(VeDDRA) list of clinical terms for reporting suspected adverse

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15 June 2017 EMA/CVMP/PhVWP/10418/2009-Rev.9 Committee for Medicinal Products for Veterinary Use

Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products Revision agreed by Pharmacovigilance Working Party (PhVWP-V) Adoption by CVMP Date for coming into effect

16-17 May 2017 15 June 2017 1 October 2017

Glossary of abbreviations used in VeDDRA:

SOC: System organ class HLT: High level term PT: Preferred term LLT: Low level term NOS: Not otherwise specified

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

site

1

Application site blister

3

Application site blister

4

C

site

1

site

1

Application site burn

934

Application site burn

2063

C

site

1

site

1

C

site

1

1332

C

site

1

site

1

Application site erythema Application site reddening Application site rubra

5

1

6

C

site

1

site

1

A

1

site

1

2604

A

site

1

site

1

Application site feather change Application site feather loss Application site fibrosis

2603

site

2003

C

site

1

site

1

C

1

site

1

7

Application site granuloma Application site bleeding

7

site

12

C

site

1

site

1

7

Application site bruising

8

C

site

1

site

1

7

C

1

site

1

11

C

site

1

site

1

9

C

site

1

site

1

Application site haematoma Application site haemorrhage Application site petechiae Application site alopecia

10

site

Application site erythema Application site erythema Application site erythema Application site feather change Application site feather change Application site fibrosis Application site granuloma Application site haemorrhage Application site haemorrhage Application site haemorrhage Application site haemorrhage Application site haemorrhage Application site hair change

4

site

Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions

2

C

2 3 4 5 6 7 8 9 10 11 12 13 14 15

4 4 1016 1016 917 5

7 7 2

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 2/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

16

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

site

1

2

2057

A

site

1

hair

2

hair

1878

C

site

1

site

1

hair

2

hair coat

2519

A

site

1

site

1

hair

2

Application site fur Application site change Application site discolouration Application site

greasy

1

hair loss

3

C

site

1

site

1

hair

2

C

1

site

1

hair

2

Application site leukotrichia Application site residue

2148

site

2191

C

site

1

site

1

918

Application site abscess

2004

C

site

1

site

1

918

Application site infection

2005

C

site

1

site

1

8

C

1

site

1

Application site dermatitis Application site eczema

1934

site

2064

C

site

1

site

1

C

1

site

1

2065

C

site

1

site

1

8

Application site inflammation Application site moist eczema Application site rash

13

site

1331

C

site

1

site

1

8

Application site warmth

2406

C

site

1

site

1

Application site change Application site change Application site change Application site change Application site change Application site change Application site infection Application site infection Application site inflammation Application site inflammation Application site inflammation Application site inflammation Application site inflammation Application site inflammation Application site

hair

site

lesion

9

Application site crust

16

C

site

1

Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions

site

1

Application site lesion

9

Application site lesion

14

C

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

8 8 8

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 3/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

32

Application disorders Application disorders Application disorders Application disorders

site

1

site

1

Application site lesion

9

Application site scab

15

C

site

1

site

1

Application site lesion

9

Application site scar

2518

C

site

1

site

1

Application site lesion

9

Application site sore

2602

C

site

1

Application reactions Application reactions Application reactions Application reactions

site

1

10

Application site mucopurulent discharge

17

C

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

site

1

11

Application site necrosis

18

C

site

1

site

1

12

Application site oedema

19

C

site

1

site

1

12

Application site swelling

20

C

site

1

site

1

13

H

1

site

1

Application site pain

13

Application site burning sensation Application site pain

2555

site

22

C

site

1

site

1

Application site pain

13

C

1

site

1

948

2192

C

site

1

site

1

2112

C

site

1

site

1

948

2193

H

site

1

site

1

14

Application site itching

23

C

site

1

site

1

14

Application site pruritus

25

C

site

1

site

1

Application site paraesthesia Application site paraesthesia Application site paraesthesia Application site pruritus Application site pruritus Application site pruritus

Immediate pain upon application Application site numbness Application site paraesthesia Application site tingling

2408

site

Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions

Application site mucopurulent discharge Application site necrosis Application site oedema Application site oedema Application site pain

14

Application site scratching

26

C

33 34 35

36 37 38 39 40 41 42 43 44 45 46 47

948

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 4/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

48

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

site

1

Application site hot spot

2407

A

1

site

1

15

Application site pustule

27

C

site

1

site

1

15

C

1

site

1

16

Application site pyoderma Application site irritation

28

site

24

C

site

1

site

1

16

Application site lump

21

C

site

1

site

1

16

C

1

site

1

Application site reaction NOS Application site sarcoma

29

site

30

C

site

1

site

1

C

1

site

1

31

C

site

1

site

1

1973

A

site

1

site

1

33

C

59

Application site disorders

1

Application site reactions

1

Application site excoriation Application site self trauma Licking at application site Application site serosanguinous discharge Application site weeping (see also 'skin')

2194

site

32

C

60

Application site disorders Application site disorders Application site disorders

1

Application site reactions Application site reactions Application site reactions

1

Application site pyoderma Application site pyoderma Application site pyoderma Application site reaction NOS Application site reaction NOS Application site reaction NOS Application site sarcoma Application site self trauma Application site self trauma Application site self trauma Application site serosanguinous discharge Application site serosanguinous discharge Application site serous discharge Application site skin change Application site skin change

15

site

Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions Application reactions

Application site serous discharge Application site dry skin

34

C

2514

C

Application site hyperkeratosis

2516

C

49 50 51 52 53 54 55 56 57 58

61 62

1 1

1 1

17 18 18 18 19

19

20 963 963

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 5/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

63

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

1

963

Application site papule

2195

C

1

site skin

963

C

1

site skin

963

2200

C

site

1

site skin

963

2197

C

site

1

site skin

963

2198

C

site

1

site skin

963

2199

C

site

1

site skin

963

2515

C

site

1

site

964

2196

C

site

1

1

site ulcer

21

Application site pigmentation disorders Application site skin change NOS Application site skin discolouration Application site skin scaling Application site skin squamosis Application site thickening Application site twitching Application site ulcer

2517

site

Application change Application change Application change Application change Application change Application change Application change Application twitching Application

site skin

site

35

C

site

1

Application site reactions Application site reactions Application site reactions Application site reactions Application site reactions Application site reactions Application site reactions Application site reactions Application site reactions Implant site reactions

2

Implant site blister

24

Implant site blister

39

A

site

1

Implant site reactions

2

Implant site erythema

25

Implant site erythema

41

A

site

1

Implant site reactions

2

Implant site erythema

25

Implant site rubra

40

A

site

1

Implant site reactions

2

Implant site fibrosis

919

Implant site fibrosis

2006

C

site

1

Implant site reactions

2

26

Implant site granuloma

42

A

site

1

Implant site reactions

2

28

Implant site bleeding

47

A

site

1

Implant site reactions

2

Implant site granuloma Implant site haemorrhage Implant site haemorrhage

28

Implant site bruising

43

A

64 65 66 67 68 69 70 71 72 73 74 75 76 77 78

1 1 1 1 1 1 1

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 6/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

79

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

Implant site reactions

2

28

Implant site haematoma

44

A

site

1

Implant site reactions

2

28

A

1

Implant site reactions

2

28

Implant site haemorrhage Implant site petechiae

46

site

45

A

site

1

Implant site reactions

2

23

Implant site alopecia

37

A

site

1

Implant site reactions

2

23

Implant site hair change

2151

C

site

1

Implant site reactions

2

23

Implant site hair loss

38

A

site

1

Implant site reactions

2

23

Implant site leukotrichia

2152

C

site

1

Implant site reactions

2

Implant site haemorrhage Implant site haemorrhage Implant site haemorrhage Implant site hair change Implant site hair change Implant site hair change Implant site hair change Implant site infection

22

Implant site abscess

36

A

site

1

Implant site reactions

2

Implant site infection

22

Implant site infection

2201

A

site

1

Implant site reactions

2

29

Implant site dermatitis

2007

C

site

1

Implant site reactions

2

29

A

1

Implant site reactions

2

29

Implant site inflammation Implant site warmth

48

site

2409

C

site

1

Implant site reactions

2

Implant site inflammation Implant site inflammation Implant site inflammation Implant site lesion

30

Implant site crust

51

A

site

1

Implant site reactions

2

Implant site lesion

30

Implant site lesion

50

A

site

1

Implant site reactions

2

Implant site lesion

30

Implant site scab

49

A

site

1

Implant site reactions

2

Implant site mucopurulent discharge

31

Implant site mucopurulent discharge

52

A

80 81 82 83 84 85 86 87 88 89 90 91 92 93 94

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 7/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

95

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

Implant site reactions

2

Implant site necrosis

32

Implant site necrosis

53

A

site

1

Implant site reactions

2

Implant site oedema

33

Implant site oedema

55

A

site

1

Implant site reactions

2

Implant site oedema

33

Implant site swelling

56

A

site

1

Implant site reactions

2

Implant site pain

34

Implant site pain

57

A

site

1

Implant site reactions

2

Implant site pruritus

35

Implant site irritation

58

A

site

1

Implant site reactions

2

Implant site pruritus

35

Implant site itching

59

A

site

1

Implant site reactions

2

Implant site pruritus

35

Implant site pruritus

61

A

site

1

Implant site reactions

2

Implant site pruritus

35

Implant site scratching

60

A

site

1

Implant site reactions

2

36

Implant site pustule

62

A

site

1

Implant site reactions

2

36

Implant site pyoderma

63

A

site

1

Implant site reactions

2

37

Implant site lump

54

A

site

1

Implant site reactions

2

37

A

1

Implant site reactions

2

38

Implant site reaction NOS Implant site sarcoma

64

site

Implant site pyoderma Implant site pyoderma Implant site reaction NOS Implant site reaction NOS Implant site sarcoma

65

A

site

1

Implant site reactions

2

39

Implant site self trauma

66

A

site

1

Implant site reactions

2

40

Implant site serosanguinous discharge

68

A

96 97 98 99 100 101 102 103 104 105 106 107 108 109

Implant site self trauma Implant site serosanguinous discharge

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 8/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

110

Application site disorders

1

Implant site reactions

2

40

Implant site weeping (see also 'skin')

67

A

111

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

Implant site reactions

2

41

A

1

Implant site reactions

2

42

Implant site serous discharge Implant site ulcer

69

site

Implant site serosanguinous discharge Implant site serous discharge Implant site ulcer

70

A

site

1

Implant site reactions

2

Movement of implant

43

Movement of implant

71

A

site

1

Injection site reactions

3

Injection site blister

46

Injection site blister

75

C

site

1

Injection site reactions

3

782

C

1

Injection site reactions

3

1543

C

site

1

Injection site reactions

3

1545

C

site

1

Injection site reactions

3

1413

C

site

1

Injection site reactions

3

47

Injection site complication NOS Injection site joint reaction Injection site nerve damage Injection site related digit amputation Injection site erythema

1540

site

77

C

site

1

Injection site reactions

3

47

Injection site reddening

1552

C

site

1

Injection site reactions

3

47

Injection site rubra

76

C

site

1

Injection site reactions

3

1017

A

1

Injection site reactions

3

2607

A

site

1

Injection site reactions

3

920

Injection site feather change Injection site feather loss Injection site fibrosis

2606

site

Injection site complication Injection site complication Injection site complication Injection site complication Injection site erythema Injection site erythema Injection site erythema Injection site feather change Injection site feather change Injection site fibrosis

2008

C

site

1

Injection site reactions

3

Injection site granuloma

48

Injection site granuloma

78

C

112 113 114 115 116 117 118 119 120 121 122 123 124 125

782 782 782

1017

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 9/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

126

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

Injection site reactions

3

50

Injection site bleeding

83

C

site

1

Injection site reactions

3

50

Injection site bruising

79

C

site

1

Injection site reactions

3

50

C

1

Injection site reactions

3

82

C

site

1

Injection site reactions

3

50

Injection site haematoma Injection site haemorrhage Injection site petechiae

80

site

81

C

site

1

Injection site reactions

3

45

Injection site alopecia

73

C

site

1

Injection site reactions

3

45

C

1

Injection site reactions

3

Injection site hair change Injection site hair loss

2149

site

74

C

site

1

Injection site reactions

3

C

1

Injection site reactions

3

44

Injection site leukotrichia Injection site abscess

2150

site

Injection site haemorrhage Injection site haemorrhage Injection site haemorrhage Injection site haemorrhage Injection site haemorrhage Injection site hair change Injection site hair change Injection site hair change Injection site hair change Injection site infection

