The Anthrax Vaccine: Is It Safe? Does It Work? (2002)

Chapter: Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Appendix G
DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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TABLE G-1 Among Service Members Receiving at Least One Dose of AVA Hospitalization Diagnoses with Rate Ratios Above 1.0, U.S. Armed Forces, Active Duty, 1998 to 2000

ICD-9-CM Code(s)

Description

Anthrax Immunization Status

Adjusted Rate Ratio

95% Confidence Intervals

Post

Pre

Number

Rate per 100,000

Number

Rate per 100,000

193

Malignant neoplasm of thyroid gland

41

5.6

9

1.9

2.40

1.05

5.49

233

Carcinoma in situ of breast and genitourinary system

19

2.6

5

1.0

5.14

1.81

14.57

250

Diabetes mellitus

67

9.1

8

1.7

3.46

1.51

7.90

296

Affective psychoses

600

81.3

120

25.1

2.15

1.71

2.71

298

Other nonorganic psychoses

69

9.3

14

2.9

2.50

1.29

4.83

309

Adjustment reaction

1,219

165.1

403

84.3

1.38

1.20

1.59

311

Depressive disorder, not elsewhere classified

187

22.6

46

9.6

1.79

1.21

2.66

374

Other disorders of eyelids

16

2.2

7

1.5

2.71

1.05

7.00

550

Inguinal hemia

293

39.7

172

35.0

1.31

1.04

1.65

569

Other disorders of intestine

34

4.6

6

1.3

2.94

1.23

7.07

724

Other and unspecified disorders of back

108

14.6

38

7.9

1.51

1.04

2.20

726

Peripheral enthesopathies and allied syndromes

213

28.8

97

20.3

1.29

1.01

1.64

732

Osteochondropathies

38

5.1

11

2.3

2.03

1.03

3.98

808

Fracture of pelvis

53

7.2

16

3.3

1.81

1.03

3.20

823

Fracture of tibia and fibula

169

22.9

60

12.5

1.63

1.14

2.32

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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TABLE G-2 Among Service Members Receiving at Least One Dose of AVA, Hospitalization Diagnoses with Rate Ratios Above 1.0, by Number of Days after Immunization, U.S. Armed Forces, Active Duty, 1998 to 2000

ICD-9-CM Code(s)

Description

Anthrax immunization Status

Comparison*

Pre

0-45 days

>45days

0-45/Pre

>45/Pre

Number

Rate per 100,000

Number

Rate per 100,000

Number

Rate per 100,000

Adjusted Rate Ratio

98% CI

Adjusted Rate Ratio

95% CI

193

Malignant neoplasm of thyroid gland

9

1.88

10

6.04

31

5.41

2.88

1.12

7.37

2.16

0.90

5.17

220

Benign neoplasm of ovary

9

1.88

8

4.83

12

2.10

2.61

1.01

6.77

1.13

0.48

2.68

233

Carcinoma in situ of breast and genitourinary system

5

1.05

5

3.02

14

2.44

4.12

1.17

14.49

5.85

1.95

17.58

250

Diabetes mellitus

8

1.67

13

7.85

54

9.43

3.49

1.39

8.79

3.44

1.47

8.06

296

Affective psychoses

120

25.10

102

61.56

498

86.96

1.84

1.39

2.43

2.31

1.82

2.94

298

Other nonorganic psychoses

14

2.93

9

5.43

60

10.48

1.52

0.64

3.62

3.08

1.55

6.13

304

Drug dependence

6

1.25

2

1.21

33

5.76

.

.

.

3.06

1.08

8.66

309

Adjustment reaction

403

84.29

258

155.72

961

167.80

1.37

1.16

1.62

1.38

1.19

1.61

311

Depressive disorder, not elsewhere classified

46

9.62

35

21.12

132

23.05

1.78

1.11

2.84

1.80

1.19

2.72

312

Disturbance of conduct, not elsewhere classified

6

1.25

0

0.00

12

2.10

.

.

.

1.41

1.41

1.41

414

Other forms of chronic ischemic heart disease

18

3.76

20

12.07

81

14.14

2.15

1.09

4.23

1.65

0.89

3.07

429

III-defined desoriptions and complications of heart disease

6

1.25

0

0.00

12

2.10

.

