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A simulation study of the statistical power and signaling characteristics of an early season sequential test for influenza vaccine safety

The US Food and Drug Administration monitors the risk of Guillain‐Barré syndrome (GBS) following influenza vaccination using several data sources including Medicare. In the 2017 to 2018 season, we transitioned our near real‐time surveillance in Medicare to more effectively detect large GBS risk increases early in the season while avoiding false positives.