Ferreira-da-Silva Renato, Lobo Mariana Fernandes, Pereira Ana Margarida, Morato Manuela, Polónia Jorge Junqueira, Ribeiro-Vaz Inês
Porto Pharmacovigilance Centre, Faculty of Medicine of the University of Porto, Porto, Portugal.
RISE-Health, Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS), Faculty of Medicine of the University of Porto, Porto, Portugal.
Front Med (Lausanne). 2025 Feb 19;12:1501921. doi: 10.3389/fmed.2025.1501921. eCollection 2025.
OBJECTIVE: To analyses real-world safety data of mRNA COVID-19 vaccines within the European Economic Area (EEA), using Individual Case Safety Reports (ICSR), and to evaluate the variability in safety profiles between different vaccine versions. METHODS: We utilized EudraVigilance data from 1 January 2020, to 31 December 2023, focusing on Moderna (Spikevax) and Pfizer/BioNTech (Comirnaty) vaccines against COVID-19. We performed descriptive statistics, co-occurrence analysis, and correspondence analysis to identify patterns and clusters of adverse events following immunization (AEFI). RESULTS: We retrieved 993,199 ICSR (Moderna: 394,484; Pfizer: 605,794), with most reports related to women patients (69%) and non-healthcare professionals (65%). A total of 10,804 distinct AEFI terms were described across the retrieved ICSR, with a cumulative occurrence frequency of 3,558,219 (Moderna: 1,555,638; Pfizer: 2,031,828). The most prominent serious clusters included headache, fatigue, pyrexia, myalgia, arthralgia, malaise, nausea, and chills, which frequently co-occurred with vaccination failure. Specific AEFI like fever, chills, malaise, arthralgia, injection site pain, inflammation, and warmth were more often linked to Moderna, while Pfizer was more commonly associated with vaccination failure, menstrual disorders (heavy menstrual bleeding and dysmenorrhea), and hypoesthesia. In older adults, serious clusters included confusional states, cerebrovascular accidents, and myocardial infarctions, while myocarditis and pericarditis were noted in younger males. Although rare, serious systemic AEFI, like anaphylactic reactions, were identified but require further causality evaluation. CONCLUSION: The overall safety of mRNA COVID-19 vaccines for mass vaccination is supported, but continuous pharmacovigilance remains essential. Identified clusters of AEFI, particularly serious and systemic ones, although rare and potentially influenced by other underlying causes, underscore the need for continuous monitoring and further epidemiological investigations to explore potential causal relationships.
目的：利用个体病例安全报告（ICSR）分析欧洲经济区（EEA）内mRNA新冠疫苗的真实世界安全性数据，并评估不同疫苗版本之间安全性概况的差异。 方法：我们使用了2020年1月1日至2023年12月31日的欧洲药品不良反应监测数据库（EudraVigilance）数据，重点关注Moderna（Spikevax）和辉瑞/生物科技（Comirnaty）的新冠疫苗。我们进行了描述性统计、共现分析和对应分析，以确定免疫接种后不良事件（AEFI）的模式和聚类。 结果：我们检索到993,199份个体病例安全报告（Moderna：394,484份；辉瑞：605,794份），大多数报告与女性患者（69%）和非医护人员（65%）有关。在检索到的个体病例安全报告中，共描述了10,804个不同的AEFI术语，累积发生频率为3,558,219次（Moderna：1,555,638次；辉瑞：2,031,828次）。最突出的严重聚类包括头痛、疲劳、发热、肌痛、关节痛、不适、恶心和寒战，这些症状常与疫苗接种失败同时出现。特定的AEFI如发热、寒战、不适、关节痛、注射部位疼痛、炎症和发热更常与Moderna疫苗相关，而辉瑞疫苗更常与疫苗接种失败、月经紊乱（月经过多和痛经）以及感觉减退相关。在老年人中，严重聚类包括意识模糊状态、脑血管意外和心肌梗死，而年轻男性中则发现了心肌炎和心包炎。虽然罕见，但已识别出严重的全身性AEFI，如过敏反应，但需要进一步进行因果关系评估。 结论：mRNA新冠疫苗大规模接种的总体安全性得到支持，但持续的药物警戒仍然至关重要。已识别出的AEFI聚类，特别是严重和全身性的聚类，虽然罕见且可能受其他潜在原因影响，但强调了持续监测和进一步流行病学调查以探索潜在因果关系的必要性。
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