Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

Public Health and Emergency Response Work GroupMaturity Level: 3 Trial UseSecurity Category: Patient Compartments: Patient, Practitioner

Detailed Descriptions for the elements in the Immunization resource.

Immunization
Element IdImmunization
Definition

Describes the event of a patient being administered a vaccine or a record of an immunization as reported by a patient, a clinician or another party.

Cardinality0..*
TypeDomainResource
Summaryfalse
Immunization.identifier
Element IdImmunization.identifier
Definition

A unique identifier assigned to this immunization record.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summaryfalse
Immunization.instantiatesCanonical
Element IdImmunization.instantiatesCanonical
Definition

The URL pointing to a FHIR-defined protocol, guideline, orderset or other definition that is adhered to in whole or in part by this Immunization.

Cardinality0..*
Typecanonical(Definition[ActivityDefinition, EventDefinition, EvidenceVariable, Measure, OperationDefinition, PlanDefinition, Questionnaire, SubscriptionTopic])
Summarytrue
Immunization.instantiatesUri
Element IdImmunization.instantiatesUri
Definition

The URL pointing to an externally maintained protocol, guideline, orderset or other definition that is adhered to in whole or in part by this Immunization.

Cardinality0..*
Typeuri
Summarytrue
Comments

This might be an HTML page, PDF, etc. or could just be a non-resolvable URI identifier.

Immunization.basedOn
Element IdImmunization.basedOn
Definition

A plan, order or recommendation fulfilled in whole or in part by this immunization.

Cardinality0..*
TypeReference(CarePlan | MedicationRequest | ImmunizationRecommendation)
PatternsReference(CarePlan,MedicationRequest,ImmunizationRecommendation): Common patterns = Request
Summarytrue
Comments

Allows tracing of an authorization for the Immunization.

Immunization.status
Element IdImmunization.status
Definition

Indicates the current status of the immunization event.

Cardinality1..1
Terminology BindingImmunization Status Codes (Required)
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it is a status element that contains statuses entered-in-error and not-done which means that the resource should not be treated as valid)
Summarytrue
Comments

Will generally be set to show that the immunization has been completed or not done. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Immunization.statusReason
Element IdImmunization.statusReason
Definition

Indicates the reason the immunization event was not performed.

Cardinality0..1
Terminology BindingImmunization Status Reason Codes (Example)
TypeCodeableConcept
Summaryfalse
Comments

This is generally only used for the status of "not-done". The reason for performing the immunization event is captured in reasonCode, not here.

Immunization.vaccineCode
Element IdImmunization.vaccineCode
Definition

Vaccine that was administered or was to be administered.

Cardinality1..1
Terminology BindingVaccine Administered Value Set (Example)
TypeCodeableConcept
Summarytrue
Comments

The code for the administered vaccine may be reported at various levels of granularity from a very generic code for a general type of vaccine (e.g. the SNOMED or CVX code for the flu vaccine) to a very discrete code for a specific product including the form and packaging (e.g. an NDC code). Because vaccineCode uses the CodeableConcept data type, multiple codes at different levels of granularity may be reported for a single immunization event provided that all codes are appropriate for the same vaccine. For example, both NDC and CVX codes may be provided for a given immunization event by repeating the coding element within vaccineCode.

Immunization.manufacturer
Element IdImmunization.manufacturer
Definition

Name of vaccine manufacturer.

Cardinality0..1
TypeReference(Organization)
Summaryfalse
Immunization.lotNumber
Element IdImmunization.lotNumber
Definition

Lot number of the vaccine product.

Cardinality0..1
Typestring
Summaryfalse
Immunization.expirationDate
Element IdImmunization.expirationDate
Definition

Date vaccine batch expires.

Cardinality0..1
Typedate
Summaryfalse
Immunization.patient
Element IdImmunization.patient
Definition

The patient who either received or did not receive the immunization.

Cardinality1..1
TypeReference(Patient)
Summarytrue
Immunization.encounter
Element IdImmunization.encounter
Definition

The visit or admission or other contact between patient and health care provider the immunization was performed as part of.

Cardinality0..1
TypeReference(Encounter)
Summaryfalse
Immunization.occurrence[x]
Element IdImmunization.occurrence[x]
Definition

Date vaccine administered or was to be administered.

