The causal relationship between vaccination and the side effects and fatal outcome was assessed as probable, and the man died of the thrombosis with thrombocytopenia syndrome, HALMED said.
So far no other cases of this side effect have been reported nor has any other reported fatal outcome been found to be related to vaccination.
The man in question died 12 days after vaccination with the AstraZeneca vaccine (Vaxzevria) and the report on the case was received in March 2021, after which extensive medical checks and analyses were conducted.
Based on reports filed with the European database of suspected adverse drug reactions, the European Medicines Agency (EMA) identified the said syndrome and established that it can occur very rarely if viral vector vaccines are applied.
EMA also determined that even though this very rare syndrome can occur, as can related risks from hospitalisation and fatal outcome, the overall benefit of the said vaccine in preventing COVID-19 by far outweighs the potential risks.
According to the latest information by EMA, by 14 October 2021, 624 reports of suspected thrombosis with thrombocytopenia were filed with the European database of suspected adverse drug reactions, and around 69 million doses of the AstraZeneca vaccine were administered in the EU by 29 October 2021.
In Croatia, 562,938 doses of the Vaxzevria vaccine were administered by 6 December 2021, and 1,584 reports of suspected side effects were filed. Most or 81% of the side effects reported so far were not serious, were mild or moderate and lasted several days.
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