アブストラクト | PURPOSE: The etiology and pathophysiology of vaccine-associated chronic urticaria (CU) remain unclear, particularly during the coronavirus disease 2019 (COVID-19) pandemic. Thus, this study aimed to comprehensively investigate the global burden and long-term trends of vaccine-associated CU, with a focus on the associated vaccines and the distribution of cases across different age groups and sexes. METHODS: Using data from the World Health Organization international pharmacovigilance database (VigiBase), which encompasses reports from 156 countries and territories between 1968 and 2023, we systematically analyzed the global burden and long-term trends in vaccine-associated CU reports (total individual case safety reports = 131,255,418). We estimated the global and regional reports, information component (IC) with IC(0.25) using disproportionality analyses, and reporting odds ratio (ROR) with 95% confidence interval (CI) to investigate the potential associations between 27 vaccines and CU. RESULTS: Among the 3,474 reports of all-cause CU, 1,898 vaccine-associated CU reports were identified between 2010 and 2023. A dramatic surge in vaccine-associated CU reports has been observed since 2020, primarily driven by the COVID-19 mRNA vaccines. The COVID-19 mRNA vaccines were associated with the most CU reports (ROR, 26.52 [95% CI, 24.33-28.90]; IC, 3.18 [IC(0.25), 3.10]), followed by papillomavirus (ROR, 4.23 [95% CI, 2.55-7.03]; IC, 1.93 [IC(0.25), 1.06]), influenza (ROR, 3.09 [95% CI, 2.16-4.43]; IC, 1.57 [IC(0.25), 0.96]), Ad5-vectored COVID-19 (ROR, 2.82 [95% CI, 2.40-3.31]; IC, 1.42 [IC(0.25), 1.16]), and zoster vaccines (ROR, 2.28 [95% CI, 1.32-3.93]; IC, 1.12 [IC(0.25), 0.18]). These increased risks were particularly pronounced for males and older adults. No fatal outcomes have been reported in vaccine-associated CU. CONCLUSIONS: This study underscores the importance of clinicians considering the potential risk factors associated with vaccine-associated CU, especially in the context of COVID-19-related vaccines. Ongoing pharmacovigilance efforts facilitated by robust reporting systems are required to further validate our findings. |
投稿者 | Kang, Jeewoo; Park, Jaeyu; Jo, Hyesu; Lee, Hyeri; Lee, Kyeongmin; Kim, Soeun; Kang, Jiseung; Lee, Jun Hyuk; Papadopoulos, Nikolaos G; Smith, Lee; Shin, Ju-Young; Rahmati, Masoud; Cho, Seong H; Cho, Joong Ki; Lee, Sooji; Pizzol, Damiano; Yeo, Seung Geun; Lee, Hayeon; Jin, Seon-Pil; Yon, Dong Keon |
組織名 | Department of Dermatology, Seoul National University College of Medicine, Seoul,;Korea.;Department of Dermatology, Seoul National University Hospital, Seoul, Korea.;Center for Digital Health, Medical Science Research Institute, Kyung Hee;University College of Medicine, Seoul, Korea.;Department of Regulatory Science, Kyung Hee University, Seoul, Korea.;Department of Precision Medicine, Kyung Hee University College of Medicine,;Seoul, Korea.;Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General;Hospital, Boston, MA, USA.;Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.;Health and Human Science, University of Southern California, Los Angeles, CA,;USA.;Allergy Department, 2nd Paediatric Clinic, National Kapodistrian University of;Athens, Athens, Greece.;Lydia Becker Institute of Immunology & Inflammation, University of Manchester,;Manchester, UK.;Centre for Health, Performance and Wellbeing, Anglia Ruskin University,;Cambridge, UK.;School of Pharmacy, Sungkyunkwan University, Suwon, Korea.;CEReSS-Health Service Research and Quality of Life Center, Assistance;Publique-Hopitaux de Marseille, Aix-Marseille University, Marseille, France.;Department of Physical Education and Sport Sciences, Faculty of Literature and;Human Sciences, Lorestan University, Khorramabad, Iran.;Department of Physical Education and Sports Sciences, Faculty of Literature and;Humanities, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.;Division of Allergy and Immunology, Department of Internal Medicine, University;of South Florida Morsani College of Medicine, Tampa, FL, USA.;Department of Pediatrics, Columbia University Irving Medical Center, New York,;NY, USA.;Department of Medicine, Kyung Hee University College of Medicine, Seoul, Korea.;Health Unit Eni, San Donato Milanese, Italy.;Health Unit Eni, Maputo, Mozambique.;Department of Otorhinolaryngology Head & Neck Surgery, Kyung Hee University;Medical Center, Kyung Hee University School of Medicine, Seoul, Korea.;University College of Medicine, Seoul, Korea. wwhy28@khu.ac.kr.;Institute of Human-Environment Interface Biology, Medical Research Center, Seoul;National University, Seoul, Korea. seonpil@gmail.com.;Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee;University College of Medicine, Seoul, Korea. yonkkang@gmail.com. |