1Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea
2Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea
© 2022 Korea Disease Control and Prevention Agency.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Ethics Approval
The passive surveillance activity was conducted and authorized by the public health authority; the study was not subject to the institutional review board approval under government regulations. The study of text message-based surveillance was exempted from review by the Public Institutional Review Board designated by the Korea Ministry of Health and Welfare (No: P01-202206-01-033).
Conflicts of Interest
The authors have no conflicts of interest to declare.
Funding
None.
Availability of Data
The data used in this study are protected under the Personal Information Protection Act.
Authors’ Contributions
Conceptualization: SK, SYS, YKL, EC; Data curation: SK, YH, DSL; Formal analysis: SK, YH, DSL; Investigation: SK, YH; Methodology: all authors; Validation: SK, SYS, YKL; Visualization: SK, YH; Writing–original draft: SK, YKL; Writing–review & editing: all authors.
Variable | No. of doses administered |
Adverse events (n=14,786)a) |
|||||
---|---|---|---|---|---|---|---|
Total | Non-serious adverse eventsb) |
Serious adverse eventsc) |
|||||
Sub-total | Death | Anaphylaxis | Othersd) | ||||
Total | 4,995,280 | 14,786 (296.0) | 14,334 (287.0) | 452 (9.0) | 5 (0.1) | 101 (2.0) | 346 (6.9) |
Dose 1 | 2,555,595 | 6,899 (270.0) | 6,659 (260.6) | 240 (9.4) | 0 | 82 (3.2) | 158 (6.2) |
Dose 2 | 2,439,685 | 7,887 (323.3) | 7,675 (314.6) | 212 (8.7) | 5 (0.2) | 19 (0.8) | 188 (7.7) |
Sex | |||||||
Male | 2,568,739 | 7,284 (283.6) | 7,028 (273.6) | 256 (10.0) | 3 (0.1) | 46 (1.8) | 207 (8.1) |
Dose 1 | 1,314,670 | 3,329 (253.2) | 3,199 (243.3) | 130 (9.9) | 0 | 36 (2.7) | 94 (7.2) |
Dose 2 | 1,254,069 | 3,955 (315.4) | 3,829 (305.3) | 126 (10.0) | 3 (0.2) | 10 (0.8) | 113 (9.0) |
Female | 2,426,541 | 7,502 (309.2) | 7,306 (301.1) | 196 (8.1) | 2 (0.1) | 55 (2.3) | 139 (5.7) |
Dose 1 | 1,240,925 | 3,570 (287.7) | 3,460 (278.8) | 110 (8.9) | 0 | 46 (3.7) | 64 (5.2) |
Dose 2 | 1,185,616 | 3,932 (331.6) | 3,846 (324.4) | 86 (7.3) | 2 (0.2) | 9 (0.8) | 75 (6.3) |
Age (y) | |||||||
5–11 | 94,518 | 61 (64.5) | 59 (62.4) | 2 (2.1) | 0 | 1 (1.1) | 1 (1.1) |
Dose 1 | 58,636 | 47 (80.2) | 45 (76.7) | 2 (3.4) | 0 | 1 (1.7) | 1 (1.7) |
Dose 2 | 35,882 | 14 (39.0) | 14 (39.0) | 0 | 0 | 0 | 0 |
12–17 | 4,900,762 | 14,725 (300.5) | 14,275 (291.3) | 450 (9.2) | 5 (0.1) | 100 (2.0) | 345 (7.0) |
Dose 1 | 2,496,959 | 6,852 (274.4) | 6,614 (264.9) | 238 (9.5) | 0 | 81 (3.2) | 157 (6.3) |
Dose 2 | 2,403,803 | 7,873 (327.5) | 7,661 (318.7) | 212 (8.8) | 5 (0.2) | 19 (0.8) | 188 (7.8) |
Data are presented as n (per 100,000): the reporting rate of adverse events per 100,000 doses administered.
