Immunization Definitions
<a id="Immunization"></a>
Immunization
Immunization event information
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.
Cardinality: 0..*
Mappings: workflow=Event; v2=VXU_V04; rim=SubstanceAdministration; w5=clinical.medication
<a id="Immunization.identifier"></a>
Immunization.identifier
Business identifier
Definition: A unique identifier assigned to this immunization record.
Cardinality: 0..*
Type: Identifier
Mappings: workflow=Event.identifier; w5=FiveWs.identifier; rim=.id; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/id
<a id="Immunization.basedOn"></a>
Immunization.basedOn
Authority that the immunization event is based on
Definition: A plan, order or recommendation fulfilled in whole or in part by this immunization.
Comments: Allows tracing of an authorization for the Immunization.
Cardinality: 0..*
Type: Reference(CarePlan, MedicationRequest, ServiceRequest)
Summary: true
Mappings: workflow=Event.basedOn; rim=N/A
<a id="Immunization.status"></a>
Immunization.status
completed | entered-in-error | not-done
Definition: Indicates the current status of the immunization event.
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.
Cardinality: 1..1
Type: code
Binding: required:immunization-status
Summary: true
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)
Mappings: workflow=Event.status; w5=FiveWs.status; rim=statusCode
<a id="Immunization.statusReason"></a>
Immunization.statusReason
Reason for current status
Definition: Indicates the reason the immunization event was not performed.
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.
Cardinality: 0..1
Type: CodeableConcept
Binding: example:immunization-status-reason
Mappings: workflow=Event.statusReason; rim=.inboundRelationship[typeCode=SUBJ].source[classCode=CACT, moodCode=EVN].reasonCOde
<a id="Immunization.vaccineCode"></a>
Immunization.vaccineCode
Vaccine administered
Definition: Vaccine that was administered or was to be administered.
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.
Cardinality: 1..1
Type: CodeableConcept
Binding: example:vaccine-code
Summary: true
Mappings: workflow=Event.code; w5=FiveWs.what[x]; v2=RXA-5; rim=.code; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/consumable/manfacturedProduct/manufacturedMaterial/realmCode/code
<a id="Immunization.administeredProduct"></a>
Immunization.administeredProduct
Product that was administered
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.
Cardinality: 0..1
Type: CodeableReference
Mappings: workflow=Event.code; w5=FiveWs.what[x]; v2=RXA-5; rim=.code; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/consumable/manfacturedProduct/manufacturedMaterial/realmCode/code
<a id="Immunization.manufacturer"></a>
Immunization.manufacturer
Vaccine manufacturer
Definition: Name of vaccine manufacturer.
Cardinality: 0..1
Type: CodeableReference
Mappings: v2=RXA-17; rim=.participation[typeCode=CSM].role[classCode=INST].scopedRole.scoper[classCode=ORG]; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/consumable/manfacturedProduct/manufacuturerOrganization/name
<a id="Immunization.lotNumber"></a>
Immunization.lotNumber
Vaccine lot number
Definition: Lot number of the vaccine product.
Cardinality: 0..1
Type: string
Mappings: v2=RXA-15; rim=.participation[typeCode=CSM].role[classCode=INST].scopedRole.scoper[classCode=MMAT].id; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/consumable/manfacturedProduct/manufacturedMaterial/lotNumberText
<a id="Immunization.expirationDate"></a>
Immunization.expirationDate
Vaccine expiration date
Definition: Date vaccine batch expires.
Cardinality: 0..1
Type: date
Mappings: v2=RXA-16; rim=.participation[typeCode=CSM].role[classCode=INST].scopedRole.scoper[classCode=MMAT].expirationTime
<a id="Immunization.patient"></a>
Immunization.patient
Who was immunized
Definition: The patient who either received or did not receive the immunization.
Cardinality: 1..1
Type: Reference(Patient)
Summary: true
Mappings: workflow=Event.subject; w5=FiveWs.subject; v2=PID-3; rim=.partipication[ttypeCode=].role
<a id="Immunization.encounter"></a>
Immunization.encounter
Encounter immunization was part of
Definition: The visit or admission or other contact between patient and health care provider the immunization was performed as part of.
Cardinality: 0..1
Type: Reference(Encounter)
Mappings: workflow=Event.encounter; w5=FiveWs.context; v2=PV1-19; rim=component->EncounterEvent
<a id="Immunization.supportingInformation"></a>
Immunization.supportingInformation
Additional information in support of the immunization
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.
Cardinality: 0..*
Type: Reference(Resource)
Mappings: w5=FiveWs.context
<a id="Immunization.occurrence[x]"></a>
Immunization.occurrence[x]
Vaccine administration date
Definition: Date vaccine administered or was to be administered.
Comments: When immunizations are 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 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.
