| アブストラクト | A serious adverse reaction (SADR) may follow a vaccination against SARS-CoV-2 infection. We aimed to explore symptoms and reporting trends of SADRs to anti-SARS-CoV-2 vaccines based on the EudraVigilance database. This retrospective observational study analysed 250,966 suspected SADRs (with 62.8% reported in females), following the administration of 733,837,251 vaccine doses against SARS-CoV-2. Pfizer BioNTech (Comirnaty-Tozinameran), Moderna (Spikevax-Elastomeran), Janssen (Jcovden) and AstraZeneca (Vaxzevria) vaccines were analysed. The assessment included 897 types of SADRs across 12 categories. The most common clinical manifestations of SADRs to anti-SARS-CoV-2 vaccines vaccines encompassed neuropsychiatric (n = 121,877), cardiovascular (n = 78,167), as well as musculoskeletal and connective tissue disorders (n = 63,994). After summarising all SADRs, vaccination with Comirnaty was associated with the lowest risk of experiencing SADRs (754/million administered doses), followed by Spikevax (785/million doses), Jcovden (1,248/million doses) and Vaxzevria (2,301/million doses; p < 0.001). Regarding the vaccine administration timelines, the reporting of SADRs tends to be delayed and occurs over a longer time (p < 0.001). SADRs associated with anti-SARS-CoV-2 vaccines seem to be relatively rare. Compared to adenovirus-based vector vaccines (Jcovden, Vaxzevria), mRNA vaccines appear to offer improved safety profiles (Comirnaty, Spikevax). The risk of SADR to any SARS-CoV-2 vaccine seems to be outweighed by the benefits of active immunization against the virus. |
|---|
| 組織名 | Faculty of Medicine, Medical University of Gdansk, Marii Sklodowskiej-Curie 3a,;80-210, Gdansk, Poland. wojciech.nazar@gumed.edu.pl.;Laboratory of Experimental and Translational Allergology, Department of;Allergology, Faculty of Medicine, Medical University of Gdansk, Smoluchowskiego;17, 80-214, Gdansk, Poland. wojciech.nazar@gumed.edu.pl.;Department of Allergology, Faculty of Medicine, Medical University of Gdansk,;Smoluchowskiego 17, 80-214, Gdansk, Poland.;80-210, Gdansk, Poland.;Department of Cardiology and Angiology, Otto Von Guericke University Magdeburg,;Leipziger Street 44, 39120, Magdeburg, Germany.;Department of Cardiology and Electrotherapy, Faculty of Medicine, Medical;University of Gdansk, Smoluchowskiego 17, 80-214, Gdansk, Poland. |
|---|