CVMS, COVID-19 vaccination management system; COVID-19, coronavirus disease 2019.
a) Data were based on suspected adverse events following COVID-19 vaccination reported by medical institutions or doctors. The results do not indicate medically confirmed diagnoses or causality between the events and the vaccines.
b) Non-serious adverse events include common symptoms such as redness at the injection site, pain, swelling, myalgia, fever, headache, chills, and others.
c) Serious adverse events include the following: death, suspected anaphylaxis, and others.
d) Others include major adverse events including adverse events of special interest, intensive care unit admission, life-threatening events, permanent disability or sequelae, and others.
Symptoms and signs (n=14,786)a) | Case (per 100,000) |
---|---|
Non-serious adverse events (n=14,334) | |
Headache | 3,765 (75.4) |
Chest pain | 3,417 (68.4) |
Myalgia | 2,152 (43.1) |
Dizziness | 2,065 (41.3) |
Nausea | 1,843 (36.9) |
Fever | 1,550 (31.0) |
Allergic reactions | 918 (18.4) |
Vomiting | 889 (17.8) |
Abdominal pain | 872 (17.5) |
Chills | 848 (17.0) |
Pain, redness, or swelling at the injection site within 3 days after | 541 (10.8) |
Diarrhea | 526 (10.5) |
Lymphadenitis | 447 (8.9) |
Abnormal uterine bleeding | 140 (2.8) |
Cellulitis | 71 (1.4) |
Arthritis | 59 (1.2) |
Dyspneab) | 46 (0.9) |
Severe local adverse events | 33 (0.7) |
Itchingb) | 13 (0.3) |
Abscess at the injection site | 2 (<0.1) |
Systemic disseminated Bacillus Calmette-Guerin infection | 1 (<0.1) |
Severe adverse events (n=452) including reports of death | |
Acute cardiovascular injuryc) | 125 (2.5) |
Anaphylaxisd) | 101 (2.0) |
Convulsions or seizures | 49 (1.0) |
Acute paralysis | 42 (0.8) |
Vaccine-associated enhanced disease | 42 (0.8) |
Acute respiratory distress syndrome | 18 (0.4) |
Encephalopathy or encephalitis | 17 (0.3) |
Thrombocytopenia | 7 (0.1) |
Thrombocytopenic purpura | 6 (0.1) |
Osteitis or osteomyelitis | 5 (0.1) |
Anosmia or ageusia | 5 (0.1) |
Erythema multiforme | 5 (0.1) |
Coagulation disorder | 4 (0.1) |
Acute kidney injury | 4 (0.1) |
Single organ cutaneous vasculitis | 3 (0.1) |
Multisystem inflammatory syndrome | 3 (0.1) |
Acute liver injury | 3 (0.1) |
Thrombosis | 3 (0.1) |
Meningitis | 2 (<0.1) |
Guillain-Barre syndrome | 2 (<0.1) |
Myelitis | 1 (<0.1) |
Capillary leak syndrome | 1 (<0.1) |
Chilblains | 1 (<0.1) |
Data are presented as n (per 100,000): the reporting rate of adverse events per 100,000 doses administered.
CVMS, COVID-19 vaccination management system; COVID-19, coronavirus disease 2019.
a) Data were based on suspected adverse events following COVID-19 vaccination reported by medical institutions or doctors. The results do not indicate medically confirmed diagnoses or causality between the events and the vaccines.
b) These were reported from March 10, 2022.
c) Acute cardiovascular injury includes myocarditis, pericarditis, and others.
d) Anaphylaxis includes anaphylactoid reactions.
