대한의료관련감염관리학회 Korean Society for Healthcare-associated infection Control and Prevention.

pISSN 0705-3797. eISSN 2586-1298.

Table. 4.

Table. 4.

Known adverse drug reactions after COVID-19 vaccination

Vaccine name AZD1222 [9,44] Ad26.COV2.S [8,46] mRNA-1273 [7,47] BNT162b2 [6,45] NVX-CoV2373 [14,15]
Manufacturer AstraZeneca Janssen Moderna Pfizer-BioNTech Novavax
Authorization date England (30th, December, 2020) U.S. (27th, Feburary, 2021) England (Feburary, 2021) U.S. (18th, December, 2020) England (8th, January, 2021) U.S. (11th, December, 2020) England (2nd, December, 2020)
1st date of administration England (4th, January, 2021) U.S. (1st, March, 2021) U.S. (21st, December, 2020) U.S (14st, December, 2020) England (8th, December, 2020)
Phase 3 trial candidates (N) ≥18 years (23,745) ≥18 years (39,321) ≥18 years (30,351) ≥16 years (43,448) 18-84 years (15,000)
Solicited adverse events - After 2nd dose
Fatigue: 53.1%
Headache: 52.6%
Myalgia: 44.0%
Malasie: 44.2%
Pyrexia: 33.6%
Fever (≥38℃): 7.9%
Althralgia: 26.4%
- After one dose
Injection site pain: 48.6%
Fever: 9.0%
Fatigue: 38.2%
Headache: 38.9%
Myalgia: 33.2%
Nausea: 14.2%
- After 2nd dose
Fatigue: 65.3%
Headache: 58.9%
Myalgia: 58.0%
Chills: 44.2%
Arthralgia: 42.9%
Nausea/vomiting: 19.0%
Fever: 15.5%
- After 2nd dose:
1) 16-55 years old
Fever: 16%
Fatigue: 59%
Headache: 52%
Muscle pain: 37.3%
Joint pain: 21.9%
2) ≥55 years old
Fever: 11%
Fatigue: 51%
Headache: 39%
Muscle pain: 28.7%
Joint pain: 21.9%
Severe, serious, and medically attended adverse events occurred at low levels and were balanced
Serious adverse events (SAE) Considered related to vaccination:
1) Vaccine group (N=2)
Transverse myelitis: N=1
Pyrexia>40.0℃: N=1
2) Control group (N=1)
Hemolytic anemia: N=1
Considered related to vaccination:
1) Vaccine group (N=7)
Guillain-Barre syndrome: N=1
Pericarditis: N=1
Brachial radiculitis: N=1
Type IV hypersensitivity: N=1
Bell’s palsy: N=2
Post-vaccination syndrome*: N=1
2) Placebo group: DVT: N=1
EBV infection: N=1
Atrial flutter: N=1
Considered related to vaccination:
1) Vaccine group (N=3)
Intractable nausea/vomiting: N=1
Facial swelling with a history of dermal fillers: N=2
2) Placebo group: not assessable
Considered related to vaccination:
1) Vaccine group (N=4)
Shoulder injury related to vaccine administration: N=1
Right axillary lymph- denopathy: N=1
Paroxysmal ventricular arrhythmia: N=1
Right leg paresthesia: N=1
2) Placebo group: none

* Severe generalized weakness, fever, and headache.

Korean J healthc assoc Infect Control Prev 2021;26:3~15 https://doi.org/10.14192/kjicp.2021.26.1.3
© Korean J healthc assoc Infect Control Prev