Table 2.
Cutaneous side effects reported in the trial data of 11 authorized COVID-19 vaccines
| Vaccine name(s) | Erythema | Swelling | Tenderness | Pain | Induration | Pruritus | Other Skin Findings | Serious Cutaneous Reactions |
|---|---|---|---|---|---|---|---|---|
| BNT162b2, Comirnaty | Dose 1: 16–55 y: 5% >55 y 5% Dose 2: 16–55 y 6% >55 y 7% |
Dose 1: 16–55 y 6% >55 y 7% Dose 2: 16–55 y 6% >55 y 7% |
N/A | Dose 1: 16–55 y 83% >55 y 71% Dose 2: 16–55 y 78% >55 y 66% |
N/A | N/A | N/A | None |
| mRNA-1273 | Dose 1: 2.8% Dose 2: 8.6% |
Dose 1: 6.1% Dose 2: 12.2% |
Dose 1: 10.2% Dose 2: 14.2% |
Dose 1: 83.7% Dose 2: 88.2% |
N/A | N/A | Allergic, hand, atopic and contact dermatitis; eczema; exfoliative rash; hypersensitivity; injection site urticaria; erythematous rash; macular rash; maculopapular rash; pruritic rash; vesicular rash; urticaria; papular urticaria (<0.2%) | None |
| AZD1222, ChAdOx1 nCoV-19 | Group 1a, 1b, 2a, 2b: Without paracetamol prophylaxis: 3% With paracetamol prophylaxis: 2% Group 3 None |
Group 1a, 1b, 2a, 2b: Without paracetamol prophylaxis: 4% With paracetamol prophylaxis: 2% Group 3 None |
Group 1a, 1b, 2a, 2b: Without paracetamol prophylaxis: 83% With paracetamol prophylaxis: 77% Group 3 Dose 1: 50% Dose 2: 50% |
Group 1a, 1b, 2a, 2b: Without paracetamol prophylaxis: 67% With paracetamol prophylaxis: 50% Group 3 Dose 1: 50% Dose 2: 20% |
Group 1a, 1b, 2a, 2b: Without paracetamol prophylaxis: 3% With paracetamol prophylaxis: 0% Group 3 None |
Group 1a, 1b, 2a, 2b: Without paracetamol prophylaxis: 7% With paracetamol prophylaxis: 12% Group 3 Dose 1: 10% Dose 2: 10% |
One case each of psoriasis, rosacea, vitiligo and Raynaud phenomenon (<0.1%) | One case of severe cellulitis |
| Sputnik V, Gam-COVID-Vac | N/A | N/A | N/A | N/A | N/A | N/A | Acneiform dermatitis, allergic rash, alopecia, indeterminate rash, petechial rash, and eczema (<0.1%) | None |
| Ad26.COV2.S, JNJ-78436735 | 7.3% | 5.3% | N/A | 48.6% | N/A | N/A | N/A | None |
| CoronaVac | 0/14 schedule: Dose 1: 3μg group: 0.8% 6μg group: None Dose 2: 3μg group: None 6μg group: 1.7% 0/28 schedule: Dose 1: 3μg group: None 6μg group: 0.8% Dose 2: None |
0/14 schedule: Dose 1: 3μg group: 0.8% 6μg group: None Dose 2: 3μg group: 0.8% 6μg group: 2.5% 0/28 schedule: Dose 1: None Dose 2: 3μg group: None 6μg group: 0.9% |
N/A | 0/14 schedule: Dose 1: 3μg group: 9.2% 6μg group: 16.7% Dose 2: 3μg group: 13.3% 6μg group: 11.8% 0/28 schedule: Dose 1: 3μg group: 7.5% 6μg group: 10% Dose 2: 3μg group: 2.6% 6μg group: 5.9% |
0/14 schedule: Dose 1: None Dose 2: 3μg group: 0.8% 6μg group: 0.8% 0/28 schedule: None |
0/14 schedule: Dose 1: None Dose 2: 3μg group: 0.8% 6μg group: 0.8% 0/28 schedule: None |
N/A | One case of acute hypersensitivity with urticaria 48 h after dose 1 (6 μg group) |
| BBIBP-CorV | 1% | 2% | N/A | 16% | N/A | 2% | Unspecified rash in 1 participant (<1%) | None |
| Convidicea, Ad5-nCoV |
Low dose: 2% High dose: 1% |
Low dose: 4% High dose: 4% |
N/A | Low dose: 57% High dose: 56% |
Low dose: 2% High dose: 2% |
Low dose: 6% High dose: 2% |
One case of buccal ulceration within 14 d One case of oral herpes |
None |
| Covaxin, BBV152 | Dose 1: 3μg group: 1% 6μg group: 1% Dose 2: None |
N/A | N/A | Dose 1: 3μg group: 3% 6μg group: 3% Dose 2: 3μg group: 4% 6μg group: 2% |
N/A | Dose 1: 3μg group: 1% 6μg group: 1% Dose 2: 3μg group: None 6μg group: 1% |
One case of mild unspecified rash after dose 2 (3 μg group) | None |
| WIBP-CorV | Phase I (0, 28, 56-d group): Low dose: None Medium dose: None High dose: 4.2% Phase II 0 and 14-d group: Medium dose: None 0 and 21-d group: Medium dose: None |
Phase I (0, 28, 56-d group): Low dose: 4.2% Medium dose: None High dose: 4.2% Phase II 0 and 14-d group: Medium dose: None 0 and 21-d group: Medium dose: 1.2% |
N/A | Phase I (0, 28, 56-d group): Low dose: 20.8% Medium dose: 4.2% High dose: 25% Phase II 0 and 14-d group: Medium dose: 2.4% 0 and 21-d group: Medium dose: 14.3% |
N/A | Phase I (0, 28, 56-d group): Low dose: None Medium dose: None High dose: None Phase II 0 and 14-d group: Medium dose: None 0 and 21-d group: Medium dose: 1.2% |
N/A | None |
| ZF2001 | Phase I 25 μg group: 20% 50 μg group: 20% Phase II Two-dose group: 25 μg group: 8% 50 μg group: 8% Three-dose group: 25 μg group: 16% 50 μg group: 14% |
Phase I 25 μg group: 5% 50 μg group: 15% Phase II Two-dose group: 25 μg group: 4% 50 μg group: 6% Three-dose group: 25 μg group: 14% 50 μg group: 13% |
N/A | Phase I 25 μg group: 20% 50 μg group: 55% Phase II Two-dose group: 25 μg group: 3% 50 μg group: 5% Three-dose group: 25 μg group: 12% 50 μg group: 12% |
Phase I 25 μg group: 10% 50 μg group: 25% Phase II Two-dose group: 25 μg group: 3% 50 μg group: 5% Three-dose group: 25 μg group: 9% 50 μg group: 7% |
Phase I 25 μg group: 20% 50 μg group: 35% Phase II Two-dose group: 25 μg group: 6% 50 μg group: 9% Three-dose group: 25 μg group: 19% 50 μg group: 17% |
One case of unspecified rash in the phase I trial (50 μg group) Three cases of unspecified rash in the phase II trial, 2-dose schedule, 25 μg group Four cases of unspecified rash in the phase II trial, 2-dose schedule, 50 μg group 2 cases of unspecified rash in phase II trial, three-dose schedule, 25 μg group One case of unspecified rash in phase II trial, three-dose schedule, 50 μg group |
One case of unspecified grade ≥3 rash (50 μg group) |
Abbreviation: N/A, not applicable.