FHIR Release 3 (STU) CI-Build

This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 5.0.0 . For a full list Continuous Integration Build of available versions, see FHIR (will be incorrect/inconsistent at times).
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Responsible Owner: Public Health and Emergency Response icon Work Group   Normative Maturity Level : 3   Trial Use Security Category : Patient Compartments : Patient , Practitioner

Detailed Descriptions for the elements in the Immunization resource.

Control : (notGiven = true).not() or (reaction.empty() and explanation.reason.empty()), xpath: not(f:notGiven/@value=true() and (count(f:reaction) > 0 or exists(f:explanation/f:reason)))) imm-2 : If immunization was administered (notGiven=false) then explanation.reasonNotGiven SHALL be absent. ( expression Control Control Control Control Control Control Control Control Control Control Control Immunization.reaction.reported Definition Self-reported indicator. Immunization.vaccinationProtocol.authority Control Control Control Control Control
Definition Element Id Immunization
Definition

Describes the event of a patient being administered a vaccination vaccine or a record of a vaccination an immunization as reported by a patient, a clinician or another party and may include vaccine reaction information and what vaccination protocol was followed. party.

Short Display Immunization event information
Cardinality 1..1 0..*
Invariants Type Defined on this element DomainResource imm-1 : If immunization was not administered (notGiven=true) then there SHALL be no reaction nor explanation.reason present ( expression
Summary : (notGiven = true) or explanation.reasonNotGiven.empty(), xpath: not(f:notGiven/@value=false() and exists(f:explanation/f:reasonNotGiven))) false
Definition Element Id Immunization.identifier
Definition

A unique identifier assigned to this immunization record.

Note Short Display Business identifier
Note This is a business identifer, identifier, not a resource identifier (see discussion )
Control Cardinality 0..*
Type Identifier
Summary false
Element Id Immunization.basedOn
Definition

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

Short Display Authority that the immunization event is based on
Cardinality 0..*
Type Reference ( CarePlan | MedicationRequest | ServiceRequest )
Summary true
Comments

Allows tracing of an authorization for the Immunization.

Definition Element Id Immunization.status
Definition

Indicates the current status of the vaccination immunization event.

Short Display completed | entered-in-error | not-done
Cardinality 1..1
Terminology Binding Immunization Status Codes ( Required )
Type code
Is Modifier true (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)
Summary true
Comments

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

Definition Element Id Immunization.statusReason
Definition

Indicates if the vaccination was or reason the immunization event was not given. performed.

Short Display Reason for current status
Cardinality 1..1 0..1
Type Terminology Binding boolean Immunization Status Reason Codes ( Example )
Is Modifier Type true CodeableConcept
Summary true false
Comments

This element is labeled as a modifier because it indicates that an generally only used for the status of "not-done". The reason for performing the immunization didn't happen. event is captured in reasonCode, not here.

Definition Element Id Immunization.vaccineCode
Definition

Vaccine that was administered or was to be administered.

Short Display Vaccine administered
Control Cardinality 1..1
Terminology Binding Vaccine Administered Value Set ( Example )
Type CodeableConcept
Summary true
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.

Element Id Immunization.administeredProduct
Definition

An indication of which product was administered to the patient. This is typically a more detailed representation of the concept conveyed by the vaccineCode data element. If a Medication resource is referenced, it may be to a stand-alone resource or a contained resource within the Immunization resource.

Short Display Product that was administered
Cardinality 0..1
Type CodeableReference ( Medication )
Summary false
Element Id Immunization.manufacturer
Definition

Name of vaccine manufacturer.

Short Display Vaccine manufacturer
Cardinality 0..1
Type CodeableReference ( Organization )
Summary false
Element Id Immunization.lotNumber
Definition

Lot number of the vaccine product.

Short Display Vaccine lot number
Cardinality 0..1
Type string
Summary false
Element Id Immunization.expirationDate
Definition

Date vaccine batch expires.

Short Display Vaccine expiration date
Cardinality 0..1
Type date
Summary false
Definition Element Id Immunization.patient
Definition

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

Short Display Who was immunized
Cardinality 1..1
Type Reference ( Patient )
Summary true
Definition Element Id Immunization.encounter
Definition

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

Short Display Encounter immunization was part of
Control Cardinality 0..1
Type Reference ( Encounter )
Summary false
Element Id Immunization.supportingInformation
Definition

Additional information that is relevant to the immunization (e.g. for a vaccine recipient who is pregnant, the gestational age of the fetus). The reason why a vaccine was given (e.g. occupation, underlying medical condition) should be conveyed in Immunization.reason, not as supporting information. The reason why a vaccine was not given (e.g. contraindication) should be conveyed in Immunization.statusReason, not as supporting information.

