1Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea
2Adverse Event Management Team, Immunization 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 institutional review board approval under government regulations. The study with the text message-based surveillance was exempted from review by the Public Institutional Review Board designated by the Korea Ministry of Health and Welfare (No. P01-202203-01-035).
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: YK, YKL; Data curation: SK, IH, MK; Formal analysis: SK, IH; Investigation: SK, MK; Methodology: all authors; Validation: YK, YKL; Writing-original draft: SK, YKL; Writing-review & editing: all authors.
Variable | Number of doses administered |
Adverse events (n=12,216)a) |
|||||
---|---|---|---|---|---|---|---|
Total | Non-serious adverse eventsb) |
Serious adverse eventsc) |
|||||
Sub-total | Death | Anaphylaxis | Others | ||||
Total | 4,340,710 | 12,216 (281.4) | 11,867 (273.4) | 349 (8.0) | 2 (0) | 85 (2.0) | 262 (6.0) |
Dose 1 | 2,254,487 | 6,044 (268.1) | 5,845 (259.3) | 199 (8.8) | 0 | 71 (3.1) | 128 (5.7) |
Dose 2 | 2,086,223 | 6,172 (295.8) | 6,022 (288.7) | 150 (7.2) | 2 (0.1) | 14 (0.7) | 134 (6.4) |
Sex | |||||||
Male | 2,229,864 | 6,055 (271.5) | 5,854 (262.5) | 201 (9.0) | 2 (0.1) | 38 (1.7) | 161 (7.2) |
Dose 1 | 1,158,684 | 2,915 (251.6) | 2,809 (242.4) | 106 (9.1) | 0 | 30 (2.6) | 76 (6.6) |
Dose 2 | 1,071,180 | 3,140 (293.1) | 3,045 (284.3) | 95 (8.9) | 2 (0.2) | 8 (0.7) | 85 (7.9) |
Female | 2,110,846 | 6,161 (291.9) | 6,013 (284.9) | 148 (7.0) | 0 | 47 (2.2) | 101 (4.8) |
Dose 1 | 1,095,803 | 3,129 (285.5) | 3,036 (277.1) | 93 (8.5) | 0 | 41 (3.7) | 52 (4.7) |
Dose 2 | 1,015,043 | 3,032 (298.7) | 2,977 (293.3) | 55 (5.4) | 0 | 6 (0.6) | 49 (4.8) |
Age (y) | |||||||
12–15 | 2,644,362 | 5,940 (224.6) | 5,762 (217.9) | 178 (6.7) | 0 | 42 (1.6) | 136 (5.1) |
Dose 1 | 1,424,052 | 3,026 (212.5) | 2,918 (204.9) | 108 (7.6) | 0 | 36 (2.5) | 72 (5.1) |
Dose 2 | 1,220,310 | 2,914 (238.8) | 2,844 (233.1) | 70 (5.7) | 0 | 6 (0.5) | 64 (5.2) |
16–17 | 1,696,348 | 6,276 (370.0) | 6,105 (359.9) | 171 (10.1) | 2 (0.1) | 43 (2.5) | 126 (7.4) |
Dose 1 | 830,435 | 3,018 (363.4) | 2,927 (352.5) | 91 (11.0) | 0 | 35 (4.2) | 56 (6.7) |
Dose 2 | 865,913 | 3,258 (376.3) | 3,178 (367.0) | 80 (9.2) | 2 (0.2) | 8 (0.9) | 70 (8.1) |
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 calculated using the information on suspected adverse events after COVID-19 vaccination reported by medical facilities or doctors. The results do not indicate an accurate diagnosis 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 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=12,216)a) | Case (per 100,000) |
---|---|
Non-serious adverse events (n=11,867) | |
