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 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