72

C

site

1

Injection site reactions

3

Injection site infection

44

Injection site infection

1542

C

site

1

Injection site reactions

3

51

Injection site dermatitis

1938

C

site

1

Injection site reactions

3

51

C

1

Injection site reactions

3

51

Injection site inflammation Injection site warmth

84

site

1556

C

site

1

Injection site reactions

3

Injection site inflammation Injection site inflammation Injection site inflammation Injection site lesion

52

Injection site crust

87

C

site

1

Injection site reactions

3

Injection site lesion

52

Injection site lesion

86

C

127 128 129 130 131 132 133 134 135 136 137 138 139 140 141

50

45 45

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 10/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

142

Application site disorders Application site disorders

1

Injection site reactions

3

Injection site lesion

52

Injection site scab

85

C

1

Injection site reactions

3

53

Injection site mucopurulent discharge

88

C

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

Injection site reactions

3

Injection site mucopurulent discharge Injection site necrosis

54

Injection site gangrene

2093

C

site

1

Injection site reactions

3

Injection site necrosis

54

2094

C

site

1

Injection site reactions

3

Injection site necrosis

54

Injection site gaseous gangrene Injection site necrosis

89

C

site

1

Injection site reactions

3

875

C

1

Injection site reactions

3

784

Injection site neoplasm NOS Injection site numbness

1879

site

1546

C

site

1

Injection site reactions

3

Injection site neoplasm NOS Injection site numbness Injection site oedema

55

Injection site oedema

90

C

site

1

Injection site reactions

3

Injection site oedema

55

Injection site swelling

91

C

site

1

Injection site reactions

3

Injection site pain

56

2410

C

site

1

Injection site reactions

3

Injection site pain

56

Immediate pain upon injection Injection site pain

93

C

site

1

Injection site reactions

3

623

C

1

Injection site reactions

3

1548

C

site

1

Injection site reactions

3

785

Injection site panniculitis Injection site paraesthesia Injection site tingling

1053

site

1555

H

site

1

Injection site reactions

3

Injection site panniculitis Injection site paraesthesia Injection site paraesthesia Injection site pruritus

57

Injection site irritation

94

C

site

1

Injection site reactions

3

Injection site pruritus

57

Injection site itching

95

C

143

144 145 146 147 148 149 150 151 152 153 154 155 156 157

785

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 11/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

158

Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders Application disorders

site

1

Injection site reactions

3

Injection site pruritus

57

Injection site pruritus

97

C

site

1

Injection site reactions

3

Injection site pruritus

57

Injection site scratching

96

C

site

1

Injection site reactions

3

58

Injection site pustules

98

C

site

1

Injection site reactions

3

58

Injection site pyoderma

99

C

site

1

Injection site reactions

3

reaction

59

Injection site lump

92

C

site

1

Injection site reactions

3

reaction

59

Injection site mass

2113

C

site

1

Injection site reactions

3

reaction

59

Injection site nodule

2605

C

site

1

Injection site reactions

3

reaction

59

C

1

Injection site reactions

3

reaction

59

2153

C

site

1

Injection site reactions

3

sarcoma

60

Injection site reaction NOS Injection site vaccine leakage Injection site sarcoma

100

site

Injection site pyoderma Injection site pyoderma Injection site NOS Injection site NOS Injection site NOS Injection site NOS Injection site NOS Injection site

101

C

site

1

Injection site reactions

3

102

C

site

1

Injection site reactions

3

Injection site self trauma Injection site seroma

1880

C

site

1

Injection site reactions

3

104

C

171

Application site disorders

1

Injection site reactions

3

Injection site serosanguinous discharge Injection site weeping (see also 'skin')

103

C

172

Application site disorders

1

Injection site reactions

3

Injection site serous discharge

105

C

159 160 161 162 163 164 165 166 167 168 169 170

Injection site self trauma Injection site seroma

61

Injection site serosanguinous discharge Injection site serosanguinous discharge Injection site serous discharge

62

876

62

63

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

173

1

Injection site reactions

3

site skin

965

C

Injection site reactions

3

site skin

965

2202

C

1

Injection site reactions

3

site skin

965

2203

C

1

Injection site reactions

3

site skin

965

2204

C

1

Injection site reactions

3

site stiffness

786

Injection site skin change NOS Injection site skin discolouration Injection site skin scaling Injection site skin squamosis Injection site stiffness

2205

1

Injection change Injection change Injection change Injection change Injection

1553

C

1

Injection site reactions

3

Injection site ulcer

64

Injection site ulcer

106

C

179

Application site disorders Application site disorders Application site disorders Application site disorders Application site disorders Application site disorders Behavioural disorders

2

4

A

2

108

A

181

Behavioural disorders

2

109

A

182

Behavioural disorders

2

6

Abnormal swimming in fish Leaping behaviour in fish Miscellaneous eating disorder NOS Aggression

107

Behavioural disorders

Abnormal swimming in fish Leaping behaviour in fish Miscellaneous eating disorder NOS Aggression

65

180

113

A

183

Behavioural disorders

2

Fish behavioural disorders Fish behavioural disorders Miscellaneous eating disorders NOS Other behavioural disorders Other behavioural disorders

6

Aggression

69

112

A

184

Behavioural disorders

2

6

Aggression

69

1559

C

185

Behavioural disorders

2

6

Anxiety

70

Acting tense

2206

C

186

Behavioural disorders

2

6

Anxiety

70

Anxiety

115

A

187

Behavioural disorders

2

6

Anxiety

70

Apprehension

1055

A

188

Behavioural disorders

2

Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders

Biting -aggression (see also 'Skin and appendages disorders') Irritability

6

Anxiety

70

Attention-seeking behaviour

2609

A

174 175 176 177 178

4 5

66 67 69

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

189

Behavioural disorders

2

6

Anxiety

70

Distress

114

A

190

Behavioural disorders

2

6

Anxiety

70

Panic

2610

A

191

Behavioural disorders

2

6

A

2

71

Behavioural disorder NOS Destructive behaviour

116

Behavioural disorders

2388

C

193

Behavioural disorders

2

71

Dummy foal syndrome

2502

A

194

Behavioural disorders

2

71

C

Behavioural disorders

2

71

Head shake behavioural disorder Head shy

2412

195

2413

A

196

Behavioural disorders

2

71

Hiding

2207

A

197

Behavioural disorders

2

71

Less social

2411

C

198

Behavioural disorders

2

71

Rolling

2391

C

199

Behavioural disorders

2

6

Behavioural disorder NOS Behavioural disorder NOS Behavioural disorder NOS Behavioural disorder NOS Behavioural disorder NOS Behavioural disorder NOS Behavioural disorder NOS Behavioural disorder NOS Grooming disorder

71

192

908

A

Behavioural disorders

2

6

Grooming disorder

908

Excessive licking and/or grooming Grooming disorder

1974

200

1975

A

201

Behavioural disorders

2

6

Hallucination

72

Hallucination

117

A

202

Behavioural disorders

2

6

Hyperactivity

73

Agitation

121

A

203

Behavioural disorders

2

Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders

6

Hyperactivity

73

2611

C

204

Behavioural disorders

2

Other behavioural disorders

6

Hyperactivity

73

Circling - behavioural disorder (see also 'Neurological disorders') Excitation

120

A

6 6 6 6 6 6 6

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

205

Behavioural disorders

2

6

Hyperactivity

73

Hyperactivity

118

A

206

Behavioural disorders

2

6

Hyperactivity

73

Hyperexcitation

122

A

207

Behavioural disorders

2

6

Hyperactivity

73

Pacing

2208

C

208

Behavioural disorders

2

6

Hyperactivity

73

Restlessness

119

A

209

Behavioural disorders

2

6

Inappropriate defecation

123

A

Behavioural disorders

2

75

Inappropriate urination

124

A

211

Behavioural disorders

2

75

Not urinating

2520

C

212

Behavioural disorders

2

6

Inappropriate defecation Inappropriate urination Inappropriate urination Mothering disorder

74

210

984

A

Behavioural disorders

2

6

Mothering disorder

984

2416

A

214

Behavioural disorders

2

6

Mothering disorder

984

Maternal aggression to offspring Maternal neglect of offspring Mothering disorder

2417

213

2414

A

215

Behavioural disorders

2

6

Mothering disorder

984

216

Behavioural disorders

2

6

Self mutilation

217

Behavioural disorders

2

6

218

Behavioural disorders

2

219

Behavioural disorders

2

220

Behavioural disorders

2

Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders Other behavioural disorders

6 6

2415

A

667

Poor mothering behaviour Self mutilation

1222

A

Teeth grinding

77

Teeth grinding

128

A

6

Vocalisation

78

Barking

132

A

6

Vocalisation

78

Crying

130

A

6

Vocalisation

78

Groaning

2393

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

221

Behavioural disorders

2

6

Vocalisation

78

Impaired vocalisation

1935

A

222

Behavioural disorders

2

6

Vocalisation

78

Mewing

131

A

223

Behavioural disorders

2

6

Vocalisation

78

Vocalisation

129

A

224

Behavioural disorders

2

Other behavioural disorders Other behavioural disorders Other behavioural disorders Pica

7

Coprophagia

79

Coprophagia

133

A

225

Behavioural disorders

2

Pica

7

Pica NOS

80

Pica NOS

134

A

226

Behavioural disorders

2

Sexual disorders NOS

8

Sexual disorder NOS

82

Attractiveness to males

2061

A

227

Behavioural disorders

2

Sexual disorders NOS

8

Sexual disorder NOS

82

2067

C

228

Behavioural disorders

2

Sexual disorders NOS

8

Sexual disorder NOS

82

2029

A

229

Behavioural disorders

2

Sexual disorders NOS

8

Sexual disorder NOS

82

138

A

230

Behavioural disorders

2

Sleep disturbance

9

83

140

A

231

Behavioural disorders

2

Sleep disturbance

9

83

Sleep disturbance NOS

141

A

232

Behavioural disorders

2

Sleep disturbance

9

83

Vocalizing while sleeping

2505

A

233

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

11

88

C

12

89

Blood and lymphatic system disorder NOS Bone marrow aplasia

148

3

Blood and lymphatic system disorders NOS Bone marrow disorders

Sleep disturbance NOS Sleep disturbance NOS Sleep disturbance NOS Blood and lymphatic system disorder NOS Bone marrow aplasia

Increased sexual interest Reduced sexual interest (see 'Reproductive' for named sexual disorders) Sexual disorder NOS (see 'Reproductive' for named sexual disorders) Not sleeping

149

C

3

Bone marrow disorders

12

Bone marrow aplasia

89

Bone Marrow hypoplasia

2385

C

3

Bone marrow disorders

12

Bone marrow aplasia

89

Bone marrow suppression

150

C

234 235 236

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

237

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Bone marrow disorders

12

Bone marrow aplasia

89

2289

C

3

Bone marrow disorders

12

Bone marrow aplasia

89

NT - bone marrow aplasia Pancytopenia

2114

C

3

Bone marrow disorders

12

877

C

Coagulation abnormalities Coagulation abnormalities Coagulation abnormalities Coagulation abnormalities Coagulation abnormalities Coagulation abnormalities Coagulation abnormalities Coagulation abnormalities

13

Bone marrow disorder NOS Coagulopathy

1882

3

Bone marrow disorder NOS Other coagulation abnormality Other coagulation abnormality Other coagulation abnormality Other coagulation abnormality Other coagulation abnormality Other coagulation abnormality Other coagulation abnormality Other coagulation abnormality

1057

C

2209

C

90

Increased coagulation time Mucosa petechiae

1213

C

90

Organ petechiae

2087

C

90

152

C

90

Other coagulation abnormality Petechiae NOS

2115

C

90

Profuse bleeding

178

C

90

2210

C

Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Coagulation abnormalities Coagulation abnormalities

13

Other coagulation abnormality Other coagulation abnormality

90

Prolonged activated partial thrombin time (APTT) Prolonged bleeding NOS

151

C

2211

C

Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Coagulation abnormalities Coagulation abnormalities

