Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Biopsy skin, Computerised tomogram thorax, Cutaneous vasculitis
Clinical narrative: Pulmonary alveolar haemorrhage; Cutaneous vasculitis/cutaneous leukocytoclastic vasculitis; ANCA + systemic vasculitis; This spontaneous case was reported by a non-health professional and describes the occurrence of PULMONARY ALVEOLAR HAEMORRHAGE (Pulmonary alveolar haemorrhage), CUTANEOUS VASCULITIS (Cutaneous vasculitis/cutaneous leukocytoclastic vasculitis) and ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA + systemic vasculitis) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032233) for COVID-19 immunisation.     Concurrent medical conditions included Bladder cancer (In remission (topical therapy)). Concomitant products included ASA, MIRTAZAPINE and GEMCITABINE for an unknown indication.    On 01-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 14-Nov-2023, the patient experienced PULMONARY ALVEOLAR HAEMORRHAGE (Pulmonary alveolar haemorrhage) (seriousness criteria hospitalization, medically significant and life threatening), CUTANEOUS VASCULITIS (Cutaneous vasculitis/cutaneous leukocytoclastic vasculitis) (seriousness criterion medically significant) and ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA + systemic vasculitis) (seriousness criterion medically significant). The patient was hospitalized on 25-Jan-2024 due to PULMONARY ALVEOLAR HAEMORRHAGE. At the time of the report, PULMONARY ALVEOLAR HAEMORRHAGE (Pulmonary alveolar haemorrhage), CUTANEOUS VASCULITIS (Cutaneous vasculitis/cutaneous leukocytoclastic vasculitis) and ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (ANCA + systemic vasculitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2023, Computerised tomogram thorax: Bilateral opacities. On 06-Dec-2023, Full blood count: Decreasing hemoglobin. On 22-Jan-2024, Biopsy skin: Leukocytoclastic vasculitis. On 24-Jan-2024, Antineutrophil cytoplasmic antibody: Positive. On 24-Jan-2024, Full blood count: Decreasing hemoglobin. On 26-Jan-2024, Computerised tomogram thorax: Progressive opacities.         Treatment medications were not reported.  Reported that patient developed ANCA + systemic vasculitis (no prior history) including cutaneous leukocytoclastic vasculitis and life threatening diffuse alveolar hemorrhage. Symptoms began around 14-Nov, about 1 week following Moderna vaccination.  Company comment: This spontaneous case concerns a 72-year-old, male patient with medical history of bladder cancer, who experienced the unexpected serious (life threatening, hospitalization and medically significant) event of pulmonary alveolar haemorrhage, unexpected serious (medically significant) events of leukocytoclastic vasculitis (AESI) and ANCA positive systemic vasculitis. The events occurred approximately 13 days after the sixth dose of SPIKEVAX 2023-2024 PFS. As reported, the patient developed ANCA + systemic vasculitis (no prior history) including cutaneous leukocytoclastic vasculitis and life threatening diffuse alveolar hemorrhage. No further information about the events was provided. Above mentioned medical history of malignancy is a risk factor for ANCA associated vasculitis.  The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.