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Instructions for the Use of
VACCINE INFORMATION STATEMENTS

Required Use

1. Provide VIS when vaccination is given.
As required under the National Childhood Vaccine Injury Act, all health care providers in the United States who administer any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis B, Haemophilus influenzae type b (Hib), varicella (chickenpox), or pneumococcal conjugate vaccine shall prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC):

  • to the parent or legal representative* of any child to whom the provider intends to administer such vaccine, or
  • to any adult to whom the provider intends to administer such vaccine.
* "Legal representative" is defined as a parent or other individual who is qualified under State law to consent to the immunization of a minor.

The materials shall be supplemented with visual presentations or oral explanations, as appropriate.

If there is not a single VIS for a combination vaccine (e.g., hepatitis A/hepatitis B), use the VISs for both component vaccines.

2. Record information for each VIS provided.
Health care providers shall make a notation in each patient's permanent medical record at the time VISs are provided indicating:
(1) the edition date of the materials, and
(2) the date these materials were provided.

This recordkeeping requirement supplements the requirement of 42 U.S.C. § 300aa-25 that all health care providers administering these vaccines must record in the patient's permanent medical record or in a permanent office log:
(3) the name, address and title of the individual who administers the vaccine,
(4) the date of administration, and
(5) the vaccine manufacturer and lot number of the vaccine used.

Additional Recommended Use

Health care providers may also want to give parents copies of all vaccine information materials prior to the first immunization visit, such as at the first well baby visit.

Applicability of State Law
Health care provides should consult their legal counsel to determine additional State requirements pertaining to immunization. The Federal requirements to provide the vaccine information materials supplements any applicable State laws.

Availability of Copies
Single camera-ready copies of the vaccine information materials are available from State health departments. Copies are also available on the Centers for Disease Control and Prevention's website at http://www.cdc.gov/nip/publications/VIS. Copies are available in English and in other languages.

Current Editions of VISs
Diphtheria, Tetanus, Pertussis (DTaP/DT): 7/30/01
Tetanus Diphtheria (Td): 6/10/94
Measles, Mumps, Rubella (MMR): 1/15/03
Hepatitis B: 7/11/01
Polio: 1/1/00
Haemophilus influenzae type b: 12/16/98
Varicella (chickenpox): 12/16/98
Pneumococcal conjugate: 9/30/02

Reference 42 U.S.C. § 300aa-26

1/15/2003

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Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: (651) 647-9009Fax: (651) 647-913
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