Cardinality: 1..1
Summary: true
Mappings: workflow=Event.occurrence[x]; w5=FiveWs.done[x]; v2=RXA-3; rim=.effectiveTime; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/effectiveTime/value
<a id="Immunization.primarySource"></a>
Immunization.primarySource
Indicates context the data was captured in
Definition: Indicates whether the data contained in the resource was captured by the individual/organization which was responsible for the administration of the vaccine rather than as 'secondary reported' data documented by a third party. A value of 'true' means this data originated with the individual/organization which was responsible for the administration of the vaccine.
Comments: Reflects the “reliability” of the content.
Cardinality: 0..1
Type: boolean
Summary: true
Mappings: workflow=Event.reported; w5=FiveWs.source; v2=RXA-9; rim=immunization.uncertaintycode (if primary source=false, uncertainty=U)
<a id="Immunization.informationSource"></a>
Immunization.informationSource
Indicates the source of a reported record
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.
Comments: Typically will not be populated if primarySource = True, not required even if primarySource = False.
Cardinality: 0..1
Type: CodeableReference
Binding: example:immunization-origin
Mappings: workflow=Event.reported; w5=FiveWs.source; v2=RXA-9; rim=.participation[typeCode=INF].role[classCode=PAT] (this syntax for self-reported) .participation[typeCode=INF].role[classCode=LIC] (this syntax for health care professional) .participation[typeCode=INF].role[classCode=PRS] (this syntax for family member)
<a id="Immunization.location"></a>
Immunization.location
The service delivery location
Definition: The service delivery location where the vaccine administration occurred.
Cardinality: 0..1
Type: Reference(Location)
Mappings: workflow=Event.location; w5=FiveWs.where[x]; v2=RXA-27 (or RXA-11, deprecated as of v2.7); rim=.participation[typeCode=LOC].COCT_MT240000UV
<a id="Immunization.site"></a>
Immunization.site
Body site vaccine was administered
Definition: Body site where vaccine was administered.
Cardinality: 0..1
Type: CodeableConcept
Binding: example:immunization-site
Mappings: v2=RXR-2; rim=observation.targetSiteCode; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/approachSiteCode/code
<a id="Immunization.route"></a>
Immunization.route
How vaccine entered body
Definition: The path by which the vaccine product is taken into the body.
Cardinality: 0..1
Type: CodeableConcept
Binding: example:immunization-route
Mappings: v2=RXR-1; rim=.routeCode; cda=ClinicalDocument/component/StructuredBody/component/section/entry/substanceAdministration/routeCode/code
<a id="Immunization.doseQuantity"></a>
Immunization.doseQuantity
Amount of vaccine administered
Definition: The quantity of vaccine product that was administered.
Cardinality: 0..1
Type: Quantity(SimpleQuantity)
Mappings: v2=RXA-6 / RXA-7; rim=.doseQuantity
<a id="Immunization.performer"></a>
Immunization.performer
Who performed event
Definition: Indicates who performed the immunization event.
Cardinality: 0..*
Type: BackboneElement
Summary: true
Mappings: workflow=Event.performer; v2=ORC-12 / RXA-10; rim=.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
<a id="Immunization.performer.function"></a>
Immunization.performer.function
Type of performance
Definition: Describes the function played by the performer in the immunization event (e.g. ordering provider, administering provider, etc.).
Cardinality: 0..1
Type: CodeableConcept
Binding: extensible:immunization-function
Summary: true
Mappings: workflow=Event.performer.function; rim=.participation.functionCode
<a id="Immunization.performer.actor"></a>
Immunization.performer.actor
Individual or organization who performed the event
Definition: The practitioner or organization who performed the action.
Comments: When the individual practitioner who performed the action is known, it is best to send.
Cardinality: 1..1
Type: Reference(Practitioner, PractitionerRole, Organization, Patient, RelatedPerson)
Summary: true
Mappings: workflow=Event.performer.actor; w5=FiveWs.actor; rim=.player
<a id="Immunization.note"></a>
Immunization.note
Additional immunization notes
Definition: Extra information about the immunization that is not conveyed by the other attributes.
Cardinality: 0..*
Type: Annotation
Summary: true
Mappings: workflow=Event.note; v2=OBX-5 : OBX-3 = 48767-8; rim=note
<a id="Immunization.reason"></a>
Immunization.reason
Why immunization occurred
Definition: Describes why the immunization occurred in coded or textual form, or indicates another resource (Condition, Observation or DiagnosticReport) whose existence justifies this immunization.
Cardinality: 0..*
Type: CodeableReference
Binding: example:immunization-reason
Mappings: workflow=Event.reason; rim=[actionNegationInd=false].reasonCode
<a id="Immunization.isSubpotent"></a>
Immunization.isSubpotent
Dose potency
Definition: Indication if a dose is considered to be subpotent. By default, a dose should be considered to be potent.
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.
Meaning if Missing: By default, a dose should be considered to be potent.
Cardinality: 0..1
Type: boolean
Summary: true
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.)
