ACIP’s “General Best Practice Guidelines for Immunization” still states that a patient’s undocumented history can generally be accepted as proof of vaccination only for influenza and pneumococcal polysaccharide vaccines. See the Adult Vaccination section at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/programs.html.
Ask the Experts: Documenting Vaccination
The Food and Drug Administration (FDA) website has a list of all vaccines licensed for use in the United States at www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM093833. Note that some licensed vaccines may not currently be distributed in the United States (for example the Cervarix brand of HPV vaccine and the Zostavax brand of shingles vaccine).
One way to handle this is to indicate if the vaccination was given either in the “upper” or “lower” portion of the injection area selected (e.g., DTaP: right thigh, upper; Hib: right thigh, lower; or PCV13: left thigh, upper; HepB: left thigh, lower). It is helpful if everyone in your office or clinic uses the same sites for each vaccine. Use of a standardized site map can facilitate this. Here are some helpful site maps for different ages so you can record where shots were given:
For infants and toddlers: www.eziz.org/PDF/IMM-718.pdf
For adults: eziz.org/assets/docs/ADA/IMM-718A.pdf
Vaccination providers frequently encounter people who do not have adequate documentation of vaccinations. Providers should only accept written, dated records as evidence of vaccination. CDC recommends that, with the exception of influenza and pneumococcal polysaccharide vaccines, self-reported doses of vaccine without written documentation should generally not be accepted. An attempt to locate missing records should be made whenever possible by contacting previous healthcare providers, reviewing state or local immunization information systems, and searching for a personally held record. However, if records cannot be located or will definitely not be available anywhere because of the patient’s circumstances, people without adequate documentation should be considered susceptible and should be started on the age-appropriate vaccination schedule. Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, or hepatitis A).
In general, although it is not ideal, receiving extra doses of vaccine poses no medical problem. Receiving excessive doses of tetanus toxoid (DTaP, DT, Tdap, or Td) can increase the risk of a local adverse reaction, however. For details, consult the ACIP’s “Best Practice Guidelines for Immunization” chapter titled Timing and Spacing of Immunobiologics, available at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html.
If a provider suspects an invalid vaccination, including those from persons vaccinated outside the U.S., one of two approaches can be taken. Repeating the vaccinations is an acceptable option. Doing so is generally safe and avoids the need to obtain and interpret serologic tests. If avoiding unnecessary injections is desired, judicious use of serologic testing might be helpful in determining which immunizations are needed. This may be particularly helpful in determining tetanus and diphtheria antitoxin levels for children whose records indicate 3 or more doses of DTP or DTaP. This issue is discussed in detail in the ACIP’s “General Best Practice Guidelines for Immunization” chapter titled Special Situations, and summarized in Table 9-1, available at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/special-situations.html.
Appendix B of the CDC publication Epidemiology and Prevention of Vaccine-Preventable Diseases (“The Pink Book”) contains a list of vaccine-preventable disease terms used outside the U.S. You’ll find it at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/vpd-multiple-languages.pdf.
Healthcare providers (or other covered entities) may share immunization information with schools or daycare facilities, without authorization, if permitted or required by state law. These state laws would not be preempted by the HIPAA Privacy Rule [45 CFR 160.203(c)].
There is no federal law requiring such documentation. Several major medical organizations, including the American Academy of Pediatrics, have stated that healthcare providers may decide it is in their best interest to formally document a parent’s refusal to accept vaccination for their (minor) child. To read a discussion on this topic and to access a prototype refusal form, see “Record of Vaccine Declination” that can be accessed at www.immunize.org/catg.d/p4059.pdf.
As of 2021, every state has an IIS that is capable of accepting and storing immunization records on individuals of all ages. To find out the status of the IIS in your state you should contact your state IIS program. CDC maintains a listing of contact information for all state IIS programs at www.cdc.gov/vaccines/programs/iis/contacts-locate-records.html.
Yes. Patient-held cards are an extremely important part of a person’s medical history. The person may move to another state or need medical care at a facility within or outside the state without access to the IIS in which their records are documented, and the personal record may be the only vaccination record available.
The National Childhood Vaccine Injury Act (NCVIA), enacted in 1986, set forth 3 basic requirements for all vaccination providers, which are:
- Providers must give the patient (or parent/legal representative of a minor) a copy of the relevant federal “Vaccine Information Statement” (VIS) for the vaccine they are about to receive.
- Providers must record certain information about the vaccine(s) administered in the patient’s medical record or a permanent office log.
- Providers must document any adverse event following the vaccination that the patient experiences and that becomes known to the provider, whether or not it is felt to be caused by the vaccine, and submit the report to the Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov.
