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      Cutaneous adverse reactions following COVID‐19 vaccinations: A systematic review and meta‐analysis

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          Abstract

          Background

          COVID‐19 vaccines are currently the most effective interventions in controlling and preventing severe disease progression. Dermatologic reactions to COVID‐19 vaccinations may be rare among clinical trial participants. However, since global mass vaccination became a reality, these adverse effects may become more widespread, and different skin reactions would arise.

          Objective

          To systematically review the cutaneous adverse reactions in cases subject to vaccines for COVID‐19.

          Methods

          We searched the PubMed, SCOPUS, Web of Science, and Embase databases, identifying the relevant records and including the eligible observational ones. After assessing the methodological quality of the included studies, we qualitatively and quantitatively synthesized the data regarding the cutaneous side effects experienced by those in the studies' population.

          Results

          Overall, 36 studies were included in our systematic review, with the majority being cross‐sectional. We found that pain, erythema, and swelling were the most common local side effects, while different types of rashes, urticaria, and angioedema were the most non‐local. Few cases also reported experiencing flare‐ups of their underlying diseases or developing newly‐onset diseases of various etiologies. Our meta‐analyses also found that while viral vector‐based vaccines are, though insignificantly, safer in injection site complaints, individuals who received mRNA vaccines developed significantly fewer non‐local cutaneous adverse events.

          Discussion

          Cutaneous reactions to the COVID‐19 vaccines are similar to common cutaneous drug eruptions and COVID‐19 cutaneous manifestations. However, we believe that further high‐quality research is needed to assess better how and why cutaneous reactions occur in different vaccines.

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          The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

          Matthew J L Page, Joanne E McKenzie, Patrick Bossuyt … (2025)
          The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
          Article 0 comments Cited 14608 times – based on 0 reviews     Review now
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            Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

            Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
            Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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              Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

              Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
              Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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                Author and article information

                Contributors
                Najmeh Ahramiyanpour:
                ORCID: https://orcid.org/0000-0003-3171-5933
                najmeh.pour@gmail.com
                Journal
                Journal ID (nlm-ta): J Cosmet Dermatol
                Journal ID (iso-abbrev): J Cosmet Dermatol
                Journal ID (doi): 10.1111/(ISSN)1473-2165
                Journal ID (publisher-id): JOCD
                Title: Journal of Cosmetic Dermatology
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 1473-2130
                ISSN (Electronic): 1473-2165
                Publication date (Electronic): 01 August 2022
                Publication date PMC-release: 01 August 2022
                Electronic Location Identifier: 10.1111/jocd.15261
                Affiliations
                [ 1 ] Faculty of Medicine Kerman University of Medical Sciences Kerman Iran
                [ 2 ] Gene Therapy Research Center Digestive Diseases Research Institute, Tehran University of Medical Sciences Tehran Iran
                [ 3 ] Departments of Plastic Surgery Shahid Beheshti University of Medical Sciences Tehran Iran
                [ 4 ] Department of Dermatology, Afzalipour Hospital, Afzalipour Faculty of Medicine Kerman University of Medical Sciences Kerman Iran
                Author notes
                [*] [* ] Correspondence

                Najmeh Ahramiyanpour, Department of Dermatology, Afzalipour Hospital, Afzalipour Faculty of Medicine, Kerman University of Medical Sciences, Kerman 7616913555, Iran.

                Email: najmeh.pour@ 123456gmail.com

                Author information
                https://orcid.org/0000-0001-7319-000X
                https://orcid.org/0000-0002-6241-4108
                https://orcid.org/0000-0002-3315-8977
                https://orcid.org/0000-0002-9040-8899
                https://orcid.org/0000-0001-7184-0275
                https://orcid.org/0000-0003-3171-5933
                Article
                Publisher ID: JOCD15261 Other ID: JCD-05-2022-745.R1
                DOI: 10.1111/jocd.15261
                PMC ID: 9350270
                PubMed ID: 35861631
                SO-VID: fdf0f69a-c52a-4c53-abac-c5995691b973
                Copyright © © 2022 Wiley Periodicals LLC.
                License:

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                Date revision received : 02 July 2022
                Date received : 29 May 2022
                Date accepted : 18 July 2022
                Page count
                Figures: 5, Tables: 1, Pages: 15, Words: 4972
                Categories
                Subject: Review Article
                Subject: Review Articles
                Custom metadata
                source-schema-version-number 2.0
                edited-state corrected-proof
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:04.08.2022

                ScienceOpen disciplines: Dermatology
                Keywords: covid‐19,cutaneous,skin,vaccination
                Data availability:
                ScienceOpen disciplines: Dermatology
                Keywords: covid‐19, cutaneous, skin, vaccination

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