The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with local reactions at the injection site.
Patient selection: local reaction at injection site
Parameters:
(1) pain
(2) tenderness
(3) erythema (redness)
(4) induration and/or swelling
|
Reaction |
Grade |
|
none |
0 |
|
mild |
1 |
|
moderate |
2 |
|
severe |
3 |
|
potentially life threatening |
4 |
|
Local Reaction |
Finding |
Grade |
|
pain |
does not interfere with activities |
1 |
|
|
interferes with activity OR requires repeated use of nonnarcotic pain reliever for more than 24 hours |
2 |
|
|
prevents daily activities OR requires any use of narcotics |
3 |
|
|
visit to ED or hospitalized |
4 |
|
tenderness |
mild to touch |
1 |
|
|
discomfort with movement |
2 |
|
|
significant discomfort at rest |
3 |
|
|
visit to ED or hospitalized |
4 |
|
erythema |
2.5 to 5.0 cm |
1 |
|
|
5.1 to 10.0 cm |
2 |
|
|
> 10 cm |
3 |
|
|
necrosis or exfoliative dermatitis |
4 |
|
induration/swelling |
2.5 to 5.0 cm and does not interfere with activities |
1 |
|
|
5.1 to 10.0 cm OR interferes with activities |
2 |
|
|
> 10 cm OR prevents daily activity |
3 |
|
|
necrosis |
4 |
Specialty: Infectious Diseases, Pharmacology, clinical
