Table 3.
Adjusted incidence rate ratio and risk difference of adverse events of special interest and acute diabetes complications for 21-day follow-up period after vaccination of BNT162b2 and CoronaVac
| Reference | First dose | Second dose | |||||
|---|---|---|---|---|---|---|---|
| Event | Event | Adjusted IRR (95% CI) | Risk difference (95% CI), incidence per 100,000 persons | Event | Adjusted IRR (95% CI) | Risk difference (95% CI), incidence per 100,000 persons | |
| BNT162b2 | |||||||
| Overall adverse events of special interest | 4368 | 53 | 0.83 (0.61, 1.13) | − 23.77 (− 89.10, 15.92) | 56 | 0.99 (0.74, 1.32) | − 1.32 (− 49.07, 34.04) |
| Autoimmune disease | 941 | 26 | 1.10 (0.72, 1.68) | 2.64 (− 15.91, 16.38) | 13 | 0.58 (0.33, 1.05) | − 21.12 (− 83.80, 1.80) |
| Narcolepsy | 623 | 21 | 1.02 (0.63, 1.64) | 0.50 (− 20.03, 13.60) | 12 | 0.60 (0.33, 1.11) | − 16.21 (− 70.48, 3.32) |
| Acute aseptic arthritis | 305 | 5 | 1.61 (0.59, 4.38) | 1.89 (− 7.21, 7.96) | 2 | 0.77 (0.15, 3.92) | − 1.47 (− 57.33, 7.68) |
| Cardiovascular diseases | 3463 | 24 | 0.72 (0.45, 1.14) | − 19.48 (− 77.65, 7.90) | 36 | 1.22 (0.85, 1.75) | 8.95 (− 11.03, 27.24) |
| Heart failure | 1637 | 6 | 0.86 (0.35, 2.11) | − 1.72 (− 32.68, 9.38) | 9 | 1.18 (0.57, 2.43) | 1.64 (− 13.42, 10.52) |
| Coronary artery disease | 1951 | 10 | 0.47 (0.24, 0.93) | − 28.99 (− 115.92, − 1.28) | 23 | 1.30 (0.82, 2.07) | 6.01 (− 8.10, 18.84) |
| Arrhythmia | 1603 | 20 | 1.15 (0.67, 1.96) | 3.08 (− 16.07, 16.34) | 12 | 0.87 (0.47, 1.61) | − 3.60 (− 37.85, 12.60) |
| Circulatory system | 3257 | 29 | 0.92 (0.60, 1.38) | − 4.71 (− 42.46, 18.06) | 34 | 1.16 (0.80, 1.69) | 7.02 (− 16.39, 26.45) |
| Thromboembolism | 3049 | 25 | 0.82 (0.53, 1.28) | − 10.07 (− 54.09, 13.26) | 33 | 1.19 (0.82, 1.74) | 7.54 (− 13.42, 25.60) |
| Hemorrhagic disease | 445 | 6 | 2.02 (0.88, 4.64) | 3.74 (− 1.83, 10.66) | 4 | 1.71 (0.59, 4.97) | 3.08 (− 9.39, 10.85) |
| Hepato-renal system | 869 | 2 | 0.32 (0.08, 1.31) | − 8.22 (− 105.69, 2.19) | 3 | 0.61 (0.18, 2.01) | − 2.53 (− 40.68, 4.62) |
| Nerves and central nervous system | 413 | 4 | 0.95 (0.31, 2.89) | − 0.38 (− 29.60, 8.82) | 6 | 1.54 (0.56, 4.23) | 2.59 (− 10.43, 10.30) |
| Generalized convulsion | 246 | 2 | 0.84 (0.17, 4.17) | − 0.70 (− 41.82, 6.44) | 3 | 1.36 (0.29, 6.40) | 0.96 (− 20.88, 7.15) |
| Respiratory system (acute respiratory distress syndrome) | 1108 | 5 | 0.41 (0.17, 0.98) | − 10.46 (− 64.81, − 0.07) | 5 | 0.45 (0.17, 1.19) | − 8.66 (− 63.27, 2.12) |
| Acute diabetes complications | 2595 | 12 | 0.38 (0.20, 0.75) | − 40.74 (− 144.04, − 5.92) | 23 | 0.94 (0.56, 1.58) | − 1.61 (− 28.01, 13.07) |
| Hypoglycemia | 1918 | 8 | 0.39 (0.17, 0.93) | − 29.77 (− 140.76, − 0.94) | 19 | 1.26 (0.69, 2.31) | 3.99 (− 12.83, 15.97) |
| Hyperosmolar hyperglycemic syndrome | 958 | 5 | 0.45 (0.15,1.34) | − 7.82 (− 68.25, 3.14) | 4 | 0.43 (0.14, 1.37) | − 8.49 (− 77.80, 3.33) |
