Table 2.
Adverse reactions | After the first dose (n = 868) | After the second dose (n = 854) | P value |
---|---|---|---|
Any (n, %) | 800 (92.2) | 822 (96.3) | 03 |
Focal reactions (n, %) | 755 (87.0) | 738 (86.4) | <.01 |
Systemic reactions (n, %) | 332 (38.2) | 665 (77.9) | <.01 |
Administration site pain (n, %) | 746 (85.9) | 720 (84.3) | <.01 |
Administration site pain (short)* (n, %) | 475 (54.7) | 394 (45.9) | <.01 |
Administration site pain (long)** (n, %) | 271 (31.2) | 326 (38.2) | <.01 |
Administration site swelling (n, %) | 119 (13.7) | 205 (24.0) | <.01 |
Administration site redness (n, %) | 44 (5.1) | 115 (13.5) | <.01 |
Fever (n, %) | 23 (2.6) | 396 (46.4) | <.01 |
Fatigue (n, %) | 170 (19.6) | 542 (63.5) | <.01 |
Headache (n, %) | 97 (11.2) | 333 (39.0) | <.01 |
Chill (n, %) | 13 (1.5) | 236 (27.7) | 04 |
Emesis (n, %) | 3 (.3) | 21 (2.5) | 05 |
Diarrhea (n, %) | 16 (1.8) | 27 (3.2) | <.01 |
Generalized muscle pain (n, %) | 130 (15.0) | 229 (26.8) | <.01 |
Joint pain (n, %) | 24 (2.8) | 226 (26.5) | <.01 |
Took antipyretic (n, %) | 24 (2.8) | 291 (34.1) | <.01 |
Other symptoms (n, %) | 60 (6.9) | 84 (9.8) | <.01 |
Axillary lymphadenopathy (n, %) | 9 (1.0) | 25 (2.9) | <.01 |
Dizziness (n, %) | 6 (.7) | 6 (.7) | <.01 |
Skin rash (n, %) | 7 (.8) | 7 (.8) | <.01 |
Drowsiness (n, %) | 6 (.7) | 9 (1.0) | <.01 |
Itchiness (%) | 9 (1.0) | 10 (1.2) | 07 |
Data were analyzed by two-tailed Chi-square test or Fisher’s exact test, as appropriate. *Administration site pain that disappeared on the day after injection is defined was “Administration site pain (short)”.
**Administration site pain that remained at least two days after injection was defined as “Administration site pain (long)”.