Mappings: v2=RXA-20 = PA (partial administration); rim=N/A
<a id="Immunization.subpotentReason"></a>
Immunization.subpotentReason
Reason for being subpotent
Definition: Reason why a dose is considered to be subpotent.
Cardinality: 0..*
Type: CodeableConcept
Binding: example:immunization-subpotent-reason
Mappings: rim=N/A
<a id="Immunization.programEligibility"></a>
Immunization.programEligibility
Patient eligibility for a specific vaccination program
Definition: Indicates a patient's eligibility for a funding program.
Cardinality: 0..*
Type: BackboneElement
Mappings: v2=OBX-5 : OBX-3 = 64994-7; rim=n/a
<a id="Immunization.programEligibility.program"></a>
Immunization.programEligibility.program
The program that eligibility is declared for
Definition: Indicates which program the patient had their eligibility evaluated for.
Cardinality: 1..1
Type: CodeableConcept
Binding: example:immunization-vaccine-funding-program
Mappings: rim=n/a
<a id="Immunization.programEligibility.programStatus"></a>
Immunization.programEligibility.programStatus
The patient's eligibility status for the program
Definition: Indicates the patient's eligibility status for a specific payment program.
Cardinality: 1..1
Type: CodeableConcept
Binding: example:immunization-program-eligibility
Mappings: rim=n/a
<a id="Immunization.fundingSource"></a>
Immunization.fundingSource
Funding source for the vaccine
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 publicly purchased vaccine but due to inventory issues, vaccine purchased with private funds was actually administered).
Cardinality: 0..1
Type: CodeableConcept
Binding: example:immunization-funding-source
Mappings: rim=N/A
<a id="Immunization.reaction"></a>
Immunization.reaction
Details of a reaction that followed the immunization
Definition: Categorical data indicating that an adverse event is associated in time to an immunization.
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.
Cardinality: 0..*
Type: BackboneElement
Mappings: v2=OBX-3; rim=Observation[classCode=obs].code
<a id="Immunization.reaction.date"></a>
Immunization.reaction.date
When reaction started
Definition: Date of reaction to the immunization.
Cardinality: 0..1
Type: dateTime
Mappings: v2=OBX-14 (ideally this would be reported in an IAM segment, but IAM is not part of the HL7 V2 VXU message - most likely would appear in OBX segments if at all); rim=.effectiveTime
<a id="Immunization.reaction.manifestation"></a>
Immunization.reaction.manifestation
Additional information on reaction
Definition: Details of the reaction.
Cardinality: 0..1
Type: CodeableReference
Mappings: v2=OBX-5; rim=.value
<a id="Immunization.reaction.reported"></a>
Immunization.reaction.reported
Indicates self-reported reaction
Definition: Self-reported indicator.
Cardinality: 0..1
Type: boolean
Mappings: v2=(HL7 V2 doesn't seem to provide for this); rim=.participation[typeCode=INF].role[classCode=PAT] (this syntax for self-reported=true)
<a id="Immunization.protocolApplied"></a>
Immunization.protocolApplied
Protocol followed by the provider
Definition: The protocol (set of recommendations) being followed by the provider who administered the dose.
Cardinality: 0..*
Type: BackboneElement
Mappings: rim=N/A
<a id="Immunization.protocolApplied.series"></a>
Immunization.protocolApplied.series
Name of vaccine series
Definition: One possible path to achieve presumed immunity against a disease - within the context of an authority.
Cardinality: 0..1
Type: string
Mappings: rim=N/A
<a id="Immunization.protocolApplied.authority"></a>
Immunization.protocolApplied.authority
Who is responsible for publishing the recommendations
Definition: Indicates the authority who published the protocol (e.g. ACIP) that is being followed.
Cardinality: 0..1
Type: Reference(Organization)
Mappings: rim=N/A
<a id="Immunization.protocolApplied.targetDisease"></a>
Immunization.protocolApplied.targetDisease
Vaccine preventable disease being targeted
Definition: The vaccine preventable disease the dose is being administered against.
Cardinality: 0..*
Type: CodeableConcept
Binding: example:immunization-target-disease
Mappings: rim=N/A
<a id="Immunization.protocolApplied.doseNumber"></a>
Immunization.protocolApplied.doseNumber
Dose number within series
Definition: Nominal position in a series as intended by the practitioner administering the dose.
Comments: The dose number may be communicated as either a coded concept (for example Dose 1, Dose 2 or Booster) or as free text as needed by the use case.
Cardinality: 0..1
Type: CodeableConcept
Binding: example
Mappings: rim=N/A
<a id="Immunization.protocolApplied.seriesDoses"></a>
Immunization.protocolApplied.seriesDoses
Recommended number of doses for immunity
Definition: The recommended number of doses to achieve immunity as intended by the practitioner administering the dose.
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.
Cardinality: 0..1
Type: CodeableConcept
Binding: example
Mappings: rim=N/A