The ZVA evaluated 22 adverse reaction reports associated with Covid-19 vaccines. In one case, the ZVA concluded that the causal relationship between the very rare side effect of the Vaxzevria vaccine and thrombosis and thrombocytopenia syndrome (TTS) was considered credible. A person aged 55 to 60 received the first dose of the Covid-19 vaccine Vaxzevria in April 2021 and died on the seventh day following vaccination.
ZVA explained that TTS is a very rare side effect only for virus vector vaccines (Vaxzevria and Janssen), which in some cases occurs with bleeding and takes place most frequently within three weeks of vaccination. The TTS is included among the side effects listed for the vaccine. This side effect is not listed for the mRNA (Pfizer or Moderna) vaccines.
ZVA also indicated that TTS is a significantly different clinical status from common thrombosis in medicine and always includes concomitant thrombocytopenia (or reduced blood platelet counts). The common thrombosis in medicine without concomitant thrombocytopenia is not the same as the side effect of TTS.
ZVA evaluated all available information on this reported fatal case, including personal medical history data, information from the Emergency Medical Service, the family doctor, from the National Health Service on used medicinal products and studies performed, the conclusion of a court medical expert-examination, including histological studies of the court, and hematologist.
The evaluation of the ZVA was carried out on the basis of scientific methods and requirements that are uniform throughout the European Union (EU), in accordance with the standardized causal relationship assessment criteria for pharmacovigilance of medicinal products developed by the World Health Organisation (WHO).
The ZVA recalls that every resident should pay attention and immediately seek medical attention if a shortage of breath is observed, chest pain, legs, swelling of legs, persistent abdominal pain, spontaneous bleeding, bruising or minor subcutaneous bruising (petechiae) within three weeks of vaccination with a virus vector vaccine Vaxzevria or Janssen.
Those who have been diagnosed with thrombocytopenia within three weeks of vaccination with Vaxzevria should actively check for signs of thrombosis. Similarly, in patients who have signs of thrombosis or other symptoms within three weeks of vaccination, blood platelet counts should be monitored.