The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with hematologic reactions.
Patient selection: hematologic reaction after the vaccination
Hematology parameters affected may include:
(1) hemoglobin (based on gender) in g/dL
(2) decrease in hemoglobin in g/dL from baseline
(2) change in white blood cell count per microliter
(3) absolute lymphocyte count per µL
(4) absolute neutrophil count per µL
(5) absolute eosinophil count per µL
Changes in platelet count are handled under a separate scale for coagulopathy.
|
Reaction |
Grade |
|
None |
0 |
|
Mild |
1 |
|
moderate |
2 |
|
severe |
3 |
|
potentially life threatening |
4 |
|
Hematology Parameter |
Finding |
Grade |
|
hemoglobin |
female and 11.0-12.0 |
1 |
|
|
female and 9.5-10.9 |
2 |
|
|
female and 8.0-9.4 |
3 |
|
|
female and < 8.0 |
4 |
|
|
male and 12.5-13.5 |
1 |
|
|
male and 10.5-12.5 |
2 |
|
|
male and 8.5-10.4 |
3 |
|
|
male and < 8.5 |
4 |
|
decrease in hemoglobin |
any decrease to 1.5 |
1 |
|
|
1.6 to 2.0 |
2 |
|
|
2.1 to 5.0 |
3 |
|
|
> 5.0 |
4 |
|
WBC count |
> 25,000 |
4 |
|
|
20,001 to 25,000 |
3 |
|
|
15,001 to 20,000 |
2 |
|
|
10,800 to 15,000 |
1 |
|
|
2,500 to 3,500 |
1 |
|
|
1,500 to 2,499 |
2 |
|
|
1,000 to 1,499 |
3 |
|
|
< 1,000 |
4 |
|
absolute lymphocyte |
750 to 1,000 |
1 |
|
|
500 to 749 |
2 |
|
|
250 to 499 |
3 |
|
|
< 250 |
4 |
|
absolute neutrophil count |
1,500 to 2,000 |
1 |
|
|
1,000 to 1,499 |
2 |
|
|
500 to 999 |
3 |
|
|
< 500 |
4 |
|
absolute eosinophil count |
650 to 1,500 |
1 |
|
|
1,501 to 5,000 |
2 |
|
|
> 5,000 |
3 |
|
|
hypereosinophilic syndrome |
4 |
Specialty: Infectious Diseases, Pharmacology, clinical
