Table 3.
Reactive dermatoses to authorized COVID-19 vaccines reported in the nontrial literaturea
| Article Reference | Study Design | Study Size | Study Period | Vaccine Name(s) | Cutaneous Reactions | Dose Number | Time to Onset after Vaccination | Time to Resolution | Intervention |
|---|---|---|---|---|---|---|---|---|---|
| Delayed large local reactions | |||||||||
| Fernandez-Nieto et al,24 2021 | Retrospective study at a tertiary referral hospital in Spain | 4775 | 1/11/2021–2/12/2021 | BNT162b2/Comirnaty | 103 participants with delayed large local reactions | Dose 1: 49/103 (47.6%) Dose 2: 54/103 (52.4%) |
N/A | <8 h: 23/103 (22.3%) 8–24 h: 27/103 (26.2%) 48–72 h: 38/103 (36.9%) >72 h: 14/103 (13.6%) |
N/A |
| Blumenthal et al,23 2021 | Case series | 12 | N/A | mRNA-1273 | 12 participants with delayed large local reactions after dose 1 3 participants with similarly severe reactions, 3 participants with less severe reactions after dose 2 |
Dose 1: 12/12 (100%) Dose 2: 6/12 (50%) |
Dose 1: 4–11 d (median 8 d) Dose 2: 1–3 d (median 2 d) |
Dose 1: 2–11 d after onset (median, 6 d) Dose 2: N/A |
Ice, antihistamines, glucocorticoids (topical, oral or both), antibiotics |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 |
BNT162b2/Comirnaty: 12 reports of delayed large local reactions mRNA-1273 206 reports of delayed large local reactions |
BNT162b2/Comirnaty: Dose 1: 5/34 (15%) Dose 2: 7/40 (18%) mRNA-1273 Dose 1: 175/267 (66%) Dose 2: 31/102 (30%) |
BNT162b2/Comirnaty: N/A mRNA-1273: median 7 d after dose 1, median 3 d after dose 2 |
BNT162b2/Comirnaty: N/A mRNA-1273: median 4 d after dose 1; median 3 d after dose 2 |
Topical corticosteroids, oral antihistamines, pain relievers, antibiotics |
| Wei et al,25 2021 | Case series | 4 | N/A | mRNA-1273 | Delayed large local reactions | Dose 1 | Case 1: 8 d Case 2: 8 d Case 3: 7 d Case 4: 10 d |
Case 1: N/A Case 2: 3 d Case 3: 4 d Case 4: 2 d |
Case 1 and 2: topical corticosteroids, oral antihistamine Case 3 and 4: None |
| Ramos et al,27 2021 | Case series | 12 | N/A | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 1 report of delayed large local reaction mRNA-1273 11 reports of delayed large local reactions |
BNT162b2/Comirnaty: 1 case of delayed large local reaction after dose 2 only mRNA-1273 11 case of delayed large local reaction after dose 1 only |
5–11 d (average 7 d) | 3–8 d (average 5 d) | Topical corticosteroids, ice, oral antihistamines, pain relievers |
| Baeck et al., 2021 | Case report | 1 | N/A | BNT162b2/Comirnaty | Delayed large local reaction | Dose 1 only | 6 d | 5 d | N/A |
| Morbilliform rashes | |||||||||
| Jedlowski et al,30 2021 | Case report | 1 | N/A | BNT162b2/Comirnaty | Morbilliform rash on lower back | Dose 1 and dose 2 | Dose 1 and 2: 48 h |
Dose 1 and 2: 24 h |
None |
| CDC COVID-19 Response Team and FDA37 | Case series | 10 | 12/21/2020–1/10/2021 | mRNA-1273 | 4 cases of morbilliform rash | Dose 1 | 5–45 min | N/A | Intramuscular epinephrine |
| CDC COVID-19 Response Team and FDA37 | Case series | 21 | 12/14/2020–12/23/2020 | BNT162b2/Comirnaty | 7 cases of morbilliform rash | Dose 1 | 2–25 min | N/A | Intramuscular epinephrine |
| Ackerman et al,29 2021 | Case report | 1 | N/A | BNT162b2/Comirnaty | Maculopapular exanthema (30% body surface area) | Dose 1 (dose 2 avoided) | 3 h | >1 mo | Corticosteroids |
| Corbeddu et al., 2021 | Case series | 11 | N/A | BNT162b2/Comirnaty | 3 cases of morbilliform rashes | Dose 2: 3/3 (100%) |
Dose 2: 5 hours–3 days |
