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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 1-year-old boy and an 8-month-old boy developed Pneumocystis jirovecii pneumonia (PJP) during treatment with prednisolone or hydrocortisone for pericardiotomy syndrome or hypoglycaemia [time to reaction onsets not stated].
Case 1: A 1-year-old boy, who was diagnosed with pericardiotomy syndrome at the age of 6 months, started receiving IV prednisolone 1.2 mg/kg/day from the age of 7 months and was scheduled for 5 months. He required positive pressure ventilation by continuous positive airway pressure (CPAP) for tracheomalacia. Nine months later, CPAP was changed to high flow nasal cannula (HFNC), and he was hospitalised for a long period of time in the neonatal ICU due to respiratory symptoms of unknown aetiology. An infection was suspected due to a chief complaint was...