Headache | 3,214 (74.0) |
Chest pain | 3,127 (72.0) |
Myalgia | 1,845 (42.5) |
Dizziness | 1,732 (39.9) |
Nausea | 1,573 (36.2) |
Fever | 1,183 (27.3) |
Vomiting | 754 (17.4) |
Abdominal pain | 748 (17.2) |
Allergy reactions | 745 (17.2) |
Chills | 692 (15.9) |
Pain, redness or swelling at the injection site within 3 days after | 455 (10.5) |
Diarrhea | 451 (10.4) |
Lymphadenitis | 381 (8.8) |
Abnormal uterine bleeding | 130 (3.0) |
Cellulitis | 58 (1.3) |
Arthritis | 44 (1.0) |
Severe local adverse events | 29 (0.7) |
Abscess at the injection site | 2 (0) |
Systemic disseminated Bacillus Calmette-Guerin infection | 1 (0) |
Severe adverse events (n=349) including reports of death | |
Acute cardiovascular injury | 90 (2.1) |
Anaphylaxis (including anaphylactoid reactions) | 85 (2.0) |
Convulsions or seizures | 40 (0.9) |
Acute paralysis | 33 (0.8) |
Vaccine-associated enhanced disease | 30 (0.7) |
Acute respiratory distress syndrome | 14 (0.3) |
Encephalopathy or encephalitis | 11 (0.3) |
Thrombocytopenic purpura | 6 (0.1) |
Thrombocytopenia | 5 (0.1) |
Acute kidney injury | 4 (0.1) |
Osteitis or osteomyelitis | 4 (0.1) |
Erythema multiforme | 3 (0.1) |
Coagulation disorder | 3 (0.1) |
Thrombosis with thrombocytopenia syndrome | 3 (0.1) |
Anosmia or ageusia | 3 (0.1) |
Acute liver injury | 2 (0) |
Meningoencephalitis | 2 (0) |
Multisystem inflammatory syndrome | 2 (0) |
Single organ cutaneous vasculitis | 2 (0) |
Acute disseminated encephalomyelitis | 1 (0) |
Chilblains | 1 (0) |
Guillain-Barre syndrome | 1 (0) |
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 calculated using the information on suspected adverse events after COVID-19 vaccination reported by medical facilities or doctors. The results do not indicate an accurate diagnosis or causality between the events and the vaccines.
Eventsa) | Age group (12–15 y) | Age group (16–17 y) | ||
---|---|---|---|---|
Dose 1 (n=8,909) | Dose 2 (n=2,744) | Dose 1 (n=1,480) | Dose 2 (n=403) | |
Health problemsb) | 4,803 (53.9) | 1,617 (58.9) | 766 (51.8) | 234 (58.1) |
Fever or sensation of heat | 694 (7.8) | 634 (23.1) | 103 (7.0) | 89 (22.1) |
Local adverse events | 4,323 (48.5) | 1,460 (53.2) | 686 (46.4) | 212 (52.6) |
Pain | 3,978 (44.7) | 1,346 (49.1) | 634 (42.8) | 200 (49.6) |
Redness | 195 (2.2) | 88 (3.2) | 39 (2.6) | 20 (5.0) |
Swelling | 843 (9.5) | 316 (11.5) | 130 (8.8) | 55 (13.6) |
Itching | 232 (2.6) | 95 (3.5) | 44 (3.0) | 12 (3.0) |
Urticaria | 42 (0.5) | 13 (0.5) | 9 (0.6) | 1 (0.2) |
Others | 506 (5.7) | 164 (6.0) | 86 (5.8) | 31 (7.7) |
Systemic adverse events | 3,736 (41.9) | 1,434 (52.3) | 615 (41.6) | 217 (53.8) |
Chills | 494 (5.5) | 386 (14.1) | 102 (6.9) | 66 (16.4) |
Headache | 1,455 (16.3) | 853 (31.1) | 262 (17.7) | 146 (36.2) |
