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This methodological replication study compared effect estimates from case-control and cohort designs applied to the same vaccine safety datasets. Analyzing six vaccine-adverse event pairs across three databases, we found high concordance between designs when confounding control and outcome definitions were standardized. Discrepancies arose primarily from differential misclassification and selection biases. The findings support the utility of both designs in vaccine safety assessment when rigorously implemented.
Keywords: Vaccine Safety; Case-Control; Cohort; Methodology; Comparative Design; Bias; Pharmacoepidemiology