2–3 d | None |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 9 reports of morbilliform rash mRNA-1273 18 reports of morbilliform rash |
BNT162b2/Comirnaty: Dose 1: 6/9 (67%) Dose 2: 3/9 (33%) mRNA-1273 Dose 1: 11/18 (61%) Dose 2: 7/18 (39%) |
Dose 1: Median of 3 d Dose 2: Median of 2 d |
Dose 1: Median of 4.5 d Dose 2: Median of 2.5 d |
Topical corticosteroids, oral antihistamines, pain relievers, antibiotics |
| Urticaria | |||||||||
| CDC COVID-19 Response Team and FDA37 | Case series | 10 | 12/21/2020–1/10/2021 | mRNA-1273 | 1 case of urticaria | Dose 1 | 11 min | N/A | Intramuscular epinephrine |
| CDC COVID-19 Response Team and FDA37 | Case series | 21 | 12/14/2020–12/23/2020 | BNT162b2/Comirnaty | 10 cases of urticaria | Dose 1 | 5–54 min | N/A | Intramuscular epinephrine |
| John M. Kelso, 2021 | Case series | 4 | N/A | mRNA-1273 | 1 case of urticaria | Dose 1 (dose 2 refused) | 1 min | N/A | Diphenhyramine, IV epinephrine, diazepam |
| Corbeddu et al., 2021 | Case series | 11 | N/A | BNT162b2/Comirnaty | 2 cases of urticaria | Dose 1: 2/2 (100%) |
Dose 1: 1 hour–2 days |
2–3 d | None |
| Park et al,38 2021 | Case report | 1 | N/A | BNT162b2/Comirnaty | Urticaria with immediate anaphylaxis | Dose 1 only | 3 min | 2 d | Intramuscular epinephrine and diphenhydramine |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 |
BNT162b2/Comirnaty: 17 reports of urticaria mRNA-1273 23 reports of urticaria |
BNT162b2/Comirnaty: Dose 1: 9/17 (53%) Dose 2: 8/17 (47%) mRNA-1273 Dose 1: 16/23 (70%) Dose 2: 7/23 (30%) |
BNT162b2/Comirnaty: Dose 1: 9 cases after 24 h Dose 2: 1 case within 24 h, 7 cases after 24 h mRNA-1273 Dose 1: 13 cases after 24 h 3 cases of unknown timing Dose 2: 2 cases within 24 h, 5 cases after 24 h |
Dose 1: Median 5 d Dose 2: Median 3 d |
Topical corticosteroids, oral antihistamines, pain relievers, antibiotics |
| EM | |||||||||
| Gambichler et al., 2021 | Case report | 1 | N/A | BNT162b2/Comirnaty | Rowell’s syndrome | Dose 1 | 1 d | N/A | Oral corticosteroids |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | mRNA-1273 | 3 reports of EM | mRNA-1273 Dose 1: 3/3 (100%) |
N/A | N/A | N/A |
| DIRs to hyaluronic acid dermal fillers | |||||||||
| Munavalli et al,40 2021 | Case series | 2 | N/A | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty 1 report of DIR to hyaluronic acid dermal fillers mRNA-1273 1 report of DIRs to hyaluronic acid dermal fillers |
BNT162b2/Comirnaty: Dose 2: 1/2 (50%) mRNA-1273 Dose 1: 1/2 (50%) |
BNT162b2/Comirnaty: Dose 2: 24 h mRNA-1273 Dose 1: 48 h |
BNT162b2/Comirnaty: Dose 2: 24 h mRNA-1273 Dose 1: Initiation of lisinopril at 48 h, resolved after 24 h |
BNT162b2/Comirnaty: Corticosteroids mRNA-1273: Antihistamines, acetaminophen, lisinopril |
| Munavalli et al,41 2021 | Case series | 4 | N/A | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty 2 reports of DIRs to hyaluronic acid dermal fillers mRNA-1273 2 reports of DIRs to hyaluronic acid dermal fillers |
BNT162b2/Comirnaty: Dose 1: 1/2 (50%) Dose 2: 1/2 (50%) mRNA-1273 Dose 1: 16/23 (70%) Dose 2: 1/2 (50%) |
BNT162b2/Comirnaty: Dose 1: 10 d Dose 2: 2 d mRNA-1273 Dose 1: 18 h (recurred with dose 2) Dose 2: 24 h |
BNT162b2/Comirnaty: Dose 1: 7 d Dose 2: Initiation of lisinopril at 72 h, resolved after 24 h mRNA-1273 Dose 1: Initiation of lisinopril at 48 h, resolved after 24 h Dose 2: Initiation of lisinopril at 48 h, resolved after 72 h |
Low-dose lisinopril |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 1 report of DIR to hyaluronic acid dermal fillers mRNA-1273 8 reports of DIR to hyaluronic acid dermal fillers |
