Table E6.
Estimated incidence rates of adverse events following immunization
| Events | Total dose (N = 1,201,688) |
First doses (N = 611,779) |
Second doses (N = 589,909) |
P value | |||
|---|---|---|---|---|---|---|---|
| Total no. of events | Incidence rate (95% CI) | Total no. of events | Incidence rate (95% CI) | Total no. of events | Incidence rate (95% CI) | ||
| IHSR | 318 | 265.6 (236.3-295.3) | 213 | 348.2 (303.0-398.2) | 105 | 178.0 (145.6-215.5) | <.001 |
| ISRR | 2558 | 2128.7 (2047.1-2212.7) | 1842 | 3010.9 (2875.1-3151.4) | 714 | 1210.4 (1123.2-1302.4) | <.001 |
| Anaphylaxis | 2 | 1.7 (0.2-6.0) | 1 | 1.6 (0-9.1) | 1 | 1.7 (0-9.4) | 1.000 |
| Vasovagal syncope | 86 | 71.6 (57.2-88.4) | 76 | 123 (97.9-155.5) | 10 | 17.0 (8.1-31.1) | <.001 |
Incidence rates of acute adverse events were calculated by using vaccine administration of doses in a center as the denominator. Incidence rates were shown as per million doses.
CI, Confidence interval; IHSR, immediate hypersensitivity reactions; ISRR, immunization stress-related responses.