Korean Journal of Family Practice

Table. 2.

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 timea 1.93±1.38 2.65±1.60 <0.001
Durationb 2.96±2.34 3.80±2.25 <0.001
Painc 0.92±0.762 1.27±0.839 <0.001
Tendernessd 0.94±0.875 1.30±0.968 <0.001
Erythema/rednesse 0.06±0.275 0.21±0.545 <0.001
Induration/swellinge 0.18±0.485 0.29±0.607 0.022
Nausea/vomitingf 0.14±0.421 0.32±0.660 0.005
Diarrheag 0.01±0.120 0.14±0.490 0.002
Headacheh 0.39±0.0707 0.80±0.957 <0.001
Fatiguei 0.56±0.886 1.17±1.154 <0.001
Myalgiah 0.063±0.886 1.36±1.180 <0.001
Allergyh 0.09±0.359 0.19±0.600 0.067
Feverj 0.07±0.286 0.33±0.653 <0.001
Other reactionsi 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.

Korean J Fam Pract 2021;11:357~364 https://doi.org/10.21215/kjfp.2021.11.5.357
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