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. 2015 Mar 23;2015:196–200.

Table 1.

Vaccine-ADE Results for Phase 1 and 2 Trials.

Phase 1: Association Between Vaccine Administration and Adverse Effect
Phase 2: Adjusting for Demographics and Only Including Patients Returning Within 3 Months
Shortened Vaccine Name Origin Organism No.Cases1 No. Vaccinated Prop.2 Odds Ratio (OR) Adj. P4 No. VaccinatedwhoReturnedwithin 3 Months Prop.3 OR Adj. P4
Associated with ADEs After Confounder Adjustment:
 Mumps Human 5 785 0.006 0.451 1 8 0.625 106.793 9.54×10−9
 H1N1/H3N2 / Inactivated B-Brisbane-60-2008 strain Swine Virus (first 2), HumanVirus 503 19517 0.026 2.119 3.10×10−41 6904 0.073 3.207 5.86×10−103
 Pertussis / Diphtheria/ Haemophilus b / Polio / Tetanus Bacteria(first 3),virus,bacteria 68 11575 0.006 0.399 1.83×10−16 163 0.417 31.216 9.42×10−90
 H1N1v-like virus vaccine (0.25–0.5 mg/ml) Swine Virus 103 3701 0.028 2.070 1.90×10−9 423 0.243 9.469 7.70×10−79
Associated with Fewer ADEs After Confounder Adjustment:
 Pneumococcal Type 1, 10A, 11A, 12F Bacteria 1186 34983 0.034 4.149 5.68×10−230 33976 0.035 0.406 7.20×10−66
 Rubella Human 21 13568 0.002 0.101 1.21×10−56 13565 0.002 0.055 2.01×10−37
 Pertussis / Diphtheria/Hepatitis B Surface Antigen (0.02 mg/ml) Bacteria(first 2),Primatevirus 64 11406 0.006 0.381 2.30×10−17 10660 0.006 0.208 8.65×10−33
Insignificant After Confounder Adjustment:
 Hepatitis B (0.01 or 0.02 mg/ml) Primate virus 1 1659 0.001 0.042 5.37×10−8 1617 0.001 0.056 0.079
 Varicella-Zoster Live (Oka-Merck)[Varivax] Vertebrate Virus 3 99 0.030 2.208 1 30 0.1 5.618 0.103
 Pertussis / Diphtheria / Tetanus [Infanrix] Bacteria 59 11301 0.005 0.353 3.35×10−19 59 1 8982647 1
 Hepatitis B (0.04 mg/ml) Primate virus 9 1474 0.006 0.431 0.133 9 1 135359422 1
 Tetanus Bacteria 57 11301 0.005 0.341 4.28×10−20 57 1 89762087 1
 Diphtheria / Haemophilus B Bacteria 49 10242 0.005 0.325 2.11×10−19 49 1 90639367 1
 Polio Types 1–3 Virus 5 1453 0.003 0.242 0.002 5 1 82665283 1
 Meningococcal Group A/C/W/Y Bacteria 10 291 0.034 2.519 0.161 273 0.037 1.154 1
 Measles / Mumps / Rubella Human 21 13571 0.002 0.101 1.23×10−56 21 1 129593962 1
 Streptococcus Pneumonia Bacteria 3 545 0.006 0.390 1 56 0.054 2.665 1
 Haemophilus B Bacteria 13 13 0.008 0.600 1 1545 1 104864930 1
 Diphtheria / Tetanus Bacteria 58 11301 0.005 0.347 1.42×10−19! 58 1 89078106 1
1

Vaccinated and ADE within 3 months

2

Cases / No. Vaccinated

3

Cases / No. Vaccinated and Returned to CUMC Within 3 months

4

Adjustment made using Bonferroni. Only Bonferroni-adjusted p-values <=0.05 were considered significant.