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5.
Dermatol Clin ; 39(4): 653-673, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1252657

ABSTRACT

In 2021, we entered a new phase of the COVID-19 pandemic. As mass vaccinations are underway and more vaccines are approved, it is important to recognize cutaneous adverse events. We review the dermatologic manifestations of COVID-19 vaccines as reported in clinical trial data and summarize additional observational reports of skin reactions to COVID-19 vaccines. Early-onset local injection reactions were the most common cutaneous side effects observed in clinical trials; delayed injection reactions were the most common cutaneous side effect reported outside of clinical trials. Understanding the landscape of cutaneous manifestations to COVID-19 vaccines is key to providing appropriate vaccine guidance.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , COVID-19 Vaccines/adverse effects , Drug Eruptions/etiology , Drug-Related Side Effects and Adverse Reactions/diagnosis , Registries , Administration, Cutaneous , Drug Eruptions/epidemiology , Humans
6.
J Drugs Dermatol ; 19(9): 889-892, 2020 Sep 01.
Article in English | MEDLINE | ID: covidwho-1231668

ABSTRACT

Early December 2019 witnessed an international outbreak of a novel coronavirus (COVID 19) designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). Since then, a number of therapeutic molecules have been explored to have potential efficacy against the SARS-Cov-2 per se or its sequelae. There are no Food and Drug Administration specific therapies approved so far; however, numerous drugs based on varying levels of evidence, in vitro studies and compassionate drug trials are being established as therapeutic agents, especially drugs approved for previous emergence of the severe acute respiratory syndrome (SARS-CoV-1) and Middle east respiratory syndrome coronavirus (MERS-Cov). Numerous active clinical trials for COVID-19 with more than 150 drugs and products are under study. Needless to say, many dermatological drugs are being employed to mitigate this pandemic threat. We aim to review drugs with potential against SARS-Cov-2 widely used in dermatology practice. Additionally, rampant and overzealous use of these drugs as well as introduction of new molecules might lead to emergence of adverse effects associated with these agents. Dermatologists must be on lookout for any cutaneous adverse effects of these drugs. J Drugs Dermatol. 2020;19(9):889-892. doi:10.36849/JDD.2020.5323.


Subject(s)
Antiviral Agents/adverse effects , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Dermatologic Agents/adverse effects , Drug Eruptions/etiology , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Severe Acute Respiratory Syndrome/drug therapy , Adenosine Monophosphate/administration & dosage , Adenosine Monophosphate/adverse effects , Adenosine Monophosphate/analogs & derivatives , Alanine/administration & dosage , Alanine/adverse effects , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , Biological Products/administration & dosage , Biological Products/adverse effects , COVID-19 , Dermatologic Agents/therapeutic use , Drug Eruptions/epidemiology , Drug Eruptions/physiopathology , Drug-Related Side Effects and Adverse Reactions , Female , Humans , Incidence , Male , Pandemics , Prognosis , Risk Assessment , Severe Acute Respiratory Syndrome/diagnosis , Severe Acute Respiratory Syndrome/epidemiology
7.
JAMA Dermatol ; 157(6): 716-720, 2021 06 01.
Article in English | MEDLINE | ID: covidwho-1224947

ABSTRACT

Importance: In response to the coronavirus disease 2019 (COVID-19) pandemic, 2 mRNA vaccines (Pfizer-BioNTech and Moderna) received emergency use authorization from the US Food and Drug Administration in December 2020. Some patients in the US have developed delayed localized cutaneous vaccine reactions that have been dubbed "COVID arm." Objective: To describe the course of localized cutaneous injection-site reactions to the Moderna COVID-19 vaccine, subsequent reactions to the second vaccine dose, and to characterize the findings of histopathologic examination of the reaction. Design, Setting, and Participants: This retrospective case series study was performed at Yale New Haven Hospital, a tertiary medical center in New Haven, Connecticut, with 16 patients referred with localized cutaneous injection-site reactions from January 20 through February 12, 2021. Main Outcomes and Measures: We collected each patient's demographic information, a brief relevant medical history, clinical course, and treatment (if any); and considered the findings of a histopathologic examination of 1 skin biopsy specimen. Results: Of 16 patients (median [range] age, 38 [25-89] years; 13 [81%] women), 14 patients self-identified as White and 2 as Asian. The delayed localized cutaneous reactions developed in a median (range) of 7 (2-12) days after receiving the Moderna COVID-19 vaccine. These reactions occurred at or near the injection site and were described as pruritic, painful, and edematous pink plaques. None of the participants had received the Pfizer-BioNTech vaccine. Results of a skin biopsy specimen demonstrated a mild predominantly perivascular mixed infiltrate with lymphocytes and eosinophils, consistent with a dermal hypersensitivity reaction. Of participants who had a reaction to first vaccine dose (15 of 16 patients), most (11 patients) developed a similar localized injection-site reaction to the second vaccine dose; most (10 patients) also developed the second reaction sooner as compared with the first-dose reaction. Conclusions and Relevance: Clinical and histopathologic findings of this case series study indicate that the localized injection-site reactions to the Moderna COVID-19 vaccine are a delayed hypersensitivity reaction. These reactions may occur sooner after the second dose, but they are self-limited and not associated with serious vaccine adverse effects. In contrast to immediate hypersensitivity reactions (eg, anaphylaxis, urticaria), these delayed reactions (dubbed "COVID arm") are not a contraindication to subsequent vaccination.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Drug Eruptions/epidemiology , Injection Site Reaction/epidemiology , Adult , Aged , Aged, 80 and over , Connecticut/epidemiology , Drug Eruptions/diagnosis , Drug Eruptions/drug therapy , Drug Eruptions/immunology , Female , Histamine Antagonists/therapeutic use , Humans , Injection Site Reaction/diagnosis , Injection Site Reaction/drug therapy , Injection Site Reaction/immunology , Male , Middle Aged , Retrospective Studies , Skin/immunology , Skin/pathology
8.
J Am Acad Dermatol ; 85(1): 46-55, 2021 07.
Article in English | MEDLINE | ID: covidwho-1171221

