Abnormal reaction of vaccination refers to qualifiedvaccineThe body of the recipient is caused during or after the implementation of standard vaccinationTissue and organ. Functional damage without fault of all parties concernedAdverse drug reactions。
（2） Damage to recipients due to unqualified vaccine quality;
（3） Violation by vaccination unitVaccination specificationDamage to recipients caused by immunization procedures, guiding principles for vaccine use, and vaccination programs;
（4） The recipient is in the incubation period or prodromal period of a certain disease at the time of vaccination, and the disease happens by coincidence after vaccination;
（5） The recipient has the vaccination taboo specified in the vaccine specification, the recipient or its guardian fails to truthfully provide the recipient's health status and vaccination taboo and other information before vaccination, and the recipient's original disease has an acute relapse or aggravation after vaccination;
Disease prevention and control institutions, vaccination units and their medical and health personnel found abnormal reactions to vaccinationSuspected abnormal reaction of vaccinationOr receive relevant reports according toVaccination specificationTimely deal with it and immediately report it to the competent health department of the local people's government at the county levelDrug supervision and managementDepartment.The competent health department and drug regulatory department receiving the report shall immediately organize investigation and handling[1]。
The competent health departments of the local people's governments at or above the county levelDrug supervision and managementThe department shall report to the competent health department under the State Council and the drug regulatory department level by level the abnormal reaction of vaccination occurred in its own administrative region and its handling.
After a dispute arises over the abnormal reaction of vaccination, the vaccination unit or the recipient may request the competent health department of the people's government at the county level where the vaccination unit is located to handle it.
Death, serious disability or mass vaccination of recipientsSuspected abnormal reaction of vaccinationIf the vaccination unit or recipient requests the competent health department of the people's government at the county level to deal with the problem, the competent health department receiving the request should take necessary emergency measures, report to the people's government at the same level in a timely manner, and transfer the problem to the competent health department of the people's government at the next higher level.
In case of death, serious disability or organ and tissue damage of the recipient due to abnormal reaction of vaccination, one-off compensation shall be made.
Because of vaccinationCategory I vaccineIf the recipient needs to be compensated for the abnormal reaction of vaccination, the compensation expenses shall be arranged by the financial department of the people's government of the province, autonomous region, or municipality directly under the Central Government in the funds for vaccination work.Because of vaccinationCategory II vaccineIf the recipient needs to be compensated for the abnormal reaction of vaccination, the compensation cost shall be borne by the relevant vaccine manufacturer.
The specific compensation measures for abnormal reactions to vaccination shall be formulated by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
If the vaccine quality is substandard and causes damage to the recipientDrug Administration LawHandling of relevant regulations of;Violation by vaccination unitVaccination specificationIf the vaccination procedure, the guiding principles for vaccine use, and the vaccination program cause harm to the recipients《Regulations on Handling Medical Accidents》Treatment according to relevant regulations of.
