Specifically, of the 73 799 volunteers (36 901 effectively receiving at least one vaccine dose) taking part in the two large phase 3 vaccine trials, 4, 5 eight cases of suspect Bell's palsy were reported, with a total of seven in the groups receiving a vaccine and one in placebo groups. In addition to systemic ADRs with orofacial manifestations such as anaphylaxis, both vaccines were associated with acute peripheral facial paralysis. For example, patient information leaflets in North America do not report orofacial side effects except those related to allergic reactions. There appear to be inconsistencies in the description of these effects in the information provided to patients and healthcare professionals. Our study shows that COVID‐19 vaccines have possible, albeit rare, orofacial side effects including Bell's palsy, facial swelling, and swelling of the lips, face or tongue associated with anaphylaxis. Dentists’ knowledge of these orofacial manifestations will improve recognition, management and reporting of vaccine‐related adverse effects. Hence, the aim of this study was to research and compare the reported orofacial adverse effects of two COVID‐19 vaccines. Initial efficacy and safety data for both BNT162b2 (Pfizer‐BioNTech) and mRNA‐1273 (Moderna) vaccines have been published 4, 5 and product monographs including relevant information from the trials are available.Īs vaccination campaigns kick off worldwide, and with several billion doses predicted to be administered in the near future, 6 it is likely that a sizeable number of adverse events will be observed. A third vaccine (AZD1222, Oxford–AstraZeneca) has currently been approved for use in the UK. 3 Of the many candidates, currently two RNA‐based COVID‐19 vaccines have been granted emergency use and marketing authorisation by the relevant regulatory agencies in North America and Europe and are being used worldwide. The development of effective and safe vaccines against this virus has been extremely fast. 2 Recently, severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), a virus that causes coronavirus disease 2019 (COVID‐19), has emerged as a highly pathogenic agent and has spread globally. Over the past decade, the scientific community and the vaccine industry have been asked to respond urgently to epidemics of H1N1 influenza, Ebola, Zika viruses, and this has resulted in an acceleration of vaccine‐development programmes worldwide. To this aim, dentists and other health professionals should be prepared to detect orofacial ADRs as being drug‐induced. 1 It is important, however, that adverse events are recognised and managed in a timely fashion to minimise the possible harm. By and large, the benefits of vaccination clearly outweigh the risks-vaccines prevent between 2 and 3 million deaths from infectious diseases every year. Adverse drug reactions (ADRs) and medication‐related events are potentially life‐threatening consequences of the use of medicines, including vaccines.
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