13

Other coagulation abnormality Thrombosis

90

Prolonged one stage prothrombin time (OSPT) Skin petechiae

1205

C

91

Blood clot

153

C

238 239 240 241 242 243 244 245 246 247

248 249

250 251

3 3 3 3 3 3 3

3

3

13 13 13 13 13 13 13

13

13

90 90

90

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

252

Blood and lymphatic system disorders

3

Coagulation abnormalities

13

Thrombosis

91

154

C

253

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

13

Thrombosis

91

155

C

13

Thrombosis

91

Thrombosis

156

C

14

Congenital coagulopathy NOS

92

Congenital coagulopathy NOS

157

C

256

Blood and lymphatic system disorders

3

14

C

3

94

Congenital haematological disorder NOS Haemophilia

158

Blood and lymphatic system disorders

Congenital haematological disorder NOS Haemophilia

93

257

159

C

258

Blood and lymphatic system disorders

3

259

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Coagulation abnormalities Coagulation abnormalities Congenital haematological disorders Congenital haematological disorders Congenital haematological disorders Congenital haematological disorders Disorders of platelets and coagulopathies Disorders of platelets and coagulopathies Disorders of platelets and coagulopathies Disorders of platelets and coagulopathies Disorders of platelets and coagulopathies Disorders of platelets and coagulopathies Disorders of red blood cells

Disseminated intravascular coagulation Thromboemboli

254 255

260 261 262 263 264 265

3 3

3 3 3 3 3 3

14

14

von Willebrands disease

899

von Willebrands disease

1936

C

15

Platelet disorder NOS

985

Giant platelets

2424

C

15

Platelet disorder NOS

985

Large platelets

2425

C

15

Platelet disorder NOS

985

Platelet disorder NOS

2423

C

15

Thrombocytopenia

95

Low platelet count

161

C

15

Thrombocytopenia

95

Thrombocytopenia

160

C

15

Thrombocytosis

949

Thrombocytosis

2116

C

212

Anaemia NOS

85

Anaemia NOS

142

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

266

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells Disorders cells

of red blood

212

Anaemia NOS

85

Decreased haemoglobin

2214

C

of red blood

212

Anaemia NOS

85

2215

C

of red blood

212

Anaemia NOS

85

2157

C

of red blood

212

Anaemia NOS

85

Decreased packed cell volume (PCV) Decreased red blood cell count Haemolysis

2156

C

of red blood

212

Anaemia NOS

85

Heinz body anaemia

2216

C

of red blood

212

Anaemia NOS

85

Iron deficiency anaemia

144

C

of red blood

212

Anaemia NOS

85

145

C

of red blood

212

Aplastic anaemia

86

Non-regenerative anaemia Aplastic anaemia

146

C

of red blood

212

red blood

745

Abnormal red blood cell

2217

C

of red blood

212

red blood

745

C

212

red blood

745

2419

C

of red blood

212

red blood

745

Disorder of red blood cell NOS Increased packed cell volume (PCV) Polycythaemia

1416

of red blood

2521

C

of red blood

212

red blood

745

Red blood cell disorder

181

C

of red blood

212

red blood

745

Spherocytosis

2612

C

of red blood

212

Disorder of cell NOS Disorder of cell NOS Disorder of cell NOS Disorder of cell NOS Disorder of cell NOS Disorder of cell NOS Haemolytic

anaemia

87

Haemolytic anaemia

147

C

of red blood

212

Methaemoglobinaemia

967

Methaemoglobinaemia

2218

C

267 268 269 270 271 272 273 274 275 276 277 278 279 280 281

3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

282

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Disorders of red blood cells Disorders of red blood cells Disorders of red blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Disorders of white blood cells Haemopoietic neoplasms Haemopoietic neoplasms

212

Regenerative anaemia

624

Regenerative anaemia

1056

C

212

Reticulocyte disorders

966

2212

C

212

Reticulocyte disorders

966

2213

C

16

Basophilia

968

Decreased percentage of reticulocytes Increased percentage reticulocytes Basophilia

2219

C

16

Eosinophilia

96

Eosinophilia

162

C

16

Leucocytosis

97

Leucocytosis

163

C

16

Leucocytosis

97

Monocytosis

2420

C

16

Leucopenia

98

Leucopenia

164

C

16

Lymphocytosis

99

Lymphocytosis

165

C

16

Lymphopenia

100

Lymphopenia

166

C

16

Neutropenia

101

Neutropenia

167

C

16

Neutrophilia

102

Neutrophilia

168

C

16

Panleucopenia

103

Panleucopenia

169

C

16

Stress leukogram

1012

Stress leukogram

2589

C

17

Haemangiosarcoma

935

Haemangiosarcoma

2072

C

17

Haemopoietic neoplasm NOS

104

Haemopoietic neoplasm NOS

170

C

283 284 285 286 287 288 289 290 291 292 293 294 295 296 297

3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

298

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

17

Leukaemia

105

Leukaemia

171

C

17

Lymphosarcoma

106

Lymphosarcoma

172

C

17

Splenic neoplasm

910

Splenic neoplasm

1977

C

3

Haemopoietic neoplasms Haemopoietic neoplasms Haemopoietic neoplasms Lymph node disorders

18

Lymph node abscess

932

Lymph node abscess

2060

C

3

Lymph node disorders

18

Lymphadenopathy

108

2405

C

3

Lymph node disorders

18

Lymphadenopathy

108

2426

C

3

Lymph node disorders

18

Lymphadenopathy

108

Enlarged lymph node (localised) Enlarged lymph nodes (generalised) Lymphadenitis

173

C

3

Lymph node disorders

18

Lymphadenopathy

108

Lymphadenopathy

174

C

3

Lymph node disorders

18

Lymphadenopathy

108

2344

C

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Lymph node disorders

18

Lymphadenopathy

108

2345

C

3

Lymph node disorders

18

Lymphadenopathy

108

2346

C

3

Lymph node disorders

18

Lymphadenopathy

108

2347

C

3

Lymph node disorders

18

Lymphadenopathy

108

NT - caseous lymphadenitis (tuberculosis) NT - fibrinous lymphadenitis NT - granulomatous lymphadenitis NT - purulent lymphadenitis Swollen gland

1814

C

3

Lymph node disorders

18

Lymphadenopathy

108

Swollen lymph node

1818

C

3

Lymph node disorders

18

Lymphangitis

109

Lymphangitis

175

C

3

Lymph node disorders

18

Lymphangitis

109

NT - lymphangiectasia

2348

C

299 300 301 302 303 304 305 306

307 308 309 310 311 312 313

3 3

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

314

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Lymph node disorders

18

Lymphangitis

109

NT - lymphangitis

2349

C

3

Lymph node disorders

18

Lymphoma

110

Lymphoma

176

C

3

Lymph node disorders

18

Lymphoma

110

2350

C

3

Other blood disorders

19

Blood dyscrasia NOS

626

NT - lymphoma/ lymphadenomegaly Blood dyscrasia NOS

1058

C

3

Other blood disorders

19

909

C

Other blood disorders

19

909

Change in blood protein NOS Elevated globulins

2220

3

2556

C

3

Other blood disorders

19

909

Hyperalbuminaemia

2154

C

3

Other blood disorders

19

909

Hyperproteinaemia

2155

C

3

Other blood disorders

19

909

Hypoalbuminaemia

1883

C

3

Other blood disorders

19

909

Hypoproteinaemia

1976

C

3

Other blood disorders

19

909

C

Other blood disorders

19

909

Inversion of albumin/globulin ratio Reduced globulins

2117

3

2557

C

3

Other blood disorders

19

Change in blood protein Change in blood protein Change in blood protein Change in blood protein Change in blood protein Change in blood protein Change in blood protein Change in blood protein Haemorrhage NOS

111

Blood loss NOS

1352

C

3

Other blood disorders

19

Haemorrhage NOS

111

Haemorrhage NOS

177

C

3

Other blood disorders

19

Haemorrhage NOS

111

2097

C

3

Other blood disorders

19

Haemorrhage NOS

111

Multiple organ haemorrhage Organ haemorrhage

2098

C

315 316 317 318 319 320 321 322 323 324 325 326 327 328 329

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

330

Blood and lymphatic system disorders Blood and lymphatic system disorders Blood and lymphatic system disorders

3

Other blood disorders

19

1018

C

Other blood disorders

19

1666

C

3

20

182

C

333

Blood and lymphatic system disorders

3

20

116

183

C

334

Blood and lymphatic system disorders

3

20

Spleen torsion

944

Spleen torsion

2106

C

335

Blood and lymphatic system disorders

3

20

Splenitis

117

Splenitis

184

C

336

Blood and lymphatic system disorders

3

20

Splenomegaly

118

Spleen hypertrophy

1059

C

337

Blood and lymphatic system disorders

3

20

Splenomegaly

118

Splenomegaly

185

C

338

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

21

Arrhythmia

119

Arrhythmia

186

C

system

4

21

Arrhythmia

119

Atrial fibrillation

187

C

system

4

21

Arrhythmia

119

Extrasystole

2083

C

system

4

21

Arrhythmia

119

Irregular pulse

2558

C

system

4

Spleen and reticuloendothelial system disorders Spleen and reticuloendothelial system disorders Spleen and reticuloendothelial system disorders Spleen and reticuloendothelial system disorders Spleen and reticuloendothelial system disorders Spleen and reticuloendothelial system disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders

Increased red blood cell count Other blood disorder NOS Spleen and reticuloendothelial system disorder NOS Spleen rupture

2613

3

Increased red blood cell count Other blood disorder NOS Spleen and reticuloendothelial system disorder NOS Spleen rupture

21

Arrhythmia

119

Premature ventricular contractions

2434

C

331 332

339 340 341 342

821 115

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

343

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

21

Arrhythmia

119

C

4

21

Arrhythmia

119

Supraventricular and nodal arrhythmia Ventricular arrhythmia

2221

system

2222

C

system

4

21

Arrhythmia

119

Ventricular fibrillation

2427

C

system

4

21

Bradycardia

120

Bradycardia

188

C

system

4

21

Bradycardia

120

Cardiac depression

1060

C

system

4

21

Bradycardia

120

Decreased heart rate

189

C

system

4

21

Bradycardia

120

Slow heart rate

190

C

system

4

21

Heart block

121

Heart block 1st degree

2431

C

system

4

21

Heart block

121

Heart block 2nd degree

2432

C

system

4

21

Heart block

121

Heart block 3rd degree

2433

C

system

4

21

Heart block

121

Heart block NOS

191

C

system

4

21

Tachycardia

122

Bounding pulse

2522

C

system

4

21

Tachycardia

122

Heart pounding

1514

C

system

4

21

Tachycardia

122

Increased heart rate

193

C

system

4

21

Tachycardia

122

Palpitation

1670

C

system

4

Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders Cardiac rhythm disorders

21

Tachycardia

122

Rapid pulse rate

1719

C

344 345 346 347 348 349 350 351 352 353 354 355 356 357 358

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

359

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

21

Tachycardia

122

Tachycardia

192

C

system

4

Cardiac rhythm disorders Cardiac/heart disorders

23

Cardiac disorder NOS

125

Abnormal ECG

2158

C

system

4

Cardiac/heart disorders

23

Cardiac disorder NOS

125

Cardiac disorder NOS

202

C

system

4

Cardiac/heart disorders

23

Cardiac disorder NOS

125

Cardiopathy

1061

C

system

4

Cardiac/heart disorders

23

Cardiac embolism

129

Cardiac embolism

2378

C

system

4

Cardiac/heart disorders

23

Cardiac embolism

129

Embolism

208

C

system

4

Cardiac/heart disorders

23

Cardiac enlargement

126

Cardiac enlargement

204

C

system

4

Cardiac/heart disorders

23

Cardiac enlargement

126

2301

C

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

Cardiac/heart disorders

23

Cardiac enlargement

126

2302

C

system

4

Cardiac/heart disorders

23

Cardiac enlargement

126

203

C

system

4

Cardiac/heart disorders

23

Cardiac neoplasm

980

NT - hypertrophic concentric cardiomyopathy NT - hypertrophic dilated cardiomyopathy Right ventricular dilatation Cardiac neoplasm

2309

C

system

4

Cardiac/heart disorders

23

Cardiac neoplasm

980

2310

C

system

4

Cardiac/heart disorders

23

Cardiac neoplasm

980

2311

C

Cardio-vascular system disorders Cardio-vascular system disorders

4

Cardiac/heart disorders

23

Cardiac neoplasm

980

2312

C

4

Cardiac/heart disorders

23

Cardiomyopathy

127

NT - auricular haemangiosarcoma NT - heart tumour (chemodectoma: tumour of the aortic body) NT - pericardial tumour (mesothelioma) Cardiomyopathy

