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Analysis of Allergy and Hypersensitivity Reactions to COVID-19 Vaccines According to the EudraVigilance Database.

作者信息

Romantowski Jan, Nazar Wojciech, Bojahr Kinga, Popiołek Iwona, Niedoszytko Marek

机构信息

Department of Allergology, Medical University of Gdansk, 80-210 Gdansk, Poland.

Faculty of Medicine, Medical University of Gdańsk, 80-210 Gdańsk, Poland.

出版信息

Life (Basel). 2024 May 31;14(6):715. doi: 10.3390/life14060715.


DOI:10.3390/life14060715
PMID:38929698
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11205009/
Abstract

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic presented a new challenge in modern medicine: the development of vaccines was followed by massive population vaccinations. A few reports on post-vaccination allergic reactions have made patients and medical personnel uneasy as to COVID-19 vaccines' allergic potential. Most of the studies in this area to date have been small, and some that were based on global databases skipped most of the allergic diseases and concentrated only on anaphylaxis. We aimed to analyze the incidence of serious allergic reactions based on the EudraVigilance (EV) database, regardless of the reported symptoms and allergy mechanism. METHODS: The total number of administrated vaccine doses was extracted on 5 October 2023 from Vaccine Tracker and included all administrations since vaccinations began in the European Economic Area (EEA). Data on serious allergic reactions to COVID-19 vaccines were extracted from the EudraVigilance database with the same time point. The code names of 147 allergic symptoms or diseases were used. RESULTS: The frequency of serious allergic reactions per 100,000 administered vaccine doses was 1.53 for Comirnaty, 2.16 for Spikevax, 88.6 for Vaxzevria, 2.11 for Janssen, 7.9 for Novavax, 13.3 for VidPrevtyn Beta, and 3.1 for Valneva. The most prevalent reported reactions were edema (0.46) and anaphylaxis (0.40). Only 6% of these reactions were delayed hypersensitivity-oriented. CONCLUSIONS: The overall frequency of potential serious allergic reactions to COVID-19 is very rare. Therefore, COVID-19 vaccines seem to be safe for human use. The lowest frequency of allergic reaction was observed for Comirnaty and the highest for Vaxzevria.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13a6/11205009/4d192b1753df/life-14-00715-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13a6/11205009/9d555ad08512/life-14-00715-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13a6/11205009/4d192b1753df/life-14-00715-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13a6/11205009/9d555ad08512/life-14-00715-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/13a6/11205009/4d192b1753df/life-14-00715-g002.jpg

相似文献

[1]
Analysis of Allergy and Hypersensitivity Reactions to COVID-19 Vaccines According to the EudraVigilance Database.

Life (Basel). 2024-5-31

[2]
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[3]
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[4]
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[6]
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[7]
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[8]
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[9]
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Vaccines (Basel). 2023-3-8

[10]
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引用本文的文献

[1]
Serious adverse drug reactions associated with anti-SARS-CoV-2 vaccines and their reporting trends in the EudraVigilance database.

Sci Rep. 2025-5-27

[2]
Can Labs Help With Vaccination? In Vitro Tests in Diagnosis of Allergy to COVID-19 Vaccines-A Systematic Review.

Immun Inflamm Dis. 2025-5

本文引用的文献

[1]
Global burden of vaccine-associated anaphylaxis and their related vaccines, 1967-2023: A comprehensive analysis of the international pharmacovigilance database.

Allergy. 2024-3

[2]
Nomenclature of allergic diseases and hypersensitivity reactions: Adapted to modern needs: An EAACI position paper.

Allergy. 2023-11

[3]
Clinical Application of In Vitro Tests for COVID-19 Vaccine Delayed Hypersensitivity Diagnostics.

Int J Mol Sci. 2023-8-27

[4]
A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors.

J Korean Med Sci. 2023-6-5

[5]
COVID-19 Vaccines Are Safely Tolerated in Adolescents with Cutaneous Mastocytosis.

Int Arch Allergy Immunol. 2023

[6]
Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data.

Vaccines (Basel). 2023-3-8

[7]
Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance.

Vaccine. 2023-3-31

[8]
Anaphylaxis: Revision of the Brighton collaboration case definition.

Vaccine. 2023-4-6

[9]
Anaphylaxis to SARS-CoV-2 Vaccines in the Setting of a Nationwide Passive Epidemiological Surveillance Program.

J Clin Immunol. 2022-11

[10]
Anaphylaxis after COVID-19 vaccination: A registry-based study.

J Allergy Clin Immunol Pract. 2022-11

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