Joint pain | 218 (2.4) | 146(5.3) | 48 (3.2) | 35 (8.7) |
Myalgia | 2,070 (23.2) | 729 (26.6) | 404 (27.3) | 136 (33.7) |
Fatigue or tiredness | 1,753 (19.7) | 748 (27.3) | 338 (22.8) | 144 (35.7) |
Nausea | 577 (6.5) | 267 (9.7) | 103 (7.0) | 55 (13.6) |
Vomiting | 35 (0.4) | 24 (0.9) | 12 (0.8) | 4 (1.0) |
Diarrhea | 188 (2.1) | 68 (2.5) | 36 (2.4) | 13 (3.2) |
Abdominal pain | 326 (3.7) | 145 (5.3) | 53 (3.6) | 26 (6.5) |
Rash | 25 (0.3) | 11 (0.4) | 10 (0.7) | 5 (1.2) |
Armpit tenderness | 347 (3.9) | 286 (10.4) | 65 (4.4) | 41 (10.2) |
Others | 450 (5.1) | 152 (5.5) | 73 (4.9) | 28 (6.9) |
Unable to perform normal daily activities | 867 (9.7) | 510 (18.6) | 185 (12.5) | 103 (25.6) |
Visits to medical facilities | 100 (1.1) | 39 (1.4) | 16 (1.1) | 5 (1.2) |
Emergency department visit | 15 (0.2) | 6 (0.2) | 3 (0.2) | 1 (0.2) |
Hospitalization | 2 (0) | 0 | 0 | 0 |
Clinic visit | 87 (1.0) | 34 (1.2) | 13 (0.9) | 5 (1.2) |
Data are presented as n (%): the percentage of respondents who reported health problems and adverse events at least once during days 0–7 post-vaccination.
COVID-19, coronavirus disease 2019.
a)Events were reported by respondents who completed at least 1 text message-based survey on days 0 to 7. They could report multiple adverse events on various days.
b)The proportion of respondents who answered that they had experienced any health problems after vaccination.
COVID-19, coronavirus disease 2019.
Variable | Number of doses administered | Adverse events (n=12,216) |
|||||
---|---|---|---|---|---|---|---|
Total | Non-serious adverse events |
Serious adverse events |
|||||
Sub-total | Death | Anaphylaxis | Others | ||||
Total | 4,340,710 | 12,216 (281.4) | 11,867 (273.4) | 349 (8.0) | 2 (0) | 85 (2.0) | 262 (6.0) |
Dose 1 | 2,254,487 | 6,044 (268.1) | 5,845 (259.3) | 199 (8.8) | 0 | 71 (3.1) | 128 (5.7) |
Dose 2 | 2,086,223 | 6,172 (295.8) | 6,022 (288.7) | 150 (7.2) | 2 (0.1) | 14 (0.7) | 134 (6.4) |
Sex | |||||||
Male | 2,229,864 | 6,055 (271.5) | 5,854 (262.5) | 201 (9.0) | 2 (0.1) | 38 (1.7) | 161 (7.2) |
Dose 1 | 1,158,684 | 2,915 (251.6) | 2,809 (242.4) | 106 (9.1) | 0 | 30 (2.6) | 76 (6.6) |
Dose 2 | 1,071,180 | 3,140 (293.1) | 3,045 (284.3) | 95 (8.9) | 2 (0.2) | 8 (0.7) | 85 (7.9) |
Female | 2,110,846 | 6,161 (291.9) | 6,013 (284.9) | 148 (7.0) | 0 | 47 (2.2) | 101 (4.8) |
Dose 1 | 1,095,803 | 3,129 (285.5) | 3,036 (277.1) | 93 (8.5) | 0 | 41 (3.7) | 52 (4.7) |
Dose 2 | 1,015,043 | 3,032 (298.7) | 2,977 (293.3) | 55 (5.4) | 0 | 6 (0.6) | 49 (4.8) |
Age (y) | |||||||
12–15 | 2,644,362 | 5,940 (224.6) | 5,762 (217.9) | 178 (6.7) | 0 | 42 (1.6) | 136 (5.1) |
Dose 1 | 1,424,052 | 3,026 (212.5) | 2,918 (204.9) | 108 (7.6) | 0 | 36 (2.5) | 72 (5.1) |
Dose 2 | 1,220,310 | 2,914 (238.8) | 2,844 (233.1) | 70 (5.7) | 0 | 6 (0.5) | 64 (5.2) |