Short Display Additional information in support of the immunization
Cardinality 0..*
Type Reference ( Any )
Summary false
Element Id Immunization.occurrence[x]
Definition

Date vaccine administered or was to be administered.

Short Display Vaccine administration date
Cardinality 0..1 1..1
Type dateTime | string
Comments [x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Comments

When immunizations are given given, a specific date and time should always be recorded if known. If the time is not known, it should not be included. However, systems primarily rely on the date component of the immunization record for determining dose validity and future dose forecasting. For this reason, immunization records should preserve the immunization date as recorded for the time zone where the dose was administered. Care should be taken when recording and transmitting time and time zone information, as adjustments based on time zone can shift the recorded date. Additionally, because Patient.birthDate does not include a time component, systems should ensure that comparisons between occurrence date and birth date do not introduce inconsistencies in determining patient age at vaccination. When immunizations are patient reported, a specific date might not be known.  Although 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.

Definition Element Id Immunization.primarySource
Definition

An indication that Indicates whether the content data contained in the resource was captured by the individual/organization which was responsible for the administration of the record is based on information from vaccine rather than as 'secondary reported' data documented by a third party. A value of 'true' means this data originated with the person who administered individual/organization which was responsible for the vaccine. This reflects administration of the vaccine.

Short Display Indicates context under which the data was originally recorded. captured in
Control Cardinality 1..1 0..1
Type boolean
Comments Summary true
Comments

Reflects the “reliability” of the content.

Definition Element Id Immunization.informationSource
Definition

The 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.

Short Display Indicates the source of a reported record
Control Cardinality 0..1
Terminology Binding Immunization Origin Codes ( Example )
Type CodeableReference ( Patient | Practitioner | PractitionerRole | RelatedPerson | Organization )
CodeableConcept Summary false
Comments

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

Definition Element Id Immunization.location
Definition

The service delivery location where the vaccine administration occurred.

Short Display The service delivery location
Cardinality 0..1
Type Reference ( Location )
Summary false
Definition Element Id Immunization.site
Definition

Name of Body site where vaccine manufacturer. was administered.

Short Display Body site vaccine was administered
Control Cardinality 0..1
Type Terminology Binding Reference Codes for Immunization Site of Administration ( Organization Example )
Type CodeableConcept
Summary false
Definition Element Id Immunization.route
Definition

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

Short Display How vaccine entered body
Control Cardinality 0..1
Terminology Binding Immunization Route Codes ( Example )
Type CodeableConcept
string Summary false
Definition Element Id Immunization.doseQuantity
Definition

Date The quantity of vaccine batch expires. product that was administered.

Short Display Amount of vaccine administered
Cardinality 0..1
Type SimpleQuantity
date Summary false
Definition Element Id Immunization.performer
Definition

Body site where vaccine was administered. Indicates who performed the immunization event.

Control Short Display 0..1 Who performed event
Terminology Binding Cardinality Codes for Immunization Site of Administration ( Example ) 0..*
Type Summary CodeableConcept true
Definition Element Id Immunization.performer.function
Definition

The path Describes the function played by which the vaccine product is taken into performer in the body. immunization event (e.g. ordering provider, administering provider, etc.).

Short Display Type of performance
Control Cardinality 0..1
Terminology Binding Immunization Route Function Codes ( Example Extensible )
Type CodeableConcept
Summary true
Definition Element Id Immunization.performer.actor
Definition

The quantity of vaccine product that was administered. practitioner or organization who performed the action.

Short Display Individual or organization who performed the event
Cardinality 0..1 1..1
Type Reference ( Practitioner | PractitionerRole | Organization | Patient | RelatedPerson )
SimpleQuantity Summary true
Comments

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

Definition Element Id Immunization.note
Definition

Indicates who or what performed Extra information about the event. immunization that is not conveyed by the other attributes.

Short Display Additional immunization notes
Cardinality 0..*
Type Annotation
Summary true
Definition Element Id Immunization.reason
Definition

Describes why the type of performance (e.g. ordering provider, administering provider, etc.). immunization occurred in coded or textual form, or indicates another resource (Condition, Observation or DiagnosticReport) whose existence justifies this immunization.

Short Display Why immunization occurred
Cardinality 0..1 0..*
Terminology Binding Immunization Role Reason Codes ( Extensible Example )
Type CodeableConcept CodeableReference ( Condition | Observation | DiagnosticReport )
Summary true false
Definition Element Id Immunization.isSubpotent
Definition

The device, practitioner, etc. who performed the action. Indication if a dose is considered to be subpotent. By default, a dose should be considered to be potent.

Short Display Dose potency
Control Cardinality 1..1 0..1
Type Reference boolean ( Practitioner
Is Modifier ) true (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 Missing By default, a dose should be considered to be potent.
Summary true
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.

