The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with systemic reactions.
Patient selection: systemic reaction after the vaccination
Systemic reactions may include:
(1) nausea and vomiting
(2) diarrhea
(3) headache
(4) fatigue
(5) myalgia
(6) other clinical adverse event
|
Reaction |
Grade |
|
None |
0 |
|
Mild |
1 |
|
Moderate |
2 |
|
Severe |
3 |
|
potentially life threatening |
4 |
|
Systemic Reaction |
Finding |
Grade |
|
nausea and vomiting |
no interference with activities |
1 |
|
|
some interference with activities |
2 |
|
|
prevents daily activities |
3 |
|
|
1 or 2 episodes in 24 hours |
1 |
|
|
> 2 episodes in 24 hours |
2 |
|
|
outpatient intravenous hydration |
3 |
|
|
ER visit or hospitalised |
4 |
|
diarrhea |
2 to 3 loose stools |
1 |
|
|
4 to 5 loose stools |
2 |
|
|
6 or more loose stools |
3 |
|
|
< 400 g in 24 hours |
1 |
|
|
400 to 800 g in 24 hours |
2 |
|
|
> 800 g in 24 hours |
3 |
|
|
outpatient intravenous hydration |
3 |
|
|
ER visit or hospitalised |
4 |
|
headache |
does not interfere with activities |
1 |
|
|
some interference with activities, |
2 |
|
|
prevents daily activities |
3 |
|
|
repeated use of non-narcotic pain reliever for > 24 hours |
2 |
|
|
need for narcotic pain reliever |
3 |
|
|
ER visit or hospitalised |
4 |
|
fatigue |
does not interfere with activities |
1 |
|
|
some interference with activities |
2 |
|
|
prevents daily activities, significant |
3 |
|
|
ER visit or hospitalised |
4 |
|
myalgia |
does not interfere with activities |
1 |
|
|
some interference with activities |
2 |
|
|
prevents daily activities, significant |
3 |
|
|
ER visit or hospitalised |
4 |
|
Other |
does not interfere with activities |
1 |
|
|
some interference with activities but no medical intervention needed |
2 |
|
|
prevents daily activities and requires a medical intervention |
3 |
|
|
ER visit or hospitalised |
4 |
Specialty: Infectious Diseases, Pharmacology, clinical
