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. 2025 Oct 13;12:1652401. doi: 10.3389/fmed.2025.1652401

Table 3.

Signal strength of reports of IXE with preferred terms (PTs) ≥ 45 from FAERS.

PT Case numbers ROR(95%Cl) PRR(χ2) EBGM(EBGM05) IC(IC025)
Injection site pain 3,581 16.05(15.51–16.61) 15.06 (46163.17) 14.75 (14.33) 3.88 (3.83)
Injection site erythema 2,014 26.19(25.03–27.41) 25.26 (45249.64) 24.36 (23.45) 4.61 (4.54)
Injection site swelling 1,519 28.29 (26.86–29.8) 27.53 (37306.84) 26.46 (25.33) 4.73 (4.65)
Injection site reaction 1,459 30.4 (28.83–32.06) 29.62 (38626.91) 28.37 (27.14) 4.83 (4.75)
Injection site pruritus 695 14.49(13.44–15.63) 14.32 (8434.19) 14.03 (13.17) 3.81 (3.7)
Injection site urticaria 606 32.49(29.93–35.27) 32.14 (17432.15) 30.68 (28.64) 4.94 (4.82)
Injection site mass 549 15.18(13.94–16.52) 15.03 (7034.93) 14.72 (13.71) 3.88 (3.75)
Injection site hemorrhage 512 7.79 (7.13–8.5) 7.72 (2964.55) 7.64 (7.1) 2.93 (2.81)
Nasopharyngitis 475 2.81 (2.56–3.07) 2.79 (545.06) 2.78 (2.58) 1.48 (1.34)
Injection site rash 468 20.43(18.63–22.41) 20.27 (8317.37) 19.69 (18.22) 4.3 (4.16)
Injection site warmth 451 38.5 (35–42.35) 38.19 (15,434) 36.13 (33.36) 5.18 (5.04)
Urticaria 436 3.12 (2.84–3.43) 3.1 (618.94) 3.09 (2.86) 1.63 (1.49)
Injection site bruising 415 6.66 (6.05–7.34) 6.62 (1962.04) 6.56 (6.05) 2.71 (2.57)
Sinusitis 397 4.34 (3.93–4.79) 4.31 (1005.2) 4.29 (3.95) 2.1 (1.96)
Influenza 293 2.81 (2.51–3.16) 2.81 (339.55) 2.8 (2.54) 1.48 (1.32)
Cellulitis 261 6.08 (5.38–6.87) 6.06 (1093.16) 6.01 (5.43) 2.59 (2.41)
Ear infection 213 8.66 (7.56–9.91) 8.63 (1417.93) 8.53 (7.61) 3.09 (2.89)
Upper respiratory tract infection 185 4.51 (3.9–5.21) 4.5 (500.14) 4.47 (3.96) 2.16 (1.95)
Bronchitis 175 2.76 (2.38–3.21) 2.76 (195.63) 2.75 (2.43) 1.46 (1.24)
Fungal infection 172 5.84 (5.02–6.78) 5.82 (681.08) 5.78 (5.1) 2.53 (2.31)
Herpes zoster 135 2.53 (2.14–3) 2.53 (124.68) 2.53 (2.19) 1.34 (1.09)
Oral candidiasis 134 12.94 (10.9–15.35) 12.91 (1443.68) 12.68 (10.98) 3.66 (3.41)
Candida infection 125 7.24 (6.07–8.63) 7.22 (663.12) 7.16 (6.17) 2.84 (2.58)
Pharyngitis streptococcal 111 11.46 (9.49–13.82) 11.43 (1038.89) 11.25 (9.62) 3.49 (3.22)
Inflammatory bowel disease 98 20.41(16.69–24.97) 20.38 (1751.5) 19.79 (16.73) 4.31 (4.01)
Colitis 94 2.72 (2.22–3.33) 2.72 (101.63) 2.71 (2.29) 1.44 (1.14)
Staphylococcal infection 93 3.83 (3.12–4.69) 3.82 (192.71) 3.81 (3.21) 1.93 (1.63)
Irritable bowel syndrome 83 4.65 (3.74–5.77) 4.64 (235.56) 4.62 (3.85) 2.21 (1.89)
Tooth infection 79 6.62 (5.3–8.26) 6.61 (372.37) 6.55 (5.44) 2.71 (2.39)
Respiratory tract infection 66 2.74 (2.15–3.49) 2.74 (72.59) 2.73 (2.23) 1.45 (1.1)
Diverticulitis 64 2.54 (1.99–3.25) 2.54 (59.41) 2.53 (2.06) 1.34 (0.98)
Immune system disorder 60 4.84 (3.75–6.24) 4.83 (181.03) 4.8 (3.88) 2.26 (1.89)
Kidney infection 53 2.87 (2.19–3.76) 2.87 (64.13) 2.86 (2.28) 1.51 (1.12)
Conjunctivitis 52 2.95 (2.25–3.88) 2.95 (66.69) 2.94 (2.34) 1.56 (1.16)
Tuberculosis 52 4.54 (3.45–5.96) 4.54 (142.36) 4.51 (3.59) 2.17 (1.78)
Gastroenteritis viral 47 2.95 (2.22–3.93) 2.95 (60.38) 2.94 (2.31) 1.56 (1.14)
Malignant melanoma 46 3.55 (2.66–4.74) 3.55 (83.71) 3.53 (2.77) 1.82 (1.4)