Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema multiforme, Histology
Clinical narrative: Erythema multiforme; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Histology: spongiotic and vacuolar interface dermatitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.  Distribution of the clinical reaction pattern was in the arms and hands.  The morphology (based on clinical photograph review) was reported as erythematous, targetoid papules and plaques.  This study was conducted from December 24, 2020 to May 19, 2021 and 803 cases were reported. 78 providers indicated that a skin biopsy was performed. Records listed as pending (n = 15) or incomplete (n = 5) were not included, leaving 58 complete biopsy reports for review.  Authors evaluated for a history of skin biopsy all reports of reactions associated with COVID-19 vaccination identified in an international registry. When histopathology reports were available, they categorized them by reaction patterns.  Authors discussed that the mechanism of V-REPP (vaccine-related eruption of papules and plaques) after COVID-19 vaccination was unknown, but the delayed occurrence of these reactions suggested 2 potential mechanisms: (1) delayed hypersensitivity response to vaccination; or (2) T-cell-mediated skin reaction due to molecular mimicry with a viral epitope.   Authors concluded that this case series demonstrated the clinical and histopathologic characteristics of multiple dermatologic conditions after COVID-19 vaccination and they hoped these data will aid physicians and other providers in the diagnosis of dermatologic conditions associated with the COVID-19 vaccine, which will likely be encountered more frequently as vaccine distribution expands globally.  Company comment: This literature non-study case concerns a 42 year old patient of unknown gender, with no reported autoimmune disease, who experienced the unexpected serious (medically significant) AESI of Erythema multiforme, unknown days after receiving a dose of mRNA-1273 vaccine. Distribution of clinical reaction pattern was in the arms and hands. The morphology was reported as erythematous, targetoid papules and plaques. Histopathology showed spongiotic and vacuolar interface dermatitis. Authors stated that the mechanism of V-REPP (vaccine-related eruption of papules and plaques) after COVID-19 vaccination was unknown, but the delayed occurrence of these reactions suggests 2 potential mechanisms: (1) delayed hypersensitivity response to vaccination (2) T-cell-mediated skin reaction due to molecular mimicry with a viral epitope. No information on risk factors, concomitant medications, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-691075 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Live follow up received by safety on 23-Dec-2022 has email with full text article and contains significant information. Reporter information, literature information, laboratory tests and narrative were updated.; Sender's Comments: This literature non-study case concerns a 42 year old patient of unknown gender, with no reported autoimmune disease, who experienced the unexpected serious (medically significant) AESI of Erythema multiforme, unknown days after receiving a dose of mRNA-1273 vaccine. Distribution of clinical reaction pattern was in the arms and hands. The morphology was reported as erythematous, targetoid papules and plaques. Histopathology showed spongiotic and vacuolar interface dermatitis. Authors stated that the mechanism of V-REPP (vaccine-related eruption of papules and plaques) after COVID-19 vaccination was unknown, but the delayed occurrence of these reactions suggests 2 potential mechanisms: (1) delayed hypersensitivity response to vaccination (2) T-cell-mediated skin reaction due to molecular mimicry with a viral epitope. No information on risk factors, concomitant medications, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-691075: case (46-years-old)