Abstract
Data sources The US Food and Drug Administration (FDA), Health Canada, European Medicines Agency (EMA)/European Commission and UK's Medicines and Healthcare products Regulatory Agency (MHRA).Study selection Product monographs, product information and consumer medicine information for the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines.Data extraction and synthesis Reported side/adverse/undesirable effects concerning the orofacial region were extracted and tabulated.Results There were rare reports of adverse events affecting the orofacial region for both vaccines in their pertaining documents, including acute peripheral facial paralysis (Bell's palsy), facial swelling and swelling of the lips, face or tongue associated with anaphylaxis. There was heterogeneity in the acknowledgement of vaccine-related adverse events in North America compared with Europe.Conclusions There are rare reports of orofacial adverse effects of two mRNA-based COVID-19 vaccines in their documents; however, there are inconsistencies in the description of these adverse effects in different countries.