Cutaneous Adverse Reactions to SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis.

Background: An increasing number of cutaneous adverse reactions (CARs) to SARS-CoV-2 vaccines have been reported, but their incidence is debated. Objective: To estimate the pooled incidence of CARs to SARS-CoV-2 vaccines in the general adult population. Methods: A systematic review and meta-analysis of original articles published on MEDLINE via PubMed and Web Of Science from 1 January 2020 to 18 July 2022 was undertaken. Studies reporting the incidence proportion of CARs (defined as number of new cases of CARs on the total of vaccinated people) were included. All types of SARS-CoV-2 vaccine were included. People receiving at least one dose were considered eligible. Local cutaneous reactions were excluded. Results: A total of 970 records were identified and screened by title and abstract; 22 observational studies were included with aggregate data on 93,165 participants. The pooled incidence of overall CARs was 5% (95%CI 4−6%; I2 = 99%; p < 0.001), ranging from <0.01 to 19.00%. Most CARs were new onset dermatitis including rash, urticaria and vascular lesions; one case of Steven−Johnson syndrome and six cases of erythema multiforme were reported. In the sensitivity analysis we found that the incidence of CARs after the first and second dose was similar, i.e., 3% (95%CI 2−3%; I2 = 96%; p < 0.001) and 3% (95%CI 2−4%; I2 = 97%; p < 0.001), respectively. The magnitude of incidence of CARs remained unchanged independently of vaccine platform and in the general population versus healthcare workers. Conclusions: CARs associated with SARS-CoV-2 vaccines are frequent but mild and self-remitting, whereas severe CARs are rare.