Abstract

Vaccines are actually the most effective strategy to control the COVID-19 spread and reduce mortality, but adverse reactions can occur. Skin involvement with novel messenger RNA coronavirus vaccines seems frequent but is not completely characterized. A real-world experience in the recent vaccination campaign among health care workers in Sardinia (Italy) is reported. In over a total of 1577 persons vaccinated, 9 cases of skin adverse reactions were observed (0.5%). All reactions have been reported to the Italian Pharmacovigilance Authority. Eight occurred in women (mean age 46 years), and five were physicians and four nurses. All patients had a significant allergology history but not for the known vaccine excipients. After dose one, no injection site reactions were observed, but widespread pruritus (n = 3), mild facial erythema (n = 1), and maculopapular rash (n = 3) occurred in the following 24–48 h in three patients. These three patients were excluded from the second dose. Of the remaining six patients, one developed mild anaphylaxis within the observation period at the vaccination hub and five delayed facial erythematous edema and maculopapular lesions, requiring antihistamines and short-course corticosteroid treatment. Spontaneous reporting is paramount to adjourning vaccination guidance and preventive measures in order to contribute to the development of a safe vaccine strategy. Dermatologist’ expertise might provide better characterization, treatment, and screening of individuals at high risk of skin adverse reactions.

Highlights

  • The novel messenger RNA technology vaccines are a crucial part of the worldwide fight against coronavirus disease 2019 (COVID-19), and the Pfizer-BioNTech vaccine has been the first issued in Italy for the health care workers’ vaccination program

  • Individuals with a history of a severe adverse reaction related to the vaccine and/or other severe allergic reactions were excluded from pivotal approval studies, and in a registry-based study of 414 cases, a spectrum of cutaneous reactions after messenger RNA (mRNA) COVID-19 Moderna (83%) and Pfizer (17%) vaccines was reported [3]

  • Assessment with excipient skin testing in 80 patients reporting an allergic reaction to mRNA COVID-19 vaccine dose one, a sensitization to PEG

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Summary

Introduction

The novel messenger RNA (mRNA) technology vaccines are a crucial part of the worldwide fight against coronavirus disease 2019 (COVID-19), and the Pfizer-BioNTech vaccine has been the first issued in Italy for the health care workers’ vaccination program. The Centers for Disease Control and Prevention (CDC) recommends to avoid a second dose if a severe or immediate allergic reaction to the first dose of an mRNA. Assessment with excipient skin testing in 80 patients reporting an allergic reaction to mRNA COVID-19 vaccine dose one, a sensitization to PEG (n = 5) and/or polysorbate 80 (n = 12) was documented in a minority of patients, and most of the patients received the second dose safely [5]. The present short case series documents the real-world experience in the recent vaccination campaign among health care workers in Sardinia, a major island in the Mediterranean basin, and all reactions have been reported to the Italian Pharmacovigilance Authority

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