort system for resolving vaccine injury claims.
Vaccine Adverse Events Reporting System (VAERS)
The Vaccine Adverse Events Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program that collects information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.
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.
VAERS has demonstrated its public health importance by providing health scientists with signals about possible adverse events following immunization. In one instance, VAERS detected reports for intussusception over what would be expected to occur by chance alone after the RotaShield rotavirus vaccine in 1999. Epidemiologic studies confirmed an increased risk, and these data contributed to the product's removal from the US market. In another example, VAERS determined that there may be a potential for a small increase risk for Guillain-Barre' syndrome (GBS) after the meningococcal conjugate vaccine, Menactra. As a result of this finding, a history of GBS became a contraindication to the vaccine and further controlled studies are currently underway to research this issue.
VAERS 2.0 includes a new reporting form and a new website that allows you to:
- Easily submit a VAERS report electronically
- Access VAERS data
- Learn more about how CDC and FDA monitor the safety of vaccines
There are two ways to report an adverse event following vaccination to VAERS:
- Use the online reporting tool
- Complete a writable VAERS PDF form and upload it onto the new VAERS website