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Review
. 2022 Feb 16;10(2):308.
doi: 10.3390/vaccines10020308.

Death after the Administration of COVID-19 Vaccines Approved by EMA: Has a Causal Relationship Been Demonstrated?

Aniello Maiese  1 , Arianna Baronti  1 , Alice Chiara Manetti  1 , Marco Di Paolo  1 , Emanuela Turillazzi  1 , Paola Frati  2 , Vittorio Fineschi  2
Affiliations
Review

Death after the Administration of COVID-19 Vaccines Approved by EMA: Has a Causal Relationship Been Demonstrated?

Aniello Maiese et al. Vaccines (Basel). .

Abstract

More than eight billion doses of COVID-19 vaccines have been administered globally so far and 44.29% of people are fully vaccinated. Pre-authorization clinical trials were carried out and the safety of vaccines is still continuously monitored through post-commercialization surveillance. However, some people are afraid of vaccine side effects, claiming they could lead to death, and hesitate to get vaccinated. Herein, a literature review of COVID-19-vaccine-related deaths has been carried out according to the PRISMA standards to understand if there is a causal relationship between vaccination and death and to highlight the real extent of such events. There have been 55 cases of death after COVID-19 vaccination reported and a causal relationship has been excluded in 17 cases. In the remaining cases, the causal link between the vaccine and the death was not specified (8) or considered possible (15), probable (1), or very probable/demonstrated (14). The causes of deaths among these cases were: vaccine-induced immune thrombotic thrombocytopenia (VITT) (32), myocarditis (3), ADEM (1), myocardial infarction (1), and rhabdomyolysis (1). In such cases, the demonstration of a causal relationship is not obvious, and more studies, especially with post-mortem investigations, are needed to deepen understanding of the possible pathophysiological mechanisms of fatal vaccine side effects. In any event, given the scarcity of fatal cases, the benefits of vaccination outweigh the risks and the scientific community needs to be cohesive in asserting that vaccination is fundamental to containing the spread of SARS-CoV-2.

Keywords: COVID-19; death; side effects; vaccine.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Methodology search strategy: we identified 389 articles after removing duplicates, the screening based on their abstracts left 102 studies, and after a careful evaluation based on the aims of this review 19 research articles were included.
Figure 2
Figure 2
The distribution of the cause of death among the cases. “Other causes” includes one case of massive cerebral hemorrhage not associated with thrombosis or auto-antibodies, one case of anaphylactic reaction to anesthetics associated with cerebral venous sinus thrombosis and anti-PF4 antibodies, one case of hyperglycemic coma, one case of hemorrhagic shock due to aortic dissection and rupture, and one case of death due to the complications of rhabdomyolysis. ADEM indicates acute disseminated encephalomyelitis; COVID-19, coronavirus disease 2019; PAE, pulmonary embolism; VITT, vaccine-induced immune thrombotic thrombocytopenia.
Figure 3
Figure 3
The distribution of the type of vaccine among the 55 cases of death after the vaccination.
Figure 4
Figure 4
The distribution of the probability of the causal relationship among the 55 cases of death after the vaccination.
See this image and copyright information in PMC

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