ISO/TS 5384:2024

Technical
Specification
ISO/TS 5384
First edition
Health informatics — Categorial
2024-09
structure and data elements for
the identification and exchange of
immunization data
Informatique de santé — Structure catégorielle et éléments
de données pour l'identification et l'échange des données
d'immunisation
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms .2
3.2 Terms related to subject of care data elements .3
3.3 Terms related to immunization event data elements .3
3.4 Terms related to the location, organization and provider data elements .5
3.5 Terms related to the immunization forecast data elements .6
4 Use cases . 7
5 Definition of the immunization data elements . 7
5.1 General .7
5.2 Data elements .8
5.2.1 Subject of care data elements.8
5.2.2 Immunization event data elements .8
5.2.3 Location, organization and provider data elements . .16
5.2.4 Immunization forecast data elements .17
6 Data elements by use case .18
Bibliography .22

iii
Foreword
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iv
Introduction
Public health stakeholders working with immunization information do not have a structured view of their
data that is aligned with technical stakeholders who are very familiar with Health Level Seven (HL7) and
other message standards. This document can enable effective and efficient interaction between public health
and technical stakeholders in the planning of digital health solutions with immunization data by enabling a
common understanding of the data elements required and how they can be used.
The data represented in interoperability standards such as HL7 Fast Healthcare Interoperability Resources
(FHIR) does not cover all frequently encountered immunization management use cases. This includes the
data elements required for an immunization registry and the level of data element definition detail to enable
consistent understanding and application. There is a business need for alignment across various other
existing standards such as International Patient Summary and Identification of Medicinal Products (IDMP).
There is also a need to align with emerging standards regarding the document and sharing of sex and gender
and the considerable amount of effort across all standards development organizations and the World Health
Organization in developing data standards to address the COVID-19 pandemic challenges.
The purpose of this document is to address the challenges with sharing health care information with
incompatible data structures and improve interactions and understanding of the data between technical
and business stakeholders. By defining a set of data elements to be used within an immunization registry
and other systems, recording and sharing immunization data with specific use cases implementation effort
will be enhanced.
This document can be used to harmonize the data used in interoperability standards such as Integrating the
Health Care Enterprise (IHE), HL7 FHIR and Clinical Knowledge Management Structures and other related
initiatives (such as the WHO COVID-19 vaccine certificate) by providing detailed descriptions of the data
elements and considerations for how to apply the data elements within digital health solutions including
consumer apps.
This document can also aid low and middle-income countries in the development of an immunization
registry by providing the core structures and data needed to record and monitor a population.
This document is particularly suitable for business and technical resources planning immunization digital
health solutions and immunization registries.
This document can be helpful to a broad range of stakeholders such as:
— public health immunization and communicable disease stakeholders;
— government including public health agencies responsible for public health, emergency preparedness and
response, and infectious disease control and prevention;
— software developers;
— vendors providing electronic medical record, pharmacy, immunization registry systems, knowledge
base vendors and consumer app providers;
— educators and educational organizations to educate the health informatics and healthcare communities
on the requirements for immunization terminology implementation;
— clinicians working with immunization data.

v
Technical Specification ISO/TS 5384:2024(en)
Health informatics — Categorial structure and data elements
for the identification and exchange of immunization data
1 Scope
This document specifies an immunization categorial structure and data elements for use as the basis for
an immunization registry and in digital health solutions that require interaction with the immunization
registry and other systems in the management of immunization information. The data set includes data
element descriptions, requirements, considerations for implementation and conformance with the following
use cases:
— populate an immunization registry;
— record and/or share a current immunization event;
— record and/or share a historic immunization event;
— create and/or share an immunization history;
— create an immunization reminder;
— create anonymized immunization reports;
— schedule a new immunization event.
This document has adopted data element names from relevant ISO standards and leverages and elaborates
on the immunization data element descriptions and constraints provided in HL7 specifications. The
structure of the data element definition provides:
— business rules and requirements (e.g. rationale for including the data element and how the data element
supports the use case);
— the meaning of absent data and how it can be addressed;
— how to represent the data if more information is required to clarify data type use and will include value
set considerations.
The use case and related data elements out of scope for this document include adverse event following an
immunization.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