Eventsa) | Dose 1 (n=11,414) | Dose 2 (n=3,688) | ||||
---|---|---|---|---|---|---|
5–11 y (n=1,025) | 12–17 y (n=10,389) | p-valuec) | 5–11 y (n=541) | 12–17 y (n=3,147) | p-valuec) | |
Local adverse events | 336 (32.8) | 5,009 (48.2) | <0.001 | 148 (27.4) | 1,672 (53.1) | <0.001 |
Pain | 309 (30.1) | 4,612 (44.4) | <0.001 | 133 (24.6) | 1,546 (49.1) | <0.001 |
Redness | 17 (1.7) | 234 (2.3) | 0.216 | 11 (2.0) | 108 (3.4) | 0.089 |
Swelling | 58 (5.7) | 973 (9.4) | <0.001 | 29 (5.4) | 371 (11.8) | <0.001 |
Itching | 30 (2.9) | 276 (2.7) | 0.609 | 11 (2.0) | 107 (3.4) | 0.095 |
Urticaria | 5 (0.5) | 51 (0.5) | 1 | 1 (0.2) | 14 (0.4) | 0.712 |
Others | 42 (4.1) | 592 (5.7) | 0.033 | 25 (4.6) | 195 (6.2) | 0.153 |
Systemic adverse events | 275 (26.8) | 4,351 (41.9) | <0.001 | 121 (22.4) | 1,651 (52.5) | <0.001 |
Fever | 94 (9.2) | 797 (7.7) | 0.088 | 48 (8.9) | 723 (23.0) | <0.001 |
Chills | 55 (5.4) | 596 (5.7) | 0.625 | 21 (3.9) | 452 (14.4) | <0.001 |
Headache | 97 (9.5) | 1,717 (16.5) | <0.001 | 40 (7.4) | 999 (31.7) | <0.001 |
Joint pain | 15 (1.5) | 266 (2.6) | 0.031 | 3 (0.6) | 181 (5.8) | <0.001 |
Myalgia | 132 (12.9) | 2,474 (23.8) | <0.001 | 48 (8.9) | 865 (27.5) | <0.001 |
Fatigue or tiredness | 95 (9.3) | 2,091 (20.1) | <0.001 | 45 (8.3) | 892 (28.3) | <0.001 |
Nausea | 37 (3.6) | 680 (6.5) | <0.001 | 14 (2.6) | 322 (10.2) | <0.001 |
Vomiting | 13 (1.3) | 47 (0.5) | 0.001 | 5 (0.9) | 28 (0.9) | 0.809 |
Diarrhea | 16 (1.6) | 224 (2.2) | 0.205 | 6 (1.1) | 81 (2.6) | 0.038 |
Abdominal pain | 20 (2.0) | 379 (3.6) | 0.005 | 10 (1.8) | 171 (5.4) | <0.001 |
Rash | 3 (0.3) | 35 (0.3) | 1 | 0 | 16 (0.5) | 0.151 |
Armpit tenderness | 30 (2.9) | 412 (4.0) | 0.1 | 20 (3.7) | 327 (10.4) | <0.001 |
Chest painb) | 8 (0.8) | - | - | 6 (1.1) | - | - |
Heart palpitationsb) | 4 (0.4) | - | - | 1 (0.2) | - | - |
Others | 42 (4.1) | 523 (5.0) | 0.187 | 19 (3.5) | 180 (5.7) | 0.036 |
Unable to perform normal daily activities | 95 (9.3) | 1,052 (10.1) | 0.384 | 39 (7.2) | 613 (19.5) | <0.001 |
Visits to medical facilities | 35 (3.4) | 116 (1.1) | <0.001 | 20 (3.7) | 44 (1.4) | <0.001 |
Emergency department visit | 0 | 18 (0.2) | 0.399 | 0 | 7 (0.2) | 0.603 |
Hospitalization | 0 | 2 (0) | 1 | 1 (0.2) | 0 | 0.147 |
Clinic visit | 35 (3.4) | 100 (1.0) | <0.001 | 19 (3.5) | 39 (1.2) | <0.001 |
Data are presented as n (%): the percentage of respondents who reported adverse events and health conditions at least once during days 0 to 7 post-vaccination.
COVID-19, coronavirus disease 2019.
a) Events reported by respondents who completed at least 1 text message-based survey on days 0 to 7. Respondents were able to report multiple adverse events on each day.
b) These were additionally investigated only for children aged 5 to 11 years.
c) Chi-square or Fisher exact test as appropriate.
