Table 3.
Safety of CoronaVac in clinical trials and real world surveys.
| Adverse events/reactions |
Vaccine recipients (%) |
Placebo recipients (%) |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Healthy adults in phase 3 in Turkeya 11 | Healthy adults in phase 3 in Brazilb 12 | Healthy adults in phase 3 in Indonesiac 13 | Healthy adults in phase 4 in Brazild 33 | ARD in phase 4 in Brazile 33 | Patients with AIIRDf 34 | Patients with cancerg 35 | Healthcare workers in Chinah 36 | Healthcare workers in Turkeyi 38 | Medical clerkship studentsj 37 | Healthy adults in following the third dosek 40 | Healthy adults in phase 3 in Turkeya 11 | Healthy adults in phase 3 in Brazilb 12 | Healthy adults in phase 3 in Indonesiac 13 | Healthy adults in following the third dosek 40 | |
| Total adverse events or reactions | 18.9 | 77.1 | 57.8 | 40.1 | 50.5 | 54.5 | 18.9 | 15.6 | 62.5 | 38.0 | 15.0 | 16.9 | 66.4 | 43.0 | 8.0 |
| Local adverse events or reactions | 2.7 | 61.5 | NR | 19.8 | 23.4 | 36.4 | 8.4 | 9.6 | 45.0 | 22.9 | NR | 1.5 | 34.6 | NR | NR |
| Pain | 2.4 | 60.3 | 33.5 | 17.0 | 19.8 | 36.3 | 4.2 | <9.6 | 41.5 | 17.4 | 12.0 | 1.1 | 32.5 | 23.7 | 0.0 |
| Erythema | 0.2 | 0.0 | 0.0 | 2.7 | 2.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 |
| Paraesthesia | 0.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 |
| Swelling | 0.1 | 5.8 | 2.2 | 6.6 | 4.7 | 0.0 | 2.1 | <9.6 | 2.6 | 2.1 | 2.0 | 0.1 | 2.1 | 0.7 | 0.0 |
| Induration | 0.1 | 3.8 | 8.4 | 2.2 | 6.2 | 0.0 | 0.0 | <9.6 | 0.0 | 0.0 | 0.0 | 0.1 | 1.1 | 4.4 | 0.0 |
| Pruritus | 0.0 | 4.2 | 0.0 | 2.2 | 3.1 | 0.0 | 2.1 | <9.6 | 0.0 | 1.4 | 2.0 | 0.1 | 2.9 | 0.0 | 0.0 |
| Redness | 0.0 | 3.9 | 6.2 | 0.0 | 0.0 | 0.0 | 0.0 | <9.6 | 1.4 | 2.1 | 0.0 | 0.0 | 1.4 | 3.7 | 0.0 |
| Bruising | 0.0 | 0.0 | 0.0 | 3.3 | 3.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Systemic adverse events or reactions | 17.7 | 48.4 | NR | 33.5 | 43.3 | 31.8 | 10.5 | NR | 71.0 | 25.0 | NR | 16.0 | 47.6 | NR | NR |
| Fatigue | 8.2 | 0.0 | 17.3 | 7.7 | 10.9 | 13.6 | 4.2 | 8.3 | 23.6 | 5.6 | 2.0 | 7.0 | 0.0 | 8.9 | 0.0 |
| Headache | 5.9 | 34.3 | 0.0 | 11.0 | 20.2 | 13.6 | 2.1 | <6.0 | 18.7 | 1.1 | 2.0 | 5.9 | 34.8 | 0.0 | 4.0 |
| Myalgia | 4.0 | 11.7 | 25.6 | 5.5 | 8.9 | 18.1 | 2.1 | 8.1 | 11.2 | 0.0 | 0.0 | 3.0 | 10.5 | 12.6 | 0.0 |
| Chill | 2.5 | 5.0 | 0.0 | 0.0 | 0.0 | 9.0 | 0.0 | 0.0 | 2.6 | 0.7 | 0.0 | 1.8 | 5.1 | 0.0 | 0.0 |
| Fever | 1.8 | 0.2 | 2.4 | 2.7 | 2.8 | 4.5 | 2.1 | 2.9 | 3.0 | 1.1 | 2.0 | 1.5 | 0.1 | 0.0 | 4.0 |
| Diarrhoea | 1.6 | 7.9 | 0.0 | 4.9 | 6.2 | 0.0 | 0.0 | <1.6 | 0.0 | 0.0 | 2.0 | 1.7 | 8.1 | 0.0 | 0.0 |
| Cough | 0.8 | 5.5 | 0.0 | 4.4 | 6.9 | 0.0 | 0.0 | <1.2 | 0.0 | 0.0 | 0.0 | 0.7 | 5.2 | 0.0 | 0.0 |
| Arthralgia | 0.7 | 5.7 | 0.0 | 6.0 | 13.5 | 0.0 | 0.0 | 0.0 | 5.9 | 0.0 | 0.0 | 0.5 | 5.2 | 0.0 | 0.0 |
| Nausea | 0.7 | 7.9 | 0.0 | 2.2 | 6.1 | 9.0 | 0.0 | <1.4 | 5.3 | 0.0 | 0.0 | 0.2 | 8.4 | 0.0 | 0.0 |
| Vomiting | 0.3 | 1.0 | 0.0 | 0.5 | 1.5 | 0.0 | 0.0 | <1.6 | 0.0 | 0.0 | 0.0 | 0.2 | 1.0 | 0.0 | 0.0 |
| Rash | 0.1 | 0.8 | 0.0 | 1.6 | 1.0 | 0.0 | 0.0 | <1.0 | 1.5 | 0.0 | 0.0 | 0.2 | 0.7 | 0.0 | 0.0 |
