Table 4.
Medicare Fee-for-Service Population Early-Season and End-of-Season Self-Controlled Risk Interval Analysis Results: Odds Ratios and Attributable Risks Among Influenza-Vaccinated Beneficiaries Ages ≥65 Years, 2018–2019a
Number of GBS Cases | |||||||
---|---|---|---|---|---|---|---|
Population | Risk Window | Control Window | Odds Ratio | Odds Ratio 95% CI | P Value | Attributable Risk (Per Million Vaccinations) | Attributable Risk (Per Million Vaccinations) 95% CI |
Early-Season: High-Dose Influenza-Vaccinated Beneficiaries | |||||||
Risk Window: Days 8–21 Postvaccination | |||||||
Claims-based | 16 | 26 | 1.85 | (0.99–3.44) | .054 | 0.98 | (−0.02 to 1.82) |
PPV-imputed quantitative bias analysis | 11.38 | 18.47 | 1.84 | (0.78–4.31) | .162 | 0.69 | (−0.29 to 1.47) |
Risk Window: Days 1–42 Postvaccination | |||||||
Claims-based | 34 | 26 | 1.31 | (0.78–2.18) | .303 | 1.07 | (−0.97 to 2.99) |
PPV-imputed quantitative bias analysis | 24.21 | 18.58 | 1.31 | (0.65–2.61) | .449 | 0.76 | (−1.20 to 2.56) |
End-of-Season: High-Dose Influenza-Vaccinated Beneficiaries | |||||||
Risk Window: Days 8–21 Postvaccination | |||||||
Claims-based | 18 | 33 | 1.64 | (0.92–2.91) | .093 | 0.81 | (−0.14 to 1.63) |
Risk Window: Days 1–42 Postvaccination | |||||||
Claims-based | 37 | 33 | 1.12 | (0.70–1.79) | .633 | 0.46 | (−1.42 to 2.29) |
Early-Season: Influenza-Vaccinated Beneficiariesb | |||||||
Risk Window: Days 8–21 Postvaccination | |||||||
Claims-based | 22 | 42 | 1.57 | (0.94–2.63) | .086 | 0.66 | (−0.09 to 1.33) |
PPV-imputed quantitative bias analysis | 15.67 | 29.93 | 1.56 | (0.78–3.15) | .211 | 0.46 | (−0.27 to 1.09) |
Risk Window: Days 1–42 Postvaccination | |||||||
Claims-based | 52 | 42 | 1.24 | (0.82–1.86) | .303 | 0.82 | (−0.74 to 2.32) |
PPV-imputed quantitative bias analysis | 37.03 | 30.01 | 1.24 | (0.71–2.14) | .449 | 0.58 | (−0.92 to 2.00) |
End-of-Season: Influenza-Vaccinated Beneficiariesb | |||||||
Risk Window: Days 8–21 Postvaccination | |||||||
Claims-based | 28 | 53 | 1.58 | (1.00–2.51) | .049b | 0.72 | (0.00–1.36) |
Risk Window: Days 1–42 Postvaccination | |||||||
Claims-based | 63 | 53 | 1.19 | (0.82–1.71) | .354 | 0.69 | (−0.77 to 2.11) |
Abbreviations: CI, confidence interval; GBS, Guillain-Barré syndrome; PPV, positive predictive value.
aSeasonality-adjusted results are presented in Supplementary Table S10.
bWith any influenza vaccine (including high-dose influenza vaccine).