Table 3.
Adverse reactions observed in the control and NMD groups.
| After the first vaccination | After the second vaccination | |||||
|---|---|---|---|---|---|---|
| Adverse reactions | Control group (n = 339) |
NMDs group (n = 11) |
p value | Control group (n = 339) |
NMDs group (n = 11) |
p value |
| Any adverse reactions | ||||||
| ≥grade 1 | 329 (97.1%) | 8 (72.7%) | 0.0007 | 329 (97.1%) | 8 (72.7%) | 0.0007 |
| ≥grade 2 | 61 (18.0%) | 0 (0%) | 0.2524 | 113 (33.3%) | 3 (27.2%) | 0.9244 |
| ≥grade 3 | 5 (1.5%) | 0 (0%) | 1.000 | 6 (1.8%) | 0 (0%) | 1.000 |
| Anaphylaxis | 0 (0%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
| Vasovagal reflex | 0 (0%) | 0 (0%) | 1.000 | 1 (0.3%) | 0 (0%) | 1.000 |
| Injection site reaction | ||||||
| ≥grade 1 | 271 (80.0%) | 7 (63.6%) | 0.3484 | 310 (91.4%) | 5 (45.5%) | <0.0001 |
| ≥grade 2 | 45 (13.3%) | 0 (0%) | 0.1955 | 25 (7.4%) | 0 (0%) | 0.7339 |
| ≥grade 3 | 1 (0.3%) | 0 (0%) | 1.000 | 1 (0.3%) | 0 (0%) | 1.000 |
| Fatigue | ||||||
| ≥grade 1 | 62 (18.3%) | 1 (9.1%) | 0.7019 | 184 (54.3%) | 5 (45.5%) | 0.7868 |
| ≥grade 2 | 11 (3.2%) | 0 (0%) | 1.000 | 65 (19.2%) | 2 (18.2%) | 1.000 |
| ≥grade 3 | 2 (0.6%) | 0 (0%) | 1.000 | 2 (0.6%) | 0 (0%) | 1.000 |
| Headache | ||||||
| ≥grade 1 | 54 (15.9%) | 1 (9.1%) | 0.8474 | 151 (44.5%) | 3 (27.2%) | 0.4082 |
| ≥grade 2 | 8 (2.4%) | 0 (0%) | 1.000 | 34 (10.0%) | 0 (0%) | 0.5564 |
| ≥grade 3 | 1 (0.3%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
| Fever | ||||||
| ≥grade 1 | 4 (1.2%) | 0 (0%) | 1.000 | 71 (20.9%) | 1 (9.1%) | 0.5631 |
| ≥grade 2 | 3 (0.9%) | 0 (0%) | 1.000 | 18 (5.3%) | 1 (9.1%) | 1.000 |
| ≥grade 3 | 0 (0%) | 0 (0%) | 1.000 | 1 (0.3%) | 0 (0%) | 1.000 |
| Chills | ||||||
| ≥grade 1 | 3 (0.9%) | 0 (0%) | 1.000 | 35 (10.3%) | 0 (0%) | 0.5401 |
| ≥grade 2 | 0 (0%) | 0 (0%) | 1.000 | 22 (6.5%) | 0 (0%) | 0.8091 |
| Myalgia | ||||||
| ≥grade 1 | 80 (23.6%) | 5 (45.5%) | 0.1914 | 134 (39.5%) | 5 (45.5%) | 0.9344 |
| ≥grade 2 | 9 (2.7%) | 0 (0%) | 1.000 | 24 (7.1%) | 0 (0%) | 0.7579 |
| ≥grade 3 | 2 (0.6%) | 0 (0%) | 1.000 | 2 (0.6%) | 0 (0%) | 1.000 |
| Arthralgia | ||||||
| ≥grade 1 | 29 (8.6%) | 0 (0%) | 0.6475 | 108 (31.9%) | 2 (18.2%) | 0.5276 |
| ≥grade 2 | 2 (0.6%) | 0 (0%) | 1.000 | 27 (8.0%) | 0 (0%) | 0.689 |
| ≥grade 3 | 0 (0%) | 0 (0%) | 1.000 | 2 (0.6%) | 0 (0%) | 1.000 |
| Diarrhea | ||||||
| ≥grade 1 | 13 (3.8%) | 0 (0%) | 1.000 | 18 (5.3%) | 0 (0%) | 0.9274 |
| ≥grade 2 | 2 (0.6%) | 0 (0%) | 1.000 | 4 (1.2%) | 0 (0%) | 1.000 |
| Nausea | ||||||
| ≥grade 1 | 11 (3.2%) | 0 (0%) | 1.000 | 41 (12.1%) | 1 (9.1%) | 1.000 |
| ≥grade 2 | 5 (1.5%) | 0 (0%) | 1.000 | 13 (3.8%) | 0 (0%) | 1.000 |
| ≥grade 3 | 1 (0.3%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
| Vomiting | ||||||
| ≥grade 1 | 7 (2.1%) | 0 (0%) | 1.000 | 7 (2.1%) | 0 (0%) | 1.000 |
| ≥grade 2 | 5 (1.5%) | 0 (0%) | 1.000 | 3 (0.9%) | 0 (0%) | 1.000 |
| ≥grade 3 | 2 (0.6%) | 0 (0%) | 1.000 | 0 (0%) | 0 (0%) | 1.000 |
| Use of analgesics | 41 (12.1%) | 3 (27.2%) | 0.3019 | 193 (56.9%) | 2 (18.2%) | 0.0252 |
NMDs, neuromuscular disorders.
Grades not listed in the table were not observed in patients in either group.