ABSTRACT

BACKGROUND: Cutaneous reactions after messenger RNA (mRNA)-based COVID-19 vaccines have been reported but are not well characterized. OBJECTIVE: To evaluate the morphology and timing of cutaneous reactions after mRNA COVID-19 vaccines. METHODS: A provider-facing registry-based study collected cases of cutaneous manifestations after COVID-19 vaccination. RESULTS: From December 2020 to February 2021, we recorded 414 cutaneous reactions to mRNA COVID-19 vaccines from Moderna (83%) and Pfizer (17%). Delayed large local reactions were most common, followed by local injection site reactions, urticarial eruptions, and morbilliform eruptions. Forty-three percent of patients with first-dose reactions experienced second-dose recurrence. Additional less common reactions included pernio/chilblains, cosmetic filler reactions, zoster, herpes simplex flares, and pityriasis rosea-like reactions. LIMITATIONS: Registry analysis does not measure incidence. Morphologic misclassification is possible. CONCLUSIONS: We report a spectrum of cutaneous reactions after mRNA COVID-19 vaccines. We observed some dermatologic reactions to Moderna and Pfizer vaccines that mimicked SARS-CoV-2 infection itself, such as pernio/chilblains. Most patients with first-dose reactions did not have a second-dose reaction and serious adverse events did not develop in any of the patients in the registry after the first or second dose. Our data support that cutaneous reactions to COVID-19 vaccination are generally minor and self-limited, and should not discourage vaccination.


Subject(s)
COVID-19 Vaccines/adverse effects , Drug Eruptions/etiology , Adult , Drug Eruptions/epidemiology , Female , Global Health , Humans , Male , Middle Aged , Registries
9.
Drug Saf ; 43(12): 1309-1314, 2020 12.
Article in English | MEDLINE | ID: covidwho-1092869

ABSTRACT

INTRODUCTION: In late 2019, a new coronavirus-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-was discovered in Wuhan, China, and the World Health Organization later declared coronavirus disease 2019 (COVID-19) a pandemic. Numerous drugs have been repurposed and investigated for therapeutic effectiveness in the disease, including those from "Solidarity," an international clinical trial (azithromycin, chloroquine, hydroxychloroquine, the fixed combination lopinavir/ritonavir, and remdesivir). OBJECTIVE: Our objective was to evaluate adverse drug reaction (ADR) reporting for drugs when used in the treatment of COVID-19 compared with use for other indications, specifically focussing on sex differences. METHOD: We extracted reports on COVID-19-specific treatments from the global ADR database, VigiBase, using an algorithm developed to identify reports that listed COVID-19 as the indication. The Solidarity trial drugs were included, as were any drugs reported ≥ 100 times. We performed a descriptive comparison of reports for the same drugs used in non-COVID-19 indications. The data lock point date was 7 June 2020. RESULTS: In total, 2573 reports were identified for drugs used in the treatment of COVID-19. In order of frequency, the most reported ADRs were electrocardiogram QT-prolonged, diarrhoea, nausea, hepatitis, and vomiting in males and diarrhoea, electrocardiogram QT-prolonged, nausea, vomiting, and upper abdominal pain in females. Other hepatic and kidney-related events were included in the top ten ADRs in males, whereas no hepatic or renal terms were reported for females. COVID-19-related reporting patterns differed from non-pandemic reporting for these drugs. CONCLUSION: Review of a global database of suspected ADR reports revealed sex differences in the reporting patterns for drugs used in the treatment of COVID-19. Patterns of ADR sex differences need further elucidation.


Subject(s)
Antiviral Agents/adverse effects , COVID-19/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , Abdominal Pain/chemically induced , Abdominal Pain/epidemiology , Adenosine Monophosphate/adverse effects , Adenosine Monophosphate/analogs & derivatives , Alanine/adverse effects , Alanine/analogs & derivatives , Antibodies, Monoclonal, Humanized/adverse effects , Azithromycin/adverse effects , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , Chloroquine/adverse effects , Databases, Pharmaceutical , Diarrhea/chemically induced , Diarrhea/epidemiology , Drug Combinations , Drug Eruptions/epidemiology , Drug Eruptions/etiology , Drug Repositioning , Female , Humans , Hydroxychloroquine/adverse effects , Long QT Syndrome/chemically induced , Long QT Syndrome/epidemiology , Lopinavir/adverse effects , Male , Nausea/chemically induced , Nausea/epidemiology , Oseltamivir/adverse effects , Ritonavir/adverse effects , Sex Distribution , Sex Factors , Vomiting/chemically induced , Vomiting/epidemiology
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