.

.

1.32

1.32

1.32

451

Phlebitis and thrombophlebitis

5

1.05

0

0.00

12

2.10

.

.

.

1.58

1.58

1.58

470

Deviated nasal septum

45

9.41

23

13.88

90

15.72

1.19

0.72

1.97

1.47

1.02

2.11

493

Asthma

41

8.58

30

18.11

64

11.18

1.83

1.14

2.93

1.10

0.74

1.64

541

Appendicitis, unqualified

47

9.83

19

11.47

77

13.45

1.15

0.68

1.97

1.46

1.01

2.11

550

Inguinal hernia

172

35.98

76

45.87

217

37.89

1.24

0.93

1.65

1.36

1.05

1.76

569

Other disorders of intestine

6

1.25

10

6.04

24

4.19

4.16

1.51

11.49

2.61

1.06

6.44

598

Urethral stricture

22

5.18

8

5.38

51

9.89

0.96

0.43

2.16

1.66

1.00

2.75

622

Noninflammatory disorders of cervix

15

28.20

22

129.54

48

84.26

2.64

1.30

5.35

1.55

0.78

3.09

724

Other and unspecified disorders of back

38

7.95

19

11.47

89

15.54

1.25

0.72

2.18

1.59

1.08

2.33

733

Other disorders of bone and cartilage

95

19.87

45

27.16

194

33.87

1.12

0.77

1.62

1.45

1.06

1.98

735

Acquired deformities of toe

34

7.11

20

12.07

83

14.49

1.15

0.66

2.01

1.58

1.06

2.37

808

Fracture of pelvis

16

3.35

11

6.64

42

7.33

1.66

0.77

3.60

1.86

1.04

3.34

823

Fracture of tibia and fibula

60

12.55

36

21.73

133

23.22

1.53

0.99

2.37

1.68

1.15

2.46

865

Injury to spleen

9

1.88

10

6.04

19

3.32

2.83

1.15

6.99

1.61

0.72

3.58

999

Complications of medical care, not elsewhere classified

7

1.46

5

3.02

5

0.87

3.70

1.05

13.04

1.25

0.30

5.11

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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TABLE G-3 Among Service Members Receiving at Least One Dose of AVA, Hospitalization Diagnoses with Rate Ratios Above 1.0, by Number of Doses After Immunization, U.S. Armed Forces, Active Duty, 1998 to 2000

 

Anthrax Immunization Status

Comparison

Pre

1 to 3 doses

4 or more doses

1 to 3 doses/Pre

4 or more/Pre

ICD-9-CM

Description

Number

Rate/100,000

Number

Rate/100,000

Number

Rate/100,000

Adjusted Rate ratio

95% CI

Adjusted Rate ratio

95% CI

193

Malignant neoplasm of thyroid gland

9

1.88

12

6.51

29

5.23

2.55

0.94-6.94

2.35

1.01-5.48

225

Benign neoplasm of brain and other parts of nervous system

6

1.25

8

4.34

6

1.08

2.99

1.02-8.77

0.70

0.22-2.19

250

Diabetes mellitus

8

1.67

24

13.02

43

7.76

4.98

2.02-12.25

3.05

1.31-7.09

296

Affective psychoses

120

25.10

229

124.27

371

66.95

3.65

2.81-4.74

1.79

1.42-2.27

298

Other nonorganic psychoses

14

2.93

26

14.11

43

7.76

4.08

1.92-8.68

2.11

1.07-4.18

300

Neurotic disorders

69

14.43

70

37.99

101

18.23

2.20

1.46-3.30

0.92

0.64-1.32

301

Personality disorders

64

13.39

115

62.41

81

14.62

1.95

1.32-2.87

0.69

0.46-1.02

304

Drug dependence

6

1.25

13

7.05

22

3.97

4.20

1.37-12.91

1.81

0.64-5.07

309

Adjustment reaction

403

84.29

460

249.63

759

136.98

2.28

1.94-2.69

1.16

1.00-1.34

311

Depressive disorder, not elsewhere classified

46

9.62

49

26.59

118

21.30

2.60

1.62-4.20

1.63

1.09-2.44

346

Migraine

36

7.53

30

16.28

46

8.30

1.82

1.12-2.98

0.90

0.58-1.40

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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348

