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Deprecated: Implicit conversion from float 219.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Pharm+Policy+Pract 2021 ; 14 (1): 46 Nephropedia Template TP
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Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech) #MMPMID34059124
Shimazawa R; Ikeda M
J Pharm Policy Pract 2021[May]; 14 (1): 46 PMID34059124show ga
Reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety. Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. In Japan, 10 fatal cases (five men and women) have been reported to date. Four of the five women died of ICH and the other died of aspiration pneumonia, whereas all five men died of causes other than stroke. This imbalance is incompatible with the mortality data on cardiovascular diseases in the National Statistics, which show no apparent disparity between sexes or between hemorrhagic and ischemic stroke. Cumulatively, our analysis reveals a disproportionately high incidence of death by ICH in Japanese women who received tozinameran, suggesting a potential association of ICH with the vaccine. Although we understand that the benefits of tozinameran still outweigh the risks, we believe that a causal link with the vaccine is not proven but possible and warrants further analysis.