Temporal changes in auditory adverse event reporting in the U.S. vaccine adverse event reporting system associated with the COVID-19 vaccine rollout: an interrupted time series analysis with negative control evaluation

Description

Jingyi Wu, Junfeng Huo, Xindan Wang, Juan Wei, and Gaiyan Du published a pharmacovigilance study in twenty twenty-six on whether hearing problems after vaccination were a real signal or a reporting mirage. The team mined the national adverse event system from twenty eighteen through twenty twenty-five, over one point three million reports, of which about twenty-eight thousand mentioned auditory events.

Interrupted time series showed reporting rates jumping right after the COVID vaccine authorization. Crucially, skin events served as a negative control for pure reporting enthusiasm, and comparisons across vaccine types tested specificity. Count models confirmed the level shift. The design's virtue is separating a surge in reporting from a surge in harm, the central ambiguity of passive surveillance that this study builds its machinery around.

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Source: https://europepmc.org/articles/PMC13619909