Table 3.
Comparison of the number of spontaneous intussusception reports received and number expected to have occurred by chance in 30 days and 7 days after vaccination (worldwide, Europe, US, and Japan)
| Risk period (days) | Dose | Total number of doses | Expected number of cases (range) | Observed number of cases (95% CI) | ||
|---|---|---|---|---|---|---|
| BCWG L1a | BCWG L1–3a | BCWG L1–4a | ||||
| Worldwide | ||||||
| 30 | First | 319,695,721.12 | 614.4–17,025.2 | 440 (399.8–483.1) | 469 (427.5–513.4) | 741 (688.6–796.3) |
| 30 | Second | 319,695,721.12 | 1,164.8–32,277.9 | 217 (189.1–247.9) | 230 (201.2–261.7) | 364 (327.6–403.4) |
| 30 | Anyb | 639,391,442.23 | 1,598.5–44,295.2 | 659 (609.6–711.3) | 701 (650.1–754.9) | 1108 (1043.7–1175.2) |
| 7 | First | 319,695,721.12 | 143.4–3,972.5 | 321 (286.8–358.1) | 342 (306.7–380.2) | 559 (513.6–607.3) |
| 7 | Second | 319,695,721.12 | 271.8–7,531.5 | 114 (94.0–136.9) | 121 (100.4–144.6) | 213 (185.4–243.6) |
| 7 | Anyb | 639,391,442.23 | 373.0–10,335.6 | 436 (396.0–478.9) | 464 (422.7–508.2) | 774 (720.4–830.5) |
| Europe | ||||||
| 30 | First | 16,029,101 | 170.2–680.2 | 187 (161.2–215.8) | 199 (172.3–228.7) | 325 (290.6–362.3) |
| 30 | Second | 16,029,101 | 277.3–1,108.1 | 44 (32.0–59.1) | 46 (33.7–61.4) | 98 (79.6–119.4) |
| 30 | Anyb | 32,058,202 | 427.6–1,708.6 | 231 (202.2–262.8) | 245 (215.3–277.7) | 423 (383.6–465.3) |
| 7 | First | 16,029,101 | 39.7–158.7 | 138 (115.9–163.0) | 148 (125.1–173.9) | 249 (219.0–281.9) |
| 7 | Second | 16,029,101 | 64.7–258.5 | 22 (13.8–33.3) | 23 (14.6–34.5) | 51 (38.0–67.1) |
| 7 | Anyb | 32,058,202 | 99.8–398.7 | 160 (136.2–186.8) | 171 (146.3–198.6) | 300 (267.0–335.9) |
| US | ||||||
| 30 | First | 10,945,330 | 250.5–410.0 | 6 (2.2–13.1) | 8 (3.5–15.8) | 19 (11.4–29.7) |
| 30 | Second | 10,945,330 | 307.2–502.7 | 6 (2.2–13.1) | 6 (2.2–13.1) | 13 (6.9–22.2) |
| 30 | Anyb | 21,890,660 | 576.4–943.3 | 13 (6.9–22.2) | 15 (8.4–24.7) | 34 (23.5–47.5) |
| 7 | First | 10,945,330 | 58.5–95.7 | 5 (1.6–11.7) | 6 (2.2–13.1) | 14 (7.7–23.5) |
| 7 | Second | 10,945,330 | 71.7–117.3 | 5 (1.6–11.7) | 5 (1.6–11.7) | 9 (4.1–17.1) |
| 7 | Anyb | 21,890,660 | 134.5–220.1 | 10 (4.8–18.4) | 11 (5.5–19.7) | 24 (15.4–35.7) |
| Japan | ||||||
| 30 | First | 3,406,093 | 109.5–145.8 | 105 (85.9–127.1) | 110 (90.4–132.6) | 140 (117.8–165.2) |
| 30 | Second | 3,406,093 | 398.1–529.9 | 67 (51.9–85.1) | 70 (54.6–88.4) | 78 (61.7–97.3) |
| 30 | Anyb | 6,812,186 | 437.6–582.4 | 172 (147.3–199.7) | 180 (154.7–208.3) | 218 (190.0–248.9) |
| 7 | First | 3,406,093 | 25.6–34.0 | 78 (61.7–97.3) | 80 (63.4–99.6) | 103 (84.1–124.9) |
| 7 | Second | 3,406,093 | 92.9–123.6 | 36 (25.2–49.8) | 37 (26.1–51.0) | 43 (31.1–57.9) |
| 7 | Anyb | 6,812,186 | 102.1–135.9 | 114 (94.0–136.9) | 117 (96.8–140.2) | 146 (123.3–171.7) |
BCWG L1, Brighton Collaboration Working Group level 1, BCWG L1–3 Brighton Collaboration Working Group levels 1–3, BCWG L1–4 Brighton Collaboration Working Group levels 1–4, CI confidence interval
aAs defined by Bines et al. [22]
bNote that an extra third dose was admin in a few instances