205

C

360 361 362 363 364 365 366

367 368 369 370 371

372 373

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

374

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

Cardiac/heart disorders

23

Cardiomyopathy

127

2159

A

system

4

Cardiac/heart disorders

23

Carditis

128

Taurine-deficient cardiomyopathy Carditis

206

C

system

4

Cardiac/heart disorders

23

737

Angina pectoris

1315

H

system

4

Cardiac/heart disorders

23

737

C

4

Cardiac/heart disorders

23

209

C

system

4

Cardiac/heart disorders

23

Coronary artery disorder NOS Endocardial fibroelastosis Endocarditis

1398

system

Coronary artery disorder Coronary artery disorder Endocardial fibroelastosis Endocarditis

210

C

system

4

Cardiac/heart disorders

23

Endocarditis

131

2303

C

system

4

Cardiac/heart disorders

23

Infarction

132

NT - valvular endocarditis Infarction

211

C

system

4

Cardiac/heart disorders

23

Infarction

132

NT - myocardial infarct

2304

C

system

4

Cardiac/heart disorders

23

Murmur

133

Cardiac murmur

212

C

system

4

Cardiac/heart disorders

23

Murmur

133

Heart murmur

213

C

system

4

Cardiac/heart disorders

23

Murmur

133

Murmur

214

C

system

4

Cardiac/heart disorders

23

Myocarditis

134

Myocarditis

215

C

system

4

Cardiac/heart disorders

23

Myocarditis

134

2305

C

system

4

Cardiac/heart disorders

23

Myocarditis

134

2306

C

system

4

Cardiac/heart disorders

23

Myocarditis

134

NT - necrotic myocarditis NT - non suppurative myocarditis NT - suppurative myocarditis

2307

C

375 376 377 378 379 380 381 382 383 384 385 386 387 388 389

130 131

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

390

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

Cardiac/heart disorders

23

Valvular disorder

136

2428

A

system

4

Cardiac/heart disorders

23

Valvular disorder

136

Chordae tendonae rupture Heart valve disorder

1515

C

system

4

Cardiac/heart disorders

23

Valvular disorder

136

NT - endocardiosis

2308

C

system

4

Cardiac/heart disorders

23

Valvular disorder

136

Valvular disorder

217

C

system

4

Cardiac/heart disorders

23

Valvular disorder

136

Valvular insufficiency

218

C

system

4

22

Cardiac arrest

123

Cardiac arrest

195

C

system

4

22

Cardiac insufficiency

957

Cardiac failure

196

C

system

4

22

Cardiac insufficiency

957

Cardiac insufficiency

2160

C

system

4

22

Cardiac insufficiency

957

Congestive heart failure

2429

C

system

4

22

Cardiac insufficiency

957

Heart failure

197

C

system

4

22

Cardiac insufficiency

957

Heart insufficiency

200

C

system

4

22

Heart disorder aggravated Heart valve opening

199

C

4

201

C

system

4

C

4

Circulatory disorders

24

958

Circulatory disorder NOS Fainting

2161

system

227

C

system

4

Circulatory disorders

24

Heart disorder aggravated Heart disorder aggravated Circulatory disorder NOS Circulatory disorder NOS Circulatory disorder NOS

124

system

Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Cardiac/heart disorders aggravated Circulatory disorders

958

Syncope

226

C

391 392 393 394 395 396 397 398 399 400 401 402 403 404 405

22 24

124 958

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

406

Cardio-vascular system disorders Cardio-vascular system disorders

4

Circulatory disorders

24

Circulatory shock

137

Cardiorespiratory arrest

219

C

4

Circulatory disorders

24

Circulatory shock

137

223

C

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

Circulatory disorders

24

Circulatory shock

137

Circulatory collapse (see also 'Neurological' and 'Systemic disorders') Circulatory shock

221

C

system

4

Circulatory disorders

24

Circulatory shock

137

Shock

220

C

system

4

Circulatory disorders

24

Circulatory shock

137

Vagal Shock

2381

C

system

4

Circulatory disorders

24

Hypertension

138

High blood pressure

225

C

system

4

Circulatory disorders

24

Hypertension

138

Hypertension

224

C

system

4

Circulatory disorders

24

Hypertension

138

Pulmonary hypertension

2559

C

system

4

Circulatory disorders

24

Hypotension

139

Hypotension

228

C

system

4

Circulatory disorders

24

Hypotension

139

Hypovolaemia

2614

C

system

4

Circulatory disorders

24

Hypotension

139

Low blood pressure

229

C

system

4

Circulatory disorders

24

Hypotension

139

Orthostatic hypotension

1662

H

system

4

Circulatory disorders

24

Hypotension

139

1937

C

system

4

Circulatory disorders

24

Ischaemia NOS

140

Prolonged capillary refill time Ischaemia NOS

230

C

system

4

Circulatory disorders

24

Ischaemia NOS

140

Visceral ischaemia

2223

C

system

4

Circulatory disorders

24

Peripheral vascular disorder

833

Cold feeling of extremity

1386

C

407

408 409 410 411 412 413 414 415 416 417 418 419 420 421

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

422

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

Circulatory disorders

24

833

Facial flushing

1463

H

system

4

Circulatory disorders

24

833

Flushing

1478

H

system

4

Circulatory disorders

24

833

Generalised flushing

1491

H

system

4

Circulatory disorders

24

833

Ischaemic necrosis

1561

C

system

4

Circulatory disorders

24

833

Peripheral ischaemia

1688

C

system

4

Circulatory disorders

24

833

C

4

Circulatory disorders

24

1691

C

system

4

Circulatory disorders

24

1702

C

system

4

25

231

C

system

4

Congenital cardiovascular disorders Congenital cardiovascular disorders

Peripheral vascular disorder Peripheral vasoconstriction Poor peripheral circulation Aortic stenosis

1690

system

Peripheral vascular disorder Peripheral vascular disorder Peripheral vascular disorder Peripheral vascular disorder Peripheral vascular disorder Peripheral vascular disorder Peripheral vascular disorder Peripheral vascular disorder Aortic stenosis

142

C

system

4

25

233

C

system

4

144

234

C

system

4

Ventricular septal defect

235

C

4

26

Ventricular septal defect Cardiac tamponade

145

system

Congenital cardiovascular disorders Congenital cardiovascular disorders Congenital cardiovascular disorders Pericardial disorders

Congenital cardiovascular disorder NOS Ductus botalli persistence Pulmonary stenosis

232

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

Congenital cardiovascular disorder NOS Ductus botalli persistence Pulmonary stenosis

146

Cardiac tamponade

236

C

system

4

Pericardial disorders

26

Pericardial effusion

147

Pericardial effusion

237

C

423 424 425 426 427 428 429 430 431

432 433 434 435 436

25

25 25

833 833 141

143

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

437

Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders Cardio-vascular disorders

system

4

Pericardial disorders

26

148

NT - hemopericardium

2356

C

system

4

Pericardial disorders

26

148

Pericardial haemorrhage

238

C

system

4

Pericardial disorders

26

Pericardial haemorrhage Pericardial haemorrhage Pericarditis

135

2357

C

system

4

Pericardial disorders

26

Pericarditis

135

2358

C

system

4

Pericardial disorders

26

Pericarditis

135

NT - fibrinous pericarditis NT - suppurative pericarditis Pericarditis

216

C

system

4

Vascular disorders

27

Aortic degeneration

149

Aortic degeneration

239

C

system

4

Vascular disorders

27

Arteritis

150

Arteritis

240

C

system

4

Vascular disorders

27

Arteritis

150

NT - aortic aneurysm

2376

C

system

4

Vascular disorders

27

Arteritis

150

2377

C

system

4

Vascular disorders

27

Phlebitis

151

NT - aortic mineralisation Phlebitis

241

C

system

4

Vascular disorders

27

152

Aneurism

243

C

system

4

Vascular disorders

27

152

Aortic rupture

244

C

system

4

Vascular disorders

27

152

Jugular distension

1062

C

system

4

Vascular disorders

27

152

C

4

Vascular disorders

27

246

C

system

4

Vascular disorders

27

Vasculitis

154

Vascular dilation and/or rupture Vascular disorder NOS (see also endocarditis) Perivascular necrosis

242

system

Vascular dilation and/or rupture Vascular dilation and/or rupture Vascular dilation and/or rupture Vascular dilation and/or rupture Vascular disorder NOS

248

C

438 439 440 441 442 443 444 445 446 447 448 449 450 451 452

153

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

453

Cardio-vascular system disorders Cardio-vascular system disorders Cardio-vascular system disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders

4

Vascular disorders

27

Vasculitis

154

Vascular inflammation

250

C

4

Vascular disorders

27

Vasculitis

154

Vascular spasm

249

C

4

Vascular disorders

27

Vasculitis

154

Vasculitis

247

C

5

Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders

cavity

28

155

C

28

Abdominal cavity disorder NOS Adhesion in fish

251

cavity

2165

A

cavity

28

A

28

2284

C

cavity

28

Melanin accumulation in fish NT - peritoneal tumour (mesothelioma) Visible vaccine in fish

2166

cavity

2167

A

cavity

28

C

28

936

Abdominal cavity haemorrhage Peritoneal haemorrhage

2073

cavity

2101

C

cavity

28

156

Abdominal cavity hernia

252

C

cavity

28

156

Hernia NOS

1521

C

cavity

28

156

Hiatus hernia

1524

C

cavity

28

Abdominal cavity disorder NOS Abdominal cavity disorder NOS Abdominal cavity disorder NOS Abdominal cavity disorder NOS Abdominal cavity disorder NOS Abdominal cavity haemorrhage Abdominal cavity haemorrhage Abdominal cavity hernia Abdominal cavity hernia Abdominal cavity hernia Abdominal pain

163

Abdominal cramp

262

C

cavity

28

Abdominal pain

163

Abdominal discomfort

2010

C

cavity

28

Abdominal pain

163

Abdominal pain

263

C

454 455 456 457 458 459 460 461 462 463 464 465 466 467 468

5 5 5 5 5 5 5 5 5 5 5 5

155 155 155 155 936

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

469

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

cavity

28

Abdominal pain

163

Colic

264

C

tract

5

cavity

28

Abdominal pain

163

Gut pain

1503

C

tract

5

cavity

28

Abdominal pain

163

Praying position

2615

C

tract

5

cavity

28

Abdominal pain

163

Stomach cramp

1797

C

tract

5

cavity

28

Abdominal pain

163

Stomach pain

1799

C

tract

5

cavity

28

Abdominal pain

163

Tense abdomen

1978

C

tract

5

cavity

28

Fluid in abdomen

627

Abdominal effusion

2164

C

tract

5

cavity

28

Fluid in abdomen

627

Abdominal exudate

2616

C

tract

5

cavity

28

Fluid in abdomen

627

Abdominal oedema

1063

C

tract

5

cavity

28

Fluid in abdomen

627

Abdominal transudate

2617

C

tract

5

cavity

28

Fluid in abdomen

627

Ascites

1030

C

tract

5

cavity

28

Fluid in abdomen

627

Dropsy

1064

C

tract

5

cavity

28

Fluid in abdomen

627

Fluid in abdomen NOS

2011

C

tract

5

cavity

28

Peritonitis

157

C

5

cavity

28

Peritonitis

157

NT - caseous peritonitis (tuberculosis) NT - fibrinous peritonitis

2285

tract

2286

C

tract

5

Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders Abdominal disorders

cavity

28

Peritonitis

157

NT - granulomatous peritonitis

2287

C

470 471 472 473 474 475 476 477 478 479 480 481 482 483 484

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

485

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

28

Peritonitis

157

C

5

28

Peritonitis

157

NT - suppurative peritonitis Omentum inflammation

2288

tract

254

C

tract

5

28

Peritonitis

157

Peritonitis

253

C

tract

5

29

C

29

931

Anal and rectal disorder NOS Anal irritation

2560

5

Anal and rectal disorder NOS Anal irritation

1003

tract

2059

C

tract

5

29

Anal sac disorder

915

Anal sac disorder

1999

A

tract

5

29

Anal sac disorder

915

Scooting

2224

A

tract

5

29

Perineal fistula

158

Perineal fistula

255

C

tract

5

29

Perineal hernia

1004

Perineal hernia

2561

C

tract

5

29

Rectal prolapse

159

Anal prolapse

256

C

tract

5

29

Rectal prolapse

159

Rectal prolapse

257

C

tract

5

30

Atresia ani

160

Absence of anus

258

C

tract

5

30

Atresia ani

160

Atresia ani

259

C

tract

5

30

Cleft palate

2078

C

5

161

C

5

Congenital digestive tract disorder NOS Hare lip

260

tract

Congenital digestive tract disorder Congenital digestive tract disorder Congenital digestive tract disorder

