Table 1. Korean and WHO causality assessment criteria for adverse events following immunization.
| Korean criteria | Previous WHO criteria | ||
|---|---|---|---|
| Definite | There is definite evidence of inoculation with the vaccine; temporal proximity in which an adverse event appeared; causal relationship between the event and vaccination rather than other causes is accepted; and the adverse event is the known reaction to the vaccine. | Very likely, certain | Clinical event with a plausible time relationship to vaccine administration, and which cannot be explained by concurrent disease or other drugs or chemicals. |
| Probable | There is definite evidence of inoculation with the vaccine; temporal proximity in which an adverse event appeared; and causal relationship between the event and vaccination rather than other causes is accepted. | Probable | Clinical event with a reasonable time relationship to vaccine administration, and is unlikely to be attributed to concurrent disease or other drugs or chemicals. |
| Possible | There is definite evidence of inoculation with the vaccine; temporal proximity in which an adverse event appeared; it is recognized at the same level of probability that the reaction may be due to vaccination or other reasons. | Possible | Clinical event with a reasonable time relationship to vaccine administration, but which could also be explained by concurrent disease or other drugs or chemicals. |
| Unlikely | There is definite evidence of inoculation with the vaccine; temporal proximity is not accepted when adverse events appeared, if the causal relationship between the event and vaccine is unclear. | Unlikely | Clinical event whose time relationship to vaccine administration makes a causal connection improbable, but which could plausibly be explained by underlying disease or other drugs or chemicals. |
| Definitely not related | There is absence of evidence of vaccine inoculation; or absence of proximity of the temporal sequence in which adverse events appeared; or presence of obvious causes resulted in the event. | Unrelated | Clinical event with an incompatible time relationship to vaccine administration, and which could be explained by underlying disease or other drugs or chemicals. |
WHO, World Health Organization.