Cardinality1..1
TypedateTime|string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
Comments

When immunizations are given a specific date and time should always be known. When immunizations are patient reported, a specific date might not be known. Although partial dates are allowed, an adult patient might not be able to recall the year a childhood immunization was given. An exact date is always preferable, but the use of the String data type is acceptable when an exact date is not known. A small number of vaccines (e.g. live oral typhoid vaccine) are given as a series of patient self-administered dose over a span of time. In cases like this, often, only the first dose (typically a provider supervised dose) is recorded with the occurrence indicating the date/time of the first dose.

Immunization.recorded
Element IdImmunization.recorded
Definition

The date the occurrence of the immunization was first captured in the record - potentially significantly after the occurrence of the event.

Cardinality0..1
TypedateTime
Summaryfalse
Immunization.primarySource
Element IdImmunization.primarySource
Definition

Indicates if this record was captured as a secondary 'reported' record rather than as an original primary source-of-truth record.

Cardinality0..1
Typeboolean
Summarytrue
Comments

Reflects the “reliability” of the content.

Immunization.informationSource[x]
Element IdImmunization.informationSource[x]
Definition

Typically the source of the data when the report of the immunization event is not based on information from the person who administered the vaccine.

Cardinality0..1
Terminology BindingImmunization Origin Codes (Example)
TypeCodeableConcept|Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | Organization)
PatternsReference(Patient,Practitioner,PractitionerRole,RelatedPerson,Organization): Common patterns = Participant
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
Comments

Typically will not be populated if primarySource = True, not required even if primarySource = False.

Immunization.location
Element IdImmunization.location
Definition

The service delivery location where the vaccine administration occurred.

Cardinality0..1
TypeReference(Location)
Summaryfalse
Immunization.site
Element IdImmunization.site
Definition

Body site where vaccine was administered.

Cardinality0..1
Terminology BindingCodes for Immunization Site of Administration (Example)
TypeCodeableConcept
Summaryfalse
Immunization.route
Element IdImmunization.route
Definition

The path by which the vaccine product is taken into the body.

Cardinality0..1
Terminology BindingImmunization Route Codes (Example)
TypeCodeableConcept
Summaryfalse
Immunization.doseQuantity
Element IdImmunization.doseQuantity
Definition

The quantity of vaccine product that was administered.

Cardinality0..1
TypeSimpleQuantity
Summaryfalse
Immunization.performer
Element IdImmunization.performer
Definition

Indicates who performed the immunization event.

Cardinality0..*
Summarytrue
Immunization.performer.function
Element IdImmunization.performer.function
Definition

Describes the type of performance (e.g. ordering provider, administering provider, etc.).

Cardinality0..1
Terminology BindingImmunization Function Codes (Extensible)
TypeCodeableConcept
Summarytrue
Immunization.performer.actor
Element IdImmunization.performer.actor
Definition

The practitioner or organization who performed the action.

Cardinality1..1
TypeReference(Practitioner | PractitionerRole | Organization)
PatternsReference(Practitioner,PractitionerRole,Organization): Common patterns = Participant
Summarytrue
Comments

When the individual practitioner who performed the action is known, it is best to send.

Immunization.note
Element IdImmunization.note
Definition

Extra information about the immunization that is not conveyed by the other attributes.

Cardinality0..*
TypeAnnotation
Summarytrue
Immunization.reason
Element IdImmunization.reason
Definition

Describes why the immunization occurred in coded or textual form, or Indicates another resource (Condition, Observation or DiagnosticReport) whose existence justifies this immunization.

Cardinality0..*
Terminology BindingImmunization Reason Codes (Example)
TypeCodeableReference(Condition | Observation | DiagnosticReport)
PatternsCodeableReference(Condition,Observation,DiagnosticReport): Common patterns = Event
Summaryfalse
Immunization.isSubpotent
Element IdImmunization.isSubpotent
Definition

Indication if a dose is considered to be subpotent. By default, a dose should be considered to be potent.

Cardinality0..1
Typeboolean
Is Modifiertrue (Reason: This element is labeled as a modifier because an immunization event with a subpotent vaccine doesn't protect the patient the same way as a potent dose.)
Meaning if MissingBy default, a dose should be considered to be potent.
Summarytrue
Comments

Typically, the recognition of the dose being sub-potent is retrospective, after the administration (ex. notification of a manufacturer recall after administration). However, in the case of a partial administration (the patient moves unexpectedly and only some of the dose is actually administered), subpotency may be recognized immediately, but it is still important to record the event.

