Guidance

​This profile of a FHIR Immunization is derived from the History of Vaccination profile of the GECCO dataset.

The valueset bindings on the Immunization.vaccineCode and Immunization.statusReason elements have been constrained to solely feature the response options for this particular parameter of the case report form.

Immunization reason

The response options to the Why did the patient get vaccinated against COVID-19/will the patient get vaccinated? are coded through the following codes of the NAPKON Vaccination Module Codes and from SNOMED CT.

Immunization not performed

In case a vaccination was not performed, the Immunization.status element shall be set to not-done and the Immunization.statusReason element shall be set to one of the codes from the value set binding or Immunization.statusReason.text shall be used to provide a free text reason for the not-done status.

The response options for Immunization.statusReason are encoded as follows:

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

Name	Flags	Card.	Type	Description & Constraints
Immunization	I	0..*	Immunization	Immunization event information immunization-status-reason-if-not-done: If status is set to #not-done, a statusReason must be supplied
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
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
identifier		0..*	Identifier	Business identifier
status	?!Σ	1..1	code	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): A set of codes indicating the current status of an Immunization.
statusReason		0..1	CodeableConcept	Reason not done Binding: COVID-19 Vaccination Contraindications (required)
vaccineCode	SΣ	1..1	CodeableConcept	Vaccine product administered Binding: VaccineAdministeredValueSet (example): The code for vaccine product administered.
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	0..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:$this
coding:snomed	SΣ	0..1	Coding	Code defined by a terminology system Binding: VaccinesSNOMED (extensible): SNOMED Vaccine Codes 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		0..1	string	Version of the system - if relevant
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
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
coding:atc	SΣ	0..1	Coding	Code defined by a terminology system Binding: VaccinesATC (extensible): ATC Vaccine Codes 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://fhir.de/CodeSystem/bfarm/atc
version		0..1	string	Version of the system - if relevant
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
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
coding:pzn	SΣ	0..1	Coding	Code defined by a terminology system Binding: PZN (required) 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://fhir.de/CodeSystem/ifa/pzn
version		0..1	string	Version of the system - if relevant
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
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
coding:absentOrUnknownImmunization	SΣ	0..1	Coding	​Code defined by a terminology system Binding: Absent or Unknown Immunization - IPS (required) 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://hl7.org/fhir/uv/ips/CodeSystem/absent-unknown-uv-ips
version		0..1	string	Version of the system - if relevant
code		0..1	code	Symbol in syntax defined by the system
display		0..1	string	Representation defined by the system
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
coding:COVID19VaccineName	Σ	0..*	Coding	Code defined by a terminology system Binding: COVID-19 Vaccine Codes (required)
text	Σ	0..1	string	Plain text representation of the concept
patient	SΣI	1..1	Reference(Patient)	Who was immunized
encounter	I	0..1	Reference(Encounter)	Encounter immunization was part of
Slices for occurrence[x]	SΣ	1..1		Vaccine administration date Slice: Unordered, Open by type:$this
occurrenceDateTime			dateTime
occurrenceString			string
occurrence[x]:occurrenceDateTime	SΣ	0..1	dateTime	Vaccine administration date
recorded		0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	Σ	0..1	boolean	Indicates context the data was recorded in
reportOrigin		0..1	CodeableConcept	Indicates 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	I	0..1	Reference(Location)	Where immunization occurred
manufacturer	I	0..1	Reference(Organization)	Vaccine manufacturer
lotNumber	SI	0..1	string	Vaccine lot number must-exist-if-vaccination-performed: This item must be specified if the vaccination was performed
expirationDate		0..1	date	Vaccine expiration date
site		0..1	CodeableConcept	Body site vaccine was administered Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
route		0..1	CodeableConcept	How vaccine entered body Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
doseQuantity	I	0..1	SimpleQuantity	Amount of vaccine administered
performer	Σ	0..*	BackboneElement	Who performed event
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
function	Σ	0..1	CodeableConcept	What type of performance was done Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
actor	ΣI	1..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization who was performing
note	Σ	0..*	Annotation	Additional immunization notes
reasonCode	SI	1..1	CodeableConcept	Why immunization occurred Binding: COVID-19 Vaccination Reasons (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'
reasonReference	I	0..*	Reference(Condition | Observation | DiagnosticReport)	Why immunization occurred
isSubpotent	?!Σ	0..1	boolean	Dose potency
subpotentReason		0..*	CodeableConcept	Reason for being subpotent Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
education	I	0..*	BackboneElement	Educational material presented to patient
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
documentType		0..1	string	Educational material document identifier
reference		0..1	uri	Educational material reference pointer
publicationDate		0..1	dateTime	Educational material publication date
presentationDate		0..1	dateTime	Educational material presentation date
programEligibility		0..*	CodeableConcept	Patient eligibility for a vaccination program Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
fundingSource		0..1	CodeableConcept	Funding source for the vaccine Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
reaction		0..*	BackboneElement	Details of a reaction that follows immunization
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
date		0..1	dateTime	When reaction started
detail	I	0..1	Reference(Vaccination Injection Site Pain | Vaccination Injection Site Erythema | Vaccination Injection Site Swelling | Body Temperature After Vaccination | Allergic Reaction To Vaccination)	Additional information on reaction
reported		0..1	boolean	Indicates self-reported reaction
protocolApplied	S	1..*	BackboneElement	Protocol followed by the provider
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
series		0..1	string	Name of vaccine series
authority	I	0..1	Reference(Organization)	Who is responsible for publishing the recommendations
targetDisease	S	1..*	CodeableConcept	Vaccine preventatable disease being targetted Binding: https://fhir.kbv.de/ValueSet/KBV_VS_MIO_Vaccination_TargetDisease (extensible): The vaccine preventable disease the dose is being administered for. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
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: 840539006
display		1..1	string	Representation defined by the system Fixed Value: Disease caused by Severe acute respiratory syndrome coronavirus 2 (disorder)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
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
coding	SΣ	1..1	Coding	Code defined by a terminology system
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
Slices for doseNumber[x]		1..1	positiveInt	Dose number within series Slice: Unordered, Closed by type:$this
doseNumber[x]:doseNumberPositiveInt		1..1	positiveInt	Dose number within series
seriesDoses[x]		0..1		Recommended number of doses for immunity
seriesDosesPositiveInt			positiveInt
seriesDosesString			string
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Immunization	I	0..*	Immunization	Immunization event information immunization-status-reason-if-not-done: If status is set to #not-done, a statusReason must be supplied
vaccineCode	Σ	1..1	CodeableConcept	Vaccine product administered Binding: VaccineAdministeredValueSet (example): The code for vaccine product administered.
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Binding: VaccinesSNOMED (extensible): SNOMED Vaccine Codes Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
coding:atc	Σ	0..1	Coding	Code defined by a terminology system Binding: VaccinesATC (extensible): ATC Vaccine Codes Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/CodeSystem/bfarm/atc
coding:pzn	Σ	0..1	Coding	Code defined by a terminology system Binding: PZN (required) Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/CodeSystem/ifa/pzn
coding:absentOrUnknownImmunization	Σ	0..1	Coding	​Code defined by a terminology system Binding: Absent or Unknown Immunization - IPS (required) Required Pattern: At least the following
system		1..1	uri	​Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/ips/CodeSystem/absent-unknown-uv-ips
patient	ΣI	1..1	Reference(Patient)	Who was immunized
Slices for occurrence[x]	Σ	1..1		Vaccine administration date Slice: Unordered, Open by type:$this
occurrenceDateTime			dateTime
occurrenceString			string
occurrence[x]:occurrenceDateTime	Σ	0..1	dateTime	Vaccine administration date
lotNumber	I	0..1	string	Vaccine lot number must-exist-if-vaccination-performed: This item must be specified if the vaccination was performed
reasonCode	I	1..1	CodeableConcept	Why immunization occurred Binding: COVID-19 Vaccination Reasons (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'
protocolApplied		1..*	BackboneElement	Protocol followed by the provider
targetDisease		1..*	CodeableConcept	Vaccine preventatable disease being targetted Binding: https://fhir.kbv.de/ValueSet/KBV_VS_MIO_Vaccination_TargetDisease (extensible): The vaccine preventable disease the dose is being administered for. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
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: 840539006
display		1..1	string	Representation defined by the system Fixed Value: Disease caused by Severe acute respiratory syndrome coronavirus 2 (disorder)
coding	Σ	1..1	Coding	Code defined by a terminology system
Documentation for this format

