TABLE 1.
Frequent skin manifestations following mRNA‐based coronavirus disease 2019 vaccines (mRNA‐1273, BNT162b2) in different populations as of June 2021
| Frequency and type of cutaneous ADR | Onset | Management | Type of study/population (reference) | Comments |
|---|---|---|---|---|
| 15 185 included in verum group; cutaneous ADR: mild to moderate local reactions 84–88%, delayed local reactions in ~1% | Mostly within 7 days | Local reactions resolved within 4–5 days | Phase III clinical trial of mRNA‐1273 (Baden et al.) 1 |
47.3% of patients included were female, 79.2% Caucasian, mean age was 51.4 years. Exclusion criteria included patients receiving immunosuppressive treatment and immunosuppressive condition |
| 18 860 included in verum group; cutaneous ADR: mild to moderate local reactions 66–83% | Mostly within 7 days | Local reactions mostly resolved within 1–2 days | Phase II/III clinical trial of BNT162b2 (Polack et al.) 2 |
49% of patients included were female, >80% Caucasian, median age was 52 years. Exclusion criteria included patients receiving immunosuppressive treatment and immunocompromising condition |
|
Total study population not reported; any cutaneous ADR: 414. Early local reaction (<3 days), delayed local reaction (>3 days), urticaria, morbilliform and vesicular rash, erythromelalgia, flare of existing dermatological condition, perniones, reactions to cosmetic fillers |
Median 7 days; onset after 2nd vaccine quicker | Patients responded well to topical corticosteroids and oral antihistamines; no severe sequelae | Accumulated reports to a registry of AAD and ILDS (McMahon et al. 3 ) |
Participants received mRNA‐1273 (83%) or BNT162b2 (17%), no information regarding sex and age, 98% from USA, 78% white, 90% of the patients experiencing cutaneous ADR were female, median age was 44 years. Limitations: entries limited to HCW (only 30% dermatologists), no information regarding incidence |
|
Any cutaneous ADR: 67/277 (24.2%). Local reactions: itch 17 (6.1%), redness 7 (2.5%), swelling 14 (5.1%); angioedema 12 (4.3%); tongue edema 10 (3.6%); urticaria 2 (0.7%); “skin rash” 5 (1.8%) |
No exact point of time reported; all within 3 days | No information | Prospective survey of South Korean HCW (Bae et al.) 12 | Only 4.7% of all included participants received BNT162b2 mRNA vaccine (n = 277); 66.8% were female, 68.6% were 20–39 years old; Study was conducted via self‐assessment; only onset of symptoms within 3 days was included, adverse events more common after second dose |
|
Any cutaneous ADR: 11/3170 (0.3%) Local reactions: itch 2 (0.1%), redness 2 (0.1%), swelling 2 (0.1%), urticaria 1 (0.03%); erythema and itch distant from injection site 4 (0.1%); urticarial rash + flare of AD 1 (0.03%); “skin rash” 3 (0.1%) |
1 h to 8 days | Most skin symptoms resolved spontaneously within 2–3 days without treatment | Retrospective monocentric analysis among Italian HCW (Corbeddu et al. 13 ) |
All Participants received BNT162b2 (n = 3170), no information regarding sex and age; 63.6% of the patients experiencing cutaneous ADR were female and mean age was 50 years; 63.6% of reactions occurred after the first dose. Limitations: brief report, no detailed information on the mode of reporting |
|
Any cutaneous ADR: 44/19 485 (0.2%). Local reactions 17 (0.09%); urticarial reaction 8 (0.04%); angioedema 3 (0.02%); generalized itch 6 (0.03%); erythema distant from inoculation site 2 (0.01%); other 8 (0.04%) |
60 h to 10 days | Course mostly mild and self‐limiting | Reports to the Pharmacovigilance Service in Trieste, North Italy (Farinazzo et al. 14 ) |
All participants received BNT162b2 (n = 19 485), no information regarding sex and age; 89.1% of the patients experiencing cutaneous ADR were female and mean age was 44 years, 80.4% of reactions occurred after the first dose. Limitations: potential bias of under‐ and overreporting |
|
Any ADR: 214/2000 (10.7%) Any cutaneous ADR: not exactly specified. “Rash” 8 (0.4%); analysis of EUDRAVigilance (10 December to 6 March): “rash” (2.2%) |
No information | No information | Reports to the Pharmacovigilance Service in Milan, North Italy (Gringeri et al. 15 ) |
All participants received BNT162b2 (n = 2000), no information regarding sex and age; amongst patients experiencing any ADR female/male ratio was 4.5, mean age was 47.5 years. Limitations: potential bias of under‐ and overreporting |
Abbreviations: AAD, American Academy of Dermatology; AD, atopic dermatitis; ADR, adverse drug reaction; EUDRA, European Union Drug Regulating Authorities; HCW, health‐care workers; ILDS, International League of Dermatological Societies.