Table 2.
Occurrence of symptoms/adverse events over the week after vaccine administration.
| t1—One week after the first dose N = 488 | t2—One week after the second dose N = 489 | PPV (%) | NPV (%) | Kappa | |||||
|---|---|---|---|---|---|---|---|---|---|
| Not at all (%) | Moderate (%) | Severe (%) | Not at all (%) | Moderate (%) | Severe (%) | ||||
| Pain | 194 (39.8) | 263 (53.9) | 31 (6.4) | 218 (44.6) | 246 (50.3) | 25 (5.1) | 17.2 | 96.2 | 0.15 |
| Fatigue | 341 (69.9) | 125 (25.6) | 22 (4.5) | 285 (58.3) | 171 (35.0) | 33 (6.7) | 28.6 | 93.9 | 0.18 |
| Headache | 430 (88.1) | 48 (9.8) | 10 (2.0) | 397 (81.2) | 78 (16.0) | 14 (2.9) | 25.0 | 97.7 | 0.18 |
| Pain bone | 408 (83.6) | 67 (13.7) | 13 (2.7) | 356 (72.8) | 114 (23.3) | 19 (3.9) | 25.0 | 96.8 | 0.18 |
| Fever | 459 (94.1) | 23 (4.7) | 6 (1.2) | 411 (84.0) | 49 (10.0) | 29 (5.9) | 83.5 | 94.8 | 0.28 |
| Enlarged lymph nodes | 487 (99.8) | – | 1 (0.2) | 478 (97.8) | 10 (2.0) | 1 (0.2) | NE | 99.8 | NE |
| Skin rash | 471 (96.5) | 14 (2.9) | 3 (0.6) | 458 (93.7) | 22 (4.5) | 9 (1.8) | NE | 98.4 | NE |
| Insomnia | 464 (95.1) | 22 (4.5) | 2 (0.4) | 443 (90.6) | 41 (8.4) | 5 (1.0) | NE | 99.1 | NE |
| Diarrhea | 461 (94.5) | 25 (5.1) | 2 (0.4) | 454 (92.8) | 32 (6.5) | 3 (0.6) | NE | 99.6 | NE |
| Nausea or vomiting | 471 (96.5) | 15 (3.1) | 2 (0.4) | 457 (93.5) | 29 (5.9) | 3 (0.6) | NE | 99.6 | NE |
PPV (positive predictive value) probability of occurrence of a severe symptom after the second dose according to the occurrence of the same symptom after the first dose.
NPV (negative predictive value) probability of absence of a severe symptom after the second dose according to the not occurrence of the same after the first dose.
NE, not evaluable.
Kappa (Cohen’s kappa statistics) is a measure of agreement between severe vs. non-severe symptoms between the two doses.
“Moderate” and “Severe” include patients who have been troubled slightly or moderately (moderate) and severely or overwhelmingly (severe), respectively.