NAPKON-VACCINATION\Allergic Reaction To Vaccination

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

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

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.

Snapshot Table
Snapshot Table (Must Support)
Differential Table
Text Summary

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	Observation	Measurements and simple assertions
id	Σ	0..1	string	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan \| DeviceRequest \| ImmunizationRecommendation \| MedicationRequest \| NutritionOrder \| ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy)	Part of referenced event
status	?!Σ	1..1	code	registered \| preliminary \| final \| amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category		0..*	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:sct	Σ	1..*	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		1..1	string	Version of the system - if relevant Fixed Value: http://snomed.info/sct/900000000000207008/version/20210731
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 15920121000119103
display		1..1	string	Representation defined by the system Fixed Value: Allergic reaction caused by vaccine product (disorder)
userSelected		0..1	boolean	If this coding was chosen directly by the user
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	A reference from one resource to another
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	Σ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson)	Who is responsible for the observation
Slices for value[x]	SΣI	0..1	CodeableConcept	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	ΣI	0..1	CodeableConcept	Actual 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	I	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
device		0..1	Reference(Device \| DeviceMetric)	(Measurement) Device
referenceRange	I	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	I	0..1	SimpleQuantity	Low Range, if relevant
high	I	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation \| QuestionnaireResponse \| MolecularSequence)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	I	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	I	0..*	Observation	Measurements and simple assertions
subject	Σ	1..1	Reference(Patient)	A reference from one resource to another
Slices for value[x]	ΣI	0..1	CodeableConcept	Actual result Slice: Unordered, Closed by type:$this
Documentation for this format

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	Measurements and simple assertions
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:sct		1..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		1..1	string	Version of the system - if relevant Fixed Value: http://snomed.info/sct/900000000000207008/version/20210731
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 15920121000119103
display		1..1	string	Representation defined by the system Fixed Value: Allergic reaction caused by vaccine product (disorder)
system		1..1	uri	Identity of the terminology system
code		1..1	code	Symbol in syntax defined by the system
subject	S	1..1	Reference(Patient)	A reference from one resource to another
Slices for value[x]	S	0..1	CodeableConcept	Actual result Slice: Unordered, Open by type:$this
valueCodeableConcept	I	0..1	CodeableConcept	Actual 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'
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:

MII-Reference (https://www.medizininformatik-initiative.de/fhir/core/StructureDefinition/MII-Reference)

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

Path	Conformance	ValueSet
Observation.language	preferred	CommonLanguages Max Binding: AllLanguages
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.code	example	LOINCCodes
Observation.value[x]:valueCodeableConcept	required	PresentNotPresentUndeterminedOther
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	example	ObservationMethods
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes
Observation.component.code	example	LOINCCodes
Observation.component.dataAbsentReason	extensible	DataAbsentReason
Observation.component.interpretation	extensible	ObservationInterpretationCodes

Constraints

Id	Path	Details	Requirements
codeable-concept-text-present-if-code-other	Observation.value[x]:valueCodeableConcept	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' : (coding.system = 'http://snomed.info/sct' and coding.code = '74964007') implies text.exists()
obs-3	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()