16–17 | 1,696,348 | 6,276 (370.0) | 6,105 (359.9) | 171 (10.1) | 2 (0.1) | 43 (2.5) | 126 (7.4) |
Dose 1 | 830,435 | 3,018 (363.4) | 2,927 (352.5) | 91 (11.0) | 0 | 35 (4.2) | 56 (6.7) |
Dose 2 | 865,913 | 3,258 (376.3) | 3,178 (367.0) | 80 (9.2) | 2 (0.2) | 8 (0.9) | 70 (8.1) |
Symptoms and signs (n=12,216) |
Case (per 100,000) |
---|---|
Non-serious adverse events (n=11,867) | |
Headache | 3,214 (74.0) |
Chest pain | 3,127 (72.0) |
Myalgia | 1,845 (42.5) |
Dizziness | 1,732 (39.9) |
Nausea | 1,573 (36.2) |
Fever | 1,183 (27.3) |
Vomiting | 754 (17.4) |
Abdominal pain | 748 (17.2) |
Allergy reactions | 745 (17.2) |
Chills | 692 (15.9) |
Pain, redness or swelling at the injection site within 3 days after | 455 (10.5) |
Diarrhea | 451 (10.4) |
Lymphadenitis | 381 (8.8) |
Abnormal uterine bleeding | 130 (3.0) |
Cellulitis | 58 (1.3) |
Arthritis | 44 (1.0) |
Severe local adverse events | 29 (0.7) |
Abscess at the injection site | 2 (0) |
Systemic disseminated Bacillus Calmette-Guerin infection | 1 (0) |
Severe adverse events (n=349) including reports of death | |
Acute cardiovascular injury | 90 (2.1) |
Anaphylaxis (including anaphylactoid reactions) | 85 (2.0) |
Convulsions or seizures | 40 (0.9) |
Acute paralysis | 33 (0.8) |
Vaccine-associated enhanced disease | 30 (0.7) |
Acute respiratory distress syndrome | 14 (0.3) |
Encephalopathy or encephalitis | 11 (0.3) |
Thrombocytopenic purpura | 6 (0.1) |
Thrombocytopenia | 5 (0.1) |
Acute kidney injury | 4 (0.1) |
Osteitis or osteomyelitis | 4 (0.1) |
Erythema multiforme | 3 (0.1) |
Coagulation disorder | 3 (0.1) |
Thrombosis with thrombocytopenia syndrome | 3 (0.1) |
Anosmia or ageusia | 3 (0.1) |
Acute liver injury | 2 (0) |
Meningoencephalitis | 2 (0) |
Multisystem inflammatory syndrome | 2 (0) |
Single organ cutaneous vasculitis | 2 (0) |
Acute disseminated encephalomyelitis | 1 (0) |
Chilblains | 1 (0) |
Guillain-Barre syndrome | 1 (0) |
Characteristic | Dose 1 (n=10,389) | Dose 2 (n=3,147) |
---|---|---|
Sex | ||
Male | 4,828 (46.5) | 1,436 (45.6) |
Female | 5,561 (53.5) | 1,711 (54.4) |
Age (y) | ||
12–15 | 8,909 (85.8) | 2,744 (87.2) |
12 | 1,948 (18.8) | 639 (20.3) |
13 | 2,432 (23.4) | 766 (24.3) |
14 | 1,857 (17.9) | 584 (18.6) |
15 | 2,672 (25.7) | 755 (24.0) |
16–17 | 1,480 (14.2) | 403 (12.8) |
16 | 864 (8.3) | 247 (7.8) |
17 | 616 (5.9) | 156 (5.0) |
Events |
Age group (12–15 y) | Age group (16–17 y) | ||
---|---|---|---|---|
Dose 1 (n=8,909) | Dose 2 (n=2,744) | Dose 1 (n=1,480) | Dose 2 (n=403) | |
Health problems |
4,803 (53.9) | 1,617 (58.9) | 766 (51.8) | 234 (58.1) |
Fever or sensation of heat | 694 (7.8) | 634 (23.1) | 103 (7.0) | 89 (22.1) |
Local adverse events | 4,323 (48.5) | 1,460 (53.2) | 686 (46.4) | 212 (52.6) |
