An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

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 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. The adverse event status may be determined by the timing of the clinical trial assessments and is not necessarily the same as the condition status.

Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

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

Specific event that occurred or that was 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.resultingEffect differs among members of the group, then use Patient as the subject.

The Encounter associated with the start of the AdverseEvent.

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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.

The date (and perhaps time) when the cause of the AdverseEvent occurred.

The date (and perhaps time) when the effect of the AdverseEvent 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.

Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall.

The information about where the adverse event occurred.

Assessment whether this event, or averted event, was of clinical importance.

Using an example, a rash can have an AdverseEvent.resultingEffect.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.resultingEffect.severity = mild, yet an 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.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.

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

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

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

The participant should not be used when there is another element to capture the participation, such as subject or recorder.

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

Indicates who or what 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. The subject can be a participant if the subject was involved in the adverse event in another capacity beyond just being the subject, such as when the subject is a contributor or informant.

The research study that the subject is enrolled in.

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.

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.

The method of evaluating the relatedness of the suspected entity to the event.

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

The author of the information on the possible cause of the event.

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

Preventive actions that contributed to avoiding 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.

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