Table 2.
Adverse events rate after first and second vaccination.
| Adverse Event | After 1st Dose N = 831 (100%) | After 2nd Dose N = 738 (100%) | p * |
|---|---|---|---|
| At least one adverse event | 711 (85.6) | 673 (91.2) | 0.0003 |
| Any local AE | 693 (83.4) | 615 (83.3) | 0.5807 |
| Pain at injection site | 693 (83.4) | 614 (83.2) | 0.5279 |
| Heat at injection site | 61 (7.3) | 62 (8.4) | 0.4855 |
| Local erythema | 40 (4.8) | 50 (6.8) | 0.1229 |
| Any systemic AE | 274 (33.0) | 614 (83.2) | <0.0001 |
| Axillary Lymphadenopathy | 8 (1.0) | 48 (6.5) | <0.0001 |
| Fever > 38 °C | 5 (0.6) | 53 (7.2) | <0.0001 |
| Fatigue | 174 (20.9) | 359 (48.6) | <0.0001 |
| Myalgia | 95 (11.4) | 274 (37.1) | <0.0001 |
| Headache | 125 (15.0) | 279 (37.8) | <0.0001 |
| Arthralgia | 23 (2.8) | 105 (14.2) | <0.0001 |
| Throat pain | 22 (2.6) | 35 (4.7) | 0.0159 |
| Facial paresthesia | 9 (1.1) | 9 (1.2) | 0.7963 |
| Non-facial paresthesia | 9 (1.1) | 23 (3.1) | 0.0025 |
| Pruritus | 6 (0.7) | 17 (2.3) | 0.0105 |
| Systemic AEs total Score—median (Q1–Q3) | 0 (0–2) | 2.5 (0–6) | <0.0001 |
| Missing 1 workday | 2 (0.2) | 53 (7.2) | <0.0001 |
| Missing 2 + workdays | 2 (0.2) | 26 (3.5) | <0.0001 |
| Need for anti-fever or anti-pain medication | 86 (10.3) | 222 (30.1) | <0.0001 |
* By McNemar’s test.