Table 1 Incidence of total adverse reactions among vaccination group versus control group
From: Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials
| Â | No. of studies | Reactions/total | RR (95% CI) | I2 | |
|---|---|---|---|---|---|
Vaccination | Control | ||||
Overall | |||||
 Total adverse reactions | 10 | 33 673/54 752 | 16 446/52 400 | 1.75 (1.59–1.92)* | 0.93 |
 Systemic adverse reactions (any) | 7 | 25 286/39 698 | 14 972/38 088 | 1.41 (1.11–1.78)* | 0.99 |
 Local adverse reactions (any) | 7 | 32 077/39 698 | 6687/38 088 | 4.49 (3.79–5.30)* | 0.94 |
Total adverse reactions to different vaccine types | |||||
 Inactivated vaccine | 5 | 523/2244 | 107/630 | 1.34 (1.11–1.61)* | 0.00 |
 Vectored vaccine | 2 | 670/886 | 177/382 | 1.65 (1.31–2.07)* | 0.75 |
 mRNA vaccine | 3 | 32 480/51 622 | 16 162/51 388 | 2.01 (1.78–2.26)* | 0.98 |
Systemic adverse reactions (any) to different vaccine types | |||||
 Inactivated vaccine | 4 | 193/1764 | 52/468 | 0.92 (0.69–1.23) | 0.00 |
 mRNA vaccine | 2 | 25 020/37 696 | 14 911/37 560 | 1.65 (1.21–2.24)* | 1.00 |
Local adverse reactions (any) to different vaccine types | |||||
 Inactivated vaccine | 4 | 172/1164 | 29/320 | 1.94 (1.10–3.41)* | 0.54 |
 mRNA vaccine | 2 | 31 735/37 696 | 6653/37 560 | 5.37 (4.54–6.36)* | 0.98 |
Fever | |||||
 Inactivated vaccine | 5 | 64/2244 | 16/630 | 0.99 (0.56–1.73) | 0.00 |
 Vectored vaccine | 3 | 410/1121 | 80/968 | 3.05 (1.56–5.99)* | 0.84 |
 mRNA vaccine | 5 | 3175/38 365 | 128/37 591 | 7.90 (2.72–22.94)* | 0.95 |
Headache | |||||
 Inactivated vaccine | 4 | 22/1644 | 6/480 | 0.72 (0.29–1.77) | 0.00 |
 Vectored vaccine | 3 | 555/1121 | 311/968 | 1.68 (1.51–1.86)* | 0.00 |
 mRNA vaccine | 5 | 17 152/38 365 | 9300/37 591 | 2.06 (1.49–2.83)* | 0.99 |
Fatigue | |||||
 Inactivated vaccine | 5 | 88/2244 | 6/630 | 0.85 (0.55–1.30) | 0.00 |
 Vectored vaccine | 3 | 639/1121 | 334/968 | 1.88 (1.31–2.69)* | 0.81 |
 mRNA vaccine | 5 | 19 471/38 365 | 9506/37 591 | 1.98 (1.46–2.67)* | 0.99 |
Pain | |||||
 Inactivated vaccine | 5 | 329/2244 | 39/630 | 2.24 (1.37–3.65)* | 0.50 |
 Vectored vaccine | 2 | 573/925 | 209/660 | 3.29 (0.92–11.77) | 0.95 |
 mRNA vaccine | 4 | 31 924/38 065 | 5946/37 519 | 5.63 (4.89–6.48)* | 0.93 |
Redness | |||||
 Inactivated vaccine | 5 | 15/2244 | 2/630 | 0.90 (0.32–2.59) | 0.00 |
 Vectored vaccine | 2 | 22/925 | 13/660 | 1.34 (0.67–2.65) | 0.00 |
 mRNA vaccine | 3 | 2127/37 650 | 194/37 457 | 7.59 (3.74–15.39)* | 0.93 |
Swelling | |||||
 Inactivated vaccine | 4 | 19/1644 | 3/480 | 1.08 (0.39–3.03) | 0.00 |
 Vectored vaccine | 2 | 37/925 | 18/660 | 2.23 (0.33–14.96) | 0.53 |
 mRNA vaccine | 4 | 3843/38 065 | 149/37 519 | 12.69 (6.50–24.79)* | 0.89 |
Total adverse reactions of different sample sizes | |||||
 Sample size ≥ 500 | 5 | 32 976/52 928 | 16 246/51 758 | 1.95 (1.75–2.17)* | 0.97 |
 Sample size < 500 | 6 | 697/1824 | 200/652 | 1.43 (1.25–1.64)* | 0.12 |
Total adverse reactions of different trial phases | |||||
 Phase I trial | 4 | 137/468 | 26/155 | 1.62 (1.12–2.36)* | 0.00 |
 Phase II trial | 5 | 650/1966 | 120/564 | 1.49 (1.14–1.94)* | 0.54 |
 Phase III trial | 2 | 32 423/51 466 | 16 154/51 352 | 2.03 (1.79–2.29)* | 0.99 |