Tozinameran

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 76-year-old man developed cutaneous and gastrointestinal immune complex vasculitis, myalgia, fever, hoarseness and fatigue following administration of tozinameran to prevent COVID-19 [route and dosage not stated; not all duration of treatment to reactions onsets and outcomes not stated].

The man, who had a history of NYHA II heart failure, compensated alcoholic liver cirrhosis, prostatectomy after prostate cancer, gastrectomy after gastroesophageal junction cancer and indwelling suprapubic catheter observed lesions on feet and hands, and presented with progressive pruritus and swelling. Upon presentation, physical examination showed a purpuric rash with palpable maculae on extensor and flexor parts of both legs, thighs and hands extending to the lower abdomen with symmetric distal limb swelling. Diascopy showed persisted lesions. He had no history of systemic autoimmune diseases or allergic predispositions. He motioned that he received second dose of tozinameran [BNT162b2 vaccine] to prevent COVID-19, 12 days prior. On last regular visit it was noted that these symptoms were absent before administration of vaccine. He had received first dose of vaccine tozinameran 6 weeks before, and experienced significant vaccine related fever (39.5°C), fatigue, myalgia and hoarseness, However, no skin related adverse events were reported at that time. He had never experienced any adverse events on previous vaccinations including pneumococcal vaccinations, influenza or herpes zoster. At the current presentation, laboratory investigation showed elevated C-reactive protein levels, interleukin-6 levels and blood sedimentations rate. Additionally, elevated ammonium levels and signs of discrete haemolysis were observed. Stool tests on occult blood showed positive result, and moderate elevated levels of stool calprotectin were noted. No new reactivation or infection were noted on virological tests on human herpes viruses and human pathogenic viruses. Based on laboratory findings and recent COVID-19 vaccine administration, a diagnosis of cutaneous and gastrointestinal immune complex vasculitis probably triggered by tozinameran was established.

The man was treated with prednisolone. Subsequently, his symptoms resolved. A small remaining scabs were observed on both lower legs at follow up 23 days after second dose of tozinameran. He reported remaining hyperalgesia while touching these lesions. His purpuric lesions, oedema and pruritus were fully recovered. Additionally, decrease in inflammation markers were reported. Stool colour and formation returned to normal. Then, prednisolone tapered quickly and subsequently stopped.