Sex: U
Vaccine: COVID19
Symptoms: Cutaneous vasculitis, Histology
Clinical narrative: Leukocytoclastic vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) in an adult 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Histology: Epidermal infiltrate of neutrophils and extravasated erythrocytes with perivascular neutrophils and leukocytoclasis.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CUTANEOUS VASCULITIS (Leukocytoclastic vasculitis) to be related.    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. 8 patients biopsied after the first dose were not planning to receive the second dose, given the severity of the cutaneous reaction. These included 2 cases of leukocytoclastic vasculitis, 2 cases of papulosquamous eruptions, 1 case of urticaria, 1 case of dermal hypersensitivity reaction, 1 case of bullous pemphigoid, and 1 case of Stevens-Johnson syndrome.  Patient age was reported between 57-61 years. Patient experienced leukocytoclastic vasculitis on the lower extremity. It was deep red to maroon palpable purpura. The authoris suggested two potential mechanisms of V-REPP: delayed hypersensitivity response to vaccination, or T-cell- mediated skin reaction due to molecular mimicry with a viral epitope. Authors stated immune-mediated dermatologic disorders, such as bullous pemphigoid and leukocytoclastic vasculitis potentially driven by off-target immune activation following COVID-19 vaccination. These shifts in the immune response after vaccination may also be associated with reactivation of other viruses.  This case referred to an adult patient who experienced leukocytoclastic vasculitis after moderna vaccination from table 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-691075 (E2B Linked Report).  Company comment: This literature-non-study case report concerns an adult patient of an unknown gender, with no medical history specified, who experienced serious (medically significant) unexpected event of special interest - Cutaneous vasculitis. The event occurred after the patient had received the first dose of the mRNA-1273 vaccine, however, the exact temporal relationship cannot be determined as the results were provided cumulatively for all reported patients. The patient developed deep red to maroon palpable purpura on the lower extremity. It was stated that histopathology results of skin biopsy showed epidermal infiltrate of neutrophils and extravasated erythrocytes with perivascular neutrophils and leukocytoclasis, therefore, leukocytoclastic vasculitis was diagnosed. No information regarding treatment medications were provided and the outcome of the event was not clearly specified. Reportedly, given the severity of the cutaneous reaction, the patient was not planning to receive the second dose. The authors stated that immune-mediated dermatologic disorders, such as leukocytoclastic vasculitis, were potentially driven by off-target immune activation following COVID-19 vaccination, however, these shifts in the immune response after vaccination might also be associated with reactivation of other viruses. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this 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 FTA received and contains significant information: Reporter information, literature information, product details and event information were updated.; Sender's Comments: This literature-non-study case report concerns an adult patient of an unknown gender, with no medical history specified, who experienced serious (medically significant) unexpected event of special interest - Cutaneous vasculitis. The event occurred after the patient had received the first dose of the mRNA-1273 vaccine, however, the exact temporal relationship cannot be determined as the results were provided cumulatively for all reported patients. The patient developed deep red to maroon palpable purpura on the lower extremity. It was stated that histopathology results of skin biopsy showed epidermal infiltrate of neutrophils and extravasated erythrocytes with perivascular neutrophils and leukocytoclasis, therefore, leukocytoclastic vasculitis was diagnosed. No information regarding treatment medications were provided and the outcome of the event was not clearly specified. Reportedly, given the severity of the cutaneous reaction, the patient was not planning to receive the second dose. The authors stated that immune-mediated dermatologic disorders, such as leukocytoclastic vasculitis, were potentially driven by off-target immune activation following COVID-19 vaccination, however, these shifts in the immune response after vaccination might also be associated with reactivation of other viruses. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-691075:Master case (46-years-old)