Vaccine Safety Signal & Background Rate Analyzer Pharmacovigilance Workbench

Disproportionality Analysis, Observed vs Expected Comparison, and Population Risk-Benefit Trade-offs

Cohort & Event Parameters

Loads validated clinical trial and surveillance baseline presets.

Estimated severe disease outcomes averted in this cohort.

Epidemiological Equations
Observed vs Expected (O/E)

Expected Events ($E$) = Cohort $\times$ (Background Rate / 100,000) $\times$ (Days / 365).

Reporting Odds Ratio (ROR)

Disproportionality measure comparing reported cases in exposed vs non-exposed background reporting databases.

Observed vs Expected (O/E)
52.17
95% CI: [37.76 - 70.43]
Reporting Odds Ratio (ROR)
48.60
PRR: 47.92
Excess Risk / Million
41.20
Expected background: 0.81 events
Statistically Significant Signal (Requires Clinical Risk-Benefit Context)
Observed incidence significantly exceeds expected population baseline (O/E > 1.0, lower CI > 1.0).
Time-to-Onset Distribution (14-Day Window)
Risk-Benefit Trade-off (per 1,000,000)
Calculated Statistical Evidence Table
Metric Parameter Calculated Value 95% Confidence Interval Interpretation
Expected Background Events ($E$) 0.805 [0.32 - 1.66] Expected baseline cases in unexposed cohort
Observed Reported Events ($O$) 42 [30.12 - 56.88] Actual reported post-vaccination cases
Observed-to-Expected (O/E) Ratio 52.17 [37.76 - 70.43] Statistical signal flag if lower CI > 1.0
Excess Cases per Million Doses 41.20 - Attributable risk window incidence
Prevented Severe Outcomes / Million 640.00 - Disease hospitalizations averted
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