Pain | 3,978 (44.7) | 1,346 (49.1) | 634 (42.8) | 200 (49.6) |
Redness | 195 (2.2) | 88 (3.2) | 39 (2.6) | 20 (5.0) |
Swelling | 843 (9.5) | 316 (11.5) | 130 (8.8) | 55 (13.6) |
Itching | 232 (2.6) | 95 (3.5) | 44 (3.0) | 12 (3.0) |
Urticaria | 42 (0.5) | 13 (0.5) | 9 (0.6) | 1 (0.2) |
Others | 506 (5.7) | 164 (6.0) | 86 (5.8) | 31 (7.7) |
Systemic adverse events | 3,736 (41.9) | 1,434 (52.3) | 615 (41.6) | 217 (53.8) |
Chills | 494 (5.5) | 386 (14.1) | 102 (6.9) | 66 (16.4) |
Headache | 1,455 (16.3) | 853 (31.1) | 262 (17.7) | 146 (36.2) |
Joint pain | 218 (2.4) | 146(5.3) | 48 (3.2) | 35 (8.7) |
Myalgia | 2,070 (23.2) | 729 (26.6) | 404 (27.3) | 136 (33.7) |
Fatigue or tiredness | 1,753 (19.7) | 748 (27.3) | 338 (22.8) | 144 (35.7) |
Nausea | 577 (6.5) | 267 (9.7) | 103 (7.0) | 55 (13.6) |
Vomiting | 35 (0.4) | 24 (0.9) | 12 (0.8) | 4 (1.0) |
Diarrhea | 188 (2.1) | 68 (2.5) | 36 (2.4) | 13 (3.2) |
Abdominal pain | 326 (3.7) | 145 (5.3) | 53 (3.6) | 26 (6.5) |
Rash | 25 (0.3) | 11 (0.4) | 10 (0.7) | 5 (1.2) |
Armpit tenderness | 347 (3.9) | 286 (10.4) | 65 (4.4) | 41 (10.2) |
Others | 450 (5.1) | 152 (5.5) | 73 (4.9) | 28 (6.9) |
Unable to perform normal daily activities | 867 (9.7) | 510 (18.6) | 185 (12.5) | 103 (25.6) |
Visits to medical facilities | 100 (1.1) | 39 (1.4) | 16 (1.1) | 5 (1.2) |
Emergency department visit | 15 (0.2) | 6 (0.2) | 3 (0.2) | 1 (0.2) |
Hospitalization | 2 (0) | 0 | 0 | 0 |
Clinic visit | 87 (1.0) | 34 (1.2) | 13 (0.9) | 5 (1.2) |
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. Data were calculated using the information on suspected adverse events after COVID-19 vaccination reported by medical facilities or doctors. The results do not indicate an accurate diagnosis 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 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 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. Data were calculated using the information on suspected adverse events after COVID-19 vaccination reported by medical facilities or doctors. The results do not indicate an accurate diagnosis or causality between the events and the vaccines.
Data are presented as COVID-19, coronavirus disease 2019. Adolescents aged 12 to 17 years who completed at least 1 text message-based survey on days 0 to 7 following Pfizer-BioNTech COVID-19 vaccination, Republic of Korea, December 13, 2021 to January 26, 2022.
Data are presented as COVID-19, coronavirus disease 2019. Events were reported by respondents who completed at least 1 text message-based survey on days 0 to 7. They could report multiple adverse events on various days. The proportion of respondents who answered that they had experienced any health problems after vaccination. COVID-19, coronavirus disease 2019.