Differences in the adverse events of 1 dose and the 2 dose SARS-CoV-2 vaccine (BNT162b2, Pfizer/BioNTech)
| 1 Dose | 2 Dose | P-value | |
|---|---|---|---|
| Onset time |
1.93±1.38 | 2.65±1.60 | <0.001 |
| Duration |
2.96±2.34 | 3.80±2.25 | <0.001 |
| Pain |
0.92±0.762 | 1.27±0.839 | <0.001 |
| Tenderness |
0.94±0.875 | 1.30±0.968 | <0.001 |
| Erythema/redness |
0.06±0.275 | 0.21±0.545 | <0.001 |
| Induration/swelling |
0.18±0.485 | 0.29±0.607 | 0.022 |
| Nausea/vomiting |
0.14±0.421 | 0.32±0.660 | 0.005 |
| Diarrhea |
0.01±0.120 | 0.14±0.490 | 0.002 |
| Headache |
0.39±0.0707 | 0.80±0.957 | <0.001 |
| Fatigue |
0.56±0.886 | 1.17±1.154 | <0.001 |
| Myalgia |
0.063±0.886 | 1.36±1.180 | <0.001 |
| Allergy |
0.09±0.359 | 0.19±0.600 | 0.067 |
| Fever |
0.07±0.286 | 0.33±0.653 | <0.001 |
| Other reactions |
1.89±0.600 | 2.11±1.072 | 0.003 |
Values are presented as mean±standard deviation.
a1, none; 2, Within 15 minutes; 3, 15 minutes to several hours later; 4, several hours later–1 day; 5, 1 day later. b1, none; 2, within minutes; 3, within a few hours; 4, 1 day; 5, 2 day; 6, 3 day; 7, 4 day; 8, 5 day; 9, 6 day; 10, 7 day; 13, 10 day. cGrade 0, Any, does not have adverse event; Grade 1, Mild, does not interfere with activity; Grade 2, Moderate, requires a Tylenol-type drug because it interferes with daily life; Grade 3, Severe, requires a strong pain reliever (SEVER) because it is very difficult to daily life; Grade 4, emergency room visit or hospitalization. dGrade 0, Any, does not have adverse event; Grade 1, Mild, does not interfere with activity; Grade 2, Moderate, interferes with activity; Grade 3, Severe, prevents daily activity; Grade 4, emergency room visit or hospitalization. eGrade 0, Any, does not have adverse event; Grade 1, Mild, 2.0–5.0 cm in diameter; Grade 2, Moderate, >5.0–10.0 cm in diameter; Grade 3, 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. fGrade 0, Any, does not have adverse event; Grade 1, Mild, 1–2 times in 24 h; Grade 2, Moderate, >2 times in 24 h; Grade 3, Severe, requires intravenous hydration; Grade 4 for all events: emergency room visit or hospitalization. gGrade 0, Any, does not have adverse event; Grade 1, Mild, 2–3 loose stools in 24 h; Grade 2, Moderate, 4–5 loose stools in 24 h; Grade 3, Severe: 6 or more loose stools in 24 h; Grade 4 for all events: emergency room visit or hospitalization. hGrade 0, Any, does not have adverse event; Grade 1, Mild, does not interfere with activity; Grade 2, Moderate, requires a Tylenol-type drug because it interferes with daily life; Grade 3, Severe, requires a strong pain reliever (SEVER) because it is very difficult to daily life; Grade 4, emergency room visit or hospitalization. iGrade 0, Any, does not have adverse event; Grade 1, Mild, does not interfere with activity; Grade 2, Moderate, some interference with activity; Grade 3, Severe, prevents daily activity; Grade 4, emergency room visit or hospitalization; Grade 4 for all events: emergency room visit or hospitalization; and fever (jGrade 0, Any, does not have adverse event; Grade 1, Mild, 38.0°C –38.4°C; Grade 2, Moderate, 38.5°C–38.9°C; Grade 3, 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.
P-value by Wilcoxon signed rank test.