3.1 General terms
3.1.1
data element
basic unit of identifiable and definable data
[SOURCE: ISO 2146:2010, 3.4]
3.1.2
immunization registry
confidential, population-based, information system that records and manages all immunization doses
administered by participating providers to persons residing within a given geopolitical area
3.1.3
active immunizing agent
complex biologic product designed to induce a protective immune response effectively and safely
3.1.4
passive immunizing agent
preparation containing pre-formed antibodies derived from humans or animals or produced by recombinant
DNA technology
Note 1 to entry: Administration of passive immunizing agents can prevent certain infections or reduce the severity of
illness caused by the infectious agent.
3.1.5
cold chain break
breach or failure in following a set of rules and procedures that ensure the proper storage and distribution
of an immunizing agent
3.1.6
combined vaccine
vaccine that is designed to protect against two or more diseases or against one disease caused by different
strains or serotypes of the same organism
Note 1 to entry: Combined vaccines contain two or more antigens that are either combined by the manufacturer
[7]
(3.3.10) or mixed immediately before administration .
3.1.7
vaccine certificate
receipt provided by a health care authority that identifies the immunization information to enable proof of
vaccination
3.1.8
immunization protocol
policy and/or schedule developed by government jurisdiction or their expert immunization advisory
committees, based on jurisdiction-specific needs, other immunization recommendations, program resource
availability and constraints, and identified priorities
3.1.9
immunization forecast
ability to provide recommendation for a client’s future immunizations by considering certain information
about the client and the application of a jurisdiction’s immunization protocol (3.1.8)
3.1.10
pharmaceutical product
qualitative and quantitative composition of a medicinal product (3.1.11) in the dose form approved for
administration in line with the regulated product information
Note 1 to entry: In many instances, the pharmaceutical product is equal to the manufactured product. However, there
are instances where the manufactured item shall undergo a transformation before being administered to the patient
(as the pharmaceutical product) and the two are not equal.

3.1.11
medicinal product
pharmaceutical product (3.1.10) or combination of pharmaceutical products that can be administered to
human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical
diagnosis or to restore, correct or modify physiological functions
[SOURCE: ISO 11615:2017, 3.1.50 modified — notes were removed.]
3.2 Terms related to subject of care data elements
Note 1 to entry This subclause includes the subject of care data elements elaborated in further detail in 5.2.1.
3.2.1
family name
part of a name a person usually has in common with some other members of their family, as distinguished
from their preferred and given names
[SOURCE: ISO/TS 22220:2011, 6.2.2]
3.2.2
preferred name
name by which the subject chooses to be identified
[SOURCE: ISO/TS 22220:2011, 6.3]
3.2.3
subject of care identifier
number or code assigned to a person by an organization, establishment, agency or domain in order
to uniquely identify that person as a subject of health care within the jurisdiction of that health care
organization, establishment, agency or domain
[SOURCE: ISO/TS 22220:2011, 5.2]
3.2.4
birth date
date, as exact as possible, when the subject of care is known or estimated to have been born
3.2.5
gender identity
individual’s personal sense of being a man, woman, boy, girl, nonbinary, or something else
Note 1 to entry: Gender identity represents an individual's identity, ascertained by asking them what that identity is.
3.3 Terms related to immunization event data elements
Note 1 to entry This subclause includes the immunization event data elements elaborated in further detail in 5.2.2.
3.3.1
immunization administration status
information on the status of the immunization event
3.3.2
immunization target disease
disease caused by bacteria or virus that immunization provides protection against
3.3.3
common name
official non-proprietary or generic name recommended by the World Health Organisation (WHO), or, if one
does not exist, a non-proprietary name recommended by the region within which the name is used
[SOURCE: ISO 11615:2017, 3.1.15 modified — note was removed.]

