Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Jul;36(4):443-458.
doi: 10.1007/s40259-022-00536-8. Epub 2022 Jun 13.

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management

Nicoletta Luxi #  1 , Alexia Giovanazzi #  1 , Alessandra Arcolaci  2 , Patrizia Bonadonna  3 , Maria Angiola Crivellaro  4 , Paola Maria Cutroneo  5 , Carmen Ferrajolo  6 , Fabiana Furci  2 , Lucia Guidolin  3 , Ugo Moretti  1 , Elisa Olivieri  3 , Giuliana Petrelli  1 , Giovanna Zanoni  2 , Gianenrico Senna  3 , Gianluca Trifirò  7
Affiliations
Review

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management

Nicoletta Luxi et al. BioDrugs. 2022 Jul.

Abstract

Conventional vaccines have been widely studied, along with their risk of causing allergic reactions. These generally consist of mild local reactions and only rarely severe anaphylaxis. Although all the current COVID-19 vaccines marketed in Europe have been shown to be safe overall in the general population, early post-marketing evidence has shown that mRNA-based vaccines using novel platforms (i.e., lipid nanoparticles) were associated with an increased risk of severe allergic reactions as compared to conventional vaccines. In this paper we performed an updated literature review on frequency, risk factors, and underlying mechanisms of COVID-19 vaccine-related allergies by searching MEDLINE and Google Scholar databases. We also conducted a qualitative search on VigiBase and EudraVigilance databases to identify reports of "Hypersensitivity" and "Anaphylactic reaction" potentially related to COVID-19 vaccines (Comirnaty, Spikevax, Vaxzevria and COVID-19 Janssen Vaccine), and in EudraVigilance to estimate the reporting rates of "Anaphylactic reaction" and "Anaphylactic shock" after COVID-19 vaccination in the European population. We also summarized the scientific societies' and regulatory agencies' recommendations for prevention and management of COVID-19 vaccine-related allergic reactions, especially in those with a history of allergy.

PubMed Disclaimer

Conflict of interest statement

Gianluca Trifirò has served in the last three years on advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, AbbVie, Servier, Mylan, Gilead, Amgen; he was the scientific director of a Master program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until Oct 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also scientific coordinator of the academic spin-off "INSPIRE srl" which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). All the above-mentioned activities are not related to the topic of the manuscript. Carmen Ferrajolo declares that she is a member and vice-chief of academic Spin-off "INSPIRE SRL– INnovative Solutions for medical Prediction and big data Integration in REal world setting SRL which has received funding for conducting observational studies from various pharmaceutical companies. All the above-mentioned activities are not related to the topic of the manuscript. The other authors have no conflicts of interest to disclose.

References

    1. European Medicines Agency. COVID-19 vaccines: authorised [Internet]. 2021. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-thr.... Accessed 14 Dec 2021.
    1. Nilsson L, Brockow K, Alm J, Cardona V, Caubet J-C, Gomes E, et al. Vaccination and allergy: EAACI position paper, practical aspects. Pediatr Allergy Immunol. 2017;28:628–640. doi: 10.1111/pai.12762. - DOI - PubMed
    1. McNeil MM, Weintraub ES, Duffy J, Sukumaran L, Jacobsen SJ, Klein NP, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol. 2016;137:868–878. doi: 10.1016/j.jaci.2015.07.048. - DOI - PMC - PubMed
    1. European Medicines Agency. How the safety of the new COVID-19 vaccines will be monitored [Internet]. 2021. https://www.ema.europa.eu/en/documents/presentation/presentation-how-saf.... Accessed 14 Dec 2021.
    1. Centers for Disease Control and Prevention. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—United States, December 14–23, 2020 [Internet]. 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm?s_cid=mm7002e1_w. Accessed 14 Dec 2021.