Also, arthralgia, malaise, nausea, headache, dizziness, and pyrexia are clustered toward the center of the biplot, indicating that there is not a predominantly association between these AEFI and any of the vaccine versions. On the other quadrant, vaccination site lymphadenopathy is aligned with versions 3 and 8. Moreover, immunization and off-label use are aligned with vaccine failure and aligned with version 5 suggesting an association between these AEFI and this vaccine version. Positioned on the left side of this dimension and closely aligned with vaccine version 5, these AEFI indicate a strong association with this vaccine version, contributing to the overall variance explained by this axis. The biplot in Figure 6 shows that vaccine versions 5, 2, and 6 are separated from the rest on the left side regarding dimension 1; dimension 2 further separates vertically version 6 from other versions. These two dimensions together account for 89% of the total variance (inertia) in the data.
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Myocarditis after BNT162b2 mRNA vaccine against COVID-19 in Israel. Surveillance for adverse events after COVID-19 mRNA vaccination. SARS-CoV-2 vaccination and myocarditis in a Nordic cohort study of 23 million residents. The conundrum of COVID-19 mRNA vaccine-induced anaphylaxis. Fischinger S, Boudreau CM, Butler AL, Streeck H, Alter G. Sex differences in vaccine-induced humoral immunity.
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- SARS-CoV-2 vaccination and myocarditis in a Nordic cohort study of 23 million residents.
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This subjectivity can lead to inconsistencies in reported severity patterns and may impact the observed distribution of serious versus non-serious events. This limitation prevents the determination of dose-specific AEFI patterns and highlights the need for future studies with access to more granular data to address this gap. While such information may occasionally be present in individual case narratives, it was not accessible in the dataset we used. Additionally, the inherent subjectivity of the reporting process can lead to over-representation or misclassification of certain patterns. Secondly, spontaneous reporting systems like EudraVigilance are subject to underreporting, a well-known limitation that can introduce reporting biases, thus limiting the ability to estimate the true incidence of AEFI. The reported events are based on suspicion and may be influenced by other factors such as underlying diseases or interactions with other medications.
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Mild sensory symptoms, such as numbness and tingling, are frequently reported in the literature, including cases of Bell’s palsy (58). Lee et al. (27) identified five distinct safety profiles – infection, cardiac, respiratory/thrombotic, systemic, and nervous system – that closely align with the AEFI clusters found in our study. The literature shows that for any authorized COVID-19 vaccine, whether mRNA or not, grade 1 severity for local and systemic events was most common, followed by grades 2 and 3 (53, 54).
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- The raw data supporting the conclusions of this article will be made available by the authors, upon reasonable request.
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In the infection AEFI cluster, the most reported issue was vaccine ineffectiveness, supporting our findings. Injection site pain was the most frequent local AEFI, while fever, fatigue, and headache were the common systemic AEFI across mRNA vaccines (53, 55). It is also noted that reactogenicity and AEFI are more prevalent in participants receiving mRNA-based vaccines than other types (49). Our comprehensive analysis enhances the understanding of AEFI associations and mechanisms, informing policy, regulatory, and clinical decisions, and refining risk stratification and vaccine protocols against COVID-19. This study aimed to bridge the gap between clinical trials and real-world settings by identifying potential safety concerns that could become significant as vaccine coverage expands globally.
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