Variable | No. of doses administered | Adverse events (n=14,786) |
|||||
---|---|---|---|---|---|---|---|
Total | Non-serious adverse events |
Serious adverse events |
|||||
Sub-total | Death | Anaphylaxis | Others |
||||
Total | 4,995,280 | 14,786 (296.0) | 14,334 (287.0) | 452 (9.0) | 5 (0.1) | 101 (2.0) | 346 (6.9) |
Dose 1 | 2,555,595 | 6,899 (270.0) | 6,659 (260.6) | 240 (9.4) | 0 | 82 (3.2) | 158 (6.2) |
Dose 2 | 2,439,685 | 7,887 (323.3) | 7,675 (314.6) | 212 (8.7) | 5 (0.2) | 19 (0.8) | 188 (7.7) |
Sex | |||||||
Male | 2,568,739 | 7,284 (283.6) | 7,028 (273.6) | 256 (10.0) | 3 (0.1) | 46 (1.8) | 207 (8.1) |
Dose 1 | 1,314,670 | 3,329 (253.2) | 3,199 (243.3) | 130 (9.9) | 0 | 36 (2.7) | 94 (7.2) |
Dose 2 | 1,254,069 | 3,955 (315.4) | 3,829 (305.3) | 126 (10.0) | 3 (0.2) | 10 (0.8) | 113 (9.0) |
Female | 2,426,541 | 7,502 (309.2) | 7,306 (301.1) | 196 (8.1) | 2 (0.1) | 55 (2.3) | 139 (5.7) |
Dose 1 | 1,240,925 | 3,570 (287.7) | 3,460 (278.8) | 110 (8.9) | 0 | 46 (3.7) | 64 (5.2) |
Dose 2 | 1,185,616 | 3,932 (331.6) | 3,846 (324.4) | 86 (7.3) | 2 (0.2) | 9 (0.8) | 75 (6.3) |
Age (y) | |||||||
5–11 | 94,518 | 61 (64.5) | 59 (62.4) | 2 (2.1) | 0 | 1 (1.1) | 1 (1.1) |
Dose 1 | 58,636 | 47 (80.2) | 45 (76.7) | 2 (3.4) | 0 | 1 (1.7) | 1 (1.7) |
Dose 2 | 35,882 | 14 (39.0) | 14 (39.0) | 0 | 0 | 0 | 0 |
12–17 | 4,900,762 | 14,725 (300.5) | 14,275 (291.3) | 450 (9.2) | 5 (0.1) | 100 (2.0) | 345 (7.0) |
Dose 1 | 2,496,959 | 6,852 (274.4) | 6,614 (264.9) | 238 (9.5) | 0 | 81 (3.2) | 157 (6.3) |
Dose 2 | 2,403,803 | 7,873 (327.5) | 7,661 (318.7) | 212 (8.8) | 5 (0.2) | 19 (0.8) | 188 (7.8) |
Symptoms and signs (n=14,786) |
Case (per 100,000) |
---|---|
Non-serious adverse events (n=14,334) | |
Headache | 3,765 (75.4) |
Chest pain | 3,417 (68.4) |
Myalgia | 2,152 (43.1) |
Dizziness | 2,065 (41.3) |
Nausea | 1,843 (36.9) |
Fever | 1,550 (31.0) |
Allergic reactions | 918 (18.4) |
Vomiting | 889 (17.8) |
Abdominal pain | 872 (17.5) |
Chills | 848 (17.0) |
Pain, redness, or swelling at the injection site within 3 days after | 541 (10.8) |
Diarrhea | 526 (10.5) |
Lymphadenitis | 447 (8.9) |
Abnormal uterine bleeding | 140 (2.8) |
Cellulitis | 71 (1.4) |
Arthritis | 59 (1.2) |
Dyspnea |
46 (0.9) |
Severe local adverse events | 33 (0.7) |
Itching |
13 (0.3) |
Abscess at the injection site | 2 (<0.1) |
Systemic disseminated Bacillus Calmette-Guerin infection | 1 (<0.1) |
Severe adverse events (n=452) including reports of death | |
Acute cardiovascular injury |
125 (2.5) |
Anaphylaxis |
101 (2.0) |
Convulsions or seizures | 49 (1.0) |
Acute paralysis | 42 (0.8) |
