新型冠状病毒疫苗接种不良反应及预防方法的研究

Study On the Adverse Reactions and Preventive Methods of Novel Coronavirus Vaccination

目的分析新型冠状病毒疫苗接种的不良反应种类,为预防接种和科学研究提供借鉴。方法调取2020年12月28日至2022年7月27日来自抚州市免疫规划信息系统疑似预防接种异常反应(AEFI)监测管理中COVID-19疫苗不良反应报告,对其按性别、年龄、临床症状等信息进行汇总分析。结果共368例不良反应,其中男131例(35.60%)、女237例(64.40%);3~14岁43例(11.68%)、15~29岁68例(18.48%)、30~39岁47例(12.77%)、40~49岁36例(9.78%)、50~59岁69例(18.75%)、60~69岁45例(12.23%)、70~79岁35例(9.51%)、80~90岁25例(6.79%);严重报告19例(5.16%),男性13例、女性6例。229例为第一次接种、102例为第二次接种、37例为第三次接种。共涉及105种(1023例次)临床症状,主要表现为头晕(141例次)、发热(112例次)、乏力(70例次)等,其中说明书未描述的不良反应症状有64种,主要表现为胸闷(51例次)、麻木(32例次)、气促(16例次)。涉及损害系统主要为全身性损害占比为31.87%;神经系统损害占比为25.02%;胃肠系统损害占比为14.47%。结论持续开展疫苗安全性监测,可补充临床研究数据短板,挖掘新的不良反应,为上市后产品的改进提供数据支持,积极预防,减少疫苗不良反应的发生率,降低对接种者身体的危害。

Objective To study and analyze the types of adverse reactions of novel coronavirus vaccination,explore new adverse reactions,and provide reference for vaccination and scientific research.Methods This study collected and analyzed the adverse reaction reports of COVID-19 vaccination reported in the city from December 28,2020 to July 27,2022,based on gender,age,clinical symptoms,and other information.Results There were 368 adverse reactions in total,including 131 males(35.60%)and 237 females(64.40%);43 cases(11.68%)aged 3-14 years,68 cases(18.48%)aged 15-29 years,47 cases(12.77%)aged 30-39 years,36 cases(9.78%)aged 40-49 years,69 cases(18.75%)aged 50-59 years,45 cases(12.23%)aged 60-69 years,35 cases(9.51%)aged 70-79 years,and 25 cases(6.79%)aged 80-90 years;19 cases(5.16%)were seriously reported,including 13 males and 6 females.229 cases were inoculated for the first time,102 cases were inoculated for the second time and 37 cases were inoculated for the third time.A total of 105 kinds(1023 cases)of clinical symptoms were involved,mainly including dizziness(141 cases),fever(112 cases),fatigue(70 cases),et al.Among them,64 kinds of symptoms were not described in the description,mainly including chest tightness(51 cases),numbness(32 cases),and shortness of breath(16 cases).The proportion of systemic damage involving the damaged system was 31.87%;the proportion of neurological damage was 25.02%;the proportion of gastrointestinal system damage was 14.47%.Conclusion Continuously conducting vaccine safety monitoring can supplement clinical research data gaps,explore new adverse reactions,provide data support for product improvement after launch,actively prevent,reduce the incidence of vaccine adverse reactions,and minimize the harm to the health of vaccinators.