The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with changes in the patient's vital signs.
Patient selection: vital signs after vaccine administration
Parameters:
(1) fever (body temperature)
(2) tachycardia in beats per minute (bpm)
(3) bradycardia in beats per minute
(4) systolic hypertension in mm Hg
(5) diastolic hypertension in mm Hg
(6) systolic hypotension in mm Hg
(7) respiratory rate in breaths or minute
|
Reaction |
Grade |
|
none |
0 |
|
mild |
1 |
|
moderate |
2 |
|
severe |
3 |
|
potentially life threatening |
4 |
|
Local Reaction |
Finding |
Grade |
|
fever |
38.0 to 38.4°C |
1 |
|
|
38.5 to 38.9°C |
2 |
|
|
39.0 to 40°C |
3 |
|
|
> 40°C |
4 |
|
tachycardia |
101 to 115 bpm |
1 |
|
|
116 to 130 bpm |
2 |
|
|
> 130 bpm |
3 |
|
|
visit to ED or hospitalized |
4 |
|
bradycardia |
50 to 54 bpm |
1 |
|
|
45 to 49 bpm |
2 |
|
|
< 45 bpm |
3 |
|
|
visit to ED or hospitalized |
4 |
|
systolic hypertension |
141 to 150 mm Hg |
1 |
|
|
151 to 155 mm Hg |
2 |
|
|
> 155 mm Hg |
3 |
|
|
visit to ED or hospitalized |
4 |
|
diastolic hypertension |
91 to 95 mm Hg |
1 |
|
|
96 to 100 mm Hg |
2 |
|
|
> 100 mm Hg |
3 |
|
|
visit to ED or hospitalized |
4 |
|
systolic hypotension |
85 to 89 mm Hg |
1 |
|
|
80 to 84 mm Hg |
2 |
|
|
< 80 mm Hg |
3 |
|
|
visit to ED or hospitalized |
4 |
|
respiratory rate |
17 to 20 breaths per minute |
1 |
|
|
21 to 25 breaths per minute |
2 |
|
|
> 25 breaths per minute |
3 |
|
|
intubated |
4 |
Specialty: Infectious Diseases, Pharmacology, clinical
