National Pharmacovigilance Assessment of Oral Adverse Events Following COVID-19 Vaccination in Germany (2020-2023)
Overview
Paper Summary
This German study found that taste disturbances, oral herpes, and swollen tongue were the most common oral adverse events reported after COVID-19 vaccination, echoing similar findings in US data. However, the study relies on passive surveillance data and lacks comparator vaccines/drugs in the German dataset, making it hard to draw firm conclusions about causality or compare reporting rates across different vaccines.
Explain Like I'm Five
Scientists looked at reports from people in Germany after their COVID shots. They found some people said their taste changed, or they got cold sores, or their tongue felt big. But the scientists aren't sure if the shot caused it or if it just happened.
Possible Conflicts of Interest
The study was supported by the NPO 'Systemic Risk Institute', funded by the European Union. No other conflicts were disclosed.
Identified Limitations
Rating Explanation
This is an average study with several limitations inherent to its reliance on passive surveillance data and the lack of comparator data in the primary dataset. While the cross-database comparison and multivariable regression analyses provide some strengths, the inability to establish causality and potential underestimation of reporting rates limit the strength of the conclusions. Therefore, a rating of 3 is appropriate.
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