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2021 年 7 月 1 日至 2022 年 6 月 30 日,疫苗不良事件报告系统(VAERS)中 mRNA COVID-19 疫苗与季节性流感灭活疫苗联合接种的安全性。

Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021-June 30, 2022.

机构信息

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.

出版信息

Vaccine. 2023 Mar 10;41(11):1859-1863. doi: 10.1016/j.vaccine.2022.12.069. Epub 2023 Jan 9.

Abstract

BACKGROUND

COVID-19 vaccines may be co-administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.

OBJECTIVE

To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of mRNA COVID-19 and seasonal influenza vaccines.

METHODS

We searched the VAERS database for reports of adverse events (AEs) following co-administration of mRNA COVID-19 and seasonal influenza vaccines and following a first booster dose mRNA COVID-19 vaccine alone, during July 1, 2021-June 30, 2022. We assessed the characteristics of these reports and described the most frequently reported MedDRA preferred terms (PTs). Clinicians reviewed available medical records for serious reports and reports of adverse events of special interest (AESI) and categorized the main diagnosis by system organ class.

RESULTS

From July 1, 2021 through June 30, 2022, VAERS received 2,449 reports of adverse events following co-administration of mRNA COVID-19 and seasonal influenza vaccines. Median age of vaccinees was 48 years (IQR: 31, 66); 387 (15.8%) were classified as serious. Most reports (1,713; 69.3%) described co-administration of a first booster dose of an mRNA COVID-19 vaccine with seasonal influenza vaccine. The most common AEs among non-serious reports were injection site reactions (193; 14.5%), headache (181; 13.6%), and pain (171; 12.8%). The most common AEs among reports classified as serious were dyspnea (38; 14.9%), COVID-19 infection (32; 12.6%), and chest pain (27; 10.6%).

DISCUSSION

This review of reports to VAERS following co-administration of mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19 disease) was expected. CDC will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines, including co-administration involving bivalent mRNA COVID-19 booster vaccines that have been recommended for people ages ≥ 6 months in the United States.

摘要

背景

COVID-19 疫苗可与其他推荐疫苗同时接种,包括季节性流感疫苗。然而,很少有研究评估 mRNA COVID-19 与季节性流感疫苗同时接种的安全性。

目的

描述 2021 年 7 月 1 日至 2022 年 6 月 30 日期间,向疫苗不良事件报告系统(VAERS)报告的 mRNA COVID-19 和季节性流感疫苗同时接种以及单独接种 mRNA COVID-19 疫苗第一剂加强针后不良事件(AE)的报告。

方法

我们在 VAERS 数据库中搜索了 2021 年 7 月 1 日至 2022 年 6 月 30 日期间报告的同时接种 mRNA COVID-19 和季节性流感疫苗以及单独接种 mRNA COVID-19 疫苗第一剂加强针后不良事件的报告。我们评估了这些报告的特征,并描述了最常报告的 MedDRA 首选术语(PT)。临床医生对严重报告和不良事件特别关注(AESI)报告进行了可用病历审查,并按系统器官分类对主要诊断进行了分类。

结果

从 2021 年 7 月 1 日至 2022 年 6 月 30 日,VAERS 收到了 2449 份关于同时接种 mRNA COVID-19 和季节性流感疫苗的不良事件报告。疫苗接种者的中位年龄为 48 岁(IQR:31,66);387 例(15.8%)被归类为严重。大多数报告(1713 例;69.3%)描述了接种 mRNA COVID-19 疫苗第一剂加强针和季节性流感疫苗。非严重报告中最常见的 AE 是注射部位反应(193 例;14.5%)、头痛(181 例;13.6%)和疼痛(171 例;12.8%)。严重报告中最常见的 AE 是呼吸困难(38 例;14.9%)、COVID-19 感染(32 例;12.6%)和胸痛(27 例;10.6%)。

讨论

本 review 对 VAERS 报告的同时接种 mRNA COVID-19 和季节性流感疫苗的不良事件进行了审查,并未发现任何异常或意外的 AE 模式。预计会有更多的特定事件(例如 COVID-19 疾病)报告。CDC 将继续监测 mRNA COVID-19 和季节性流感疫苗同时接种的安全性,包括在美国推荐用于≥6 个月人群的 bivalent mRNA COVID-19 加强疫苗的同时接种。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f61d/9826985/08ca8cf7a484/gr1_lrg.jpg

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