161

tract

Abdominal cavity disorders Abdominal cavity disorders Abdominal cavity disorders Anal and rectal disorders Anal and rectal disorders Anal and rectal disorders Anal and rectal disorders Anal and rectal disorders Anal and rectal disorders Anal and rectal disorders Anal and rectal disorders Congenital digestive tract disorders Congenital digestive tract disorders Congenital digestive tract disorders Congenital digestive tract disorders Congenital digestive tract disorders

2089

C

486 487 488 489 490 491 492 493 494 495 496 497 498 499 500

30 30

161

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

501

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

30

C

31

162

NT - Meckel's diverticulum Swim bladder disorder

2313

5

Congenital digestive tract disorder Swim bladder disorder

161

tract

261

A

tract

5

Congenital digestive tract disorders Fish digestive tract disorders Intestinal disorders

236

Colitis

164

Colitis

265

C

tract

5

Intestinal disorders

236

Colitis

164

2330

C

tract

5

Intestinal disorders

236

Colitis

164

NT - granulomatous colitis NT - ulcerative colitis

2331

C

tract

5

Intestinal disorders

236

203

C

tract

5

Intestinal disorders

236

166

Digestive tract malabsorption disorder NOS Diverticular disorder

324

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

Digestive tract malabsorption disorder NOS Diverticular disorder

268

C

tract

5

Intestinal disorders

236

Duodenitis

204

Duodenitis

325

C

tract

5

Intestinal disorders

236

Enteritis

205

Enteritis

327

C

tract

5

Intestinal disorders

236

Enteritis

205

Intestinal congestion

326

C

tract

5

Intestinal disorders

236

Enteritis

205

Jejunitis

2439

C

tract

5

Intestinal disorders

236

Enteritis

205

2332

C

tract

5

Intestinal disorders

236

Enteritis

205

NT - (luminal) enteropathy NT - catarrhal enteritis

2333

C

tract

5

Intestinal disorders

236

Enteritis

205

2334

C

tract

5

Intestinal disorders

236

Enteritis

205

2335

C

tract

5

Intestinal disorders

236

Enteritis

205

NT - eosinophilic enteritis NT - fibrinonecrotic enteritis NT - granulomatous enteritis

2336

C

502 503 504 505 506

507 508 509 510 511 512 513 514 515 516

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

517

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Intestinal disorders

236

Enteritis

205

2337

C

tract

5

Intestinal disorders

236

Enteritis

205

NT - haemorrhagic enteritis NT - histiocytic enteritis

2338

C

tract

5

Intestinal disorders

236

Enteritis

205

2339

C

tract

5

Intestinal disorders

236

Enteritis

205

2340

C

tract

5

Intestinal disorders

236

Enteritis

205

2341

C

tract

5

Intestinal disorders

236

1005

2562

C

tract

5

Intestinal disorders

236

Gastrointestinal foreign body NOS Ileitis

206

NT - lymphoplasmacytic enteritis NT - necrohemorrhagic enteritis NT - proliferative enteritis Gastrointestinal foreign body NOS Ileitis

328

C

tract

5

Intestinal disorders

236

987

Intestinal disorder NOS

2440

C

tract

5

Intestinal disorders

236

Intestinal disorder NOS Intestinal perforation

633

Intestinal perforation

1082

C

tract

5

Intestinal disorders

236

Intestinal stasis

628

Constipation

267

C

tract

5

Intestinal disorders

236

Intestinal stasis

628

1939

C

tract

5

Intestinal disorders

236

Intestinal stasis

628

Decreased bowel movements Faecal impaction

266

C

tract

5

Intestinal disorders

236

Intestinal stasis

628

Intestinal occlusion

2095

C

tract

5

Intestinal disorders

236

Intestinal stasis

628

Intestinal stasis

1066

C

tract

5

Intestinal disorders

236

Intestinal torsion

629

Bowel torsion

1068

C

tract

5

Intestinal disorders

236

Intestinal torsion

629

Intestinal torsion

1067

C

518 519 520 521 522 523 524 525 526 527 528 529 530 531 532

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

533

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Intestinal disorders

236

Intestinal torsion

629

NT - intestinal torsion

2342

C

tract

5

Intestinal disorders

236

Intussusception

207

Intussusception

329

C

tract

5

Intestinal disorders

236

Intussusception

207

2343

C

tract

5

Intestinal disorders

236

Involuntary defecation

168

NT - intestinal intussusception Faecal incontinence

1069

C

tract

5

Intestinal disorders

236

Involuntary defecation

168

Involuntary defecation

270

C

tract

5

Intestinal disorders

236

Involuntary defecation

168

Loss of bowel control

1070

C

tract

5

Intestinal disorders

236

788

H

5

Intestinal disorders

236

630

Irritable bowel syndrome Large intestine ulcer

1560

tract

Irritable bowel syndrome Large intestine ulcer

1071

C

tract

5

Intestinal disorders

236

Paralytic colon

901

Paralytic colon

1955

C

tract

5

Intestinal disorders

236

Paralytic ileus

634

Ileus

1086

C

tract

5

Intestinal disorders

236

Paralytic ileus

634

Paralytic ileus

1085

C

tract

5

Intestinal disorders

236

Rectal haemorrhage

169

Rectal bleeding

272

C

tract

5

Intestinal disorders

236

Rectal haemorrhage

169

Rectal haemorrhage

271

C

tract

5

Intestinal disorders

236

Small intestine ulcer

635

Duodenal ulcer

1088

C

tract

5

Intestinal disorders

236

Small intestine ulcer

635

Jejunal ulcer

1089

C

tract

5

Intestinal disorders

236

Small intestine ulcer

635

Small intestine ulcer

1087

C

534 535 536 537 538 539 540 541 542 543 544 545 546 547 548

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

549

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Intestinal disorders

236

Tenesmus

170

Straining to defecate

2453

C

tract

5

Intestinal disorders

236

Tenesmus

170

Tenesmus

273

C

tract

5

33

Megaoesophagus

171

Megaoesophagus

274

C

tract

5

33

Oesophageal paralysis

172

Oesophageal paralysis

275

C

tract

5

33

Oesophagitis

173

Oesophageal ulcer

1979

C

tract

5

33

Oesophagitis

173

Oesophagitis

276

C

tract

5

33

Oesophagus obstruction

277

C

5

175

Oesophagus perforation

278

C

tract

5

33

Oesophagus obstruction Oesophagus perforation Pharyngeal disorder

174

tract

176

Branchial cyst

1884

H

tract

5

33

Pharyngeal disorder

176

Pharyngeal disorder

279

C

tract

5

33

Pharyngeal disorder

176

Pharyngeal oedema

1224

C

tract

5

33

Pharyngeal disorder

176

Pharyngeal ulceration

281

C

tract

5

33

Pharyngeal disorder

176

Pharyngitis

280

C

tract

5

33

Pharyngeal disorder

176

Tonsillitis

2452

C

tract

5

Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oesophageal and pharyngeal disorders Oral cavity disorders

34

Chattering of teeth

631

Chattering of teeth

1072

C

tract

5

Oral cavity disorders

34

Chewing

632

Chewing - oral cavity disorder (see also 'Pruritus')

1073

C

550 551 552 553 554 555 556 557 558 559 560 561 562 563 564

33

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

565

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Oral cavity disorders

34

Chewing disorder

989

Chewing disorder

2449

C

tract

5

Oral cavity disorders

34

Chewing disorder

989

Difficulty chewing

2450

C

tract

5

Oral cavity disorders

34

Chewing disorder

989

Unable to chew

2451

C

tract

5

Oral cavity disorders

34

Dysphagia

178

Dysphagia

285

C

tract

5

Oral cavity disorders

34

Dysphagia

178

Heartburn

1516

H

tract

5

Oral cavity disorders

34

Dysphagia

178

Impaired swallowing

284

C

tract

5

Oral cavity disorders

34

Dysphagia

178

Swallowing difficult

1808

C

tract

5

Oral cavity disorders

34

Dysphagia

178

1809

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Swallowing disorder NOS Gingival disorder

1885

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gingival erythema

2442

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gingival hyperplasia

1886

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gingival swelling

2441

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gingivitis

286

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gum bruising

1887

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gum disorder NOS

1501

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Gum pain

1502

C

566 567 568 569 570 571 572 573 574 575 576 577 578 579 580

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

581

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Oral cavity disorders

34

Gingival disorder

179

Periodontal disorder

2225

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Pyorrhoea

287

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Swollen gum

1815

C

tract

5

Oral cavity disorders

34

Gingival disorder

179

Tooth loss

2448

C

tract

5

Oral cavity disorders

34

Halitosis

181

Halitosis

291

C

tract

5

Oral cavity disorders

34

Halitosis

181

Smelly breath

1779

C

tract

5

Oral cavity disorders

34

Hypersalivation

182

Drooling

292

C

tract

5

Oral cavity disorders

34

Hypersalivation

182

Foaming at the mouth

1074

C

tract

5

Oral cavity disorders

34

Hypersalivation

182

Hypersalivation

293

C

tract

5

Oral cavity disorders

34

Hypersalivation

182

Increased salivation

1533

C

tract

5

Oral cavity disorders

34

Hypersalivation

182

Ptyalism

1075

C

tract

5

Oral cavity disorders

34

Hyposalivation

183

Dry lip

1426

C

tract

5

Oral cavity disorders

34

Hyposalivation

183

Dry mouth

295

C

tract

5

Oral cavity disorders

34

Hyposalivation

183

Dry throat

1429

C

tract

5

Oral cavity disorders

34

Hyposalivation

183

Hyposalivation

1076

C

tract

5

Oral cavity disorders

34

Hyposalivation

183

Oral dryness

294

C

582 583 584 585 586 587 588 589 590 591 592 593 594 595 596

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

597

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Oral cavity disorders

34

Lip disorder NOS

988

Lip disorder NOS

2446

C

tract

5

Oral cavity disorders

34

Lip disorder NOS

988

Lip erythema

2447

C

tract

5

Oral cavity disorders

34

969

Oral cavity disorder NOS

2229

C

tract

5

Oral cavity disorders

34

Oral cavity disorder NOS Oral discomfort

816

1366

H

tract

5

Oral cavity disorders

34

Oral discomfort

816

Burning mouth sensation Oral discomfort

1657

C

tract

5

Oral cavity disorders

34

Oral discomfort

816

Sore lip

2105

C

tract

5

Oral cavity disorders

34

Oral haemorrhage

184

Oral bleeding

297

C

tract

5

Oral cavity disorders

34

Oral haemorrhage

184

Oral haemorrhage

296

C

tract

5

Oral cavity disorders

34

Oral mass

970

Oral mass

2230

C

tract

5

Oral cavity disorders

34

Oral pain

818

Mouth pain

1623

C

tract

5

Oral cavity disorders

34

Oral pain

818

Oral pain

1660

C

tract

5

Oral cavity disorders

34

982

Ranula

2384

C

tract

5

Oral cavity disorders

34

982

Salivary gland disorder

2383

C

tract

5

Oral cavity disorders

34

Salivary gland disorder Salivary gland disorder Stomatitis

185

Blistering of mouth

1348

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Buccal irritation

299

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Buccal ulceration

298

C

598 599 600 601 602 603 604 605 606 607 608 609 610 611 612

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

613

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Oral cavity disorders

34

Stomatitis

185

Mouth blister

1622

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Mouth irritation

245

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Mouth ulcer

1624

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Oral abscess

2012

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Oral erythema

2445

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Oral mucosal blistering

1659

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Oral oedema

2443

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Oral swelling

2444

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Oral ulceration

301

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Sore mouth

1782

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Stomatitis

300

C

tract

5

Oral cavity disorders

34

Stomatitis

185

Swollen mouth

1819

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Glossitis

289

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Sore tongue

1783

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Swollen furry tongue

1813

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Swollen tongue

1820

C

614 615 616 617 618 619 620 621 622 623 624 625 626 627 628

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

629

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

Oral cavity disorders

34

Tongue disorder

180

Tongue disorder NOS

1845

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Tongue inflammation

288

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Tongue necrosis

1980

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Tongue oedema

1077

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Tongue protrusion

1078

C

tract

5

Oral cavity disorders

34

Tongue disorder

180

Tongue ulceration

290

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Dental calculus

2226

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Dental discolouration

283

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Dental disease

2227

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Dental plaque

2228

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Discoloured teeth

282

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Tooth disorder

1846

C

tract

5

Oral cavity disorders

34

Tooth disorder

177

Toothache

1847

C

tract

5

35

Diarrhoea

186

Diarrhoea

302

C

tract

5

35

Diarrhoea

186

C

5

35

Diarrhoea

186

Increased bowel movements (frequency) Loose bowel

2231

tract

Other digestive tract disorders Other digestive tract disorders Other digestive tract disorders

