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ISSN 2063-5346
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EVIDENCE OF COVID-19 VACCINE SAFETY: A REVIEW OF REPORTED ADVERSE EVENTS

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Salem Hussen Mosfer Alsaad, Ojeam Mana Saleh Al Mutared, Wael Hamad Al Jamhoor, Saleh Mohammed Hamad Al Yami, Khaled Hassan Hadi Al Hokash, Saleh Mohaimeed Saleh Al Sharmah, Masoud Saleh Ahmed Al Haydar, Yahya Ali Al Qanass
» doi: 10.53555/ecb/2023.12.4.322

Abstract

Introduction: Vaccine hesitancy, influenced by complex behavioral factors such as the "theory of planned behavior," necessitates both quantitative and qualitative research to uncover the underlying causes of reluctance toward COVID-19 vaccination, which could undermine pandemic management efforts. This study focuses on assessing the reported side effects of COVID-19 vaccines as documented in scholarly article. Methods: We targeted studies of a randomized controlled trial design to assess COVID-19 vaccine side effects. Databases including PubMed, Web of Science, Embase, CINAHL, PsycINFO, LILACS, SCOPUS, ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), medRxiv.org, biorxiv.org, preprints.org, and the Cochrane Library were searched up to November 2022. Three independent reviewers were involved in the study selection, methodological quality assessment, and data extraction processes. A meta-analysis was conducted where feasible, and findings were summarized using the Grading of Recommendations, Assessment, Development, and Evaluations framework. Results: A variety of vaccine-related adverse effects were identified, including anaphylaxis, fever, musculoskeletal pain, headaches, fatigue, nausea, chills, skin redness, swollen lymph nodes, tingling sensations, vomiting, dizziness, heart rhythm anomalies, blood pressure fluctuations, and facial paralysis. The initial 15-day period post-vaccination was identified as carrying a heightened risk for these adverse effects. Our search yielded 29 results from PubMed and one from manual searching. To date, eight COVID-19 vaccine candidates have received emergency use authorization in various countries, and 12 are undergoing clinical trials tell the third quarter of this year. Conclusions: Given the expedited emergency approval of COVID-19 vaccines without the full completion of clinical trials, it is imperative to rigorously establish their safety. The available information on these vaccines and their clinical trial safety outcomes remain to be fully determined.

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