By Nicolas Hulscher, MPH A major pharmacovigilance study published in the International Dental Journal analyzed nearly 1 million adverse event reports submitted to Germany’s Paul-Ehrlich-Institut (PEI) between December 2020 and December 2023. The focus: oral adverse events (AEs) following COVID-19 vaccination—an area largely overlooked in official safety assessments. Researchers performed a retrospective review of 974,931 individual case safety reports (ICSRs) from the German PEI database. To validate their findings, they compared oral AE reporting trends to the U.S. VAERS database. They used both frequentist methods (Proportional Reporting Ratio [PRR], Reporting Odds Ratio [ROR]) and Bayesian signal detection (Information Component [IC]) to identify true safety signals—events reported disproportionately more often than expected compared to all other adverse events.
By Nicolas Hulscher, MPH
A major pharmacovigilance study published in the International Dental Journal analyzed nearly 1 million adverse event reports submitted to Germany’s Paul-Ehrlich-Institut (PEI) between December 2020 and December 2023. The focus: oral adverse events (AEs) following COVID-19 vaccination—an area largely overlooked in official safety assessments.
Researchers performed a retrospective review of 974,931 individual case safety reports (ICSRs) from the German PEI database. To validate their findings, they compared oral AE reporting trends to the U.S. VAERS database. They used both frequentist methods (Proportional Reporting Ratio [PRR], Reporting Odds Ratio [ROR]) and Bayesian signal detection (Information Component [IC]) to identify true safety signals—events reported disproportionately more often than expected compared to all other adverse events.
https://open.substack.com/pub/petermcculloughmd/p/new-study-covid-19-vaccination-linked?selection=cb133fd6-2f9c-40ec-a6f1-0302df62f4a3
尼古拉斯·霍尔彻（Nicolas Hulscher），mph
一项在国际牙科杂志上发表的一项主要药物警惕研究分析了2020年12月至2023年12月之间向德国的Paul-Ehrlich-Institut（PEI）提交给德国的近100万例不良事件报告。重点：口服不良事件（AES）在COVID-19疫苗接种后，在官方安全评估中被官方安全评估大大忽视。
研究人员对德国PEI数据库的974,931个个人案例安全报告（ICSR）进行了回顾性评论。 为了验证他们的发现，他们将口头AE报告趋势与美国VAERS数据库进行了比较。 他们使用了常见的方法（比例报告比[PRR]，报告优势比[ROR]）和贝叶斯信号检测（信息组件[IC]）来识别真正的安全信号 - 与所有其他不良事件相比，事件报告的频率比预期的频率更高。