BNT162b2/Comirnaty: Dose 2: 1/1 (100%) mRNA-1273 Dose 1: 3/8 (38%) Dose 2: 5/8 (63%) |
N/A | N/A | N/A |
| Local injection site reactions | |||||||||
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 16 reports of local injection site reactions mRNA-1273 186 reports of local injection site reactions |
BNT162b2/Comirnaty: Dose 1: 8/16 (50%) Dose 2: 8/16 (50%) mRNA-1273 Dose 1: 117/186 (63%) Dose 2: 69/186 (37%) |
Dose 1: Median day 1 Dose 2: Median day 1 |
Dose 1: Median days 4 Dose 2: Median days 3 |
N/A |
| Erythromelalgia | |||||||||
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 3 reports of erythromelalgias mRNA-1273 11 reports of erythromelalgias |
BNT162b2/Comirnaty: Dose 1: 1/3 (33%) Dose 2: 2/3 (67%) mRNA-1273 Dose 1: 5/11 (45%) Dose 2: 6/11 (55%) |
Dose 1: Median day 7 Dose 2: Median day 1 |
Dose 1: Median days 5.5 Dose 2: Median days 3 |
N/A |
| Lichen planus | |||||||||
| Hiltun et al., 2021 | Case report | 1 | N/A | BNT162b2/Comirnaty | Lichen planus flare | Dose 2 | 48 h | N/A | Topical corticosteroids |
| Varicella zoster | |||||||||
| Bostan et al., 2021 | Case report | 1 | N/A | N/A | Varicella zoster flare | N/A | 5 d | 1 wk | Oral valacyclovir |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 5 reports of varicella zoster mRNA-1273 5 reports of varicella zoster |
BNT162b2/Comirnaty: Dose 1: 1/5 (20%) Dose 2: 4/5 (80%) mRNA-1273 Dose 1: 5/5 (100%) |
N/A | N/A | N/A |
| Herpes simplex | |||||||||
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | N/A | 4 reports of herpes simplex flares | N/A | N/A | N/A | N/A |
| Pityriasis rosea | |||||||||
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 3 reports of pityriasis rosea mRNA-1273 1 report of pityriasis rosea |
BNT162b2/Comirnaty: Dose 1: 2/3 (67%) Dose 2: 1/3 (33%) mRNA-1273 Dose 1: 1/1 (100%) |
N/A | N/A | N/A |
| Busto-Leis et al,47 2021 | Case series | 2 | N/A | BNT162b2/Comirnaty | 2 reports of pityriasis rosea | Dose 2 | 24 h, 7 d |
N/A | N/A |
| Pernio/chilblains | |||||||||
| Kha et al,45 2021 | Case report | 1 | N/A | mRNA-1273 | 1 report of pernio/chilblains | Dose 1 and 2 | Dose 1: 2 d Dose 2: 3 d |
Dose 1: 14 d Dose 2: 7 d |
Topical corticosteroids |
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 | BNT162b2/Comirnaty: 5 reports of pernio/chilblains mRNA-1273 3 reports of pernio/chilblains |
BNT162b2/Comirnaty: Dose 1: 3/5 (60%) Dose 2: 2/5 (40%) mRNA-1273 Dose 1: 3/3 (100%) |
N/A | N/A | N/A |
| Lopez et al,44 2021 | Case report | 1 | 1/2021 | BNT162b2 | Pernio/chilblains | Dose 2 | 3 d | >28 d | Clobetasol as needed, avoidance of cold exposure |
| Petechiae | |||||||||
| McMahon et al,4 2021 | Retrospective review of AAD/ILDS registry of vaccine-related cutaneous reactions | 414 | 12/24/2020–2/14/2021 | BNT162b2/Comirnaty mRNA-1273 |
BNT162b2/Comirnaty: 1 report of petechiae mRNA-1273 3 reports of petechiae |
BNT162b2/Comirnaty: Dose 1: 1/1 (100%) mRNA-1273 Dose 1: 1/3 (33%) Dose 2: 2/3 (67%) |
N/A | N/A | N/A |
| Purpura | |||||||||
| Malayala et al,48 2021 | Case report | 1 | 3/2021 | mRNA-1273 | Brown to red purpuric, nonblanchable rash | Dose 1 | 1 d | N/A | Monitoring of platelet, liver, renal function panels; antihypertensives |
Abbreviations: AAD, American Academy of Dermatology; CDC, Centers for Disease Control and Prevention; DIRs, delayed inflammatory reaction; EM, erythema multiforme; FDA, Food and Drug Administration; ILDS, International League of Dermatologic Societies; N/A, not applicable.
a
Articles within each morphology group are organized in order of publication date.