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Question: Can vaccine companies default the results of the "serious AEFI" field in the quarterly case reports (an Ex table) provided by the national direct reporting system as an evaluation of "severity", and the results of the "final reaction classification" (general reaction/abnormal reaction/coincidence) as an evaluation of "relevance", Is the content of "final clinical diagnosis" (all adverse reactions listed in the instruction manual) an evaluation of the expected outcome?
Answer: Regarding "severity", please refer to the table header prompt. The result of "whether it is a serious AEFI" is a judgment of "severity",. Regarding the "final reaction type", according to the "Regulations on Vaccination Work" and the "Vaccine Management Law of the People's Republic of China" Suspected abnormal reactions to vaccination refer to reactions that may cause damage to the recipient's tissues, organs, and functions during or after vaccination, and are suspected to be related to vaccination. Abnormal reactions during preventive vaccination refer to adverse drug reactions caused by qualified vaccines during or after the implementation of standardized vaccination, resulting in damage to the recipient's tissues, organs, and functions, with no fault on the part of relevant parties. General reactions refer to reactions that occur after vaccination and are caused by the inherent characteristics of the vaccine itself, which only cause temporary physiological dysfunction to the body, mainly including fever and local redness and swelling, and may be accompanied by comprehensive symptoms such as general discomfort, fatigue, loss of appetite, and fatigue. Coincident disease, in which the recipient is in the incubation or prodromal stage of a certain disease at the time of vaccination, and occurs coincidentally after vaccination, does not constitute an abnormal response to vaccination. Therefore, the "correlation" can be determined accordingly. Regarding the "final clinical diagnosis", the final clinical diagnosis of the general reaction is made by the vaccination unit, while other types of final clinical diagnosis (including abnormal reactions, coincidence, psychogenic reactions, vaccine quality accidents, vaccination accidents) are made by the disease control department at or above the county level, and are not expected judgments.