3.3.4
medicinal product name
name of a medicinal product as authorised by a medicines regulatory agency
[SOURCE: ISO 11615:2017, 3.1.54, modified — note was removed.]
3.3.5
medicinal product identifier
unique identifier allocated to a medicinal product (3.1.11) supplementary to any existing authorisation
number as ascribed by a medicines regulatory agency in a region
[SOURCE: ISO 11615:2017, 3.1.53, modified — notes were removed.]
3.3.6
medicinal product package identifier
unique identifier allocated to a packaged medicinal product (3.1.11) supplementary to any existing
authorisation number as ascribed by a medicines regulatory agency in a region
[SOURCE: ISO 11615:2017]
3.3.7
medicinal product batch identifier
unique identifier (BAID2), allocated to a specific batch of a medicinal product (3.1.11), which appears on the
immediate packaging, where this is not the outer packaging
[SOURCE: ISO 11615:2017, 3.1.5.2, modified — “2” was removed from end of term, note was removed.]
3.3.8
medicinal product batch expiration date
date until which the manufacturer (3.3.10) guarantees the full potency and safety of a particular batch or lot
of medicinal product (3.1.11)
3.3.9
marketing authorization holder
organization that holds the authorization for marketing a medicinal product (3.1.11) in a region
[SOURCE: ISO 11615:2017, 3.1.41]
3.3.10
manufacturer
organization that holds the authorization for the manufacturing process
[SOURCE: ISO 11615:2017, 3.1.38, modified — note was removed.]
3.3.11
antigen grouper name
substance or group of substances that are recognized by the immune system and induce an immune response
to a specific disease
3.3.12
antigen grouper identifier
coded representation of a substance or group of substances that are recognized by the immune system and
induce an immune response to a specific disease
3.3.13
dose quantity
volume of the dose of a medicinal product (3.1.11) given to a subject of care
3.3.14
dose quantity unit of measure
unit of measure in which the dose quantity (3.3.13) is expressed

3.3.15
dose number
number of the dose received within a specific immunization series
3.3.16
series number of doses
recommended number of doses in a series that are required for immunity
3.3.17
immunization administration date
date the medicinal product (3.1.11) was administered to the subject of care
3.3.18
immunization estimated date flag
flag to indicate that the immunization administration date (3.3.17) was estimated
3.3.19
immunization reporting source
source of information regarding the reported immunization event
3.3.20
route of administration
path by which the pharmaceutical product (3.1.10) is taken into or makes contact with the body
[SOURCE: ISO 11615:2017, 3.1.76]
3.3.21
immunization anatomical site
body location to or through which a medicinal product (3.1.11) was administered
3.3.22
adverse reaction following immunization flag
flag to indicate that an adverse reaction was reported following administration of a medicinal product
(3.1.11)
3.3.23
adverse reaction date
date the adverse reaction following immunization (3.3.22) occurred
3.3.24
adverse reaction manifestation
specific type of adverse reaction following immunization (3.3.22) that occurred
3.3.25
immunization notes
additional information relevant to the immunization record
3.3.26
reason for immunization
reason an immunization event was scheduled, planned, or given
3.3.27
reason for immunization not given
reason a planned or scheduled immunization event was not carried through
3.4 Terms related to the location, organization and provider data elements
Note 1 to entry This subclause includes the immunization event location, organization and provider data elements
elaborated in further detail in 5.2.3.

