C

Appendix C

Appendix C-5

Instructions for the Use of

Vaccine Information Statements

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 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.

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.

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.

Applicability of State Law

Health care 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 and many other 

languages from CDC’s website at www.cdc.gov/

vaccines/pubs/vis. Single camera-ready copies may 

also be available from State health departments.

Current VIS Editions

DTaP: 4/1/20†

Hib: 10/30/19†

Hepatitis A: 7/28/20†

Hepatitis B: 8/15/19†

HPV (Gardasil-9): 10/30/19†

Influenza (inactivated): 8/15/19†

Influenza (live): 8/15/19†

MMR: 8/15/19†

MMRV: 8/15/19†

Meningococcal ACWY: 8/15/19†

Meningococcal B: 8/15/19†

Pneumococcal (PCV13): 10/30/19†

Polio: 10/30/19†

Rotavirus: 10/30/19†

Td: 4/1/20†

Tdap: 4/1/20†

Varicella: 8/15/19†

Multi-Vaccine*: 4/1/20†

*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

07/28/2020

42 U.S.C. § 300aa-26