HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: ICSR Immunization

Defining URL:http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-immunization
Version:0.1.0
Name:ICSRImmunization
Title:ICSR Immunization
Status:Active as of 2021-08-05T14:34:06+00:00
Definition:

The fields needed to submit an Immunization for a ICSR Report.

Publisher:Biomedical Research & Regulation WG
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-immunization

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from USCoreImmunizationProfile

Summary

Must-Support: 7 elements
Fixed Value: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

This structure is derived from USCoreImmunizationProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Immunization 0..*USCoreImmunizationProfileImmunization event information
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageatvaccination 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageatvaccination
... status 1..1codecompleted | entered-in-error | not-done
Fixed Value: completed
... patient 1..1Reference(ICSR Patient)Who was immunized
... location S0..1Reference(US Core Location Profile)Where immunization occurred
... manufacturer S0..1Reference(Organization)Vaccine manufacturer
... lotNumber S0..1stringVaccine lot number
... expirationDate S0..1dateVaccine expiration date
... site S0..1CodeableConceptBody site vaccine was administered
... route S0..1CodeableConceptHow vaccine entered body
... doseQuantity S0..1SimpleQuantityAmount of vaccine administered

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Immunization 0..*USCoreImmunizationProfileImmunization event information
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageatvaccination 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageatvaccination
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierBusiness identifier
... status ?!SΣ1..1codecompleted | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: completed
... statusReason S0..1CodeableConceptReason not done
Binding: ImmunizationStatusReasonCodes (example)
... vaccineCode SΣI1..1CodeableConceptVaccine Product Type (bind to CVX)
Binding: Vaccine Codes (extensible)
... patient SΣ1..1Reference(ICSR Patient)Who was immunized
... encounter 0..1Reference(Encounter)Encounter immunization was part of
... occurrence[x] SΣ1..1Vaccine administration date
.... occurrenceDateTimedateTime S
.... occurrenceStringstring
... recorded 0..1dateTimeWhen the immunization was first captured in the subject's record
... primarySource SΣ1..1booleanIndicates context the data was recorded in
... reportOrigin 0..1CodeableConceptIndicates the source of a secondarily reported record
Binding: ImmunizationOriginCodes (example): The source of the data for a record which is not from a primary source.

... location S0..1Reference(US Core Location Profile)Where immunization occurred
... manufacturer S0..1Reference(Organization)Vaccine manufacturer
... lotNumber S0..1stringVaccine lot number
... expirationDate S0..1dateVaccine expiration date
... site S0..1CodeableConceptBody site vaccine was administered
Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.

... route S0..1CodeableConceptHow vaccine entered body
Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.

... doseQuantity S0..1SimpleQuantityAmount of vaccine administered
... performer Σ0..*BackboneElementWho performed event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... function Σ0..1CodeableConceptWhat type of performance was done
Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.

.... actor Σ1..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization who was performing
... note Σ0..*AnnotationAdditional immunization notes
... reasonCode 0..*CodeableConceptWhy immunization occurred
Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.


... reasonReference 0..*Reference(Condition | Observation | DiagnosticReport)Why immunization occurred
... isSubpotent ?!Σ0..1booleanDose potency
... subpotentReason 0..*CodeableConceptReason for being subpotent
Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.


... education I0..*BackboneElementEducational material presented to patient
imm-1: One of documentType or reference SHALL be present
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... documentType 0..1stringEducational material document identifier
.... reference 0..1uriEducational material reference pointer
.... publicationDate 0..1dateTimeEducational material publication date
.... presentationDate 0..1dateTimeEducational material presentation date
... programEligibility 0..*CodeableConceptPatient eligibility for a vaccination program
Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.


... fundingSource 0..1CodeableConceptFunding source for the vaccine
Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.

... reaction 0..*BackboneElementDetails of a reaction that follows immunization
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... date 0..1dateTimeWhen reaction started
.... detail 0..1Reference(Observation)Additional information on reaction
.... reported 0..1booleanIndicates self-reported reaction
... protocolApplied 0..*BackboneElementProtocol followed by the provider
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... series 0..1stringName of vaccine series
.... authority 0..1Reference(Organization)Who is responsible for publishing the recommendations
.... targetDisease 0..*CodeableConceptVaccine preventatable disease being targetted
Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.


.... doseNumber[x] 1..1Dose number within series
..... doseNumberPositiveIntpositiveInt
..... doseNumberStringstring
.... seriesDoses[x] 0..1Recommended number of doses for immunity
..... seriesDosesPositiveIntpositiveInt
..... seriesDosesStringstring

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Immunization 0..*USCoreImmunizationProfileImmunization event information
... status ?!Σ1..1codecompleted | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: completed
... statusReason 0..1CodeableConceptReason not done
Binding: ImmunizationStatusReasonCodes (example)
... vaccineCode ΣI1..1CodeableConceptVaccine Product Type (bind to CVX)
Binding: Vaccine Codes (extensible)
... occurrence[x] Σ1..1Vaccine administration date
.... occurrenceDateTimedateTime
... primarySource Σ1..1booleanIndicates context the data was recorded in
... location 0..1Reference(US Core Location Profile)Where immunization occurred
... manufacturer 0..1Reference(Organization)Vaccine manufacturer
... lotNumber 0..1stringVaccine lot number
... expirationDate 0..1dateVaccine expiration date
... site 0..1CodeableConceptBody site vaccine was administered
Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.

... route 0..1CodeableConceptHow vaccine entered body
Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.

