COVID-vaccines associated chilblains: Analysis of the reports in VigiBase®

ABSTRACT

Introduction: Cases of COVID-vaccine induced chilblains have recently been reported in the literature. The goal of this study was to assess the link between COVID vaccines and chilblains using VigiBase®, the WHO pharmacovigilance database. Material and methods: Chilblains reports were extracted from a deduplicated dataset of VigiBase® (dataset date 02/01/2022) using the following MedDRA preferred terms chillblains and pernio-like erythema. Sex-ratio, seriousness and median age and time to onset were calculated for each vaccine (ATC class J07) as well as the Information Component (IC). Results: For tozinameran (Pfizer®) 293 reports of chilblains were found with an IC of 3.1 (2.9-3.2). The sex ratio was 0.43, patients had a median age of 45.5 years (IQR37-61). Reports were considered serious in 18% and median time to onset was 4 days (IQR 1-8). For elasomeran (Moderna®) 66 reports of chilblains were found with an IC of 2.3 (1.9-2.6). The sex ratio was 0.29, patients had a median age of 45.5 years (IQR35-55). Reports were considered serious in 18% and median time to onset was 4 days (IQR1.5-8.5). For chAdOx1 (Astra-Zeneca®) 121 reports of chilblains were found with an IC of 2.8 (2.5-3.0). The sex ratio was 0.42, patients had a median age of 54.5 years (IQR 42-66). Reports were considered serious in 35% and median time to onset was 5 days (IQR 2-15). No significant signals were found with any other vaccine. Discussion/Conclusion: A significant signal between chilblains and tozinameran, elasomeran and chAdOx1 was found, but not with any other vaccine. Women over 35 years old might be more at risk of developing this symptom. As high type I interferon response to COVID infection has been associated with the onset of chilblains [1], it is plausible that the same mechanism is implied in COVID-vaccines associated chilblains. Physicians should be aware of this possible adverse effect.