​This structure is derived from Immunization

Name	Flags	Card.	Type	Description & Constraints
Immunization	I	0..*	Immunization	Immunization event information immunization-status-reason-if-not-done: If status is set to #not-done, a statusReason must be supplied
statusReason		0..1	CodeableConcept	Reason not done Binding: COVID-19 Vaccination Contraindications (required)
vaccineCode
coding:COVID19VaccineName		0..*	Coding	Code defined by a terminology system Binding: COVID-19 Vaccine Codes (required)
lotNumber	SI	0..1	string	Vaccine lot number must-exist-if-vaccination-performed: This item must be specified if the vaccination was performed
reasonCode	SI	1..1	CodeableConcept	Why immunization occurred Binding: COVID-19 Vaccination Reasons (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'
reaction
detail		0..1	Reference(Vaccination Injection Site Pain | Vaccination Injection Site Erythema | Vaccination Injection Site Swelling | Body Temperature After Vaccination | Allergic Reaction To Vaccination)	Additional information on reaction
protocolApplied		1..*	BackboneElement	Protocol followed by the provider
targetDisease		1..*	CodeableConcept	Vaccine preventatable disease being targetted Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
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: 840539006
display		1..1	string	Representation defined by the system Fixed Value: Disease caused by Severe acute respiratory syndrome coronavirus 2 (disorder)
doseNumberPositiveInt		1..1	positiveInt	Dose number within series
Documentation for this format