The Croatian Agency for Medicinal Products and Medical Devices (HALMED) said on Wednesday that it had received the first report about a suspected side-effect of vaccination with the AstraZeneca vaccine with a fatal outcome, the patient being a 33-year-old person who died 12 days after vaccination.

HALMED is in touch with the health institution where the case occurred to obtain the necessary medical documentation based on which a possible causal relationship can be investigated.

“The report cites thrombocytopenia and bleeding but it contains very little information and does not contain documents on the cause of death or the course of events that led to death. We expect to receive the requested medical documentation as soon as possible, including the discharge papers and the autopsy report,” HALMED said, adding that it would report on the case as soon as more information was available.

The report on the case will also be sent to the European Medicines Agency.

HALMED notes that so far it has not received any reports of suspected side-effects with fatal outcome for which a causal relationship with vaccination was established.

HALMED has received nine reports of suspected side-effects resulting in fatal outcome, which happened after vaccination.

For six of them, HALMED could not establish a causal relationship with vaccination based on available documents so additional information was requested.

In the case of three reports, it was established that the causal relationship of the fatal outcome, including the latest case of pulmonary thromboembolism, and vaccination was not probable.

HALMED has also received six reports of unwanted events with fatal outcome which happened after vaccination but it found no causal relationship to vaccination.

Of the total of 15 reported cases, nine referred to the Pfizer vaccine and six to the AstraZeneca vaccine.