Instructions for Use: Vaccine Information Statements [2025]

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.)
• Description:
  A VIS or Vaccine Information Statement is a document, produced by CDC, that informs vaccine recipients – or their parents or legal representatives – about the benefits and risks of a vaccine they are receiving. All vaccine providers, public or private, are required by the National Vaccine Childhood Injury Act (NCVIA – 42 U.S.C. § 300aa-26) to give the appropriate VIS to the patient (or parent or legal representative) prior to every dose of specific vaccines. The appropriate VIS must be given prior to the vaccination, and must be given prior to each dose of a multi-dose series. It must be given regardless of the age of the recipient: from https://www.cdc.gov/vaccines/hcp/about-vis/index.html.
  
  VISs have been translated into about 40 languages. These can be found on the website of CDC's partner, https://www.immunize.org/vis/. Not every VIS has been translated into every language.
  
  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), 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 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. 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. Health care 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 Vaccine Information Statement distributed, and (2) the date the VIS was 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.
  
  
• Subjects:
  Adenovirus Vaccines Anthrax Vaccines Chickenpox Vaccine Cholera Vaccines COVID-19 Vaccines Dengue Vaccines Diphtheria-Tetanus-acellular Pertussis Vaccines Diphtheria-Tetanus-Pertussis Vaccine Diphtheria-Tetanus Vaccine Ebola Vaccines Encephalitis Viruses, Tick-Borne Haemophilus Influenzae Type B Hepatitis A Hepatitis A Vaccines Hepatitis B Hepatitis B Vaccines Heptavalent Pneumococcal Conjugate Vaccine Herpes Zoster Vaccine Influenza Vaccines Japanese Encephalitis Vaccines Measles-Mumps-Rubella Vaccine Meningococcal Vaccines Papillomavirus Vaccines Pneumococcal Vaccines Poliomyelitis Rabies Vaccines Respiratory Syncytial Virus Vaccines Rotavirus Vaccines Smallpox Vaccine Typhoid-Paratyphoid Vaccines Vaccination Vaccines Yellow Fever Vaccine

  More +
• Keywords:
  Vaccine Information Statements VIS
• Series:
  Vaccine Information Statement
• Subseries:
  VIS Instructions
• Publisher:
  Centers for Disease Control and Prevention (CDC) (U.S.)
• Document Type:
  Text
• Genre:
  Fact Sheet ; Patient Education Handout
• Place as Subject:
  United States
• Rights:
  Public Domain
• CIO:
  National Center for Immunization and Respiratory Diseases (NCIRD)
• Topic:
  Diseases & Conditions
• Location:
  North America
• Pages in Document:
  1 pdf page
• Volume:
  2025
• Collection(s):
  Infectious Diseases
• Main Document Checksum:
  urn:sha-512:4e71bcf96c175b75bca61b491ebf65858a5460ed1379b0d814ae3c5f072e0e887d62737b2120a0584b2292da8746362b0e854f3fcd9d24d72d766d7fecc4e0d1
• Download URL:
  https://stacks.cdc.gov/view/cdc/256451/cdc_256451_DS1.pdf
• File Type:
  [PDF - 127.44 KB ]