Table 1.
The cumulative incidence rate of adverse events associated with pentavalent vaccination in male and female children and related risk ratios
| Adverse events | Incidence (per 100 children) | P-value | Risk ratio (95% CI)a | ||
|---|---|---|---|---|---|
| Sex | |||||
| Male | Female | ||||
| Swelling | Yes | 103(16.9) | 74(14.5) | 0.149 | 1.16 (0.88–1.50) |
| No | 505(83.1) | 437(85.5) | |||
| Redness | Yes | 64(10.5) | 59(11.5) | 0.327 | 0.91 (0.65–1.27) |
| No | 544(89.5) | 452(88.5) | |||
| Pain | Yes | 282(53.6) | 213(41.7) | 0.065 | 1.11 (0.97–1.27) |
| No | 326(53.6) | 298(58.3) | |||
| Mild fever | Yes | 75(12.3) | 66(12.9) | 0.420 | 0.95 (0.70–1.30) |
| No | 533(87.7) | 445(87.1) | |||
| High fever | Yes | 0 | 1(0.2) | 0.457 | NA |
| No | 608(100) | 510(99.8) | |||
| Drowsiness | Yes | 123(20.2) | 102(20) | 0.486 | 1.01 (0.80–1.28) |
| No | 485(79.8) | 409(80) | |||
| Anorexia | Yes | 91(15) | 77(15.1) | 0.514 | 0.99 (0.75–1.31) |
| No | 517(85) | 434(84.9) | |||
| Restlessness | Yes | 204(33.6) | 165(32.3) | 0.351 | 1.03 (0.87–1.22) |
| No | 404(66.4) | 346(67.7) | |||
| Vomiting | Yes | 29(4.8) | 23(4.5) | 0.474 | 1.05 (0.62–1.80) |
| No | 579(95.2) | 488(95.5) | |||
| Long-term crying | Yes | 43(7.1) | 19(3.7) | 0.010 | 1.90 (1.13–3.22) |
| No | 565(92.9) | 492(96.3) | |||
| Encephalopathy | Yes | 0 | 0 | 1 | NA |
| No | 608(100) | 511(100) | |||
| Convulsion | Yes | 0 | 0 | 1 | NA |
| No | 608(100) | 511(100) | |||
| History of convulsion | Yes | 3(0.49) | 0 | 0.43 | NA |
| No | 605(99.5) | 511(100) | |||
| Family history of convulsion | Yes | 10(1.64) | 10(1.9) | 0.16 | 0.84 (0.35–2) |
| No | 598(98.3) | 501(98.0) | |||
NA not applicable
aFemale gender was considered as reference for RR calculation