Cocchio Silvia, Girolametto Gloria, Pierobon Alice, Furlan Patrizia, Destefani Emanuela, Bulegato Lorenzo, Stano Antonio, Fietta Silvia, Poletto Annachiara, Baldo Vincenzo
Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padua, Via Loredan 18, 35100 Padova, Italy.
Department of Prevention of Local Health Unit n. 7, 36061 Bassano del Grappa, Italy.
Vaccines (Basel). 2023 Mar 2;11(3):574. doi: 10.3390/vaccines11030574.
Adverse events after SARS-CoV-2 vaccinations have caused alarm to some individuals with previously diagnosed allergies. The aim of this study was to investigate whether the risk of adverse reactions was actually higher in this subgroup. To this end, we carried out an observational descriptive analysis of vaccines administered in a "protected setting" in the Veneto region of Italy between December 2020 and December 2022. Reactions were classified using systemic organic classification (SOC), and their severity was assessed using the criteria of the Italian Drug Agency (AIFA). A total of 421 subjects were vaccinated with 1050 doses, 95.0% of which were administered without adverse events. In all, 53 subjects reported 87 SOC reactions (1.6 reactions/person), and 18.3% of these reactions were severe. One person was hospitalized, but all subjects enjoyed complete remission. Reporting rates were 9.0%, 3.1%, and 1.2% for first, second, and third doses, respectively. The most frequent reactions involved the respiratory system (2.3%), the cutaneous and subcutaneous systems (2.1%), and the nervous system (1.7%). Multivariate analyses (adjOR (95% CI)) revealed that the probability of experiencing at least one reaction significantly declined with increases in age [0.95 (0.94-0.97)] and in the number of doses received, i.e., 75% [0.25 (0.13-0.49)] for second doses and 88% [0.12 (0.04-0.39)] for third doses. These results indicated that vaccinations could be safely administered; few reactions were reported, and there were no permanent adverse outcomes.
新型冠状病毒2疫苗接种后的不良事件引起了一些先前被诊断为过敏个体的恐慌。本研究的目的是调查这一亚组中不良反应的风险是否实际上更高。为此，我们对2020年12月至2022年12月期间在意大利威尼托地区“受保护环境”中接种的疫苗进行了观察性描述分析。使用系统器官分类（SOC）对反应进行分类，并根据意大利药品管理局（AIFA）的标准评估其严重程度。共有421名受试者接种了1050剂疫苗，其中95.0%的接种未发生不良事件。总共53名受试者报告了87次SOC反应（每人1.6次反应），其中18.3%的反应为严重反应。1人住院，但所有受试者均完全康复。第一剂、第二剂和第三剂的报告率分别为9.0%、3.1%和1.2%。最常见的反应涉及呼吸系统（2.3%）、皮肤和皮下系统（2.1%）以及神经系统（1.7%）。多变量分析（调整后比值比（95%置信区间））显示，随着年龄的增加[0.95（0.94 - 0.97）]以及接种剂量的增加，即第二剂为75%[0.25（0.13 - 0.49）]，第三剂为88%[0.12（0.04 - 0.39）]，发生至少一次反应的概率显著下降。这些结果表明疫苗接种可以安全进行；报告的反应很少，且没有永久性不良后果。
