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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 28-year-old man developed cervical myelitis, diffuse muscle weakness, unconsciousness, hypotension, impaired mobility, impaired coordination, constipation, sphincter abnormalities and diminished rectal tone, urinary retention secondary to severe opioid use disorder following hydromorphone [Dilaudid] intoxication and diaphoresis, agitation and rhinorrhoea secondary to hydromorphone withdrawal [indication andtime to reactions onset not stated].
The man was brought to the emergency department (ED) after being found unconscious in a fetal position, hypotensive and with fecal incontinence. Gradually, he became cooperative and more alert. However, he complained of severe neck pain, impaired coordination and mobility and bilateral paraesthesia of the upper limbs. He had been...