What Is a Vaccine Information Statement (VIS)?

When you receive a vaccination or take your child for a vaccination, you may receive a Vaccine Information Statement (VIS) from your (or your child’s) healthcare provider. The U.S. Centers for Disease Control and Prevention (CDC) recommend that vaccine administrators provide a VIS along with each vaccine they administer. So, what is a VIS? In this article, vaccine lawyer Leah V. Durant explains what vaccine recipients and parents need to know:

Vaccine Information Statements—What Are They?

Vaccine Information Statements are, “documents produced by the Centers for Disease Control and Prevention (CDC), in consultation with panels of experts and parents, to properly inform vaccinees (or their parents/legal representatives) about the risks and benefits of each vaccine.” However, as the CDC also explains, “VISs are not meant to replace interactions with healthcare providers, who should address any questions or concerns that the vaccinee (or parent/legal representative) may have.”

In addition to being recommended by the CDC, vaccine administrators are also required to provide VISs to vaccine recipients and parents under federal law for most CDC-recommended vaccines. This includes the vaccines for:

• Diphtheria, tetanus and pertussis
• Haemophilus influenzae type b (Hib)
• Hepatitis A and B
• Human papillomavirus (HPV)
• Influenza (flu shot)
• Measles, mumps and rubella
• Meningococcal
• Pneumococcal conjugate
• Polio
• Rotavirus
• Varicella (chickenpox)

While vaccine recipients and parents can obtain (or should be able to obtain) Vaccine Information Statements from their healthcare providers, VISs are also available online. The CDC maintains a database of current VISs on its website.

Is a VIS an Informed Consent Form?

While Vaccine Information Statements are intended to provide vaccine recipients and parents with important information about the vaccines they (or their children) receive, a VIS is not an informed consent form. The CDC makes this clear, stating, “People sometimes use the term ‘informed consent’ loosely when referring to VISs. VISs are written to fulfill the information requirements of the National Childhood Vaccine Injury Act, not as informed consent forms.”

You may receive an informed consent form in addition to a VIS during a vaccination appointment. Healthcare providers routinely use these forms to mitigate their potential legal liability. However, even if you sign an informed consent form, you still have clear legal rights—including the right to file a claim under the National Vaccine Injury Compensation Program (VICP) if you meet the basic eligibility criteria.

How Up to Date are Vaccine Information Statements?

Any VIS you receive from your healthcare provider or download from the CDCs’ website should be up to date. The CDC occasionally issues updates to individual VISs, and all VISs include their release date at the bottom of the page. You can check here to see if a VIS is the latest version. Currently, the oldest current Vaccine Information Statement is the VIS for Japanese encephalitis (released on August 15, 2019), while the newest current Vaccine Information Statements are the VISs for COVID-19 and respiratory syncytial virus (RSV) (released on October 19, 2023).

What is the Most Important Information on a VIS?

All Vaccine Information Statements are divided into seven sections, and all six sections contain important information for vaccine recipients and parents. The seven sections are:

1. Why the CDC Recommends the Vaccine

This section discusses the risks associated with the illness for which the vaccine is being administered—including typical symptoms, potential complications and particular risks for certain populations.

2. Information About the Vaccine Itself

This section discusses the CDC’s recommendations regarding the vaccine covered in the VIS, including the age (or ages) at which the vaccine should be administered and how many doses are needed. It also discusses factors that may limit the vaccine’s effectiveness. For example, the flu shot VIS notes that the most prevalent flu strains vary from year to year, and the CDC and its health partners cannot predict the most prevalent strains with complete accuracy.

3. Reasons to Talk to Your Healthcare Provider Before Vaccination

This section lists potential concerns to discuss with your healthcare provider before getting vaccinated. For example, individuals with certain allergies may be at risk for anaphylaxis with certain vaccines. A VIS may also indicate that it is advisable for individuals who are pregnant or who have had certain illnesses in the past to consult with their doctors prior to immunization.

4. The Risk of an Adverse Reaction

This section lists common side effects as well as known risks for vaccine-related illnesses and injuries. For example, the flu shot VIS notes that soreness, redness and swelling are common side effects, and notes that “[t]here may be a very small increased risk of Guillain-Barre Syndrome (GBS) after . . . the flu shot.”

5. What To Do if There is a Serious Problem

This section describes what vaccine recipients and parents should do if they encounter a serious medical problem following an immunization. Typically, this includes going to the nearest hospital promptly (and calling 911 if necessary) and reporting the problem to the Vaccine Adverse Event Reporting System (VAERS).

6. Options for Vaccine Recipients and Parents of Children Diagnosed with Vaccine Injuries

This section describes the options that are available to vaccine recipients and parents of children diagnosed with vaccine-related injuries and illnesses. For most CDC-recommended vaccines, this includes talking to a vaccine lawyer about filing a claim under the National Vaccine Injury Compensation Program (VICP).

7. Where to Go for More Information

The final section of a Vaccine Information Statement lists where vaccine recipients and parents can find more information about the vaccine covered in the VIS. This includes (but is not limited to) contacting your healthcare provider, your local or state health department, or the CDC.

Do You Have a Vaccine Injury Claim Under the VICP? Talk to Vaccine Lawyer Leah V. Durant for Free

While vaccine-related injuries and illnesses are rare, they do happen. If you need to learn about filing a claim under the National Vaccine Injury Compensation Program, we invite you to get in touch. To schedule a free consultation with vaccine lawyer Leah V. Durant, please call 202-800-1711 or request a call online today.

Leah Durant Bio

Experienced litigation attorney Leah Durant focuses on representing clients in complex vaccine litigation matters. Leah Durant is the owner and principal attorney of the Law Offices of Leah V. Durant, PLLC, a litigation firm based in Washington, DC. Leah Durant and her staff represent clients and their families who suffer from vaccine-related injuries, adverse vaccine reactions and vaccine-related deaths. The Law Offices of Leah V. Durant, PLLC is dedicated to assisting individuals in recovering the highest level of compensation as quickly and efficiently as possible. To learn more, contact vaccine attorney Leah Durant today.