Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
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 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    Concurrent medical conditions included Immune thrombocytopenic purpura (potential predisposing condition to the development of vasculitis following elasomeran administration).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) was resolving. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis) to be related.    No concomitant and treatment information were reported.  The case of vasculitis in this patient, although diffuse in distribution, was self-resolving.  Patient was counseled of the potential risk of worsening reaction to the second dose of the vaccine and was instructed to proceed at their own risk. He elected to receive the second vaccination dose without any further reaction or side effects. Company comment: This literature case concerns an 80-year-old male patient, with medical history of Immune thrombocytopenic purpura, who experienced the serious (due to medically significant) AESI of cutaneous vasculitis (reported as Leukocytoclastic Vasculitis), after the first dose of mRNA-1273 vaccine. The date of vaccination and the onset of the event were not properly reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. Patient´s medical history of Immune thrombocytopenic purpura remains a potential predisposing condition to the development of vasculitis. The outcome of the event was reported as resolving. The reporter considered that cutaneous reactions should be noted as potential side effects of the vaccine The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This literature case concerns an 80-year-old male patient, with medical history of Immune thrombocytopenic purpura, who experienced the serious (due to medically significant) AESI of cutaneous vasculitis (reported as Leukocytoclastic Vasculitis), after the first dose of mRNA-1273 vaccine. The date of vaccination and the onset of the event were not properly reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. Patient´s medical history of Immune thrombocytopenic purpura remains a potential predisposing condition to the development of vasculitis. The outcome of the event was reported as resolving. The reporter considered that cutaneous reactions should be noted as potential side effects of the vaccine The benefit-risk relationship of the mRNA-1273 is not affected by this report.