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. 2021 Sep 2;41(11):1925–1931. doi: 10.1007/s00296-021-04972-7

Table 2.

Reactogenicity in patients compared to healthy controls

None Mild Moderate Severe Grade 4 Total (%) NEJM [6] (%) OR 95% CI
Pain at injection site 26.6 56.0 16.0 1.1 0.3 73.4 66 1.4 1.1–1.9
Redness 79.8 17.0 2.5 0.7 20.2 7 3.4 2.4–4.7
Swollen 73.4 21.3 4.3 1.0 26.6 7 4.8 3.5–6.5
Fever 83.0 8.1 6.4 2.5 17.0 11 1.7 1.2–2.3
Fatigue 30.9 25.5 32.3 10.6 0.7 69.1 51 2.2 1.7–2.8
Headache 47.9 28.0 18.1 6.0 52.1 39 1.7 1.3–2.2
Chills 70.2 16.7 8.5 4.3 0.3 29.8 23 1.4 1.1–1.9
Muscular pain 58.2 20.9 15.3 5.3 0.3 41.8 29 1.8 1.4–2.3
Joint pain 65.3 14.5 14.2 5.3 0.7 34.7 19 2.3 1.7–3.0
Vomiting 97.2 2.8 2.8 1 2.9 1.2–6.5
Diarrhea 92.2 5.7 1.8 0.3 7.8 8 1.0 0.6–1.5
Use of antipyretic medicine 22.3 38 0.5 0.3–0.6

Table 2 shows the reactogenicity in percentage seven days after 2nd vaccination for both SLE and RA patients (n = 285) and participants in the original phase 3 trial (abbreviated NEJM) [6]. The Odds Ratio (OR) is calculated between patients and participants in the original phase 3 study