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 (IQR:37-61). 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 (IQR:35-55). Reports were considered serious in 18% and median time to onset was 4 days (IQR:1.5-8.5). 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.
ABSTRACT
Introduction: A re-evaluation of quinolones by the European Pharmacovigilance Risk Assessment Committee (PRAC) in 2018 led to a restriction of their indications in April 2019 [1], due to the risk of serious adverse reactions. We aimed to evaluate the impact on quinolone prescriptions, dispensations, reported adverse events and switch to other classes of antibiotics. Material and methods: From 2018 to 2020, we extracted medico-administrative data from two French Insurance databases (Open Medic® and Medic'AM®) and reported adverse reactions (RAR) from Vigibase® from January 1, 2017, to April 10, 2019, and from April 11, 2019, to July 31, 2021. Results: The annual proportion of quinolones packages reimbursed among all systemic antibiotics was 5.3% in 2018, 4.6% in 2019, 5.0% in 2020. From 2018 to 2020, quinolones were slightly less prescribed by general practitioners (from 65.6% of the quinolone prescriptions to 62.5%) while the opposite was observed among hospital-based physicians (22.2% to 25.2%). There was a decrease in the number of packages of all systemic antibiotics reimbursed during the period, including quinolones. Among quinolone treated patients, the proportion of patients over 60 years-old slightly increased (49.9% to 52.5%).In VigiBase® the proportion of RAR affecting subjects over 65yo increased between the two periods (from 26,8% to 45.5%). The safety profile was similar in musculoskeletal (3.6% versus 3.4%) and in nervous (1.0%versus 1.0%) System Organ Class disorders between the two periods. Discussion/Conclusion: According to our results, there was no major impact of authorities' measure on quinolone prescriptions and dispensations and on RAR. However, our method was limited by the evolution of the number of packages delivered following the seasonality like all other systemic antibiotics, and particularly during this COVID pandemic. Further studies must be conducted to assess the impact of those measures on antibiotics prescription.
ABSTRACT
Introduction: Reports of vestibular syndrome have been associated with COVID vaccination in the recent literature. In this study, we aimed to evaluate the association between COVID-19 vaccines and vestibular disorders using Vigibase®, the WHO pharmacovigilance database. Material and methods: On January 5th, 2022, we extracted in a deduplicated dataset of VigiBase® reports of vestibular disorders for tozinameran (Pfizer®), elasomeran (Moderna®), Ad26.COV2.S (Janssen®) and ChadOx1nCov-19 (Astra-Zeneca®), using MedDRA preferred terms neuronitis vestibular, acute vestibular syndrome, vestibular disorder and the low level term vestibular vertigo. Seriousness was analyzed and reported odds ratio (ROR) were calculated. We also reviewed the management of COVID-vaccine associated vestibular disorders reported in Caen Regional Pharmacovigilance Center. Results: In Vigibase®, 226 reports of vestibular disorders were found for ChadOx1nCov-19, 40 for Ad26.COV2.S, 254 for elasomeran and 1,050 for tozinameran. The ROR were respectively 2.5 (2.2-2.8), 2.5 (1.8-3.2), 3.6 (3.2-4.0) and 7.0 (6.6-7.4). Reports were considered serious in 74.3% for ChadOx1nCov-19, 70.0% for Ad26.COV2.S, 60.6% for elasomeran and 56.01% for tozinameran. Finally, we collected 13 reports of COVID-19 vaccines associated vestibular disorders in our pharmacovigilance center. Concerning the management of those vestibular disorders, 4 patients received antiemetics, 1 received betahistine, 7 received acetylleucine, 2 received corticoids and 6 had vestibular physiotherapy sessions. After 1 month of follow-up, only one patient had recovered. Discussion/Conclusion: The Vigibase® analysis showed a statistically significant association between the 4 COVID-19 vaccines under study and vestibular disorders. Short-term anticholinergics, antiemetics, antihistamines or benzodiazepines, and a corticosteroid burst with rapid taper as well as vestibular rehabilitation are usually recommended treatments. In our case series we noticed the long duration of the symptoms despite the treatments received and the heterogeneity of the adopted therapeutic strategy. Physicians should be aware and careful of the potential association of COVID-19 vaccines and vestibular disorders. Management guidelines are needed given the wide exposure to COVID-19 vaccines.