Polymyalgia Rheumatica After COVID-19 Vaccination: Data from the EudraVigilance Database

Dear Editor,
Recently, the novel coronavirus (COVID-19) pandemic led to the rapid development of vaccines. Potential side effects have been notified on global pharmacovigilance databases, such as EudraVigilance, which contains reports of suspected adverse reaction (SAR) for drugs authorized in the European Union. These reports are generated by national competent authorities [such as Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED), the Portuguese medicines agency], marketing authorization holders, and sponsors of clinical trials. The Individual Case Safety Reports (ICSR) can be signaled by healthcare or non-healthcare professionals. Although incapable of establishing causality, the reporting of SAR can detect emerging safety signals concerning a specific drug, prompting further investigation.

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