| Allergic reaction | 0.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | <1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Appetite impaired | 0.0 | 3.5 | 0.0 | 3.8 | 4.1 | 0.0 | 0.0 | <1.4 | 0.0 | 0.0 | 0.0 | 0.0 | 3.9 | 0.0 | 0.0 |
| Hypersensitivity | 0.0 | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.9 | 0.0 | 0.0 |
| Malaise | 0.0 | 0.0 | 0.0 | 4.4 | 9.5 | 0.0 | 0.0 | 0.0 | 0.0 | 13.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Somnolence | 0.0 | 0.0 | 0.0 | 10.4 | 13.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Abdominal pain | 0.0 | 0.0 | 0.0 | 3.8 | 4.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Vertigo | 0.0 | 0.0 | 0.0 | 4.9 | 7.0 | 0.0 | 0.0 | <6.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Tremor | 0.0 | 0.0 | 0.0 | 0.5 | 2.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Sweating | 0.0 | 0.0 | 0.0 | 1.1 | 5.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Muscle weakness | 0.0 | 0.0 | 0.0 | 3.8 | 7.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Back pain | 0.0 | 0.0 | 0.0 | 4.9 | 9.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Sneezing | 0.0 | 0.0 | 0.0 | 4.9 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Coryza | 0.0 | 0.0 | 0.0 | 7.1 | 8.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Stuffy nose | 0.0 | 0.0 | 0.0 | 4.4 | 5.7 | 0.0 | 0.0 | <0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Sore throat | 0.0 | 0.0 | 0.0 | 3.8 | 7.4 | 0.0 | 0.0 | <1.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Shortness of breath | 0.0 | 0.0 | 0.0 | 3.3 | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Conjunctivitis | 0.0 | 0.0 | 0.0 | 0.0 | 1.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Leg pain | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 9.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Dyspnea | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 4.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Lymphadenopathy | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.7 | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Oropharyngeal pain | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Oral diseases | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 11.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Acne | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Urticaria | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | <1.0 | 0.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Dysphagia | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Serious adverse events | 0.1 | 0.5 | <0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.5 | 0.0 | 5.0 | 0.1 | 0.5 | <0.6 | 4.0 |
Superscript letters indicate: aadverse events after one and two doses, bsolicited adverse reactions after one and two doses, csolicited adverse events after one dose, dadverse events after one dose, eadverse events after one dose, fadverse events after vaccination, gadverse reactions after one dose, hadverse reactions after one dose, iadverse reactions after one or two doses, jadverse events after one dose, and kadverse reactions after three doses. ARD=autoimmune rheumatic diseases. AIIRD=autoimmune and inflammatory rheumatic diseases. NR=not reported.