Table 3.
Signal strength of AE reports of pneumococcal vaccines at the SOC level.
| SOC | a | ROR (95%Cl) | PRR (χ2) | EBGM (EBGM05) | IC (IC-2SD) |
|---|---|---|---|---|---|
| General disorders and administration site conditions | 235847 | 1.73 (1.72, 1.74) |
1.46 (42399.51) |
1.42 (1.42) |
0.51 (0.50) |
| Investigations | 89777 | 0.78 (0.77, 0.78) |
0.81 (4617.9) |
0.82 (0.81) |
-0.29 (-0.30) |
| Skin and subcutaneous tissue disorders | 62387 | 1.69 (1.68, 1.71) |
1.62 (14510.58) |
1.57 (1.56) |
0.65 (0.64) |
| Nervous system disorders | 46279 | 0.60 (0.6, 0.61) |
0.63 (10824.43) |
0.64 (0.64) |
-0.63 (-0.65) |
| Infections and infestations | 33754 | 1.15 (1.14, 1.17) |
1.15 (620.16) |
1.14 (1.13) |
0.19 (0.17) |
| Musculoskeletal and connective tissue disorders | 33741 | 0.79 (0.78, 0.79) |
0.80 (1790.32) |
0.81 (0.80) |
-0.31 (-0.33) |
| Gastrointestinal disorders | 29070 | 0.87 (0.86, 0.88) |
0.88 (479.35) |
0.89 (0.88) |
-0.18 (-0.19) |
| Respiratory, thoracic and mediastinal disorders | 19559 | 0.69 (0.68, 0.7) |
0.70 (2592.24) |
0.71 (0.70) |
-0.50 (-0.52) |
| Injury, poisoning and procedural complications | 19494 | 0.63 (0.62, 0.64) |
0.64 (4064.73) |
0.65 (0.64) |
-0.62 (-0.64) |
| Psychiatric disorders | 16579 | 1.47 (1.45, 1.49) |
1.46 (2225.58) |
1.42 (1.40) |
0.51 (0.48) |
| Vascular disorders | 9811 | 0.98 (0.96, 1.00) |
0.98 (3.49) |
0.98 (0.97) |
-0.03 (-0.06) |
| Metabolism and nutrition disorders | 6789 | 1.53 (1.49, 1.57) |
1.53 (1135.93) |
1.48 (1.45) |
0.57 (0.53) |
| Surgical and medical procedures | 5723 | 0.75 (0.73, 0.77) |
0.75 (462.99) |
0.76 (0.74) |
-0.4 (-0.43) |
| Eye disorders | 4711 | 0.57 (0.55, 0.59) |
0.57 (1473.45) |
0.59 (0.57) |
-0.77 (-0.81) |
| Blood and lymphatic system disorders | 4557 | 0.77 (0.75, 0.8) |
0.78 (284.22) |
0.79 (0.77) |
-0.35 (-0.39) |
| Immune system disorders | 4298 | 1.39 (1.34, 1.43) |
1.38 (425.72) |
1.36 (1.32) |
0.44 (0.39) |
| Cardiac disorders | 3163 | 0.24 (0.23, 0.25) |
0.24 (7516.35) |
0.25 (0.25) |
-1.98 (-2.03) |
| Social circumstances | 1494 | 0.55 (0.52, 0.57) |
0.55 (546.18) |
0.56 (0.54) |
-0.83 (-0.91) |
| Renal and urinary disorders | 1284 | 0.55 (0.52, 0.58) |
0.55 (463.10) |
0.56 (0.54) |
-0.83 (-0.91) |
| Ear and labyrinth disorders | 1245 | 0.23 (0.22, 0.24) |
0.23 (3158.26) |
0.24 (0.23) |
-2.05 (-2.13) |
| Product issues | 794 | 0.91 (0.85, 0.98) |
0.91 (6.26) |
0.92 (0.86) |
-0.12 (-0.23) |
| Hepatobiliary disorders | 559 | 0.68 (0.63, 0.74) |
0.68 (80.64) |
0.69 (0.65) |
-0.53 (-0.65) |
| Congenital, familial and genetic disorders | 489 | 1.62 (1.48, 1.78) |
1.62 (106.81) |
1.57 (1.45) |
0.65 (0.51) |
| Neoplasms benign, malignant and unspecified | 454 | 0.49 (0.45, 0.54) |
0.49 (233.08) |
0.51 (0.47) |
-0.98 (-1.12) |
| Reproductive system and breast disorders | 418 | 0.07 (0.06, 0.07) |
0.07 (5315.42) |
0.07 (0.07) |
-3.79 (-3.93) |
| Endocrine disorders | 123 | 0.22 (0.19, 0.26) |
0.22 (331.38) |
0.23 (0.20) |
-2.11 (-2.37) |
| Pregnancy, puerperium and perinatal conditions | 74 | 0.08 (0.06, 0.10) |
0.08 (830.46) |
0.08 (0.07) |
-3.64 (-3.98) |
AE, adverse event; CI, confidence interval; SOC, System Organ Class; ROR, reporting odds ratio; PRR, proportional reporting ratio; χ2, Chi-squared; IC, information component; IC-2SD, the lower limit of the 95% two-sided CI of the IC; EBGM, empirical Bayesian geometric mean; EBGM05, the lower 95 two-sided CI of EBGM.