... doseQuantity 0..1SimpleQuantityAmount of vaccine administered

doco Documentation for this format

This structure is derived from USCoreImmunizationProfile

Summary

Must-Support: 7 elements
Fixed Value: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from USCoreImmunizationProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Immunization 0..*USCoreImmunizationProfileImmunization event information
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageatvaccination 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageatvaccination
... status 1..1codecompleted | entered-in-error | not-done
Fixed Value: completed
... patient 1..1Reference(ICSR Patient)Who was immunized
... location S0..1Reference(US Core Location Profile)Where immunization occurred
... manufacturer S0..1Reference(Organization)Vaccine manufacturer
... lotNumber S0..1stringVaccine lot number
... expirationDate S0..1dateVaccine expiration date
... site S0..1CodeableConceptBody site vaccine was administered
... route S0..1CodeableConceptHow vaccine entered body
... doseQuantity S0..1SimpleQuantityAmount of vaccine administered

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Immunization 0..*USCoreImmunizationProfileImmunization event information
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... ibm-fda-icsr-ext-ageatvaccination 0..1AgeExtension
URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageatvaccination
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierBusiness identifier
... status ?!SΣ1..1codecompleted | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: completed
... statusReason S0..1CodeableConceptReason not done
Binding: ImmunizationStatusReasonCodes (example)
... vaccineCode SΣI1..1CodeableConceptVaccine Product Type (bind to CVX)
Binding: Vaccine Codes (extensible)
... patient SΣ1..1Reference(ICSR Patient)Who was immunized
... encounter 0..1Reference(Encounter)Encounter immunization was part of
... occurrence[x] SΣ1..1Vaccine administration date
.... occurrenceDateTimedateTime S
.... occurrenceStringstring
... recorded 0..1dateTimeWhen the immunization was first captured in the subject's record
... primarySource SΣ1..1booleanIndicates context the data was recorded in
... reportOrigin 0..1CodeableConceptIndicates the source of a secondarily reported record
Binding: ImmunizationOriginCodes (example): The source of the data for a record which is not from a primary source.

... location S0..1Reference(US Core Location Profile)Where immunization occurred
... manufacturer S0..1Reference(Organization)Vaccine manufacturer
... lotNumber S0..1stringVaccine lot number
... expirationDate S0..1dateVaccine expiration date
... site S0..1CodeableConceptBody site vaccine was administered
Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.

... route S0..1CodeableConceptHow vaccine entered body
Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.

... doseQuantity S0..1SimpleQuantityAmount of vaccine administered
... performer Σ0..*BackboneElementWho performed event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... function Σ0..1CodeableConceptWhat type of performance was done
Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.

.... actor Σ1..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization who was performing
... note Σ0..*AnnotationAdditional immunization notes
... reasonCode 0..*CodeableConceptWhy immunization occurred
Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.


... reasonReference 0..*Reference(Condition | Observation | DiagnosticReport)Why immunization occurred
... isSubpotent ?!Σ0..1booleanDose potency
... subpotentReason 0..*CodeableConceptReason for being subpotent
Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.


... education I0..*BackboneElementEducational material presented to patient
imm-1: One of documentType or reference SHALL be present
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... documentType 0..1stringEducational material document identifier
.... reference 0..1uriEducational material reference pointer
.... publicationDate 0..1dateTimeEducational material publication date
.... presentationDate 0..1dateTimeEducational material presentation date
... programEligibility 0..*CodeableConceptPatient eligibility for a vaccination program
Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.


... fundingSource 0..1CodeableConceptFunding source for the vaccine
Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.

... reaction 0..*BackboneElementDetails of a reaction that follows immunization
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... date 0..1dateTimeWhen reaction started
.... detail 0..1Reference(Observation)Additional information on reaction
.... reported 0..1booleanIndicates self-reported reaction
... protocolApplied 0..*BackboneElementProtocol followed by the provider
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... series 0..1stringName of vaccine series
.... authority 0..1Reference(Organization)Who is responsible for publishing the recommendations
.... targetDisease 0..*CodeableConceptVaccine preventatable disease being targetted
Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.


.... doseNumber[x] 1..1Dose number within series
..... doseNumberPositiveIntpositiveInt
..... doseNumberStringstring
.... seriesDoses[x] 0..1Recommended number of doses for immunity
..... seriesDosesPositiveIntpositiveInt
..... seriesDosesStringstring

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet / Code
Immunization.languagepreferredCommonLanguages
Max Binding: AllLanguages
Immunization.statusrequiredFixed Value: completed
Immunization.statusReasonexampleImmunizationStatusReasonCodes
Immunization.vaccineCodeextensibleVaccineCodeVS
Immunization.reportOriginexampleImmunizationOriginCodes
Immunization.siteexampleCodesForImmunizationSiteOfAdministration
Immunization.routeexampleImmunizationRouteCodes
Immunization.performer.functionextensibleImmunizationFunctionCodes
Immunization.reasonCodeexampleImmunizationReasonCodes
Immunization.subpotentReasonexampleImmunizationSubpotentReason
Immunization.programEligibilityexampleImmunizationProgramEligibility
Immunization.fundingSourceexampleImmunizationFundingSource
Immunization.protocolApplied.targetDiseaseexampleImmunizationTargetDiseaseCodes

Constraints

IdPathDetailsRequirements
imm-1Immunization.educationOne of documentType or reference SHALL be present
: documentType.exists() or reference.exists()