Riad Abanoub, Hocková Barbora, Kantorová Lucia, Slávik Rastislav, Spurná Lucia, Stebel Adam, Havriľak Michal, Klugar Miloslav
Czech National Centre for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Centre of Excellence, Masaryk University GRADE Centre), Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, 625 00 Brno, Czech Republic.
Department of Public Health, Faculty of Medicine, Masaryk University, 625 00 Brno, Czech Republic.
Pharmaceuticals (Basel). 2021 Aug 29;14(9):873. doi: 10.3390/ph14090873.
mRNA-based COVID-19 vaccines such as BNT162b2 have recently been a target of anti-vaccination campaigns due to their novelty in the healthcare industry; nevertheless, these vaccines have exhibited excellent results in terms of efficacy and safety. As a consequence, they acquired the first approvals from drug regulators and were deployed at a large scale among priority groups, including healthcare workers. This phase IV study was designed as a nationwide cross-sectional survey to evaluate the post-vaccination side effects among healthcare workers in Slovakia. The study used a validated self-administered questionnaire that inquired about participants' demographic information, medical anamneses, COVID-19-related anamnesis, and local, systemic, oral, and skin-related side effects following receiving the BNT162b2 vaccine. A total of 522 participants were included in this study, of whom 77% were females, 55.7% were aged between 31 and 54 years, and 41.6% were from Banska Bystrica. Most of the participants (91.6%) reported at least one side effect. Injection site pain (85.2%) was the most common local side effect, while fatigue (54.2%), headache (34.3%), muscle pain (28.4%), and chills (26.4%) were the most common systemic side effects. The reported side effects were of a mild nature (99.6%) that did not require medical attention and a short duration, as most of them (90.4%) were resolved within three days. Females and young adults were more likely to report post-vaccination side effects; such a finding is also consistent with what was previously reported by other phase IV studies worldwide. The role of chronic illnesses and medical treatments in post-vaccination side effect incidence and intensity requires further robust investigation among large population groups.
基于信使核糖核酸的新冠疫苗，如BNT162b2，由于其在医疗行业中的新颖性，最近成为了反疫苗运动的目标；然而，这些疫苗在有效性和安全性方面都表现出了出色的结果。因此，它们获得了药品监管机构的首批批准，并在包括医护人员在内的优先群体中大规模部署。这项IV期研究旨在作为一项全国性横断面调查，以评估斯洛伐克医护人员接种疫苗后的副作用。该研究使用了一份经过验证的自我管理问卷，询问参与者的人口统计学信息、病史、与新冠相关的病史，以及接种BNT162b2疫苗后的局部、全身、口腔和皮肤相关副作用。本研究共纳入522名参与者，其中77%为女性，55.7%年龄在31至54岁之间，41.6%来自班斯卡·比斯特里察。大多数参与者（91.6%）报告了至少一种副作用。注射部位疼痛（85.2%）是最常见的局部副作用，而疲劳（54.2%）、头痛（34.3%）、肌肉疼痛（28.4%）和寒战（26.4%）是最常见的全身副作用。报告的副作用性质轻微（99.6%），不需要医疗护理，且持续时间短，因为大多数副作用（90.4%）在三天内就得到了解决。女性和年轻人更有可能报告接种疫苗后的副作用；这一发现也与全球其他IV期研究之前的报告一致。慢性病和药物治疗在接种疫苗后副作用发生率和强度方面的作用，需要在大量人群中进行进一步有力的调查。
