Covered Injury means death, or a serious injury as described in 110.3(z), and determined by the Secretary in accordance with 110.20 of this part to be:
(1) An injury meeting the requirements of a Covered Countermeasures Injury Table, which is presumed to be the direct result of the administration or use of a covered countermeasure unless the Secretary determines there is another more likely cause; or
(2) An injury (or its health complications) that is the direct result of the administration or use of a covered countermeasure. This includes serious aggravation caused by a covered countermeasure of a pre-existing condition.
42 CFR § 110.3
This section defines certain words and phrases found throughout this part.