PDF(Pubmed)
Abstract：
There have been massive studies to develop an effective vaccine against SARS-CoV-2 which fortunately led to manage the recent pandemic, COVID-19. According to the quite rapidly developed vaccines in a fast window time, large investigations to assess the probable vaccine-related adverse events are crucially required. COVID-19 vaccines are available of different platforms and the primary clinical trials results presented acceptable safety profile of the approved vaccines. Nevertheless, the long-term assessment of the adverse events or rare conditions need to be investigated. The present systematic review, aimed at classification of probable vaccine-related unsolicited adverse events in Iranian population through the data collection of the published case report studies.The related published case reports were explored via PubMed, Web of Science and Google scholar according to the available published data up to 14th Dec, 2022 using PRISMA guideline. Out of 437 explored studies, the relevant data were fully investigated which totally led to 40 studies, including 64 case reports with a new onset of a problem post-vaccination. The cases were then classified according to the various items, such as the type of adverse event and COVID-19 vaccines.The reported COVID-19 vaccines in the studied cases included BBIBP-CorV, ChAdOx1-S, Sputnik V and COVAXIN. The results showed that the adverse events presented in 8 different categories, including cutaneous involvements in 43.7% (n = 28), neurologic problems (n = 16), blood/vessel involvement (n = 6), cardiovascular involvement (n = 5), ocular disorders (n = 4), liver disorder/failure (n = 2), graft rejection (n = 2) and one metabolic disorder. Notably, almost 60% of the cases had no comorbidities. Moreover, the obtained data revealed nearly half of the incidences occurred after the first dose of injection and the median duration of improvement after the symptom was 10 days (range: 2-120). In addition, 73% of all the cases were either significantly improved or fully recovered. Liver failure following ChAdOx1-S vaccination was the most serious vaccine adverse event which led to death in two individuals with no related medical history.Although the advantages of COVID-19 vaccination is undoubtedly significant, individuals including with a history of serious disease, comorbidities and immunodeficiency conditions should be vaccinated with the utmost caution. This study provides a comprehensive overview and clinical implications of possible vaccine-related adverse events which should be considered in further vaccination strategies. Nevertheless, there might be a bias regarding potential under-reporting and missing data of the case reports included in the present study. Although the reported data are not proven to be the direct vaccination outcomes and could be a possible immune response over stimulation, the people the population with a medium/high risk should be monitored after getting vaccinated against COVID-19 of any platforms. This could be achieved by a carefull attention to the subjects \' medical history and also through consulting with healthcare providers before vaccination.
摘要：
已经有大量的研究来开发针对SARS-CoV-2的有效疫苗，幸运的是，这导致了最近的大流行，COVID-19。根据在快速窗口时间内相当迅速发展的疫苗，评估可能的疫苗相关不良事件的大型调查至关重要.COVID-19疫苗可在不同的平台上使用，初步临床试验结果显示，已批准的疫苗具有可接受的安全性。然而，需要对不良事件或罕见疾病的长期评估进行调查.本系统综述，旨在通过已发表的病例报告研究的数据收集，对伊朗人群中可能的疫苗相关不良事件进行分类。通过PubMed探索了相关的已发表病例报告，WebofScience和Google学者根据截至12月14日的可用数据，2022年使用PRISMA指南。在437项探索研究中，相关数据经过充分调查，总共导致了40项研究，包括64例疫苗接种后出现新问题的病例报告。然后根据各种项目对案件进行分类，如不良事件的类型和COVID-19疫苗。研究病例中报告的COVID-19疫苗包括BBIBP-CorV，ChAdOx1-S,SputnikV和COVAXIN.结果显示，不良事件分为8个不同类别，包括43.7%的皮肤受累(n=28)，神经系统问题（n=16），血液/血管受累（n=6），心血管受累（n=5），眼部疾病（n=4），肝脏疾病/衰竭（n=2），移植排斥反应（n=2）和一种代谢紊乱。值得注意的是,近60%的病例没有合并症.此外，获得的数据显示,近一半的发病率发生在首次注射后,症状改善的中位持续时间为10天(范围:2~120).此外,所有病例中有73％显着改善或完全康复。ChAdOx1-S疫苗接种后的肝功能衰竭是最严重的疫苗不良事件，导致两名无相关病史的个体死亡。尽管COVID-19疫苗接种的优势无疑是显著的，包括有严重疾病史的个体，合并症和免疫缺陷疾病应非常谨慎地接种疫苗。本研究提供了可能的疫苗相关不良事件的全面概述和临床意义，应在进一步的疫苗接种策略中加以考虑。然而，本研究中纳入的病例报告的潜在漏报和缺失数据可能存在偏倚.虽然报告的数据没有被证明是直接的疫苗接种结果，并且可能是一种可能的免疫反应超过刺激，在接种任何平台的COVID-19疫苗后，应监测中/高危人群。这可以通过认真关注受试者的病史以及在接种疫苗之前咨询医疗保健提供者来实现。
