Table 4.
Adverse reactions list within 28 d after the last vaccination.
| Zagreb group |
Essen group |
|||||
|---|---|---|---|---|---|---|
| Age(years) | ≤ 20 N = 1426 | 21–50 N = 2474 | ≥ 51 N = 1072 | ≤ 20 N = 1600 | 21–50 N = 2740 | ≥ 51 N = 1247 |
| Total incidence of adverse reactions (%) | 463(32.4) | 736(29.7) | 271(25.2) | 276(17.3) | 803(29.3) | 272(21.8) |
| Systemic adverse reactions | ||||||
| Incidence (%) | 278(19.5) | 243(9.8) | 110(10.3) | 189(11.8) | 280(10.2) | 114(9.1) |
| Fever | 240(16.8) | 59(2.4) | 17(1.6) | 128(8.0) | 42(1.5) | 13(1.0) |
| fatigue | 33(2.3) | 132(5.3) | 64(6.0) | 25(1.6) | 147(5.4) | 71(5.7) |
| Allergy | 8(0.6) | 6(0.2) | 5(0.5) | 11(0.7) | 21(0.8) | 8(0.6) |
| Dysphoria | 1(0.1) | 6(0.2) | 4(0.4) | 2(0.1) | 4(0.1) | 1(0.1) |
| Loss of appetite | 1(0.1) | 2(0.1) | 4(0.4) | 12(0.8) | 3(0.1) | 6(0.5) |
| Nausea | 13(0.9) | 12(0.5) | 5(0.5) | 6(0.4) | 24(0.9) | 6(0.5) |
| Diarrhea | 2(0.1) | 4(0.2) | 1(0.2) | 6(0.4) | 5(0.2) | 6(0.5) |
| Dizziness | 13(0.9) | 35(1.4) | 16(1.5) | 4(0.2) | 44(1.6) | 12(1.0) |
| Headache | 6(0.5) | 16(0.6) | 6(0.6) | 8(0.5) | 22(0.8) | 10(0.8) |
| Myalgia | 0(0.0) | 12(0.5) | 5(0.5) | 2(0.1) | 11(0.4) | 5(0.4) |
| Cough | 3(0.2) | 1(0.0) | 0 | 4(0.3) | 1(0.0) | 0(0.0) |
| Others | 9(0.6) | 14(0.6) | 12(1.1) | 6(0.4) | 31(1.1) | 11(0.9) |
| Local reactions | ||||||
| Incidence (%) | 234(16.4) | 587(23.7) | 201(18.8) | 125(7.8) | 648(23.6) | 193(15.5) |
| Pain | 190(13.3) | 497(20.1) | 170(15.9) | 107(6.7) | 558(20.4) | 168(13.5) |
| Swelling | 25(1.8) | 77(3.1) | 23(2.1) | 15(0.9) | 104(3.8) | 37(3.0) |
| Itching | 13(0.9) | 39(1.6) | 26(2.4) | 6(0.4) | 72(2.6) | 23(1.8) |
| Induration | 9(0.6) | 28(1.1) | 9(0.8) | 5(0.3) | 45(1.6) | 18(1.4) |
| Erythema | 14(1.0) | 20(0.8) | 8(0.7) | 15(0.9) | 58(2.1) | 13(1.0) |
| Others | 6(0.4) | 16(0.6) | 4(0.4) | 1(0.1) | 15(0.5) | 3(0.2) |