Table 1.
Self-controlled case series analysis for COVID-19 mRNA vaccination and positive SARS-Cov-2 on risk of myocarditis/pericarditis, cerebral venous thrombosis, strokes and appendicitis.
| AESI and Time Period |
D1 Vaccination |
D2 Vaccination |
B1 Vaccination* |
COVID-19 Infection |
||||
|---|---|---|---|---|---|---|---|---|
| D1 Cases | D1 Relative Incidence (95 % CI) | D2 Cases | D2 Relative Incidence | B1 Cases | B1 Relative incidence (95 % CI) | Infection Cases | Infection Relative Incidence (95 %CI) | |
| Myocarditis/Pericarditis, 12 years & above(through September 30, 2021, modified SCCS analysis) | ||||||||
| Baseline | 101 | 1.00 | 101 | 1.00 | NA^ | 2 | Not estimated | |
| 0 day | 1 | 1.37 [0.17 to 10.92] | 1 | 1.46 [0.20 to 10.68] | 0 | NA^ | 0 | Not estimated |
| 1–7 days | 10 | 1.90 [0.84 to 4.27] | 32 | 6.96 [3.95 to 12.27] | 0 | NA^ | 1 | Not estimated |
| 8–14 days | 10 | 1.83 [0.90 to 3.72] | 5 | 1.16 [0.45 to 2.99] | 0 | NA^ | 0 | Not estimated |
| 15–21 days | 4 | 0.72 [0.25 to 2.11] | 4 | 0.95 [0.33 to 2.75] | 0 | NA^ | 0 | Not estimated |
| 22–42 days | 2 | 0.17 [0.04 to 0.74] | 6 | 0.55 [0.22 to 1.33] | 0 | NA^ | 0 | Not estimated |
| Cerebral Venous Thrombosis, 18 years & above(through October 31, 2021, modified SCCS analysis) | ||||||||
| Baseline | 51 | 1.00 | NA^ | |||||
| 0 day | 0 | NA | 0 | NA | 0 | NA^ | 0 | Not estimated |
| 1–7 days | 0 | NA | 2 | 2.11 [0.48 to 9.33] | 0 | NA^ | 0 | Not estimated |
| 8–14 days | 2 | 1.57 [0.40 to 6.37] | 2 | 2.19 [0.48 to 10.01] | 1 | NA^ | 1 | Not estimated |
| 15–21 days | 1 | 0.91 [0.12 to 6.84] | 0 | NA | 0 | NA^ | 0 | Not estimated |
| 22–42 days | 5 | 4.30 [1.30 to 14.20] | 3 | 1.14 [0.31 to 4.27] | 0 | NA^ | 0 | Not estimated |
| Strokes, 18 years & above(through October 31, 2021, modified SCCS analysis) | ||||||||
| Baseline | 5931 | 1.00 | 7361 | 1.00 | ||||
| 0 day | 7 | 0.29 [0.14 to 0.61] | 0 | NA | 0 | NA^ | 16 | 28.0 [16.7 to 47.0] |
| 1–7 days | 122 | 0.73 [0.60 to 0.87] | 124 | 0.78 [0.65 to 0.95] | 50 | NA^ | 11 | 3.06 [1.65 to 5.66] |
| 8–14 days | 153 | 0.91 [0.77 to 1.07] | 135 | 0.86 [0.72 to 1.02] | 44 | NA^ | 9 | 3.04 [1.54 to 5.99] |
| 15–21 days | 134 | 0.94 [0.78 to 1.12] | 116 | 0.75 [0.62 to 0.91] | 44 | NA^ | 8 | 3.51 [1.71 to 7.22] |
| 22–42 days | 97 | 0.70 [0.56 to 0.86] | 416 | 0.93 [0.84 to 1.04] | 57 | NA^ | 8 | 2.31 [1.11 to 4.82] |
| Appendicitis, 12 years & above(through March 31, 2022, standard SCCS analysis) | ||||||||
| Baseline | 2339 | 1 | NA | |||||
| −28 days to −1 days | 116 | 0.56 [0.47 to 0.68] | NA | NA | 98 | 0.58 [0.47 to 0.71] | NA | NA |
| 0 day | 1 | 0.13 [0.02 to 0.96] | 0 | NA | 0 | NA | 15 | 10.15 [6.07 to 16.97] |
| 1–7 days | 68 | 1.31 [1.03 to 1.67] | 55 | 1.09 [0.84 to 1.43] | 35 | 0.83 [0.59 to 1.15] | 9 | 0.88 [0.46 to 1.71] |
| 8–14 days | 48 | 0.93 [0.70 to 1.23] | 48 | 0.96 [0.72 to 1.27] | 40 | 0.95 [0.70 to 1.31] | 12 | 1.21 [0.68 to 2.15] |
| 15–21 days | 69 | 1.39 [1.10 to 1.77] | 55 | 1.10 [0.84 to 1.44] | 42 | 1.01 [0.74 to 1.37] | 9 | 0.99 [0.51 to 1.93] |
| 22–42 days | 55 | 1.03 [0.79 to 1.36] | 146 | 0.97 [0.82 to 1.15] | 99 | 0.82 [0.67 to 1.00] | 20 | 0.98 [0.63 to 1.55] |
*
Booster doses rolled out on September 14, 2021.
^
Analysis not conducted as too few events as at observation end dates indicated in parentheses next to adverse event of special interest (AESI) within table.