"Materials and methods
Case profiles: The profiles of four cases who died at home after receiving the COVID-19 vaccine are summarized in Table 1. Three cases received two doses of the Moderna mRNA COVID-19 vaccine, tozinameran, and one case received two doses of the Pfizer-BioNTech mRNA COVID-19 vaccine, elasomeran. The time from receipt of the second dose to death was 1–10 days. In case 3, side effects following vaccination, such as fever and headache, were not observed on the day before death, whereas in the other cases, they were observed on the day before death. Autopsies revealed no information about the cause of death for any patient, and pathologic analysis showed findings of sudden death, such as congestion of primary organs, and no information about the cause of death, including myocarditis...
Discussion
[T]he RNA sequencing results suggested that an abnormal secretion of cytokines, possibly a cytokine storm, may have occurred after vaccination, resulting in SIRS [systemic immune response syndrome] and death. SIRS is defined as fulfilling at least two of the following criteria: fever >38.0°C or hypothermia <36.0°C, tachycardia >90 beats/minute, tachypnea >20 breaths/minute, leukocytosis >12×109/L or leucopoenia <4×109/L. SIRS is induced by various factors, such as infection, trauma, surgery, and ischemia. It has been reported that SIRS can occur due to COVID-19 infection. COVID-19 vaccination corresponds to pseudo-COVID-19 infection. Therefore, vaccination may induce SIRS. In the present four victims, it is assumed that the immune function was sensitized by the first vaccination and that the second vaccination made the patients more susceptible to developing SIRS."
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