For current Vaccine Information Statements (VIS), please Click Here
What is a Vaccine Information Statement?
A Vaccine Information Statement (VIS) is a one-page (two-sided) information
sheet, produced by CDC. VISs inform vaccine recipients — or their parents or
legal representatives — about the benefits and risks of a vaccine. The law
requires that VISs given out whenever certain vaccinations are given.
Who must give out VISs?
All provider of vaccines, both public and private sector.
Why must VISs be used?
It is a requirement of the National Childhood Vaccine Injury Act of 1986.
Their purpose is to inform vaccine recipients, or parents of children getting
vaccines, about the benefits and risks of vaccines.
When must VISs be given out?
They must be given out at the time of each vaccination — prior to
administration of the vaccine.
Which VISs must I use?
A VIS must be provided for any vaccine that
is covered by the Vaccine Injury Compensation Program (i.e., appears on the
Vaccine Injury Table). As of August 2007, VISs that must be used are: DTaP, Td,
MMR, Polio, Hepatitis A, Hepatitis B, Hib, Varicella, Influenza, and
Pneumococcal Conjugate.
Other VISs that are available are Pneumococcal Polysaccharide,
Meningococcal*, Tdap*, Rabies, Rotavirus*, HPV*, Shingles, Yellow Fever,
Typhoid, Japanese Encephalitis, Anthrax, and Smallpox. Their use is not
required by the National Childhood Injury Act, but is strongly encouraged – and
they must be used when giving vaccines purchased through a CDC contract.
*Rotavirus
Tdap, HPV, and meningococcal vaccines are covered by the Vaccine Injury
Compensation Program, but the VISs for these recently-licensed, or
recently-covered vaccines have not yet been published in "final"
(i.e., non-interim) versions.
Provider Responsibilities
Providers Should
- Give the appropriate VIS to the recipient or to the recipient’s parent or
legal representative with each dose of vaccine. A VIS
must be given out prior to administration of the vaccine, and it must be
given out each time the vaccine is given.
- Record the following
information in the patient’s permanent medical record:
- As needed, supplement VISs
orally, with videotapes, with additional printed material, or in any other
way that will help recipients understand the disease and vaccine.
Providers Should Not
- Change a VIS or make your own
VIS. The law requires providers to use
those developed by CDC.
Providers May
Add a practice’s name, address, or phone number to an existing VIS. If the publication date is cut off during
downloading, add the date.
- Give out VISs at other times,
in addition to prior to vaccine administration, (e.g., pre-natal visits).
- Have a recipient or their
parent or legal representative sign a separate “informed consent” form if
it is required by your state. There is no Federal requirement for written
informed consent for vaccinations, and VISs are not informed consent
forms, but some states have such requirements.