1588

C

630 631 632 633 634 635 636 637 638 639 640 641 642 643 644

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

645

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

tract

35

Diarrhoea

186

Loose stool

304

C

tract

5

tract

35

Diarrhoea

186

Mucous stool

1080

C

tract

5

tract

35

Diarrhoea

186

Pasty stool

2438

A

tract

5

tract

35

Diarrhoea

186

Scour

303

C

tract

5

tract

35

C

tract

35

305

C

tract

5

tract

35

187

Abnormal stool colouration Digestive tract disorder NOS Lip licking

1981

5

2096

C

tract

5

tract

35

187

Lip smacking

2118

C

tract

5

tract

35

187

Regurgitation

1888

C

tract

5

tract

35

187

Unusual stool colour

2435

A

tract

5

tract

35

188

Blood in faeces

1081

C

tract

5

tract

35

188

C

5

tract

35

Digestive tract haemorrhage NOS Haematochezia

306

tract

1982

C

tract

5

tract

35

C

5

tract

35

879

Digestive tract hypermotility Gut sounds increased

1889

tract

1890

C

tract

5

tract

35

Digestive tract disorder NOS Digestive tract disorder NOS Digestive tract disorder NOS Digestive tract disorder NOS Digestive tract disorder NOS Digestive tract disorder NOS Digestive tract haemorrhage NOS Digestive tract haemorrhage NOS Digestive tract haemorrhage NOS Digestive tract hypermotility Digestive tract hypermotility Digestive tract hypermotility

187

tract

Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders

879

Increased borborygmus

2091

C

646 647 648 649 650 651 652 653 654 655 656 657 658 659 660

187

188 879

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

661

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

tract

35

C

tract

35

Digestive tract hypomotility Gut sounds decreased

2163

5

2162

C

tract

5

tract

35

C

5

tract

35

Digestive tract neoplasm NOS NT - intestinal adenoma

307

tract

2353

C

tract

5

tract

35

Digestive tract hypomotility Digestive tract hypomotility Digestive tract neoplasm NOS Digestive tract neoplasm NOS Digestive tract neoplasm NOS

959

tract

Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders

2354

C

Digestive tract disorders Digestive tract disorders Digestive tract disorders

5

Other digestive tract disorders Other digestive tract disorders Other digestive tract disorders

35

Digestive tract neoplasm NOS Digestive tract stasis

189

NT - intestinal tumour (adenocarcinoma/adeno ma/gastro intestinal stromal tumour (gist)) NT- gastro intestinal stromal tumour (gist) Digestive tract stasis

2355

C

308

C

191

Digestive tract stenosis and obstruction NOS

310

C

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

tract

35

192

Digestive tract tympany

311

C

tract

5

tract

35

1006

C

5

tract

35

Disorder of gastrointestinal flora Enteric pathogen NOS

2563

tract

2564

C

tract

5

tract

35

C

5

tract

35

193

Small intestinal bacterial overgrowth Distension of abdomen

2565

tract

312

C

tract

5

tract

35

921

Enterotoxaemia

2013

C

tract

5

Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders

Digestive tract stenosis and obstruction NOS Digestive tract tympany Disorder of gastrointestinal flora Disorder of gastrointestinal flora Disorder of gastrointestinal flora Distension of abdomen Enterotoxaemia

tract

35

763

Bloated

1349

C

662 663 664 665

666 667 668

669 670 671 672 673 674 675

5 5

35 35

Flatulence, bloating and distension

959 189 189 189

190

1006 1006

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

676

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

tract

35

Bloated feeling

1350

H

5

tract

35

763

Bloated stomach

1351

C

tract

5

tract

35

763

Flatulence

269

C

tract

5

tract

35

763

C

5

tract

35

763

Flatulence, bloating and distension Wind

1477

tract

1876

C

tract

5

tract

35

Flatulence, bloating and distension Flatulence, bloating and distension Flatulence, bloating and distension Flatulence, bloating and distension Flatulence, bloating and distension Gastroenteritis

763

tract

194

Gastroenteritis

313

C

tract

5

tract

35

Bloody diarrhoea

315

C

5

tract

35

195

Haemorrhagic diarrhoea

314

C

tract

5

tract

35

195

Intestinal haemorrhage

1083

C

tract

5

tract

35

196

C

5

tract

35

Haemorrhagic gastroenteritis Melaena

316

tract

Haemorrhagic diarrhoea Haemorrhagic diarrhoea Haemorrhagic diarrhoea Haemorrhagic gastroenteritis Melaena

195

tract

317

C

tract

5

Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders

tract

35

Melaena

197

318

C

Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

tract

35

Nausea

810

1470

H

tract

5

tract

35

Nausea

810

Nausea

1638

C

tract

5

tract

35

Nausea

810

Sickness

1748

C

tract

5

Other digestive disorders Other digestive disorders Other digestive disorders Other digestive disorders

Tarry or black stool (see also haemorrhagic diarrhoea) Feeling sick

tract

35

Painful defecation

911

Painful defecation

1983

C

677 678 679 680 681 682 683 684 685 686 687

688 689 690 691

197

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

692

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

35

Suckling disorder NOS

986

Suckling disorder NOS

2437

A

tract

5

Other digestive tract disorders Pancreas disorders

37

Pancreas disorder

208

Elevated amylase

2232

C

tract

5

Pancreas disorders

37

Pancreas disorder

208

Elevated lipase

2168

C

tract

5

Pancreas disorders

37

Pancreas disorder

208

1940

C

tract

5

Pancreas disorders

37

Pancreas disorder

208

Exocrine pancreatic insufficiency Pancreas disorder

330

C

tract

5

Pancreas disorders

37

Pancreatitis

880

331

C

tract

5

Pancreas disorders

37

Pancreatitis

880

Acute haemorrhagic pancreatitis Chronic pancreatitis

1892

C

tract

5

Pancreas disorders

37

Pancreatitis

880

Necrotizing pancreatitis

1893

C

tract

5

Pancreas disorders

37

Pancreatitis

880

Pancreatitis

1891

C

tract

5

stomach

36

Abomasal perforation

956

Abomasal perforation

2143

A

tract

5

stomach

36

Abomasitis

198

Abomasal ulcer

1084

A

tract

5

stomach

36

Abomasitis

198

Abomasitis

319

A

tract

5

stomach

36

Reticulitis

200

Reticulitis

321

A

tract

5

stomach

36

A

stomach

36

202

Decreased ruminal activity Displaced abomasum

2619

5

323

A

tract

5

stomach

36

Ruminant stomach disorder Ruminant stomach disorder Ruminant stomach disorder

202

tract

Ruminant disorders Ruminant disorders Ruminant disorders Ruminant disorders Ruminant disorders Ruminant disorders Ruminant disorders

202

NT - rumenitis

322

A

693 694 695 696 697 698 699 700 701 702 703 704 705 706 707

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

708

Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders Digestive disorders

tract

5

36

Rumen acidosis

2169

A

5

202

Rumen atony

1065

A

tract

5

202

Ruminal bloat

320

A

tract

5

202

Ruminal stasis

309

A

tract

5

202

A

5

38

755

Ruminant stomach disorder Dyspepsia

1230

tract

Ruminant stomach disorder Ruminant stomach disorder Ruminant stomach disorder Ruminant stomach disorder Ruminant stomach disorder Dyspepsia

202

tract

Ruminant stomach disorders Ruminant stomach disorders Ruminant stomach disorders Ruminant stomach disorders Ruminant stomach disorders Stomach disorders

1434

C

tract

5

Stomach disorders

38

Dyspepsia

755

Indigestion

1536

C

tract

5

Stomach disorders

38

Dyspepsia

755

Stomach upset

1800

C

tract

5

Stomach disorders

38

Emesis

211

Emesis

335

C

tract

5

Stomach disorders

38

Emesis

211

Emesis (multiple)

2082

C

tract

5

Stomach disorders

38

Emesis

211

Vomiting

334

C

tract

5

Stomach disorders

38

Eructation

212

Belching

337

C

tract

5

Stomach disorders

38

Eructation

212

Eructation

336

C

tract

5

Stomach disorders

38

Gastric dilation

636

Gastric bloat

1090

C

tract

5

Stomach disorders

38

Gastric dilation

636

Gastric dilation

1091

C

tract

5

Stomach disorders

38

Gastric dilation

636

Gastric distension

1092

C

709 710 711 712 713 714 715 716 717 718 719 720 721 722 723

36 36 36 36

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

724

Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Digestive tract disorders Ear and labyrinth disorders

5

Stomach disorders

38

Gastric perforation

939

Gastric perforation

1941

C

5

Stomach disorders

38

Gastric torsion

213

Gastric torsion

338

C

5

Stomach disorders

38

Gastric torsion

213

Gastric volvulus

339

C

5

Stomach disorders

38

Gastric ulcer

214

Gastric ulcer

340

C

5

Stomach disorders

38

Gastric ulcer

214

Gastric ulceration NOS

1489

C

5

Stomach disorders

38

Gastric ulcer

214

Pyloric ulcer

1717

C

5

Stomach disorders

38

Gastritis

215

Gastric irritation

1488

C

5

Stomach disorders

38

Gastritis

215

Gastritis

341

C

5

Stomach disorders

38

Gastritis

215

Stomach inflammation

1798

C

5

Stomach disorders

38

Haematemesis

216

Blood in vomit

343

C

5

Stomach disorders

38

Haematemesis

216

Haematemesis

342

C

5

Stomach disorders

38

Haematemesis

216

Haemorrhagic gastritis

1093

C

5

Stomach disorders

38

881

C

Stomach disorders

38

217

Impaired gastric function Gagging

1894

5

Impaired gastric function Retching

344

C

5

Stomach disorders

38

Retching

217

Retching

345

C

6

Congenital ear disorders

39

Congenital ear disorder NOS

218

Congenital ear disorder NOS

346

C

725 726 727 728 729 730 731 732 733 734 735 736 737 738 739

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

740

Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders

6

External ear disorders

41

Aural haematoma

221

Aural haematoma

350

C

6

External ear disorders

41

Aural haematoma

221

Ear flap haemorrhage

352

C

6

External ear disorders

41

Aural haematoma

221

Otic haematoma

351

C

6

External ear disorders

41

Aural neoplasia NOS

222

Aural neoplasia NOS

353

C

6

External ear disorders

41

Ear canal disorder

1007

Ear canal disorder

2567

C

6

External ear disorders

41

Ear canal disorder

1007

Ear canal erythema

2566

C

6

External ear disorders

41

Ear canal disorder

1007

Ear canal inflammation

2568

C

6

External ear disorders

41

Ear canal disorder

1007

Ear canal oedema

2569

C

6

External ear disorders

41

Ear canal disorder

1007

Stenotic ear canal

2570

C

6

External ear disorders

41

Ear canal disorder

1007

Swollen ear canal

2571

C

6

External ear disorders

41

ear disorder

223

Droopy ear

355

C

6

External ear disorders

41

ear disorder

223

Ear flapping/twitching

1986

C

6

External ear disorders

41

ear disorder

223

Earflap ptosis

1094

C

6

External ear disorders

41

ear disorder

223

C

External ear disorders

41

ear disorder

223

External ear disorder NOS Pinnae disorder

354

6

1985

C

6

External ear disorders

41

External NOS External NOS External NOS External NOS External NOS External NOS

ear disorder

223

Pinnal ulcer

2620

C

741 742 743 744 745 746 747 748 749 750 751 752 753 754 755

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

756

Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders

6

External ear disorders

41

Otitis externa

224

Otitis externa

356

C

6

External ear disorders

41

Otitis externa

224

Thickened ear canal(s)

2456

A

6

External ear disorders

41

Pinnal cyanosis

225

Blue ear(s)

