Amaro Carina, Monteiro Cristina, Duarte Ana Paula
Health Science Faculty, University of Beira Interior, 6201-001 Covilhã, Portugal.
UFBI-Pharmacovigilance Unit of Beira Interior, University of Beira Interior, 6201-001 Covilhã, Portugal.
J Clin Med. 2022 Sep 23;11(19):5591. doi: 10.3390/jcm11195591.
Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty, Spikevax, Vaxzevria and Jcovden. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results.
2019冠状病毒病是一种由严重急性呼吸综合征冠状病毒2引起的急性呼吸道疾病。随着该病毒迅速传播，它已成为一项重大公共卫生突发事件，这促使疫苗得以快速研发。然而，疫苗可能会出现有害的意外反应，必须向国家药物警戒系统报告。本研究的目的是对2020年12月1日至31日期间在葡萄牙贝拉内陆地区药物警戒部门（RPU）覆盖区域内报告的这些疫苗的药物不良反应（ADR）进行特征描述。在此期间，共接种了4种疫苗：辉瑞新冠疫苗（Comirnaty）、莫德纳新冠疫苗（Spikevax）、阿斯利康新冠疫苗（Vaxzevria）和卫星V新冠疫苗（Jcovden）。贝拉内陆地区药物警戒部门收到了2134份报告，涉及5685例药物不良反应，其中20.34%（n = 434）的报告被视为严重反应。其中，9.52%（n = 42）导致住院，0.45%（n = 2）导致死亡。在报告的药物不良反应中，注射部位或其周围的反应、肌痛、头痛和发热是最常报告的。大多数药物不良反应在数小时或数天内得到缓解，无后遗症。这些药物不良反应与临床试验、每种疫苗的产品特性摘要（SmPC）以及其他国家的药物不良反应报告一致。然而，需要进一步研究来证实这些结果。