Vaccine-associated enhanced disease | 42 (0.8) |
Acute respiratory distress syndrome | 18 (0.4) |
Encephalopathy or encephalitis | 17 (0.3) |
Thrombocytopenia | 7 (0.1) |
Thrombocytopenic purpura | 6 (0.1) |
Osteitis or osteomyelitis | 5 (0.1) |
Anosmia or ageusia | 5 (0.1) |
Erythema multiforme | 5 (0.1) |
Coagulation disorder | 4 (0.1) |
Acute kidney injury | 4 (0.1) |
Single organ cutaneous vasculitis | 3 (0.1) |
Multisystem inflammatory syndrome | 3 (0.1) |
Acute liver injury | 3 (0.1) |
Thrombosis | 3 (0.1) |
Meningitis | 2 (<0.1) |
Guillain-Barre syndrome | 2 (<0.1) |
Myelitis | 1 (<0.1) |
Capillary leak syndrome | 1 (<0.1) |
Chilblains | 1 (<0.1) |
Characteristic | Dose 1 (n=11,414) | Dose 2 (n=3,688) |
---|---|---|
Sex | ||
Male | 5,367 (47.0) | 1,727 (46.8) |
Female | 6,047 (53.0) | 1,961 (53.2) |
Age (y) | ||
5–11 | 1,025 (9.0) | 541 (14.7) |
5 | 66 (0.6) | 38 (1.0) |
6 | 90 (0.8) | 47 (1.3) |
7 | 122 (1.1) | 52 (1.4) |
8 | 125 (1.1) | 71 (1.9) |
9 | 160 (1.4) | 86 (2.3) |
10 | 197 (1.7) | 115 (3.1) |
11 | 265 (2.3) | 132 (3.6) |
12–17 | 10,389 (91.0) | 3,147 (85.3) |
12 | 1,948 (17.1) | 639 (17.3) |
13 | 2,432 (21.3) | 766 (20.8) |
14 | 1,857 (16.3) | 584 (15.8) |
15 | 2,672 (23.4) | 755 (20.5) |
16 | 864 (7.6) | 247 (6.7) |
17 | 616 (5.4) | 156 (4.2) |
Events |
Dose 1 (n=11,414) | Dose 2 (n=3,688) | ||||
---|---|---|---|---|---|---|
5–11 y (n=1,025) | 12–17 y (n=10,389) | p-value |
5–11 y (n=541) | 12–17 y (n=3,147) | p-value |
|
Local adverse events | 336 (32.8) | 5,009 (48.2) | <0.001 | 148 (27.4) | 1,672 (53.1) | <0.001 |
Pain | 309 (30.1) | 4,612 (44.4) | <0.001 | 133 (24.6) | 1,546 (49.1) | <0.001 |
Redness | 17 (1.7) | 234 (2.3) | 0.216 | 11 (2.0) | 108 (3.4) | 0.089 |
Swelling | 58 (5.7) | 973 (9.4) | <0.001 | 29 (5.4) | 371 (11.8) | <0.001 |
Itching | 30 (2.9) | 276 (2.7) | 0.609 | 11 (2.0) | 107 (3.4) | 0.095 |
Urticaria | 5 (0.5) | 51 (0.5) | 1 | 1 (0.2) | 14 (0.4) | 0.712 |
Others | 42 (4.1) | 592 (5.7) | 0.033 | 25 (4.6) | 195 (6.2) | 0.153 |
Systemic adverse events | 275 (26.8) | 4,351 (41.9) | <0.001 | 121 (22.4) | 1,651 (52.5) | <0.001 |
Fever | 94 (9.2) | 797 (7.7) | 0.088 | 48 (8.9) | 723 (23.0) | <0.001 |
Chills | 55 (5.4) | 596 (5.7) | 0.625 | 21 (3.9) | 452 (14.4) | <0.001 |
Headache | 97 (9.5) | 1,717 (16.5) | <0.001 | 40 (7.4) | 999 (31.7) | <0.001 |
Joint pain | 15 (1.5) | 266 (2.6) | 0.031 | 3 (0.6) | 181 (5.8) | <0.001 |
Myalgia | 132 (12.9) | 2,474 (23.8) | <0.001 | 48 (8.9) | 865 (27.5) | <0.001 |
Fatigue or tiredness | 95 (9.3) | 2,091 (20.1) | <0.001 | 45 (8.3) | 892 (28.3) | <0.001 |
Nausea | 37 (3.6) | 680 (6.5) | <0.001 | 14 (2.6) | 322 (10.2) | <0.001 |