358

C

6

External ear disorders

41

Pinnal cyanosis

225

Pinnal cyanosis

357

C

6

External ear disorders

41

Pinnal haemorrhage

226

Pinnal haemorrhage

359

C

6

External ear disorders

41

Pinnal irritation

227

Ear irritation

1436

C

6

External ear disorders

41

Pinnal irritation

227

Pinnal erythema

1095

C

6

External ear disorders

41

Pinnal irritation

227

Pinnal irritation

361

C

6

External ear disorders

41

Pinnal irritation

227

Pinnal reddening

360

C

6

External ear disorders

41

Pinnal necrosis

228

Pinnal necrosis

362

C

6

External ear disorders

41

Pinnal oedema

229

Ear flap oedema

364

C

6

External ear disorders

41

Pinnal oedema

229

Pinnal oedema

363

C

6

Impaired hearing

42

Deafness

230

Deafness

365

C

6

Impaired hearing

42

Deafness

230

Deafness NOS

368

C

6

Impaired hearing

42

Deafness

230

Loss of hearing

1591

C

6

Impaired hearing

42

Deafness

230

Temporary deafness

2455

C

757 758 759 760 761 762 763 764 765 766 767 768 769 770 771

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

772

Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders

6

Impaired hearing

42

Impaired hearing

774

Hearing affected

366

C

6

Impaired hearing

42

Impaired hearing

774

Hearing decreased

1512

C

6

Impaired hearing

42

Impaired hearing

774

Impaired hearing

1513

C

6

Impaired hearing

42

Impaired hearing

774

Partial deafness

367

C

6

Internal ear disorders

43

Internal ear disorder

231

Head tilt - ear disorder

374

C

6

Internal ear disorders

43

Internal ear disorder

231

2458

A

6

Internal ear disorders

43

Internal ear disorder

231

Idiopathic vestibular disease Internal ear disorder

369

C

6

Internal ear disorders

43

Internal ear disorder

231

Meniere's Disease

333

H

6

Internal ear disorders

43

Internal ear disorder

231

2457

C

6

Internal ear disorders

43

Internal ear disorder

231

370

C

Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders

6

Internal ear disorders

43

Internal ear disorder

231

Peripheral vestibular disorder Tumbling circling disease (see also ataxia at 'Neurological') Vestibular disorder NOS

373

C

6

Internal ear disorders

43

Labyrinthitis

790

Labyrinthitis

332

C

6

Internal ear disorders

43

Otitis interna

232

Otitis interna

376

C

6

Internal ear disorders

43

Tinnitus

868

Ringing in the ear

1732

H

6

Internal ear disorders

43

Tinnitus

868

Tinnitus

1843

H

6

Middle ear disorders

44

Otitis media

233

Otitis media

377

C

773 774 775 776 777 778 779 780 781

782 783 784 785 786 787

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

788

Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders Ear and labyrinth disorders

6

Middle ear disorders

44

Otitis media

233

1669

C

6

Middle ear disorders

44

Tympanic alteration

1019

Otitis media serous/glue ear Tympanic alteration

2621

C

6

Middle ear disorders

44

Tympanic alteration

1019

Tympanic discoloration

2622

C

6

Middle ear disorders

44

Tympanic alteration

1019

Tympanic opacity

2623

C

6

Middle ear disorders

44

Tympanic rupture

983

Eardrum rupture

2387

C

6

Middle ear disorders

44

Tympanic rupture

983

Tympanic rupture

2386

C

6

Other ear disorders

40

Ear infection NOS

757

Ear infection NOS

1435

C

6

Other ear disorders

40

Ear pain

219

Ear pain

347

C

6

Other ear disorders

40

Ear pain

219

Earache

1437

C

6

Other ear disorders

40

Ear pruritus

1008

Ear pruritus

2573

C

6

Other ear disorders

40

Ear pruritus

1008

Itchy ears

2572

C

6

Other ear disorders

40

822

C

Other ear disorders

40

822

Head shake - ear disorder Other ear disorder NOS

375

6

1667

C

6

Other ear disorders

40

Other ear disorder NOS Other ear disorder NOS Otitis NOS

912

Otitis NOS

1984

C

6

Other ear disorders

40

Otorrhoea

220

Ear discharge

349

C

6

Other ear disorders

40

Otorrhoea

220

Otorrhoea

348

C

789 790 791 792 793 794 795 796 797 798 799 800 801 802 803

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

804

Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders

system

7

Adrenal gland disorders

45

234

C

7

Adrenal gland disorders

45

382

C

system

7

Adrenal gland disorders

45

Hyperadrenocorticism

236

381

C

system

7

Adrenal gland disorders

45

Hyperadrenocorticism

236

Adrenal gland disorder NOS Cushings disease adrenal dependent Cushings disease pituitary dependent Cushings disease NOS

378

system

Adrenal gland disorder NOS Hyperadrenocorticism

380

C

system

7

Adrenal gland disorders

45

Hyperadrenocorticism

236

Hyperadrenocorticism

379

C

system

7

Adrenal gland disorders

45

Hyperadrenocorticism

236

Hypercortisolaemia

2624

C

system

7

Adrenal gland disorders

45

Hypoadrenocorticism

237

Addison's disease

384

C

system

7

Adrenal gland disorders

45

Hypoadrenocorticism

237

Hypoadrenocorticism

383

C

system

7

Adrenal gland disorders

45

Hypoadrenocorticism

237

Hypocortisolaemia

2625

C

system

7

46

Congenital endocrine disorder Endocrine neoplasm

385

C

7

Congenital endocrine disorder Endocrine neoplasm

238

system

Congenital endocrine disorders Endocrine neoplasms

386

C

system

7

232

C

48

240

Endocrine system disorder NOS Complication of diabetes

2014

7

Endocrine system disorder NOS Diabetes mellitus

922

system

393

C

system

7

48

Diabetes mellitus

240

Diabetes

387

C

system

7

48

Diabetes mellitus

240

Diabetes mellitus

389

C

system

7

Endocrine system disorders Pancreas endocrine disorders Pancreas endocrine disorders Pancreas endocrine disorders Pancreas endocrine disorders

48

Diabetes mellitus

240

Diabetic coma

391

C

805 806 807 808 809 810 811 812 813 814 815 816 817 818 819

47

236

239

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

820

Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders Endocrine disorders

system

7

48

Diabetes mellitus

240

Diabetic ketoacidosis

2053

C

system

7

48

Diabetes mellitus

240

Diabetic ketonuria

2054

C

system

7

48

Diabetes mellitus

240

Glucose intolerance

392

C

system

7

48

Diabetes mellitus

240

Uncontrolled diabetes

388

C

system

7

48

C

49

243

Pancreas endocrine disorder NOS Hyperparathyroidism

396

7

Pancreas endocrine disorder NOS Hyperparathyroidism

242

system

Pancreas endocrine disorders Pancreas endocrine disorders Pancreas endocrine disorders Pancreas endocrine disorders Pancreas endocrine disorders Parathyroid disorders

397

C

system

7

Parathyroid disorders

49

Hypoparathyroidism

244

Hypoparathyroidism

398

C

system

7

Parathyroid disorders

49

245

C

7

Pituitary disorders

50

246

Parathyroid disorder NOS Acromegaly

399

system

Parathyroid disorder NOS Acromegaly

400

C

system

7

Pituitary disorders

50

Diabetes insipidus

247

Diabetes insipidus

401

C

system

7

Pituitary disorders

50

Pituitary disorder NOS

248

Pituitary disorder NOS

402

C

system

7

Thyroid gland disorders

51

Hyperthyroidism

249

Hyperthyroidism

403

C

system

7

Thyroid gland disorders

51

Hypothyroidism

250

Hypothyroidism

404

C

system

7

Thyroid gland disorders

51

Hypothyroidism

250

2233

C

system

7

Thyroid gland disorders

51

251

405

C

system

7

Thyroid gland disorders

51

Thyroid gland disorder NOS Thyroidititis

Immune mediated hypothyroidism Thyroid gland disorder NOS Thyroidititis

1839

C

821 822 823 824 825 826 827 828 829 830 831 832 833 834 835

867

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

836

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

1293

C

837

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Abnormal vision (see also impaired vision) Diplopia

1415

H

838

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Double vision

1425

H

839

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Eyesight trouble

1231

C

840

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Flashing vision

1475

H

841

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Focusing difficult

1479

C

842

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Unable to focus

1856

C

843

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Vision blurred

1870

H

844

Eye disorders

8

Abnormal vision

52

Abnormal vision

703

Visual field defect

1871

C

845

Eye disorders

8

Abnormal vision

52

Blindness

252

Blindness

406

C

846

Eye disorders

8

Abnormal vision

52

Blindness

252

Temporary blindness

1829

C

847

Eye disorders

8

Abnormal vision

52

Blindness

252

Transient blindness

1850

C

848

Eye disorders

8

Abnormal vision

52

Impaired vision

253

1096

C

849

Eye disorders

8

Abnormal vision

52

Impaired vision

253

1097

C

850

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Abnormal menace reflex test Abnormal pupil light reflex Bumping into walls

2403

C

851

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Depressed ocular reflex

1098

C

852

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Impaired vision

407

C

853

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Loss of vision

1596

C

854

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Low vision

1598

C

855

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Partial blindness

409

C

856

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Partial sight

1684

C

857

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Poor sight

1703

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

858

Eye disorders

8

Abnormal vision

52

Impaired vision

253

Sight affected

408

C

859

Eye disorders

8

Congenital eye disorders

53

254

Congenital eye disorder

411

C

860

Eye disorders

8

Corneal disorders

54

Congenital eye disorder Corneal disorder NOS

255

Corneal disorder NOS

412

C

861

Eye disorders

8

Corneal disorders

54

Corneal oedema

256

Blue eye

414

C

862

Eye disorders

8

Corneal disorders

54

Corneal oedema

256

Corneal oedema

413

C

863

Eye disorders

8

Corneal disorders

54

Corneal ulcer

257

Corneal ulcer

415

C

864

Eye disorders

8

Corneal disorders

54

Keratitis

258

Keratitis

416

C

865

Eye disorders

8

55

Glaucoma

259

Glaucoma

417

C

866

Eye disorders

8

55

Glaucoma

259

C

Eye disorders

8

55

Hyphaemia

260

Increased intra-ocular pressure Eye haemorrhage

2234

867

1099

C

868

Eye disorders

8

55

Hyphaemia

260

Hyphaemia

418

C

869

Eye disorders

8

55

Hypopyon

261

Hypopyon

419

C

870

Eye disorders

8

Eye-chamber (anterior and posterior) disorders Eye-chamber (anterior and posterior) disorders Eye-chamber (anterior and posterior) disorders Eye-chamber (anterior and posterior) disorders Eye-chamber (anterior and posterior) disorders Eyelid disorders

56

Blepharitis

262

Blepharitis

421

C

871

Eye disorders

8

Eyelid disorders

56

Blepharitis

262

Eyelid erythema

2460

A

872

Eye disorders

8

Eyelid disorders

56

Blepharitis

262

Eyelid inflammation

422

C

873

Eye disorders

8

Eyelid disorders

56

Blepharitis

262

Eyelid oedema

1100

C

874

Eye disorders

8

Eyelid disorders

56

Blepharitis

262

Eyelid scaly

1461

C

875

Eye disorders

8

Eyelid disorders

56

Blepharitis

262

Palpebral oedema

420

C

876

Eye disorders

8

Eyelid disorders

56

Blepharospasm

263

Blepharospasm

423

C

877

Eye disorders

8

Eyelid disorders

56

Blepharospasm

263

Blinking

1101

C

878

Eye disorders

8

Eyelid disorders

56

Blepharospasm

263

Closed eyelid

1233

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

879

Eye disorders

8

Eyelid disorders

56

Blepharospasm

263

Squinting

2235

C

880

Eye disorders

8

Eyelid disorders

56

Ectropion

264

Ectropion

424

C

881

Eye disorders

8

Eyelid disorders

56

Entropion

265

Entropion

425

C

882

Eye disorders

8

Eyelid disorders

56

266

Drooping eyelid

2236

C

883

Eye disorders

8

Eyelid disorders

56

266

Eyelid lump

2461

A

884

Eye disorders

8

Eyelid disorders

56

266

Palpebral disorder NOS

426

C

885

Eye disorders

8

57

267

C

Eye disorders

8

57

268

Ciliary body and choroid disorder NOS Iris disorder

427

886

428

C

887

Eye disorders

8

57

Iris disorder

268

Iris prolapse

430

C

888

Eye disorders

8

57

Iris disorder

268

Iris tear

429

C

889

Eye disorders

8

57

Pupil disorder

269

Fixed pupil

431

C

890

Eye disorders

8

57

Pupil disorder

269

Pupil disorder

432

C

891

Eye disorders

8

57

Uveitis

270

Anterior uveitis

433

C

892

Eye disorders

8

57

Uveitis

270

C

Eye disorders

8

57

Uveitis

270

Decreased intra-ocular pressure Posterior uveitis

2463

893

434

C

894

Eye disorders

8

57

Uveitis

270

Uveitis

435

C

895

Eye disorders

8

Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Iris, ciliary body and choroid disorders Lacrimal gland disorders