Definition Element Id Immunization.subpotentReason
Definition

Extra information about the immunization that Reason why a dose is not conveyed by the other attributes. considered to be subpotent.

Short Display Reason for being subpotent
Cardinality 0..*
Terminology Binding Immunization Subpotent Reason icon ( Example )
Type Annotation CodeableConcept
Summary true false
Definition Element Id Immunization.programEligibility
Definition

Reasons why Indicates a vaccine was or was not administered. patient's eligibility for a funding program.

Short Display Patient eligibility for a specific vaccination program
Control Cardinality 0..*
0..1 Summary false
Element Id Immunization.programEligibility.program
Definition

Indicates which program the patient had their eligibility evaluated for.

Short Display The program that eligibility is declared for
Cardinality 1..1
Terminology Binding Vaccine Funding Programs ( Example )
Type CodeableConcept
Summary false
Element Id Immunization.programEligibility.programStatus
Definition

Reasons why Indicates the patient's eligibility status for a vaccine was administered. specific payment program.

Short Display The patient's eligibility status for the program
Control Cardinality 0..* 1..1
Terminology Binding Immunization Reason Codes Program Eligibility icon ( Example )
Type CodeableConcept
Summary false
Definition Element Id Immunization.fundingSource
Definition

Reason why 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 publicly purchased vaccine but due to inventory issues, vaccine purchased with private funds was not administered. actually administered).

Short Display Funding source for the vaccine
Control Cardinality 0..* 0..1
Terminology Binding Immunization Reasons for Not Immunizing Codes Funding Source icon ( Example )
Type CodeableConcept
Summary false
Definition Element Id Immunization.reaction
Definition

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

Short Display Details of a reaction that followed the immunization
Control Cardinality 0..*
Comments Summary false
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.

Definition Element Id Immunization.reaction.date
Definition

Date of reaction to the immunization.

Short Display When reaction started
Cardinality 0..1
Type dateTime
Summary false
Definition Element Id Immunization.reaction.manifestation
Definition

Details of the reaction.

Short Display Additional information on reaction
Control Cardinality 0..1
Type Reference CodeableReference ( Observation )
Control Summary 0..1 false
Definition Element Id Contains information about the protocol(s) under which the vaccine was administered. Immunization.reaction.reported
Control Definition 0..* Immunization.vaccinationProtocol.doseSequence

Self-reported indicator.

Definition Short Display Nominal position in a series. Indicates self-reported reaction
Control Cardinality 0..1
Type positiveInt boolean
Summary Immunization.vaccinationProtocol.description Definition Contains the description about the protocol under which the vaccine was administered. false
Element Id Immunization.protocolApplied
Definition

Indicates The protocol (set of recommendations) being followed by the authority provider who published administered the protocol. E.g. ACIP. dose.

Control Short Display 0..1 Protocol followed by the provider
Type Cardinality 0..*
Reference ( Organization Summary ) false
Definition Element Id Immunization.protocolApplied.series
Definition

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

Short Display Name of vaccine series
Cardinality 0..1
Type string
Summary false
Definition Element Id Immunization.protocolApplied.authority
Definition

The recommended number of doses to achieve immunity. Indicates the authority who published the protocol (e.g. ACIP) that is being followed.

Short Display Who is responsible for publishing the recommendations
Cardinality 0..1
Type Reference ( Organization )
positiveInt Summary false
Definition Element Id Immunization.protocolApplied.targetDisease
Definition

The targeted disease. vaccine preventable disease the dose is being administered against.

Short Display Vaccine preventable disease being targeted
Cardinality 1..* 0..*
Terminology Binding Vaccination Protocol Dose Immunization Target Disease Codes ( Example )
Type CodeableConcept
Summary false
Definition Element Id Immunization.protocolApplied.doseNumber
Definition

Indicates if Nominal position in a series as intended by the immunization event should "count" against practitioner administering the protocol. dose.

Short Display Dose number within series
Cardinality 1..1 0..1
Terminology Binding Vaccination Protocol Dose Status codes ( Example ) DoseNumber :
Type CodeableConcept
Comments Summary false
Comments

May need to differentiate between status declarations by a provider vs. The dose number may be communicated as either a CDS engine. coded concept (for example Dose 1, Dose 2 or Booster) or as free text as needed by the use case.

Definition Element Id Immunization.protocolApplied.seriesDoses
Definition

Provides an explanation as The recommended number of doses to why an immunization event should or should not count against achieve immunity as intended by the protocol. practitioner administering the dose.

Short Display Recommended number of doses for immunity
Cardinality 0..1
Terminology Binding Vaccination Protocol Dose Status Reason codes ( Example ) SeriesDoses :
Type CodeableConcept
Summary false
Comments

The number of doses in a series may be communicated as either a coded concept or as free text as needed by the use case.