Description

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 basic chemical tests.


 

Patient selection: renal reaction after the vaccination

 

Basic chemistry tests include:

(1) serum sodium in mEq/L

(2) serum potassium in mEq/L

(3) serum glucose in mg/dL

(4) serum calcium in mg/dL

(5) serum magnesium in mg/dL (hypomagnesemia)

(6) serum phosphorus in mg/dL (hypophosphatemia)

 

Serum BUN and creatinine are included in renal assessment.

 

Reduced urine output is not included as a measure.

 

Reaction

Grade

None

0

Mild

1

moderate

2

severe

3

potentially life threatening

4

 

 

Renal Parameter

Finding

Grade

serum sodium

> 150 mEq/L

4

 

148 to 150 mEq/L

3

 

146 to 147 mEq/L

2

 

144 to 145 mEq/L

1

 

135 to 143 mEq/L

0

 

132 to 134 mEq/L

1

 

130 to 131 mEq/L

2

 

125 to 129 mEq/L

3

 

< 125 mEq/L

4

serum potassium

> 5.6 mEq/L

4

 

5.5 to 5.6 mEq/L

3

 

5.3 to 5.4 mEq/L

2

 

5.1 to 5.2 mEq/L

1

 

3.7 to 5.0 mEq/L

0

 

3.5 to 3.6 mEq/L

1

 

3.3 to 3.4 mEq/L

2

 

3.1 to 3.2 mEq/L

3

 

< 3.1 mEq/L

4

serum glucose (fasting)

insulin required or hyperomsolar coma

4

 

> 125 mg/dL

3

 

111 to 125 mg/dL

2

 

100 to 110mg/dL

1

 

70 to 99 mg/dL

0

 

65 to 69 mg/dL

1

 

55 to 64 mg/dL

2

 

45 to 54 mg/dL

3

 

< 45 mg/dL

4

serum calcium

> 12.0 mg/dL

4

 

11.6 to 12 mg/dL

3

 

11.1 to 11.5 mg/dL

2

 

10.5 to 11.0 mg/dL

1

 

8.5 yo 10.4 mg/dL

0

 

8.0 to 8.4 mg/dL

1

 

7.5 to 7.9 mg/dL

2

 

7.0 to 7.4 mg/dL

3

 

< 7.0 mg/dL

4

serum magnesium

> 1.5 mg/dL

0

 

1.3 to 1.5 mg/dL

1

 

1.1 to 1.2 mg/dL

2

 

0.9 to 1.0 mg/dL

3

 

< 0.9 mg/dL

4


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