NAPKON Vaccination Module
1.0.0 - trial-use

NAPKON Vaccination Module - Local Development build (v1.0.0). See the Directory of published versions

Resource Profile: Allergic Reaction To Vaccination

Defining URL:https://www.napkon.de/fhir/StructureDefinition/allergic-reaction-to-vaccination
Version:1.0.0
Name:AllergicReactionToVaccination
Title:Allergic Reaction To Vaccination
Status:Active as of 2021-10-05
Definition:

Whether a vaccination caused an allergic reaction

Publisher:Charité - Universitätsmedizin Berlin
Source Resource:XML / JSON / Turtle

The official URL for this profile is:

https://www.napkon.de/fhir/StructureDefinition/allergic-reaction-to-vaccination

Guidance

Parameter Case Report Form Response Options
Has the patient suffered a severe allergic reaction after COVID-19 vaccination? If yes, then free text Yes / No / Unknown / Free text
Response Option Code
Yes Confirmed present (qualifier value)
No Definately not present (qualifier value)
Unknown Undetermined (qualifier value)
Free text Other (qualifier value), use Observation.valueCodeableConcept.text to specify

This profile of a FHIR Observation is derived from the Observation resource.

When specifying a free text response, use the Other (qualifier) value code in Observation.valueCodeableConcept and specify the free text response in Observation.valueCodeableConcept.text. This is enforced by the codeable-concept-text-present-if-code-other invariant.

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
... 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
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!Σ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..*CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code Σ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ1..*CodingCode defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:sct Σ1..*CodingCode defined by a terminology system

Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
...... version1..1stringVersion of the system - if relevant
Fixed Value: http://snomed.info/sct/900000000000207008/version/20210731
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: 15920121000119103
...... display1..1stringRepresentation defined by the system
Fixed Value: Allergic reaction caused by vaccine product (disorder)
...... userSelected0..1booleanIf this coding was chosen directly by the user
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ1..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ1..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... subject SΣ1..1Reference(Patient)A reference from one resource to another
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] Σ0..1Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... Slices for value[x] SΣI0..1CodeableConceptActual result
Slice: Unordered, Closed by type:$this
.... value[x]:valueCodeableConcept ΣI0..1CodeableConceptActual result
Binding: Present Not Present Undetermined Other (required)
codeable-concept-text-present-if-code-other: If codeableConcept.coding is set to SNOMED CT 'Other (qualifier value)', a string in codeableConcept.text must be supplied to identify the value of 'other'
... dataAbsentReason I0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange I0..*BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... 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
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component Σ0..*BackboneElementComponent results
.... 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
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*ObservationMeasurements and simple assertions
... subject Σ1..1Reference(Patient)A reference from one resource to another
... Slices for value[x] ΣI0..1CodeableConceptActual result
Slice: Unordered, Closed by type:$this

doco Documentation for this format

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationMeasurements and simple assertions
... code
.... Slices for coding 1..*CodingCode defined by a terminology system
Slice: Unordered, Open by pattern:$this
..... coding:sct 1..*CodingCode defined by a terminology system

Required Pattern: At least the following
...... system1..1uriIdentity of the terminology system
Fixed Value: http://snomed.info/sct
...... version1..1stringVersion of the system - if relevant
Fixed Value: http://snomed.info/sct/900000000000207008/version/20210731
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: 15920121000119103
...... display1..1stringRepresentation defined by the system
Fixed Value: Allergic reaction caused by vaccine product (disorder)
...... system 1..1uriIdentity of the terminology system
...... code 1..1codeSymbol in syntax defined by the system
... subject S1..1Reference(Patient)A reference from one resource to another
... Slices for value[x] S0..1CodeableConceptActual result
Slice: Unordered, Open by type:$this

doco Documentation for this format

This structure is derived from Observation

Summary

Mandatory: 5 elements
Must-Support: 2 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element Observation.code.coding is sliced based on the value of pattern:$this
  • The element Observation.value[x] is sliced based on the value of type:$this

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
Observation.languagepreferredCommonLanguages
Max Binding: AllLanguages
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.codeexampleLOINCCodes
Observation.value[x]:valueCodeableConceptrequiredPresentNotPresentUndeterminedOther
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdPathDetailsRequirements
codeable-concept-text-present-if-code-otherObservation.value[x]:valueCodeableConceptIf codeableConcept.coding is set to SNOMED CT 'Other (qualifier value)', a string in codeableConcept.text must be supplied to identify the value of 'other'
: (coding.system = 'http://snomed.info/sct' and coding.code = '74964007') implies text.exists()
obs-3Observation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()