Local and Systemic reactions reported within 10 days of 1 dose and the 2 dose SARS-CoV-2 vaccine (BNT162b2, Pfizer/BioNTech)
| Dose 1 (N=139) | Dose 2 (N=139) | |
|---|---|---|
| Paina | ||
| Any | 45 (32.4) | 32 (23.0) |
| Mild | 61 (43.9) | 41 (29.5) |
| Moderate | 32 (23.0) | 63 (45.3) |
| Severe | 1 (0.7) | 3 (2.2) |
| Grade 4 | 0 (0) | 0 (0) |
| Tendernessb | ||
| Any | 55 (39.6) | 36 (25.9) |
| Mild | 39 (28.1) | 39 (28.1) |
| Moderate | 43 (30.9) | 50 (36.0) |
| Severe | 2 (1.4) | 14 (10.1) |
| Grade 4 | 0 (0) | 0 (0) |
| Erythema/rednessc | ||
| Any | 131 (94.2) | 118 (84.9) |
| Mild | 7 (5.0) | 14 (10.1) |
| Moderate | 1 (0.7) | 6 (4.3) |
| Severe | 0 (0) | 1 (0.7) |
| Grade 4 | 0 (0) | 0 (0) |
| Induration/swellingc | ||
| Any | 119 (85.6) | 109 (78.4) |
| Mild | 13 (9.4) | 19 (13.7) |
| Moderate | 6 (4.3) | 11 (7.9) |
| Severe | 0 (0) | 0 (0) |
| Grade 4 | 0 (0) | 0 (0) |
| Nausea/vomitingd | ||
| Any | 124 (89.2) | 109 (78.4) |
| Mild | 11 (7.9) | 17 (12.2) |
| Moderate | 4 (2.9) | 12 (8.6) |
| Severe | 0 (0) | 1 (0.7) |
| Grade 4 | 0 (0) | 0 (0) |
| Diarrheae | ||
| Any | 137 (98.6) | 125 (89.9) |
| Mild | 2 (1.4) | 10 (7.2) |
| Moderate | 0 (0) | 2 (1.4) |
| Severe | 0 (0) | 2 (1.4) |
| Grade 4 | 0 (0) | 0 (0) |
| Headachef | ||
| Any | 103 (74.1) | 77 (55.4) |
| Mild | 18 (12.9) | 16 (11.5) |
| Moderate | 18 (12.9) | 43 (30.9) |
| Severe | 0 (0) | 3 (2.2) |
| Grade 4 | 0 (0) | 0 (0) |
| Fatigueg | ||
| Any | 95 (68.3) | 61 (43.9) |
| Mild | 13 (9.4) | 14 (10.1) |
| Moderate | 28 (20.1) | 43 (30.9) |
| Severe | 3 (2.2) | 21 (15.1) |
| Grade 4 | 0 (0) | 0 (0) |
| Myalgiaf | ||
| Any | 90 (64.7) | 51 (36.7) |
| Mild | 16 (11.5) | 16 (11.5) |
| Moderate | 28 (20.1) | 43 (30.9) |
| Severe | 5 (3.6) | 29 (20.9) |
| Grade 4 | 0 (0) | 0 (0) |
| Allergy |
||
| Any | 128 (92.1) | 121 (87.1) |
| Mild | 10 (7.2) | 13 (9.4) |
| Moderate | 0 (0) | 2 (1.4) |
| Severe | 1 (0.7) | 2 (1.4) |
| Grade 4 | 0 (0) | 1 (0.7) |
| Fever |
||
| Any | 130 (93.5) | 104 (74.8) |
| Mild | 8 (5.8) | 27 (19.4) |
| Moderate | 1 (0.7) | 5 (3.6) |
| Severe | 0 (0) | 3 (2.2) |
| Grade 4 | 0 (0) | 0 (0) |
| Other reactions |
||
| Any | 124 (89.2) | 109 (78.4) |
| Mild | 7 (5.0) | 5 (3.6) |
| Moderate | 5 (3.6) | 8 (5.8) |
| Severe | 3 (2.2) | 16 (11.5) |
| Grade 4 | 0 (0) | 1 (0.7) |
Values are presented as number (%).
aMild, does not interfere with activity; moderate, requires a Tylenol-type drug because it interferes with daily life; severe, requires a strong pain reliever (SEVER) because it is very difficult to daily life; grade 4, emergency room visit or hospitalization. bMild, does not interfere with activity; moderate, interferes with activity; severe, prevents daily activity; grade 4, emergency room visit or hospitalization. cMild, 2.0–5.0 cm in diameter; moderate, >5.0–10.0 cm in diameter; severe, >10.0 cm in diameter; grade 4, necrosis or exfoliative dermatitis for redness, and necrosis for swelling. Data were collected with the use of Self-check questionnaire for 10 days after 2nd vaccination. dMild, 1–2 times in 24 h; moderate, >2 times in 24 h; severe, requires intravenous hydration; grade 4 for all events: emergency room visit or hospitalization. eMild, 2–3 loose stools in 24 h; moderate, 4–5 loose stools in 24 h; severe: 6 or more loose stools in 24 h; grade 4 for all events: emergency room visit or hospitalization. fMild, does not interfere with activity; moderate, requires a Tylenol-type drug because it interferes with daily life; severe, requires a strong pain reliever (SEVER) because it is very difficult to daily life; grade 4, emergency room visit or hospitalization. gMild, does not interfere with activity; moderate, some interference with activity; severe, prevents daily activity; grade 4, emergency room visit or hospitalization; grade 4 for all events: emergency room visit or hospitalization; and fever (hMild, 38.0°C–38.4°C moderate, 38.5°C–38.9°C; severe, 39.0°C–40.0°C; grade 4, >40.0°C). Data were collected with the use of Self-check questionnaire for 10 days after 2 dose Pfizer-BioNTech COVID-19 vaccination.