SHR AdverseEvent Profile

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): back pain, headache, pulmonary embolism, death. The AdverseEvent may also document a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out.

SHR Mapping Summary

shr.adverse.AdverseEvent maps to AdverseEvent:
  CodeableConcept maps to type 
  Details maps to description
  Subject maps to subject
  OccurrenceTime maps to date
  SeriousAdverseEvent maps to seriousness
  Outcome maps to outcome
  Author maps to recorder 
  AdverseEventAttribution maps to suspectEntity.instance
  AdverseEventAttribution.Certainty maps to suspectEntity.causalityAssessment	
  AssociatedStudy maps to study