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 included in this law are COVID-19, pneumococcal polysaccharide, zoster, and certain infrequently used vaccines, such as rabies and Japanese encephalitis.
The following information must be documented on the patient’s paper or electronic medical record or on a permanent office log:
- The vaccine manufacturer.
- The lot number of the vaccine.
- The date the vaccine is administered.
- The name, office address, and title of the healthcare provider administering the vaccine.
- 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.
- 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 consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
NCVIA requirements apply to diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), varicella, seasonal influenza (inactivated and live attenuated), pneumococcal conjugate, meningococcal, rotavirus, and human papillomavirus (HPV) vaccine.
The National Childhood Vaccine Injury Act requires that a VIS must be given to parents, legal representatives, or adult patients before administering the vaccine. A VIS must be provided prior to each dose, not just the first dose. Providers should be sure they are using the most current version of each VIS. Current VISs and their dates are available from on the CDC’s website at www.cdc.gov/vaccines/hcp/vis/index.html and from Immunize.org’s website at www.immunize.org/vis.
Instructions on the use of VISs and many additional items are available on the CDC website at www.cdc.gov/vaccines/hcp/vis/index.html or from your state immunization program. You can also visit Immunize.org’s website at www.immunize.org/vis for links to many important documents about the use of VISs.
An interim VIS can sometimes be released soon after licensure of the vaccine or after the official vote by ACIP is taken. The interim VIS is not replaced with a final version until the ACIP recommendations have been published and the new VIS has been developed according to legally-mandated procedures.
Yes. The National Childhood Vaccine Injury Act requires that a VIS be given to people of any age before they receive a dose of any vaccine included in the Act. Tetanus and diphtheria toxoids (and pertussis vaccine) are included in the Act. If the patient is unaccompanied and unable to clearly read and understand the information in the VIS (e.g., the patient is unconscious), this should be noted in the patient’s chart.
Your solution will meet the spirit of the federal law, as long as you make sure to encourage the patient (or parent) to take home a paper copy of the VIS and to refer to it if needed (e.g., if they need to know what to do if there is an adverse event or how to contact VAERS).
VISs must be given, regardless of the setting, to all people, including adults, before administering HPV, Td, Tdap, DTaP, MMR, varicella, pneumococcal conjugate, hepatitis A, hepatitis B, meningococcal, influenza, rotavirus, or polio vaccine.
Current VISs are available from the CDC’s website at www.cdc.gov/vaccines/hcp/vis/index.html and from the Immunize.org website at www.immunize.org/vis, where you will also find many VIS translations in other languages.
No. There is no federal requirement for signed consent for any dose of a vaccine licensed for use by the FDA. The federal requirement is to provide all adult patients or parents/legal representatives of minor children with the appropriate VIS for each dose of vaccine administered. Some clinics, agencies, and/or state immunization programs may have requirements for signatures. Contact information for your state health department is available at www.immunize.org/coordinators.
CDC currently has no plans to develop VISs for Pediarix, Twinrix, Kinrix, Quadracel, or Pentacel. When administering these combination vaccines, use the VISs for all component vaccines. For certain combination vaccines given to children, you can use the multi-vaccine VIS (which includes DTaP, Hib, HepB, polio, and PCV) and check the appropriate box(es), just as you would if you were administering the individual vaccines. If the multi-vaccine VIS is unavailable, you should use the individual vaccine VISs. A VIS was developed for MMRV (ProQuad, by Merck) because of its unique adverse reaction profile.
Not necessarily. Providers do not need to discard their existing printed VIS stocks when nothing but the VIS format has been changed. CDC posts information on its website to alert healthcare providers when the older version of a VIS should not be used. This information is available on CDC’s web section titled “What’s New with VISs”, available at www.cdc.gov/vaccines/hcp/vis/what-is-new.html.
CDC began adding barcodes to VISs in 2012. The barcode is intended to save time and prevent documentation errors by allowing immunization providers to scan the name and edition date of the VIS, information required to be documented in the permanent record of immunization, into an electronic medical record, immunization information system, or other electronic database. Scanning the barcode instead of manually recording the information is optional but can be helpful.
Using 2D barcodes requires a 2D barcode scanner and software that is programmed to accept and process data contained in the VIS barcodes. Providers may continue to use any VISs without barcodes as long as the VIS content is otherwise the same. For more information about using barcodes, visit www.cdc.gov/vaccines/hcp/vis/barcodes.html.
CDC publishes VISs in English only; all translations have been developed by others. To access all currently available VISs in dozens of languages, go to Immunize.org’s website at www.immunize.org/vis.