| CoronaVac | |||||||
| Overall adverse events of special interest | 4792 | 79 | 0.77 (0.59, 1.00) | − 30.59 (− 83.27, 0.16) | 60 | 0.77 (0.58, 1.02) | − 30.72 (− 86.70, 1.94) |
| Autoimmune disease | 987 | 18 | 0.68 (0.40, 1.15) | − 9.09 (− 39.63, 3.49) | 20 | 0.84 (0.52, 1.34) | − 3.68 (− 23.84, 6.69) |
| Narcolepsy | 646 | 12 | 0.51 (0.27, 0.98) | − 12.65 (− 52.88, − 0.16) | 15 | 0.77 (0.45, 1.32) | − 4.00 (− 23.92, 4.73) |
| Acute aseptic arthritis | 322 | 6 | 2.72 (1.00, 7.42) | 3.05 (− 0.01, 7.67) | 4 | 1.69 (0.58, 4.94) | 1.96 (− 6.51, 7.07) |
| Cardiovascular diseases | 3768 | 55 | 0.82 (0.59, 1.13) | − 12.00 (− 45.73, 7.77) | 41 | 0.86 (0.61, 1.20) | − 9.13 (− 42.66, 11.22) |
| Heart failure | 1752 | 20 | 0.93 (0.52, 1.66) | − 1.10 (− 19.48, 8.51) | 11 | 0.84 (0.44, 1.60) | − 2.82 (− 26.90, 8.06) |
| Coronary artery disease | 2068 | 19 | 0.58 (0.34, 0.98) | − 15.71 (− 56.47, − 0.37) | 21 | 0.78 (0.48, 1.26) | − 5.97 (− 31.04, 6.05) |
| Arrhythmia | 1791 | 35 | 1.10 (0.71, 1.70) | 2.32 (− 14.15, 14.13) | 17 | 0.76 (0.45, 1.31) | − 8.11 (− 42.54, 8.02) |
| Circulatory system | 3569 | 34 | 0.62 (0.42, 0.91) | − 22.60 (− 64.20, − 2.88) | 31 | 0.69 (0.47, 1.00) | − 16.48 (− 51.73, 0.09) |
| Thromboembolism | 3352 | 33 | 0.62 (0.42, 0.92) | − 21.48 (− 62.17, − 2.44) | 30 | 0.71 (0.48, 1.04) | − 14.53 (− 48.57, 1.75) |
| Hemorrhagic disease | 463 | 7 | 0.94 (0.24, 3.66) | − 0.31 (− 27.34, 6.27) | 2 | 0.19 (0.03, 1.38) | − 19.41 (− 321.64, 2.37) |
| Hepato-renal system | 926 | 10 | 0.78 (0.38, 1.58) | − 1.83 (− 17.95, 4.09) | 2 | 0.22 (0.05, 0.90) | − 22.72 (− 198.27, − 0.35) |
| Acute kidney injury | 715 | 5 | 0.91 (0.33, 2.47) | − 0.25 (− 11.60, 3.48) | 0 | NA | NA |
| Acute pancreatitis | 220 | 3 | 0.93 (0.28, 3.13) | − 0.20 (− 16.18, 4.26) | 3 | 0.78 (0.23, 2.63) | − 0.79 (− 20.55, 3.89) |
| Nerves and central nervous system | 479 | 8 | 0.78 (0.35, 1.74) | − 1.98 (− 21.69, 4.92) | 6 | 0.67 (0.29, 1.58) | − 3.37 (− 28.88, 4.25) |
| Bell's Palsy | 204 | 8 | 1.13 (0.48, 2.64) | 0.72 (− 11.42, 6.66) | 5 | 0.88 (0.34, 2.29) | − 0.83 (− 20.75, 6.04) |
| Respiratory system (acute respiratory distress syndrome) | 1135 | 5 | 0.34 (0.12, 0.95) | − 14.73 (− 88.04, − 0.23) | 11 | 0.98 (0.52, 1.85) | − 0.16 (− 11.64, 5.78) |
| Acute diabetes complications | 2871 | 32 | 0.74 (0.47, 1.14) | − 9.35 (− 37.76, 4.22) | 21 | 0.68 (0.42, 1.09) | − 12.32 (− 46.27, 2.73) |
| Hypoglycemia | 2137 | 22 | 0.68 (0.39, 1.17) | − 8.76 (− 39.31, 3.73) | 16 | 0.76 (0.45, 1.30) | − 5.66 (− 30.92, 5.84) |
| Hyperosmolar hyperglycemic syndrome | 1053 | 15 | 1.22 (0.67, 2.21) | 1.92 (− 7.81, 8.82) | 7 | 0.65 (0.28, 1.53) | − 5.71 (− 42.29, 5.61) |
Adjusted IRR was obtained from conditional Poisson regression adjusted for seasonal effect from self-controlled case-series analysis
IRR incidence rate ratio, CI confidence interval, NA not available