Other conditions of brain

7

1.46

9

4.88

8

1.44

2.80

1.03-7.63

0.78

0.28-2.19

410

Acute myocardial infarction

22

4.60

24

13.02

44

7.94

2.60

1.42-4.75

1.15

0.69-1.94

470

Deviated nasal septum

45

9.41

18

9.77

95

17.14

1.15

0.65-2.00

1.47

1.02-2.10

493

Asthma

41

8.58

36

19.54

58

10.47

2.18

1.37-3.47

1.00

0.67-1.51

550

Inguinal hernia

172

35.98

55

29.85

238

42.95

1.24

0.88-1.75

1.32

1.04-1.68

555

Regional enteritis

5

1.05

19

10.31

20

3.61

4.90

1.55-15.44

1.96

0.65-5.95

569

Other disorders of intestine

6

1.25

6

3.26

28

5.05

2.05

0.66-6.41

3.24

1.33-7.89

724

Other and unspecified disorders of back

38

7.95

26

14.11

82

14.80

1.78

1.06-2.98

1.45

0.98-2.13

726

Peripheral enthesopathies and allied syndromes

97

20.29

57

30.93

156

28.15

1.49

1.07-2.09

1.04

0.80-1.34

732

Osteochondropathies

11

2.30

6

3.26

32

5.78

1.50

0.55-4.12

2.17

1.09-4.32

733

Other disorders of bone and cartilage

95

19.87

68

36.90

171

30.86

1.77

1.22-2.56

1.23

0.91-1.66

735

Acquired deformities of toe

34

7.11

12

6.51

91

16.42

0.93

0.48-1.82

1.60

1.07-2.39

808

Fracture of pelvis

16

3.35

15

8.14

38

6.86

2.47

1.20-5.09

1.64

0.91-2.98

813

Fracture of radius and ulna

102

21.33

54

29.30

114

20.57

1.62

1.10-2.37

1.13

0.83-1.54

823

Fracture of tibia and fibula

60

12.55

50

27.13

119

21.48

1.93

1.24-3.01

1.55

1.07-2.23

844

Sprains and strains of knee and leg

113

23.64

64

34.73

167

30.14

1.67

1.22-2.29

1.10

0.86-1.39

851

Cerebral laceration and contusion

8

1.67

2

1.09

22

3.97

-

-

2.43

1.08-5.47

891

Open wound of knee, leg [ except thigh ], and ankle

18

3.76

18

9.77

28

5.05

2.10

1.08-4.11

1.26

0.70-2.29

998

Other complications of procedures, not elsewhere classified

157

32.84

112

60.78

250

45.12

1.51

1.13-2.02

1.11

0.87-1.41

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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TABLE G-4 Among all Service Members, Hospitalization Diagnoses with Rate Ratios Above 1.0, U.S. Armed Forces, Active Duty, 1998 to 2000

ICD-9-CM Code(s)

Description

Anthrax Immunization Status

Adjusted Rate Ratio

95% Confidence Intervals

Pre

Never

Number

Rate per 100,000

Number

Rate per 100,000

084

Malaria

18

3.8

62

2.1

1.76

1.04

2.99

695

Erythematous conditions

9

1.9

22

0.8

2.74

1.25

6.00

913

Superficial injury of elbow, forearm, and wrist

10

2.1

17

0.6

3.37

1.53

7.45

986

Toxic effect of carbon monoxide

8

1.7

8

0.3

7.49

2.74

20.46

993

Effects of air pressure

11

2.3

46

1.6

2.05

1.01

4.17

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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TABLE G-5 Among All Service Members, Rates of Hospitalization for Specific Diagnoses and Adjusted Rate Ratios Comparing Hospitalization Rates Following at Least One Dose of AVA (“Post”) with Hospitalization Rates Before First AVA Dose (“Pre”), by Sex, U.S. Armed Forces, Active Duty, 1998 to 2000

 

ICD-9-CM Code(s)

