Describes an entity that is suspected to have caused the adverse event.

A contributing factors suspected to have increased the probability or severity of the adverse event.

The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm.

The current state of the adverse event or potential adverse event.

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Codes identifying the lifecycle stage of an event.

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

Detailed type of event.

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

An Extension

Communicates Research Subject related metadata.

Indicates if the subject discontinued the study due to the adverse event.

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Comments made about the adverse event by the performer, subject or other participants.

The date the adverse event was resolved.

Describes an entity that is suspected to have caused the adverse event.

A contributing factors suspected to have increased the probability or severity of the adverse event.

The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm.

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

Indicates who or what participated in the adverse event and how they were involved.

Information about the condition that occurred as a result of the adverse event.

An Extension

The current state of the adverse event or potential adverse event.

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Overall nature of the adverse event, e.g. real or potential.

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

Detailed type of event.

This subject or group impacted by the event.

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

Assessment whether this event was of real importance.

Describes the type of outcome from the adverse event.

Describes the entity that is suspected to have caused the adverse event.

AdverseEvent.subjectMedicalHistory.

AdverseEvent.referenceDocument.

AdverseEvent.study.

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

A human language.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

An Extension

Communicates Research Subject related metadata.

Indicates if the subject discontinued the study due to the adverse event.

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Comments made about the adverse event by the performer, subject or other participants.

The date the adverse event was resolved.

Describes an entity that is suspected to have caused the adverse event.

A contributing factors suspected to have increased the probability or severity of the adverse event.

The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm.

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

Indicates who or what participated in the adverse event and how they were involved.

Information about the condition that occurred as a result of the adverse event.

An Extension

The current state of the adverse event or potential adverse event.

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Overall nature of the adverse event, e.g. real or potential.

The overall type of event, intended for search and filtering purposes.

Overall categorization of the event, e.g. product-related or situational.

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

Detailed type of event.

This subject or group impacted by the event.

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

The date (and perhaps time) when the adverse event occurred.

Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

The date on which the existence of the AdverseEvent was first recorded.

The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

The information about where the adverse event occurred.

Assessment whether this event was of real importance.

Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

The severity of the adverse event itself, in direct relation to the subject.

Describes the type of outcome from the adverse event.

Information on who recorded the adverse event. May be the patient or a practitioner.

Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).

Describes the entity that is suspected to have caused the adverse event.

AdverseEvent.subjectMedicalHistory.

AdverseEvent.referenceDocument.

AdverseEvent.study.