SARS-COV-2 vaccine inactivated Sinovac Biotech

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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 88-year-old woman developed hyperactive delirium following vaccination with SARS-COV-2 vaccine inactivated Sinovac Biotech against coronavirus disease 2019 (COVID-19).

The woman, who had been isolated by her son for several months and had a history of CDR-2 Alzheimer's dementia, osteoporosis and rare prior delirium episodes, was admitted to a geriatric telemedicine consultation due to acute development of confusion, agitation, hallucinations and sleep disturbance. She had been receiving rivastigmine and alendronic-acid/colecalciferol [alendronic acid/cholecalciferol]. Anamnesis revealed that she had received the first dose of vaccination with SARS-COV-2 vaccine inactivated Sinovac Biotech [CoronaVac; route and dosage not stated] the day before the onset of the symptoms. She was hyperalert and not oriented to place, time and person. Also, her son reported that she showed fluctuating disturbance in attention and awareness and she had been talking about a man walking around the house, which indicated visual hallucination. She was noted to have hyperactive delirium. Lab tests showed a mild normocytic anaemia and leukocyturia (asymptomatic type), while other tests were unremarkable. Based on the Naranjo criteria for the adverse drug reaction, a score of 6 indicated a "probable" association between the SARS-COV-2 vaccine inactivated Sinovac Biotech and delirium.

The woman started receiving haloperidol for hyperactive delirium and trazodone for sleep disturbance. On day 2 of treatment, fluctuations in consciousness and hallucinations had reduced significantly, and she did not require haloperidol on day 3. She did not receive the second dose of the vaccination, and further episodes of delirium were not observed over 2 weeks of follow-up.