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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
An 86-year-old man developed interstitial lung disease (ILD) following immunization with coronavirus-vaccine.
The man presented to the emergency department in April 2021 with weakness, fever and dyspnoea since one day. One day prior to the onset of these symptoms, he had undergone immunization with coronavirus-vaccine [COVID-19 mRNA vaccine; route and dosage not stated]. His medical history included diabetes, hypertension and chronic renal disease that were well controlled with amlodipine, atorvastatin, linagliptin, furosemide, clopidogrel and metformin. He received influenza vaccine every year without any adverse event. Upon admission, his examination showed body temperature 38.2°C and peripheral oxygen saturation 80% on room air.
Thus, the man started receiving high-flow nasal cannula oxygen therapy to maintain partial oxygen pressure in arterial blood (PaO2)/fraction of inspired oxygen ratio (FiO2). An electrocardiograph demonstrated sinus tachycardia and blood test showed haemoglobin 136 g/L; WBC count 11.60 × 10 9/L,(eosinophils 4.1% , neutrophils 82.8% and lymphocytes 5.8%); platelet count 340 × 10 9/L, D-dimer 0.55 µg/mL, international normalised ratio (INR) 1.04, blood urea nitrogen 22.7 mg/dL, creatinine 1.85 mg/dL, alanine aminotransferase 11 IU/L and aspartate aminotransferase 18 IU/L. Thus, pneumonia was suspected and empirical treatment with antibiotics was started. But, X-ray of chest showed worsening and Chest CT scan demonstrated bilateral diffuse ground-glass opacities (GGO) with focal consolidations, interlobular septal thickening and centrilobular micronodules. Increased levels of C-reactive protein and serum procalcitonin were noted. Based on his further investigational findings and clinical course, he was diagnosed with coronavirus-vaccine-related ILD [duration of treatment to reaction onset not stated]. Thus, antibiotics were stopped and he started receiving methylprednisolone that led to improvement in chest X-ray. Three days later, the dose of steroid decreased and he was discharged after 13 days. Eventually, the steroid was tapered off.