Actual or potential/avoided An event causing unintended physical injury resulting from or contributed (i.e. any change to by medical care, current patient status) that may be related to unintended effects on a research study patient or other healthcare setting factors that requires research subject. The unintended effects may require additional monitoring, treatment, treatment or hospitalization, hospitalization or that results may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.

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.

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

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.

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

This is not the reporting of the event to any regulatory or quality organization.

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.

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

This element defines the specific type of Specific event that occurred or that was prevented from occurring. averted, such as patient fall, wrong organ removed, or wrong blood transfused.

This subject or group impacted by the event.

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

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

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 event, or averted event, was of real clinical importance.

Using an example, a rash can have an AdverseEvent.resultingCondition.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingCondition.severity = mild, yet a AdverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingCondition.severity = mild, yet a AdverseEvent.seriousness = serious.

Describes the severity type of outcome from 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. such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.

Describes the type of outcome from Information on who recorded the adverse event. May be the patient or a practitioner.

Information on Indicates who recorded or what participated in the adverse event. May be event and how they were involved.

Distinguishes the patient type of involvement of the actor in the adverse event, such as contributor or a practitioner. informant.

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), Indicates who or information about what activity was performed (e.g. informant witness). participated in the event.

For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history.

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

Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

Information on the possible cause of the event.

Assessment The method of if evaluating the relatedness of the suspected entity caused to the event.

AdverseEvent.suspectEntity.causalityProductRelatedness. The result of the assessment regarding the relatedness of the suspected entity to the event.

AdverseEvent.suspectEntity.causalityAuthor. The author of the information on the possible cause of the event.

ProbabilityScale | Bayesian | Checklist. The contributing factors suspected to have increased the probability or severity of the adverse event.

The item that is suspected to have increased the probability or severity of the adverse event.

AdverseEvent.subjectMedicalHistory. Preventive actions that contributed to avoiding the adverse event.

The action that contributed to avoiding the adverse event.

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

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

AdverseEvent.referenceDocument. Supporting information relevant to the event.

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin 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.

AdverseEvent.study. The research study that the subject is enrolled in.