Spontaneous Reports of Adverse Reactions with Fatal Outcomes After COVID-19 Vaccination During the National Vaccination Campaign in Sweden
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View abstract on PubMed
Summary
This summary is machine-generated.Fatal adverse drug reactions following COVID-19 vaccination were very rare in Sweden. Most fatalities were linked to pre-existing conditions, with few causally associated with the vaccines.
Area Of Science
- Pharmacovigilance and vaccine safety monitoring.
- Public health and epidemiology of infectious diseases.
Background
- Adverse drug reaction (ADR) reports are crucial for monitoring new vaccine safety.
- Prompt identification of safety risks and mitigation measures are essential.
Purpose Of The Study
- To review fatal ADR reports following COVID-19 vaccination in Sweden.
- To assess the safety of Comirnaty®, Spikevax®, and Vaxzevria® vaccines.
Main Methods
- Retrieved fatal ADR reports from EudraVigilance and vaccination data from the National vaccination register.
- Calculated reporting rates per vaccinated person and per vaccine dose administered.
- Conducted causality assessments by qualified reviewers.
Main Results
- Over 26 million vaccine doses administered; 456 fatal ADR reports received.
- Reporting rate of 5.7 per 100,000 persons or 1.7 per 100,000 doses.
- Most fatalities linked to pre-existing conditions, especially in those ≥70 years.
- Only 10 fatalities (0.1 per 100,000) causally associated with COVID-19 vaccination.
Conclusions
- Fatal adverse drug reactions post-COVID-19 vaccination in Sweden were extremely rare.
- No novel safety concerns were identified during the study period.
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