Table 3.
Adverse events following immunization after each administered BNT162b2 dose.
| AEFI (n = 112) | First Dose (%) | Second Dose (%) | Third Dose (%) | Fourth Dose (%) | p-Value |
|---|---|---|---|---|---|
| Presence of any AE | 90 (80.4) | 89 (79.0) | 65 (58.0) | 69 (61.6) | <0.001 |
| Time of appearance | |||||
| First 4 h after | 73 (81.1) | 41 (46.1) | 8 (13.8) | 22 (31.4) | <0.001 |
| 5 to 24 h after | 5 (4.5) | 24 (27.0) | 38 (58.5) | 36 (51.4) | <0.001 |
| 2 to 3 days after | 12 (13.3) | 22 (24.7) | 17 (26.2) | 12 (17.1) | <0.001 |
| 4 to 7 days after | 0 | 1 (1.1) | 1 (1.5) | 0 | |
| 7 to 10 days after | 0 | 1 (1.1) | 0 | 0 | |
| Symptoms | |||||
| Pain at injection site | 80 (88.9) | 80 (89.0) | 52 (80.0) | 61 (87.0) | 0.838 |
| Adenopathy | 1 (1.1) | 1 (1.1) | 7 (10.8) | 11 (15.7) | <0.001 |
| Fever (>38 °C) | 4 (4.4) | 1 (1.1) | 9 (13.8) | 8 (11.4) | 0.036 |
| Arthralgias | 5 (5.6) | 25 (28.1) | 14 (21.5) | 16 (22.9) | 0.019 |
| Headache | 34 (37.8) | 38 (42.7) | 26 (40.0) | 33 (47.1) | 0.303 |
| Fatigue | 22 (19.6) | 39 (43.8) | 27 (41.5) | 29 (41.4) | 0.110 |
| Myalgias | 7 (7.8) | 26 (29.2) | 16 (24.6) | 15 (21.4) | 0.135 |
| Local edema or erythema | 5 (5.6) | 14 (15.7) | 6 (9.2) | 8 (11.4) | 0.432 |
| Low-grade fever (37.5–37.9 °C) | 4 (4.4) | 10 (11.2) | 6 (9.2) | 12 (17.1) | 0.188 |
| Nausea | 4 (4.4) | 6 (6.7) | 3 (4.6) | 4 (5.7) | 0.392 |
| Palpitations | 3 (3.3) | 2 (2.2) | 3 (4.6) | 2 (2.9) | 0.836 |
| Nasal congestion | 3 (3.3) | 10 (11.2) | 3 (4.6) | 4 (10) | 0.095 |
| Diarrhea | 2 (2.2) | 4 (4.5) | 2 (3.1) | 1(1.4) | 0.392 |
| Pruritus | 2 (2.2) | 5 (5.6) | 1 (1.5) | 3 (4.3) | 0.682 |
| Ocular pain | 2 (2.2) | 0 | 0 | 0 | - |
| Insomnia | 2 (2.2) | 1 (1.1) | 2 (3.1) | 0 | 0.733 |
| Localized skin rash | 1 (0.9) | 2 (2.2) | 0 | 1 (1.4) | 0.572 |
| Vomiting | 1 (1.1) | 1 (1.1) | 0 | 2 (2.9) | 0.572 |
| Back pain | 1 (1.1) | 0 | 0 | 0 | - |
| Achromatopsia | 1 (1.1) | 0 | 0 | 0 | - |
| Chest pain | 0 | 4 (4.4) | 1 (1.5) | 2 (2.9) | 0.392 |
| Hypotension | 0 | 0 | 1 (1.5) | 1 (1.4) | - |
| Diffuse skin rash | 0 | 0 | 1 (1.5) | 0 | - |
| Systemic edema | 0 | 1 (1.1) | 0 | 0 | - |
| Severity | |||||
| Very mild | 60 (78.9) | 42 (47.7) | 21 (32.8) | 20 (28.6) | 0.01 |
| Mild | 6 (7.9) | 27 (30.7) | 24 (37.5) | 36 (51.4) | 0.01 |
| Moderate | 10 (13.2) | 18 (20.5) | 17 (26.6) | 12 (17.1) | 0.01 |
| Severe | 0 | 1 (1.1) | 1 (1.6) | 2 (2.9) | - |
| Very severe | 0 | 0 | 1 (1.6) | 0 | - |
Data are presented as frequencies and percentages. Cochran’s Q test was performed for comparisons. A p-value < 0.05 was considered statistically significant. AEFI: adverse events following immunization.