Table 1 Relevant adverse event rates in patients with immune-mediated diseases and controls after SARS-CoV-2 vaccination. Table showing percentages of relevant adverse events (rAEs; defined as any systemic AE higher than grade 1 or any systemic AE of grade 1 lasting more than 2 days), systemic AEs at day 7 following vaccination and local AEs higher than grade 1. Percentages are shown with their 95% confidence interval (95% CI) and separately for patients and controls, first, second and third vaccination and individuals with or without a preceding SARS-CoV-2 infection
Patients | Controls | |
|---|---|---|
First vaccination | ||
rAEs | 57.3 (54.8–59.8902/1574) | 49.7 (41.8–57.6; 81/163) |
rAEs, SARS-CoV-2 naive | 56.4 (53.7–58.9;807/1432) | 45.9 (36.9–55.1; 56/122) |
rAEs, with preceding SARS-CoV-2 | 66.9 (58.4–74.4;95/142) | 61.0 (44.5–75.4; 25/41) |
Systemic AE>1 at day 7a | 7.6 (6.3–9.1; 112/1481) | 6.3 (3.2–11.6; 10/159) |
Local AE>1a | 15.6 (14.8–18.4; 275/1664) | 18.8 (13.4–25.7; 32/170) |
Second vaccination | ||
rAEs | 61.5 (59.2–63.7;1129/1836) | 59.0 (50.8–66.7; 92/156) |
rAEs, SARS-CoV-2 naive | 60.8 (58.5–63.2; 1038/1706) | 58.3 (49.2–66.8; 74/127) |
rAEs, with preceding SARS-CoV-2 | 70.0 (61.2–77.6; 91/130) | 62.1 (42.4–78.7; 18/29) |
Systemic AE>1 at day 7a | 7.4 (6.2–8.7; 121/1647) | 4.1 (1.7–9.1; 6/146) |
Any local AE>1a | 21.4 (19.6–23.3; 400/1870) | 27.2 (20.6–35.0; 43/158) |
Third vaccination | ||
rAEs | 58.0 (55.3–60.6; 801/1381) | 51.5 (41.2–61.7; 50/97) |
Systemic AE>1 at day 7a | 6.8 (5.4–8.3; 83/1229) | 2.2 (0.4–8.4; 2/92) |
Any local AE>1a | 19.6 (17.6–21.7; 281/1437) | 12.9 (7.3–21.4; 13/101) |