Table 2. Rates of general symptoms reported by study participants during days 0–6 after masked TIV vaccine or saline placebo injections, including vaccine-attributable rates (as rate difference).
| Symptom | Following Vaccine (%) | Following Placebo (%) | Rate Difference (95% CI) | p value | |||
|---|---|---|---|---|---|---|---|
|
Myalgia |
|
|
|
|
|
|
|
| |
Any |
81/323 |
(25.1) |
21/325 |
(6.5) |
18.6% (13.2, 24.1) |
< 0.001 |
| |
Mild |
67 |
(20.7) |
18 |
(5.5) |
15.2% (10.1, 20.2) |
< 0.001 |
| |
Moderate |
11 |
(3.4) |
3 |
(0.9) |
2.5% (0.24, 4.7) |
0.03 |
| |
Severe |
3 |
(0.9) |
0 |
|
0.9% (-0.12, 2.0) |
0.12 |
| |
|
|
|
|
|
|
|
|
Tiredness |
|
|
|
|
|
|
|
| |
Any |
66/323 |
(20.4) |
34/325 |
(10.5) |
10.0% (4.5, 15.5) |
< 0.001 |
| |
Mild |
47 |
(14.6) |
25 |
(7.7) |
6.9% (2.0, 11.7) |
0.006 |
| |
Moderate |
14 |
(4.3) |
9 |
(2.8) |
1.6% (-1.3, 4.4) |
0.298 |
| |
Severe |
5 |
(1.5) |
0 |
|
1.5% (0.2, 2.9) |
0.03 |
| |
|
|
|
|
|
|
|
|
Headache |
|
|
|
|
|
|
|
| |
Any |
67/323 |
(20.7) |
40/325 |
(12.3) |
8.4% (2.7, 14.1) |
0.004 |
| |
Mild |
55 |
(17.0) |
31 |
(9.5) |
7.5% (2.3, 12.7) |
0.005 |
| |
Moderate |
10 |
(3.1) |
9 |
(2.8) |
0.3% (-2.3, 2.9) |
0.821 |
| |
Severe |
2 |
(0.6) |
0 |
|
0.6% (-0.2, 1.5) |
0.248 |
| |
|
|
|
|
|
|
|
|
Malaise/Feeling unwell |
|
|
|
|
|
|
|
| |
Any |
36/323 |
(11.1) |
21/325 |
(6.5) |
4.7% (0.3, 9.0) |
0.038 |
| |
Mild |
26 |
(8.1) |
15 |
(4.6) |
3.4% (-0.3, 7.2) |
0.078 |
| |
Moderate |
7 |
(2.2) |
5 |
(1.5) |
0.6% (-1.5, 2.7) |
0.577 |
| |
Severe |
3 |
(0.9) |
1 |
(0.3) |
0.6% (-0.6, 1.8) |
0.372 |
| |
|
|
|
|
|
|
|
|
Arthralgia |
|
|
|
|
|
|
|
| |
Any |
22/323 |
(6.8) |
9/325 |
(2.8) |
4.0% (0.8, 7.3) |
0.017 |
| |
Mild |
18 |
(5.6) |
7 |
(2.2) |
3.4% (0.5, 6.4) |
0.026 |
| |
Moderate |
2 |
(0.6) |
2 |
(0.6) |
0.0% (-1.2, 1.2) |
1 |
| |
Severe |
2 |
(0.6) |
0 |
|
0.6% (-0.2, 1.5) |
0.248 |
|
Sleep disturbance |
|
25/323 |
(7.7) |
12/325 |
(3.7) |
4.0% (0.5, 7.6) |
0.028 |
|
Diarrhea |
|
19/323 |
(5.9) |
6/325 |
(1.8) |
4.0% (1.1, 7.0) |
0.008 |
|
Fever |
|
2/322 |
(0.6) |
2/322 |
(0.6) |
0 (-1.2, 1.2) |
1 |
|
Nausea |
|
10/323 |
(3.1) |
6/325 |
(1.8) |
1.3% (-1.1, 3.6) |
0.325 |
| Vomiting | 2/323 | (0.6) | 1/325 | (0.3) | 0.3% (-0.7, 1.4) | 0.623 | |