Description

Anthrax Immunization Status

Adjusted Rate Ratio

95% Confidence Intervals

Post

Pre

Number

Rate per 100,000

Number

Rate per 100,000

Both Sexes

710-719

Arthropathies and related disorders

1,543

209.0

7,674

227.8

0.88

0.83

0.93

493

Asthma

94

12.7

629

18.7

0.63

0.51

0.79

710

Diffuse diseases of connective tissue

9

1.2

61

1.8

0.86

0.42

1.78

250

Diabetes mellitus

67

9.1

445

13.2

0.65

0.50

0.84

380-389

Diseases of the ear and mastoid process

67

9.1

368

10.9

0.87

0.67

1.14

357

Inflammatory and toxic neuropathy

13

1.8

89

2.6

0.75

0.41

1.35

427

Cardiac dysrhythmias

170

23.0

998

29.6

0.77

0.65

0.91

200-208

Lymphosarcoma and reticulosarcoma

43

5.8

311

9.2

0.70

0.51

0.97

340

Multiple sclerosis

32

4.3

103

3.1

1.31

0.87

1.98

410

Acute myocardial infarction

68

9.2

384

11.4

0.97

0.74

1.27

240-246

Disorders of thyroid gland

48

6.5

334

9.9

0.76

0.56

1.04

530-537

Diseases of esophagus, stomach, and duodenum

475

64.3

2,135

63.4

1.02

0.92

1.13

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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ICD-9-CM Code(s)

Description

Anthrax Immunization Status

Adjusted Rate Ratio

95% Confidence Intervals

Post

Pre

Number

Rate per 100,000

Number

Rate per 100,000

Women

710-719

Arthropathies and related disorders

133

179.9

849

166.7

1.02

0.84

1.23

493

Asthma

21

28.4

197

38.7

0.67

0.42

1.06

710

Diffuse diseases of connective tissue

4

5.4

39

7.7

.

.

.

250

Diabetes mellitus

4

5.4

40

7.9

.

.

.

380-389

Diseases of the ear and mastoid process

10

13.5

73

14.3

1.11

0.56

2.18

357

Inflammatory and toxic neuropathy

3

4.1

16

3.1

.

.

.

427

Cardiac dysrhythmias

11

14.9

87

17.1

0.98

0.52

1.84

200-208

Lymphosarcoma and reticulosarcoma

3

4.1

45

8.8

.

.

.

340

Multiple sclerosis

15

20.3

34

6.7

2.14

1.14

4.01

410

Acute myocardial infarction

1

1.4

14

2.7

.

.

.

240-246

Disorders of thyroid gland

23

31.1

175

34.4

0.90

0.58

1.40

530-537

Diseases of esophagus, stomach, and duodenum

40

54.1

278

54.6

1.04

0.74

1.45

Men

710-719

Arthropathies and related disorders

1,410

212.2

6,825

238.7

0.86

0.81

0.91

493

Asthma

73

11.0

432

15.1

0.65

0.50

0.83

710

Diffuse diseases of connective tissue

5

0.8

22

0.8

0.85

0.32

2.25

250

Diabetes mellitus

63

9.5

405

14.2

0.65

0.50

0.85

380-389

Diseases of the ear and mastoid process

57

8.6

295

10.3

0.87

0.65

1.16

357

Inflammatory and toxic neuropathy

10

1.5

73

2.6

0.71

0.36

1.40

427

Cardiac dysrhythmias

159

23.9

911

31.9

0.76

0.64

0.90

200-208

Lymphosarcoma and reticulosamoma

40

6.0

266

9.3

0.76

0.54

1.08

340

Multiple sclerosis

17

2.6

69

2.4

1.00

0.58

1.73

410

Acute myocardial infarction

67

10.1

370

12.9

0.97

0.74

1.27

240-246

Disorders of thyroid gland

25

3.8

159

5.6

0.68

0.44

1.04

530-537

Diseases of esophagus, stomach, and duodenum

435

65.5

1,857

65.0

1.02

0.91

1.13

NOTE: Prevaccination population includes personnel who never received AVA.

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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Page 248 Cite Bookmark
Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Page 249 Cite Bookmark
Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Page 251
Page 252 Cite Bookmark
Suggested Citation: "Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
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Page 252
Next Chapter: Appendix H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report
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