Objective To quantify the background incidence rates of 15 prespecified adverse events of special interest (AESIs) associated with covid-19 vaccines. Design Multinational network cohort study. Setting Electronic health records and health claims data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model. Participants 126 661 070 people observed for at least 365 days before 1 January 2017, 2018, or 2019 from 13 databases. Main outcome measures Events of interests were 15 prespecified AESIs (non-haemorrhagic and haemorrhagic stroke, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, anaphylaxis, Bell’s palsy, myocarditis or pericarditis, narcolepsy, appendicitis, immune thrombocytopenia, disseminated intravascular coagulation, encephalomyelitis (including acute disseminated encephalomyelitis), Guillain-Barré syndrome, and transverse myelitis). Incidence rates of AESIs were stratified by age, sex, and database. Rates were pooled across databases using random effects meta-analyses and classified according to the frequency categories of the Council for International Organizations of Medical Sciences. Results Background rates varied greatly between databases. Deep vein thrombosis ranged from 387 (95% confidence interval 370 to 404) per 100 000 person years in UK CPRD GOLD data to 1443 (1416 to 1470) per 100 000 person years in US IBM MarketScan Multi-State Medicaid data among women aged 65 to 74 years. Some AESIs increased with age. For example, myocardial infarction rates in men increased from 28 (27 to 29) per 100 000 person years among those aged 18-34 years to 1400 (1374 to 1427) per 100 000 person years in those older than 85 years in US Optum electronic health record data. Other AESIs were more common in young people. For example, rates of anaphylaxis among boys and men were 78 (75 to 80) per 100 000 person years in those aged 6-17 years and 8 (6 to 10) per 100 000 person years in those older than 85 years in Optum electronic health record data. Meta-analytic estimates of AESI rates were classified according to age and sex. Conclusion This study found large variations in the observed rates of AESIs by age group and sex, showing the need for stratification or standardisation before using background rates for safety surveillance. Considerable population level heterogeneity in AESI rates was found between databases.

中文翻译：

---

描述八个国家特别关注的 covid-19 疫苗不良事件的背景发生率：跨国网络队列研究


目的 量化与 covid-19 疫苗相关的 15 种预先指定的特殊关注不良事件 (AESI) 的背景发生率。设计跨国网络队列研究。设置来自八个国家（澳大利亚、法国、德国、日本、荷兰、西班牙、英国和美国）的电子健康记录和健康声明数据，映射到通用数据模型。参与者 126 661 070 人，在 2017 年、2018 年或 2019 年 1 月 1 日之前从 13 个数据库进行了至少 365 天的观察。主要结果指标 感兴趣的事件为 15 种预先指定的 AESI（非出血性和出血性中风、急性心肌梗死、深静脉血栓形成、肺栓塞、过敏反应、贝尔氏麻痹、心肌炎或心包炎、发作性睡病、阑尾炎、免疫性血小板减少症、弥散性血管内凝血、脑脊髓炎） （包括急性播散性脑脊髓炎）、格林-巴利综合征和横贯性脊髓炎）。 AESI 的发病率按年龄、性别和数据库进行分层。使用随机效应荟萃分析对各个数据库的比率进行汇总，并根据国际医学科学组织理事会的频率类别进行分类。结果 数据库之间的背景率差异很大。英国 CPRD GOLD 数据中的深静脉血栓形成率为每 10 万人年 387 例（95% 置信区间为 370 至 404 例），美国 IBM MarketScan 多州医疗补助数据中 65 岁女性的深静脉血栓形成率为每 10 万人年 1443 例（95% 置信区间为 1416 至 1470 例）至74岁。一些 AESI 随着年龄的增长而增加。 例如，美国 Optum 电子公司的男性心肌梗塞发病率从 18-34 岁人群中每 10 万人年 28 例（27 例至 29 例）增加到 85 岁以上人群中每 10 万人年 1400 例（1374 例至 1427 例）。健康记录数据。其他 AESI 在年轻人中更为常见。例如，Optum Electronic 的男孩和男性过敏反应发生率在 6-17 岁的人群中为每 10 万人年 78 例（75 至 80 例），在 85 岁以上的人群中每 10 万人年有 8 例（6 至 10 例）。健康记录数据。 AESI 率的荟萃分析估计值根据年龄和性别进行分类。结论 本研究发现，不同年龄组和性别的 AESI 观察率存在很大差异，表明在使用背景率进行安全监测之前需要进行分层或标准化。数据库之间的 AESI 率在人群水平上存在相当大的异质性。