Adverse Event Following Immunization

Any unfavorable or unintended symptom, sign, or disease including an abnormal laboratory finding) temporally associated with the previous administration of vaccine(s) that may or may not be considered related to the vaccine administration. Such events can be intervention related, dose related, route related, patient related, or caused by an interaction with other product(s) or procedure(s). (NCI Thesaurus)

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Adverse Event Expected Indicator

Specifies whether the specificity (nature), frequency, or severity of an adverse event is consistent with the applicable study documentation (e.g., investigator's brochure,…

Adverse Event End Timepoint

A point in time that indicates the conclusion of an adverse event.

Adverse Event End Time

The stop time of the adverse event.

Adverse Event End Relative to Reference Time Point

An indicator of the conclusion of the adverse event in relation to a specific point in time.

Adverse Event End Relative to Reference Period

A characterization of the relationship of an adverse event conclusion point in time to a reference point in time.

Adverse Event End Relative To Reference Code

A coded value specifying when this adverse event ended with respect to the sponsor-defined reference period.