Answer： According to the "Guiding Principles for Collection and Reporting of Adverse Drug Reactions in Individual Cases" 4.1, when the nature, severity, characteristics, or results of adverse reactions do not match the terms or descriptions in this holder's manual, they should be considered as new adverse reactions (or unexpected adverse reactions). According to the "ICH-E2D Postmarket Safety Data Management: Definition and Standards for Rapid Reporting" definition of unexpected ADR: If the nature, severity, characteristics, or results of an ADR are inconsistent with the terminology or description used in local/regional prescription materials (such as user manuals or product feature summaries), it should be considered unexpected. If the holder of the listing permit cannot determine whether an ADR is expected or unexpected, the ADR should be treated as unexpected.