Vomiting | 13 (1.3) | 47 (0.5) | 0.001 | 5 (0.9) | 28 (0.9) | 0.809 |
Diarrhea | 16 (1.6) | 224 (2.2) | 0.205 | 6 (1.1) | 81 (2.6) | 0.038 |
Abdominal pain | 20 (2.0) | 379 (3.6) | 0.005 | 10 (1.8) | 171 (5.4) | <0.001 |
Rash | 3 (0.3) | 35 (0.3) | 1 | 0 | 16 (0.5) | 0.151 |
Armpit tenderness | 30 (2.9) | 412 (4.0) | 0.1 | 20 (3.7) | 327 (10.4) | <0.001 |
Chest pain |
8 (0.8) | - | - | 6 (1.1) | - | - |
Heart palpitations |
4 (0.4) | - | - | 1 (0.2) | - | - |
Others | 42 (4.1) | 523 (5.0) | 0.187 | 19 (3.5) | 180 (5.7) | 0.036 |
Unable to perform normal daily activities | 95 (9.3) | 1,052 (10.1) | 0.384 | 39 (7.2) | 613 (19.5) | <0.001 |
Visits to medical facilities | 35 (3.4) | 116 (1.1) | <0.001 | 20 (3.7) | 44 (1.4) | <0.001 |
Emergency department visit | 0 | 18 (0.2) | 0.399 | 0 | 7 (0.2) | 0.603 |
Hospitalization | 0 | 2 (0) | 1 | 1 (0.2) | 0 | 0.147 |
Clinic visit | 35 (3.4) | 100 (1.0) | <0.001 | 19 (3.5) | 39 (1.2) | <0.001 |
Data are presented as CVMS, COVID-19 vaccination management system; COVID-19, coronavirus disease 2019. Data were based on suspected adverse events following COVID-19 vaccination reported by medical institutions or doctors. The results do not indicate medically confirmed diagnoses or causality between the events and the vaccines. Non-serious adverse events include common symptoms such as redness at the injection site, pain, swelling, myalgia, fever, headache, chills, and others. Serious adverse events include the following: death, suspected anaphylaxis, and others. Others include major adverse events including adverse events of special interest, intensive care unit admission, life-threatening events, permanent disability or sequelae, and others.
Data are presented as CVMS, COVID-19 vaccination management system; COVID-19, coronavirus disease 2019. Data were based on suspected adverse events following COVID-19 vaccination reported by medical institutions or doctors. The results do not indicate medically confirmed diagnoses or causality between the events and the vaccines. These were reported from March 10, 2022. Acute cardiovascular injury includes myocarditis, pericarditis, and others. Anaphylaxis includes anaphylactoid reactions.
Data are presented as COVID-19, coronavirus disease 2019.
Data are presented as COVID-19, coronavirus disease 2019. Events reported by respondents who completed at least 1 text message-based survey on days 0 to 7. Respondents were able to report multiple adverse events on each day. These were additionally investigated only for children aged 5 to 11 years. Chi-square or Fisher exact test as appropriate.