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Instructions for Using VISs
Edition: 10/22/2014

Instructions for Using VISs [1 page]

Required Use

1. Provide a Vaccine Information Statement (VIS) when a vaccination is given.

As required under the National Childhood Vaccine Injury Act (42 U.S.C. §300aa-26), all health care providers in the United States who administer, to any child or adult, any of the following vaccines – diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), trivalent influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) – 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 representative1 of any child to whom the provider intends to administer such vaccine, or
  • to any adult2 to whom the provider intends to administer such vaccine.

[1] "Legal representative" is defined as a parent or other individual who is qualified under state law to consent to the immunization of a minor child or incompetent adult.

[2] In the case of an incompetent adult, relevant VISs shall be provided to the individual’s legal representative. If the incompetent adult is living in a long-term care facility, all relevant VISs may be provided at the time of admission, or at the time of consent if later than admission, rather than prior to each vaccination.

If there is not a single VIS for a combination vaccine, use the VISs for all component vaccines.

VISs should be supplemented with visual presentations or oral explanations as appropriate.

2. Record information for each VIS provided.

Healthcare providers shall make a notation in each patient’s permanent medical record at the time vaccine information materials are provided, indicating:

  1. the edition date of the VIS distributed, and
  2. the date the VIS was provided.

This recordkeeping requirement supplements the requirement of 42 U.S.C. §300aa-25 that all healthcare providers administering these vaccines must record in the patient's permanent medical record (or in a permanent office log):

  1. the name, address and title of the individual who administers the vaccine,
  2. the date of administration, and
  3. the vaccine manufacturer and lot number of the vaccine used.

Applicability of State Law

Healthcare providers should consult their legal counsel to determine additional State requirements pertaining to immunization. The Federal requirement to provide the vaccine information materials supplements any applicable State laws.

Availability of Copies

Copies are available in English from CDC's website; copies in other languages are available from the Immunization Action Coalition. Single camera-ready copies may also be available from state health departments. See also, Where to get VISs.

Current VIS Editions

  • DTaP/DT: 5/17/07
  • Hepatitis A: 10/25/11
  • Hepatitis B: 2/2/12
  • Hib: 2/4/14
  • HPV (Cervarix): 5/3/11
  • HPV (Gardasil): 5/17/13
  • Influenza (inactivated): 8/19/14
  • Influenza (live): 8/19/14
  • MMR: 4/20/12
  • MMRV: 5/21/10
  • Meningococcal: 10/14/11
  • Pneumococcal (PCV13) 2/27/13
  • Polio: 11/8/11
  • Rotavirus: 8/26/13
  • Td: 2/4/14
  • Tdap: 5/9/13
  • Varicella: 3/13/08
  • Multi-Vaccine*: 10/22/14

*An optional alternative when two or more routine childhood vaccines (i.e., DTaP, hepatitis B, Hib, pneumococcal, or polio) are administered at the same visit.

Interim

Reference 42 U.S.C. §300aa-26

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