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Table 1 The cumulative incidence rate of adverse events associated with pentavalent vaccination in male and female children and related risk ratios

From: Adverse events following immunization with pentavalent vaccine: experiences of newly introduced vaccine in Iran

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)

  1. NA not applicable
  2. aFemale gender was considered as reference for RR calculation