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Health Sciences › Medicine › Pharmacology
National Pharmacovigilance Assessment of Oral Adverse Events Following COVID-19 Vaccination in Germany (2020-2023)
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Overview
Paper Summary
Conflicts of Interest
Identified Weaknesses
Rating Explanation
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Paper Summary
Paperzilla title
Got a Weird Taste in Your Mouth After the COVID Jab? A German Study Says You're Not Alone (But Don't Blame the Vaccine Just Yet)
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.
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 Weaknesses
Passive Surveillance Data
The study relies on passive surveillance data, which is subject to reporting biases, underreporting, and inconsistent data quality. This can affect the accuracy and reliability of the findings.
Lack of Comparator Data
The absence of comparator data in the German PEI dataset limits the ability to conduct a comprehensive disproportionality analysis. Cross-database comparisons with VAERS provide some context, but differences in reporting practices and data structure make direct comparisons challenging.
Reductive Classification Approach
The reductive classification approach of PEI (single term per report) may lead to underestimation of oral AE reporting rates. Oral AEs often co-occur with other symptoms, which may not be captured comprehensively.
Small Sample Size for Booster Series
Small sample size for the booster series group (0.65% of the dataset) may lead to increased variability and instability in the estimates, affecting the reliability of findings related to booster doses.
Lack of Causality
Causality cannot be established due to the observational nature of the study. The observed associations between vaccination and oral AEs do not necessarily imply a causal relationship.
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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File Information
Original Title:
National Pharmacovigilance Assessment of Oral Adverse Events Following COVID-19 Vaccination in Germany (2020-2023)
File Name:
1-s2.0-S0020653925001959-main.pdf
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File Size:
1.23 MB
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July 22, 2025 at 07:29 AM
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