has been refreshed! Take a tour.

Recording Vaccinations – What is Required by Federal Law?

July 2012

Technically Speaking
Monthly Column by Deborah Wexler, MD
Deborah Wexler MD
Technically Speaking is a monthly column written by IAC’s Executive Director Deborah Wexler, MD. The column is featured in The Children’s Hospital of Philadelphia Vaccine Education Center’s (VEC’s) monthly e-newsletter for healthcare professionals. Technically Speaking columns cover practical topics in immunization delivery such as needle length, vaccine administration, cold chain, and immunization schedules.
Check out a recent issue of Vaccine Update for Healthcare Providers. The VEC e-newsletter keeps providers up to date on vaccine-related issues and includes reviews of recently published journal articles, media recaps, announcements about new resources, and a regularly updated calendar of events.
Recording Vaccinations – What is Required by Federal Law?
Published July 2012
Information presented in this article may have changed since the original publication date. For the most current immunization recommendations from the Advisory Committee on Immunization Practices, visit
It is important to know the federal requirements for documenting the vaccines administered to your patients. The requirements are defined in the National Childhood Vaccine Injury Act enacted in 1986. The law applies to all routinely recommended childhood vaccines, regardless of the age of the patient receiving the vaccines. (The only vaccines not covered under this law are pneumococcal polysaccharide, zoster and certain infrequently used vaccines, such as rabies and Japanese encephalitis.)
By law, the following information must be documented on the patient’s paper or electronic medical record (or on a permanent office log): *
The vaccine manufacturer.
2. The lot number of the vaccine.
3. The date the vaccine is administered.
4. The name, office address, and title of the healthcare provider administering the vaccine. **
5. The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
6. The date the VIS is given to the patient, parent or guardian.
The federally required information should be both permanent and accessible.
Federal law does not require a parent, patient or guardian to sign a permission statement to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient.
Here is some additional information you may want to permanently record even though it is not required by law:
Anatomic site: RA (right arm), LA (left arm), RT (right thigh), LT (left thigh)
2. Route: IM (intramuscular), SC (subcutaneous), ID (intradermal), IN (intranasal), or PO (oral)
3. The funding source of your vaccine: federal (F), state (S) or private (P)
Finally, for long-term clarity in documenting vaccinations, it is preferable to record the generic abbreviation (e.g., Tdap) in addition to or instead of the trade name (e.g., Adacel® or Boostrix®). It can be difficult to ascertain the components a vaccine contains if only the brand name is recorded, particularly when a specific brand is no longer used. When administering combination vaccines, record all components in the combination (e.g., DTaP-HepB-IPV).
Before the patient leaves your office, be sure to provide a record of the vaccines administered during that visit.
The Immunization Action Coalition has created free, downloadable vaccine administration records for medical charts. They include space for all federally required information and can be used “as is” or altered as per practice needs. Sample pages that demonstrate how to fill them out are also included.
Vaccine Administration Record for Children and Teens
Vaccine Administration Record for Adults
Additional resources regarding vaccine documentation:
It’s Federal Law: You Must Give Your Patients Current VISs — IAC
Instructions for the Use of Vaccine Information Statements – CDC
Fact Sheet for Vaccine Information Statements – CDC
Wallet-size immunization record cards – IAC (Cards are available for children and teens, adults, and across the lifespan)
* Editor’s Note: Correction issued on October 17, 2013. Documentation of the expiration date of the vaccine is not required by federal law.
**Editor’s Note: Correction issued on July 31, 2014. A “signature (electronic is acceptable) of the person administering the vaccine. Initials of the vaccine administrator …” is not required by federal law.


This page was updated on .