关键词:预防接种,异常反应,质量控制

Abstract:

ObjectiveTo analyze the characteristics of cases which belong to and without excluding abnormal vaccination reaction after the investigation and diagnosis about an inactivated SARS-CoV-2 vaccine inoculation in Linyi city during 2020—2021， to establish quality assessment guidelines for vaccination investigation and diagnosis， and to explore quality control measures.MethodsAdverse events following immunization （AEFI） data during 2020 to 2021 in Linyi city about inactivated SARS-CoV-2 vaccine were collected through the Chinese Immunization Planning Information System， and were analyzed by descriptive and analytical epidemiological methods.ResultsThe total reported incidence of AEFI about SARS-CoV-2 vaccine in Linyi city was 0.995 6/10 000 from October 15， 2020 to December 31， 2021 and the incidence of abnormal reactions was 0.016 5/10 000， which were statistically significant compared with the incidence of abnormal reactions about conventional immunization vaccine in previous years （χ²= 253.271，P< 0.001）. There was no statistical significance in the incidence of the first injection （χ²= 0.260，P= 0.610） and the incidence of the second injection （χ²= 1.167，P= 0.280） in 3-17 years old and 18 years old and above. There was no statistical significance on the time difference between reporting and first symptom and on the composition ratio between reporting and first diagnosis （Fisher’s exact testχ²= 6.721，P= 0.150）. There was no statistical significance about the conclusion of abnormal response on the city and county levels （Fisher’s exact testχ²= 6.721，P= 0.150）.ConclusionsThe reported incidence of abnormal reactions to SARS-CoV-2 vaccine in Linyi City is significantly lower than that in the nationwide. The investigation and diagnosis conclusions at the city and county levels are fair and non-biased， but the basis of investigation and diagnosis in a few cases is not sufficient. So it is necessary to strengthen training and gradually improve the standardized investigation and diagnosis guidelines.

Key words:vaccination,abnormal reaction,quality control