?:definition
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Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack OTHER NAME(S): NOTE(S): The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every AdverseEvent be described by a SafetyReportVersion.
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