This page is part of the FHIR Specification (v0.0.82: DSTU 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

4.1 Resource AdverseReaction - Content

Records an unexpected reaction suspected to be related to the exposure of the reaction subject to a substance.

4.1.1 Scope and Usage

Adverse Reaction resources are used to provide information about specific reactions to a substance. These are normally associated with an AllergyIntolerance resource, but can be reported on their own when no assumption of further reactions is being made, or when specific events are being described.

4.1.2 Background and Context

An Adverse Reaction normally has a set of signs or symptoms that are reported in the Symptom class. However, it is possible to convey that an adverse reaction occurred without knowing the specific signs or symptoms that occurred, e.g. Some unknown reaction occurred. Similarly, it is possible to convey that an adverse reaction with a set of symptoms occurred but not indicate the substance if it is not known. e.g. A rash occurred for some unknown reason.

The Exposure class is used to indicate a set of exposures that preceded the reaction. There is no assertion of causality, purely a statement of timing. Each exposure can indicate a substance that might be different from the reaction if needed.

4.1.3 Resource Content

AdverseReaction (Resource)This records identifiers associated with this reaction that are defined by business processed and/ or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation)identifier : Identifier 0..*The date (and possibly time) when the reaction begandate : dateTime 0..1The subject of the adverse reactionsubject : Resource(Patient) 1..1If true, indicates that no reaction occurred (this element modifies the meaning of other elements)didNotOccurFlag : boolean 1..1Identifies the individual responsible for the information in the reaction recordrecorder : Resource(Practitioner|Patient) 0..1SymptomIndicates the specific sign or symptom that was observedcode : CodeableConcept 1..1 <<The type of symptom.SymptomType>>The severity of the sign or symptomseverity : code 0..1 <<The severity of an adverse reaction.ReactionSeverity>>ExposureIdentifies the initial date of the exposure that is suspected to be related to the reactiondate : dateTime 0..1The type of exposure: Drug Administration, Immunization, Coincidentaltype : code 0..1 <<The type of exposure that resulted in an adverse reactionExposureType>>A statement of how confident that the recorder was that this exposure caused the reactioncausalityExpectation : code 0..1 <<How likely is it that the given exposure caused a reactionCausalityExpectation>>Substance that is presumed to have caused the adverse reactionsubstance : Resource(Substance) 0..1The signs and symptoms that were observed as part of the reactionsymptom0..*An exposure to a substance that preceded a reaction occurrenceexposure0..*

This resource is referenced by AllergyIntolerance, Immunization, ImmunizationRecommendation and Procedure

<AdverseReaction xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: extension, modifierExtension, language, text, and contained -->
 <identifier><!-- 0..* Identifier External Ids for this adverse reaction --></identifier>
 <date value="[dateTime]"/><!-- 0..1 When the reaction occurred -->
 <subject><!-- 1..1 Resource(Patient) Who had the reaction --></subject>
 <didNotOccurFlag value="[boolean]"/><!-- 1..1 Indicates lack of reaction -->
 <recorder><!-- 0..1 Resource(Practitioner|Patient) Who recorded the reaction --></recorder>
 <symptom>  <!-- 0..* What was reaction? -->
  <code><!-- 1..1 CodeableConcept E.g. Rash, vomiting --></code>
  <severity value="[code]"/><!-- 0..1 severe | serious | moderate | minor -->
 </symptom>
 <exposure>  <!-- 0..* Suspected substance -->
  <date value="[dateTime]"/><!-- 0..1 When the exposure occurred -->
  <type value="[code]"/><!-- 0..1 drugadmin | immuniz | coincidental -->
  <causalityExpectation value="[code]"/><!-- 0..1 likely | unlikely | confirmed | unknown -->
  <substance><!-- 0..1 Resource(Substance) Presumed causative substance --></substance>
 </exposure>
</AdverseReaction>

Alternate definitions: Schema/Schematron, Resource Profile

4.1.3.1 Terminology Bindings

PathDefinitionTypeReference
AdverseReaction.symptom.code The type of symptom.IncompleteICD-10 Reaction codes
AdverseReaction.symptom.severity The severity of an adverse reaction.Fixedhttp://hl7.org/fhir/reactionSeverity
AdverseReaction.exposure.type The type of exposure that resulted in an adverse reactionFixedhttp://hl7.org/fhir/exposureType
AdverseReaction.exposure.causalityExpectation How likely is it that the given exposure caused a reactionFixedhttp://hl7.org/fhir/causalityExpectation

4.1.4 Notes:

4.1.5 Search Parameters

Search parameters for this resource. The standard parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionPaths
_idtokenThe logical resource id associated with the resource (must be supported by all servers)
_languagetokenThe language of the resource
datedateThe date of the reactionAdverseReaction.date
subjectreferenceThe subject that the sensitivity is aboutAdverseReaction.subject
(Patient)
substancereferenceThe name or code of the substance that produces the sensitivityAdverseReaction.exposure.substance
(Substance)
symptomtokenOne of the symptoms of the reactionAdverseReaction.symptom.code
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