Adverse case reporting science-based

March 31, 2021

The Department of Health (DH) today reiterated that its actions to determine whether an event fulfils the reporting criteria of adverse events following immunisation (AEFI) have been professional and based on scientific evidence.


Responding to media enquiries on a death case not fulfilling the reporting criteria of AEFIs, the department said it has been closely monitoring possible adverse events following COVID-19 immunisation.


Based on the World Health Organization’s guidelines, the department has enhanced the existing surveillance system and carried out active surveillance.


Under the surveillance system, the department monitors AEFIs and encourages and receives from healthcare providers and the pharmaceutical industry AEFI reports of COVID-19 immunisation.


The department also partners with the University of Hong Kong (HKU) to conduct an active surveillance programme for adverse events of special interest under the COVID-19 Vaccines Adverse Events Response & Evaluation Programme (CARE Programme).


The DH reiterated that according to the reporting criteria, when there are obvious medical causes for certain clinical events, including death cases, healthcare professionals may consider that the event does not fulfil the AEFI reporting criteria.


Under the criteria endorsed by the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation, these medical causes include clinical diagnosis and pathological evidence.


On the other hand, the DH and the Hospital Authority have set up a mechanism to refer death cases not fulfilling the AEFI reporting criteria to HKU for surveillance and analysis under the CARE Programme.


The university would provide regular reports to the expert committee. If an unusual pattern is detected, the DH will be notified and the information will be referred to the expert committee for assessment as soon as possible.


Apart from handling cases referred by the Hospital Authority, the DH’s public mortuaries had dealt with three Coroner’s Court cases with a history of COVID-19 vaccination, including an 80-year-old woman who passed away at home.


Based on a preliminary autopsy conducted by the DH’s forensic pathologist, the finding was ruptured myocardial infarction and the professional judgement was that there was no direct causal relationship between her death and vaccination.


The two other deceased, a 58-year-old man and a 30-year-old woman, passed away due to drowning and falling from height respectively. There was no direct causal relationship between their deaths and vaccinations.


The three cases do not fulfil the AEFI reporting criteria and will be passed to HKU’s CARE Programme for analysis.

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