3.4.1
country of immunization
country in which the subject of care has been immunized
3.4.2
health care provider full name
given and family name (3.2.1) of the health care provider who is medically responsible for the decision to
administer an immunization product
3.4.3
health care provider identifier
jurisdictional identifier of the health care provider who is medically responsible for the decision to
administer an immunization product
3.4.4
organization name
name of the organization or health authority responsible for the immunization event
3.4.5
organization identifier
jurisdictional identifier associated with the organization or health authority responsible for the
immunization event
3.4.6
immunization administration location name
location within the organization where the immunization event occurred
3.5 Terms related to the immunization forecast data elements
Note 1 to entry This subclause includes the data elements required for forecasting a future immunization event that
are elaborated in further detail in 5.2.4.
3.5.1
immunization forecast status
immunization status of the subject of care towards immunity against an immunization target disease (3.3.2)
3.5.2
immunization forecast description
description of the protocol as determined by the organization responsible for immunization administration
3.5.3
immunization forecast supporting information
subject of care information that supports requirements related to a forecasted immunization event
3.5.4
immunization forecast generated date
date the subject of care's immunization forecast status (3.5.1) was generated
3.5.5
immunization forecast date type
type of date classification pertinent to the administration of the forecasted immunization event
3.5.6
immunization forecast date
date provided in the subject of care's immunization forecast whose meaning relates to the immunization
forecast date type (3.5.5)
4 Use cases
Although immunization use cases (see Table 1) should be based on using data from an immunization registry,
this is not always possible in all countries and settings. Therefore, the use cases are applicable regardless of
the source of data.
Table 1 — Immunization use cases
Use case name Use case definition and considerations for use
Populate an The data required within an immunization registry to enable the control and
immunization registry elimination of vaccine preventable diseases by ensuring the provision of information
and knowledge necessary to stakeholders using the registry to achieve the best
possible immunization coverage for subjects of care.
Record and/or share a The data required by a health care provider who has just immunized a subject of care
current immunization to record and/or share the immunization event. The health care provider has complete
event information about the product (has vial in hand) and its administration to the subject
of care who received the product. This immunization record may be shared with an
immunization registry or other system.
This use case includes the scenario where a vaccine was not given.
Record and/or share a The data required by a subject of care, subject of care proxy or health care provider
historic immunization who is required to record and/or share a subject of care’s immunization event that
event occurred in the past. The information may or may not include all information
pertaining the product or its administration to the subject of care.
Create and/or share an The data required by a health care provider or subject of care with the intent to view
immunization history and/or review a subject of care’s immunization history. The immunization history can
pertain to one vaccine preventable disease or cover all immunization events over time
that pertain to a subject of care.
Ideally, summary level information is sourced from an immunization registry.
This use case aligns with the data requirements for a vaccine certificate.
Create an immunization The data required by a health care provider or subject of care that identifies the
reminder subject of care's next scheduled vaccination or dose. This may be generated by an
immunization registry or other system.
Create anonymized The data required by an authorized agency or entity to create a report that
immunization reports demonstrates an anonymized population level immunization status or summary, e.g.
a status of COVID-19 immunization, at a certain location or country.
This summary level information may be produced using data from an immunization
registry or other systems involved in public health.
Schedule a new The data required by a health care provider who is required to schedule a subject of
immunization event care’s immunization event to take place in the future.
5 Definition of the immunization data elements
5.1 General
Clause 5 provides:
a) data element groups with a general overview of the purpose of the data element grouping;
b) data element structure that includes:
1) the data element name (as provided in Clause 3);
2) a formal definition (as provided in Clause 3);
3) business requirements and notes that include dependencies to other data as applicable, synonyms etc.;
4) the meaning of missing data;
5) the data element format such as String, Coded, Date and Boolean;

6) example values.
5.2 Data elements
5.2.1 Subject of care data elements
Table 2 identifies the data elements required to assist in identification of the person who is the subject of care.
All data elements except for “gender identity” are aligned with Clauses 6 and 7 within ISO/TS 22220:2011.
Table 2 — Subject of care data elements
Data element Data element definition Business rules and notes Format Example(s)
name
Family name The part of a name a person Synonym: last name String Brown
usually has in common with
This field shall not be blank or missing.
some other members of their
family, as distinguished from
their preferred and given
names.
(ISO/TS 22220:2011)
Preferred Indicates the name by which Some people do not have a family name String Mary
name the subject chooses to be and a given name; they have only one name
identified. by which they are known. If the subject of
care has only one name, that name should
(ISO/TS 22220:2011)
be recorded in the family name field and
the given name field should be blank
...