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DH receives report of suspected serious adverse event with history of COVID-19 vaccination within 14 days from HA
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     The Department of Health (DH) announced that as of 4pm today (April 24), one death case, reported as suspected serious adverse event with history of COVID-19 vaccination within 14 days, had been received from the Hospital Authority (HA) in the past 24 hours. The report did not provide clinical evidence to support that the event was caused by the vaccine.

     According to the information provided by the HA, the case involved a 58-year-old woman with a history of hypertension and obesity. She was found collapsed at home on April 22 evening and was admitted to the United Christian Hospital for treatment. Investigation in the hospital revealed extensive subarachnoid haemorrhage with brain oedema. Her condition deteriorated and she passed away in the early morning of April 23. Provisional diagnosis was subarachnoid haemorrhage and cardiac arrest. According to information, she received the second dose of CoronaVac COVID-19 vaccination at the Kowloon Bay Sports Centre Community Vaccination Centre 10 days (i.e. April 13) prior to her death. There was no record that the woman complained of feeling unwell during observation at the vaccination centre.

     The DH contacted the HA upon notification to obtain further information on the incident to facilitate causality assessment. So far, there is no clinical evidence to indicate that the event was caused by the vaccine. The HA has referred the case to the Coroner. Also, the DH will pass the case based on the established mechanism to the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation (Expert Committee) for conducting causality assessment.

     According to the World Health Organization, an Adverse Event Following Immunisation (AEFI) is any medical occurrence that follows immunisation and that does not necessarily have a causal relationship with the usage of the vaccine.

     Up to and including April 18, 2021, there were about 1 091 100 doses of COVID-19 vaccines administered. During the same period, the DH had received a total of 1 890 AEFI reports (0.17 per cent of all doses administered). According to the background information provided by HA, between March 22 and April 18, 2021, there were on average about 47 inpatient cases (including about 3.6 deaths) diagnosed with acute stroke per day. In addition, there were about 500 deaths recorded at the HA's Accident & Emergency Department (A&ED) in the same period (on average about 18 deaths at A&ED per day). The state of inpatient cases diagnosed with acute stroke and death records at the A&ED are provided as a cross reference to enhance fuller public understanding of cases of the kind recorded on vaccine recipients.

     Separately, in response to media enquiries, the DH said that it also received a report of death case with history of COVID-19 vaccination more than 14 days from the HA. The case involved a 75-year-old man with a history of hypertension and diabetes. He was found unconscious at home this morning (April 24) and was admitted to the A&ED of Tseung Kwan O Hospital. Resuscitation failed and he passed away in the same morning. According to information, he received the second dose of CoronaVac COVID-19 vaccination 15 days (i.e. April 9) prior to his death. So far, there is no clinical evidence to indicate the event was caused by the vaccine. The DH will pass the case based on the established mechanism to the Expert Committee for conducting causality assessment.

     According to the risk communication plan endorsed by the Expert Committee, figures and summary of clinical events received will be released and updated through the designated website. When suspected adverse event fulfilling the reporting criteria of AEFIs involving death case within 14 days of vaccination is received, it will be announced via press release as soon as possible.
 
Ends/Saturday, April 24, 2021
Issued at HKT 20:32
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