Scholarlink

Purpose <p>Reports of Raynaud's phenomenon following vaccination have been steadily increasing; however, research on vaccine-associated Raynaud's phenomenon remains limited. This study aims to provide a comprehensive analysis of the association between Raynaud's phenomenon and various vaccines.</p> Method <p>This study used data from international pharmacovigilance, which contains over 35 million adverse event cases from more than 140 countries. Two established pharmacovigilance indicators, the information component (IC) and reporting odds ratio (ROR), were employed in the analysis&#xa0;with 95%&#xa0;confidence interval (CI). The IC was derived using a Bayesian methodology to compare the reporting and non-reporting groups, while the ROR, a frequentist measure of association, was calculated using contingency tables based on the number of adverse events.</p> Results <p>The signal with Raynaud's phenomenon was highest for papillomavirus vaccines (ROR: 11.49 [95% CI, 9.66–13.67]; IC: 3.45 [IC<sub>0.25</sub>, 3.16]), followed in order by typhoid (5.86 [2.93–11.72]), hepatitis B (5.63 [4.25–7.45]; 2.42 [1.95]), COVID-19 mRNA (5.00 [4.70–5.31]; 2.00 [1.91]), and hepatitis A vaccines (4.35 [2.87–6.62]; 2.02 [1.30]). The signal was higher in females (ROR: 3.74 [95% CI, 3.54–3.95]; IC: 1.67 [IC<sub>0.25</sub>, 1.59]) compared to males (3.44 [3.12–3.78]; 1.57 [1.43]), and it increased monotonically with age (0–11&#xa0;years: IC [IC<sub>0.25</sub>] 0.03 [-0.56]; 12–17&#xa0;years: 1.54 [1.25]; 18–44&#xa0;years: 1.64 [1.52]; 45–64&#xa0;years: 2.00 [1.87]; ≥ 65&#xa0;years: 2.12 [1.91]).</p> Conclusion <p>This study suggests the potential signal association between various vaccines and Raynaud's phenomenon. Although our study does not imply causality, we propose the need to strengthen post-vaccination monitoring and establish support policies to address such adverse events.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Global burden of vaccine-associated Raynaud’s phenomenon, 1968–2024: A comprehensive analysis of the pharmacovigilance database

  • 期刊论文

  • 发表日期：

    2025年6月6日

查看全文
  • Jinyoung Jeong,
  • Hyunjee Kim,
  • Hyesu Jo,
  • Jaeyu Park,
  • Jaehyeong Cho,
  • Hayeon Lee,
  • Hanseul Cho,
  • Masoud Rahmati,
  • Ho Geol Woo,
  • Dong Keon Yon

摘要

Purpose

Reports of Raynaud's phenomenon following vaccination have been steadily increasing; however, research on vaccine-associated Raynaud's phenomenon remains limited. This study aims to provide a comprehensive analysis of the association between Raynaud's phenomenon and various vaccines.

Method

This study used data from international pharmacovigilance, which contains over 35 million adverse event cases from more than 140 countries. Two established pharmacovigilance indicators, the information component (IC) and reporting odds ratio (ROR), were employed in the analysis with 95% confidence interval (CI). The IC was derived using a Bayesian methodology to compare the reporting and non-reporting groups, while the ROR, a frequentist measure of association, was calculated using contingency tables based on the number of adverse events.

Results

The signal with Raynaud's phenomenon was highest for papillomavirus vaccines (ROR: 11.49 [95% CI, 9.66–13.67]; IC: 3.45 [IC0.25, 3.16]), followed in order by typhoid (5.86 [2.93–11.72]), hepatitis B (5.63 [4.25–7.45]; 2.42 [1.95]), COVID-19 mRNA (5.00 [4.70–5.31]; 2.00 [1.91]), and hepatitis A vaccines (4.35 [2.87–6.62]; 2.02 [1.30]). The signal was higher in females (ROR: 3.74 [95% CI, 3.54–3.95]; IC: 1.67 [IC0.25, 1.59]) compared to males (3.44 [3.12–3.78]; 1.57 [1.43]), and it increased monotonically with age (0–11 years: IC [IC0.25] 0.03 [-0.56]; 12–17 years: 1.54 [1.25]; 18–44 years: 1.64 [1.52]; 45–64 years: 2.00 [1.87]; ≥ 65 years: 2.12 [1.91]).

Conclusion

This study suggests the potential signal association between various vaccines and Raynaud's phenomenon. Although our study does not imply causality, we propose the need to strengthen post-vaccination monitoring and establish support policies to address such adverse events.