Immunization.subpotentReason
Element IdImmunization.subpotentReason
Definition

Reason why a dose is considered to be subpotent.

Cardinality0..*
Terminology BindingImmunization Subpotent Reason (Example)
TypeCodeableConcept
Summaryfalse
Immunization.education
Element IdImmunization.education
Definition

Educational material presented to the patient (or guardian) at the time of vaccine administration.

Cardinality0..*
Summaryfalse
Invariants
Defined on this element
imm-1Rule One of documentType or reference SHALL be presentdocumentType.exists() or reference.exists()
Immunization.education.documentType
Element IdImmunization.education.documentType
Definition

Identifier of the material presented to the patient.

Cardinality0..1
Typestring
Summaryfalse
Immunization.education.reference
Element IdImmunization.education.reference
Definition

Reference pointer to the educational material given to the patient if the information was on line.

Cardinality0..1
Typeuri
Summaryfalse
Immunization.education.publicationDate
Element IdImmunization.education.publicationDate
Definition

Date the educational material was published.

Cardinality0..1
TypedateTime
Summaryfalse
Immunization.education.presentationDate
Element IdImmunization.education.presentationDate
Definition

Date the educational material was given to the patient.

Cardinality0..1
TypedateTime
Summaryfalse
Immunization.programEligibility
Element IdImmunization.programEligibility
Definition

Indicates a patient's eligibility for a funding program.

Cardinality0..*
Terminology BindingImmunization Program Eligibility (Example)
TypeCodeableConcept
Summaryfalse
Immunization.fundingSource
Element IdImmunization.fundingSource
Definition

Indicates the source of the vaccine actually administered. This may be different than the patient eligibility (e.g. the patient may be eligible for a publically purchased vaccine but due to inventory issues, vaccine purchased with private funds was actually administered).

Cardinality0..1
Terminology BindingImmunization Funding Source (Example)
TypeCodeableConcept
Summaryfalse
Immunization.reaction
Element IdImmunization.reaction
Definition

Categorical data indicating that an adverse event is associated in time to an immunization.

Cardinality0..*
Summaryfalse
Comments

A reaction may be an indication of an allergy or intolerance and, if this is determined to be the case, it should be recorded as a new AllergyIntolerance resource instance as most systems will not query against past Immunization.reaction elements.

Immunization.reaction.date
Element IdImmunization.reaction.date
Definition

Date of reaction to the immunization.

Cardinality0..1
TypedateTime
Summaryfalse
Immunization.reaction.detail
Element IdImmunization.reaction.detail
Definition

Details of the reaction.

Cardinality0..1
TypeReference(Observation)
Summaryfalse
Immunization.reaction.reported
Element IdImmunization.reaction.reported
Definition

Self-reported indicator.

Cardinality0..1
Typeboolean
Summaryfalse
Immunization.protocolApplied
Element IdImmunization.protocolApplied
Definition

The protocol (set of recommendations) being followed by the provider who administered the dose.

Cardinality0..*
Summaryfalse
Immunization.protocolApplied.series
Element IdImmunization.protocolApplied.series
Definition

One possible path to achieve presumed immunity against a disease - within the context of an authority.

Cardinality0..1
Typestring
Summaryfalse
Immunization.protocolApplied.authority
Element IdImmunization.protocolApplied.authority
Definition

Indicates the authority who published the protocol (e.g. ACIP) that is being followed.

Cardinality0..1
TypeReference(Organization)
Summaryfalse
Immunization.protocolApplied.targetDisease
Element IdImmunization.protocolApplied.targetDisease
Definition

The vaccine preventable disease the dose is being administered against.

Cardinality0..*
Terminology BindingImmunization Target Disease Codes (Example)
TypeCodeableConcept
Summaryfalse
Immunization.protocolApplied.doseNumber
Element IdImmunization.protocolApplied.doseNumber
Definition

Nominal position in a series as intended by the practitioner administering the dose.

Cardinality1..1
Typestring
Summaryfalse
Comments

The use of an integer is preferred if known. Text should only be used in cases where an integer is not available (such as when documenting a recurring booster dose).

Immunization.protocolApplied.seriesDoses
Element IdImmunization.protocolApplied.seriesDoses
Definition

The recommended number of doses to achieve immunity as intended by the practitioner administering the dose.

Cardinality0..1
Typestring
Summaryfalse
Comments

The use of an integer is preferred if known.