First Department of Pediatrics, Infectious Diseases and Chemotherapy Research Laboratory, Medical School, National and Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, Greece.
Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Hum Vaccin Immunother. 2021 Dec 2;17(12):4755-4760. doi: 10.1080/21645515.2021.1985356. Epub 2021 Nov 30.
The aim of the study was to investigate the prevalence and severity of adverse reactions (ARs) after immunization of healthcare workers (HCWs) with BNT162b2 vaccine and to associate them with clinical and epidemiological characteristics.
A form containing demographic and clinical data as well as ARs after both doses of the vaccine was completed, and statistical association analysis was performed.
A total of 502 HCWs (females 78.3%) with mean age (±SD) 48.17 years (±12.97) participated. After the first dose, 404 (80.5%) HCWs reported at least one local AR (LAR) and 366 (72.9%) after the second dose (-value=0.004). After the first dose, 121 (24.1%) HCWs reported at least one systemic AR (SAR) and 275 (54.8%) after the second dose (-value<0.0001).In the logistic regression analysis, there was no association of gender or medical history of underlying disease with LARs. There was a negative association of age with the cumulative score (CS) of LARs (OR: 0.82, 95% CI: 0.69-0.96) after the first dose. Females had a positive association with CS of SARs following both doses (OR, 95% CI: 2.57, 1.39-4.73 and 2.71, 1.76-4.19, respectively). Age was negatively associated with CS of SARs (OR: 0.66, 95% CI: 0.57-0.76) after the second dose. Severe ARs included Bell's palsy (1) and tinnitus with temporary hearing loss (1).
The administration of the BNT162b2 vaccine in our HCWs cohort had a good safety profile with the most common ARs being self-limited. An increasing rate of SARs following the second vaccine dose was noticed. Rare but severe possible ARs should be further investigated.
本研究旨在调查医护人员（HCWs）接种 BNT162b2 疫苗后的不良反应（ARs）发生率和严重程度，并将其与临床和流行病学特征相关联。
完成一份包含人口统计学和临床数据以及疫苗两剂后 AR 情况的表格，并进行统计关联分析。
共纳入 502 名（78.3%为女性）平均年龄（±标准差）为 48.17±12.97 岁的 HCWs。接种首剂后，404 名（80.5%）HCWs报告至少有一种局部不良反应（LAR），366 名（72.9%）HCWs报告至少有一种全身不良反应（SAR）（-值=0.004）。接种首剂后，121 名（24.1%）HCWs报告至少有一种 SAR，275 名（54.8%）HCWs报告至少有一种 SAR（-值<0.0001）。在逻辑回归分析中，性别或基础疾病史与 LAR 之间无关联。年龄与首剂后 LAR 累积评分（CS）呈负相关（OR：0.82，95%CI：0.69-0.96）。女性与两剂后 SAR 的 CS 呈正相关（OR，95%CI：2.57，1.39-4.73 和 2.71，1.76-4.19）。年龄与第二剂后 SAR 的 CS 呈负相关（OR：0.66，95%CI：0.57-0.76）。严重不良反应包括贝尔麻痹（1 例）和伴有短暂听力损失的耳鸣（1 例）。
在我们的 HCWs 队列中，BNT162b2 疫苗的使用具有良好的安全性，最常见的不良反应为自限性。接种第二剂疫苗后 SAR 的发生率增加。应进一步调查罕见但严重的可能不良反应。