Palpebral disorder NOS Palpebral disorder NOS Palpebral disorder NOS Ciliary body and choroid disorder NOS Iris disorder

58

Epiphora

271

Epiphora

436

C

896

Eye disorders

8

Lacrimal gland disorders

58

Epiphora

271

Excess tear flow

438

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

897

Eye disorders

8

Lacrimal gland disorders

58

Epiphora

271

Lacrimation

439

C

898

Eye disorders

8

Lacrimal gland disorders

58

Epiphora

271

Lacrimation increased

1572

C

899

Eye disorders

8

Lacrimal gland disorders

58

Epiphora

271

440

C

900

Eye disorders

8

Lacrimal gland disorders

58

Epiphora

271

Tear flow due to blocked or infected tear ducts Tear flow increased

437

C

901

Eye disorders

8

Lacrimal gland disorders

58

Lacrimal disorder NOS

272

Lacrimal disorder NOS

441

C

902

Eye disorders

8

Lacrimal gland disorders

58

Lacrimation decreased

273

Lacrimation decreased

442

C

903

Eye disorders

8

Lacrimal gland disorders

58

Lacrimation decreased

273

Low tear flow

1102

C

904

Eye disorders

8

Lens disorders

59

Cataract

274

Cataract

444

C

905

Eye disorders

8

Lens disorders

59

Cataract

274

Lens opacity

443

C

906

Eye disorders

8

Lens disorders

59

Lens disorder NOS

275

Lens disorder NOS

446

C

907

Eye disorders

8

Lens disorders

59

Lens luxation

276

Lens luxation

447

C

908

Eye disorders

8

60

A

8

448

A

910

Eye disorders

8

277

Prolapse of the nictitating membrane Protrusion membrana nictitans Third eyelid extrusion

1103

Eye disorders

449

A

911

Eye disorders

8

277

Third eyelid prolapse

1104

A

912

Eye disorders

8

277

Third eyelid protrusion

1105

A

913

Eye disorders

8

61

Protrusion membrana nictitans Protrusion membrana nictitans Protrusion membrana nictitans Protrusion membrana nictitans Protrusion membrana nictitans Optic nerve disorder

277

909

Membrane nictitans disorders Membrane nictitans disorders Membrane nictitans disorders Membrane nictitans disorders Membrane nictitans disorders Optic nerve disorders

278

Optic disc oedema

2237

C

914

Eye disorders

8

Optic nerve disorders

61

Optic nerve disorder

278

Optic nerve disorder

450

C

915

Eye disorders

8

Other eye disorders

62

Cloudy eye

996

Cloudy eye (for Miosis, Mydriasis, Anisocoria, Nystagmus - see 'Neurological')

445

C

60 60 60 60

277

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

916

Eye disorders

8

Other eye disorders

62

Exophthalmia

279

Bulging eye

2380

C

917

Eye disorders

8

Other eye disorders

62

Exophthalmia

279

Exophthalmia

451

C

918

Eye disorders

8

Other eye disorders

62

Eye disorder NOS

280

452

C

919

Eye disorders

8

Other eye disorders

62

Eye disorder NOS

280

Eye disorder NOS (for photophobia see 'neurological') Ocular discharge

468

C

920

Eye disorders

8

Other eye disorders

62

Eye disorder NOS

280

Strabismus

1895

C

921

Eye disorders

8

Other eye disorders

62

Eye inflammation

284

Eye inflamed

1455

C

922

Eye disorders

8

Other eye disorders

62

Eye inflammation

284

Eye inflammation NOS

1456

C

923

Eye disorders

8

Other eye disorders

62

Eye inflammation

284

459

C

924

Eye disorders

8

Other eye disorders

62

Eye inflammation

284

Generalised inflammation of eye Panophthalmitis

2015

C

925

Eye disorders

8

Other eye disorders

62

Eye irritation

281

1368

H

926

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Burning sensation of eye Eye ache

1454

H

927

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye dryness (sensation)

2524

H

928

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye irritation

453

C

929

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye itching

1457

C

930

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye numbness

1235

C

931

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye pain

1458

C

932

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye pricking

1237

H

933

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye smarting

1238

H

934

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye sore and red

1459

C

935

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye stinging

1460

H

936

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Eye tingling

1239

H

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

937

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Ocular burn

1240

C

938

Eye disorders

8

Other eye disorders

62

Eye irritation

281

Sore eye

1781

C

939

Eye disorders

8

Other eye disorders

62

Eye irritation

281

1795

H

940

Eye disorders

8

Other eye disorders

62

Eye neoplasm

913

Stinging sensation in eye Eye neoplasm

1987

C

941

Eye disorders

8

Other eye disorders

62

Eye paralysis

282

454

C

942

Eye disorders

8

Other eye disorders

62

Eye paralysis

282

Eye paralysis (for Miosis etc see 'Neurological') Ophthalmoplegia

455

C

943

Eye disorders

8

Other eye disorders

62

Eye redness

669

Bloodshot eye

1353

C

944

Eye disorders

8

Other eye disorders

62

Eye redness

669

Eye redness

457

C

945

Eye disorders

8

Other eye disorders

62

Eye redness

669

Injected sclera

2462

C

946

Eye disorders

8

Other eye disorders

62

Eye redness

669

Pink eye

2016

C

947

Eye disorders

8

Other eye disorders

62

Eye redness

669

Red eye

1721

C

948

Eye disorders

8

Other eye disorders

62

Eyeball protrusion

283

Eyeball protrusion

456

C

949

Eye disorders

8

Other eye disorders

62

Periorbital oedema

285

Periorbital oedema

460

C

950

Eye disorders

8

Other eye disorders

62

Periorbital oedema

285

Swelling around eye

461

C

951

Eye disorders

8

Other eye disorders

62

Periorbital oedema

285

Swollen eye

1810

C

952

Eye disorders

8

Retinal disorders

63

Retinal atrophy

286

Retinal atrophy

462

C

953

Eye disorders

8

Retinal disorders

63

Retinal degeneration

287

Retinal degeneration

463

C

954

Eye disorders

8

Retinal disorders

63

Retinal degeneration

287

464

A

955

Eye disorders

8

Retinal disorders

63

Retinal detachment

288

1106

C

956

Eye disorders

8

Retinal disorders

63

Retinal detachment

288

Taurine-deficient retinopathy Ocular fundus vasoconstriction Retinal detachment

465

C

957

Eye disorders

8

Retinal disorders

63

Retinal disorder NOS

289

Retinal disorder NOS

466

C

958

Eye disorders

8

Retinal disorders

63

Retinal haemorrhage

290

Retinal haemorrhage

467

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

959

Eye disorders

8

64

A

8

64

291

Conjunctival haemorrhage Chemosis

2459

Eye disorders

Conjunctival haemorrhage Conjunctivitis

990

960

1107

C

961

Eye disorders

8

64

Conjunctivitis

291

Conjunctival irritation

1394

C

962

Eye disorders

8

64

Conjunctivitis

291

Conjunctival oedema

1108

C

963

Eye disorders

8

64

Conjunctivitis

291

Conjunctivitis

469

C

964

Eye disorders

8

64

Conjunctivitis

291

Mucus in eye

1625

C

965

Eye disorders

8

64

Conjunctivitis

291

Sticky eye

1791

C

966

Eye disorders

8

64

Keratoconjunctivitis

292

Keratoconjunctivitis

470

C

967

Eye disorders

8

64

Dry eye

472

C

Eye disorders

8

293

C

Eye disorders

8

64

475

C

970

Eye disorders

8

64

Scleritis

294

Keratoconjunctivitis sicca Inflammation of eye coat Scleritis

471

969

Keratoconjunctivitis sicca Keratoconjunctivitis sicca Scleritis

293

968

473

C

971

Eye disorders

8

64

Scleritis

294

Sclerotitis

474

C

972

Hepato-biliary disorders

9

68

C

9

2314

C

974

Hepato-biliary disorders

9

Congenital hepatobiliary disorder NT - hepatic biliary cysts Portacaval shunt

503

Hepato-biliary disorders

Congenital hepatobiliary disorder Congenital hepatobiliary disorder Congenital hepatobiliary disorder

311

973

Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Scleral and conjunctival disorders Congenital hepatobiliary disorders Congenital hepatobiliary disorders Congenital hepatobiliary disorders

504

C

64

68 68

294

311 311

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

975

Hepato-biliary disorders

9

65

Cholangiohepatitis

295

Cholangiohepatitis

476

C

976

Hepato-biliary disorders

9

65

Cholangitis

296

Bile duct inflammation

1344

C

977

Hepato-biliary disorders

9

65

Cholangitis

296

Cholangitis

477

C

978

Hepato-biliary disorders

9

65

Cholangitis

296

NT - chronic cholangitis

2316

C

979

Hepato-biliary disorders

9

65

Cholangitis

296

C

Hepato-biliary disorders

9

65

Cholecystitis

297

NT - suppurative cholangitis Cholecystitis

2317

980

479

C

981

Hepato-biliary disorders

9

65

Cholecystitis

297

982

Hepato-biliary disorders

9

65

Cholelithiasis

983

Hepato-biliary disorders

9

65

984

Hepato-biliary disorders

9

985

Hepato-biliary disorders

9

986

Hepato-biliary disorders

9

987

Hepato-biliary disorders

9

988

Hepato-biliary disorders

9

Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Gall bladder and bile duct disorders Hepatic disorders

989

Hepato-biliary disorders

9

990

Hepato-biliary disorders

991

Hepato-biliary disorders

478

C

732

Gall bladder inflammation Cholelithiasis

1377

C

Cholelithiasis

732

Gall stone

1487

C

65

Cholelithiasis

732

NT - cholelithiasis

2318

C

65

298

C

1020

Gall bladder & bile duct disorder NOS Biliary sludge

480

65

Gall bladder & bile duct disorder NOS Gall bladder mucocele

2626

C

65

Gall bladder mucocele

1020

Gall bladder mucocele

2627

C

66

Fatty liver

300

Fatty liver

483

C

Hepatic disorders

66

Fatty liver

300

2321

C

9

Hepatic disorders

66

Hepatic abscess

301

NT - hepatic lipidosis (steatosis) Hepatic abscess

484

C

9

Hepatic disorders

66

Hepatic abscess

301

Liver abscess

485

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

992

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic disorder NOS

775

Hepatic disorder NOS

1520

C

993

Hepato-biliary disorders

9

Hepatic disorders

66

302

Hepatic encephalopathy

486

C

994

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic encephalopathy Hepatic failure

638

Hepatic failure

497

C

995

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic failure

638

Liver failure

1109

C

996

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic fibrosis

303

Cirrhosis

487

C

997

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic fibrosis

303

Hepatic cirrhosis

489

C

998

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic fibrosis

303

Hepatic fibrosis

488

C

999

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic fibrosis

303

Liver fibrosis

490

C

1000

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic fibrosis

303

2324

C

1001

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic fibrosis

303

2322

C

1002

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic necrosis

304

NT - cirrhosis (micronodular or macronodular) chronic active hepatitis NT - Glisson's capsule fibrosis Hepatic necrosis

491

C

1003

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatic toxicosis

305

Hepatic toxicosis

492

C

1004

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatitis

306

Hepatitis

493

C

1005

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatitis

306

2323

C

1006

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatitis

306

2325

C

1007

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatitis

306

NT caseous/granulomatous hepatitis (tuberculosis) NT - granulomatous hepatitis NT - necrotic hepatitis

2326

C

1008

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatitis

306

2327

C

1009

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatomegaly

307

NT - suppurative hepatitis Enlarged liver

495

C

1010

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatomegaly

307

Hepatomegaly

494

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1011

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Elevated ALT

2050

C

1012

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Elevated AST

2049

C

1013

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Elevated bile acids

2051

C

1014

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

2238

C

1015

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Elevated gammaglutamyl transferase (GGT) Elevated liver enzymes

1942

C

1016

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

2525

C

1017

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Elevated sorbitol dehydrogenase (SDH) Elevated total bilirubin

2052

C

1018

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Hepatic cytolysis

2119

C

1019

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Hepatic insufficiency

498

C

1020

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Hepatopathy

496

C

1021

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

1579

C

1022

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Liver damage aggravated Liver degeneration

2120

C

1023

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Liver disorder NOS

1943

C

1024

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

NT - liver amyloidosis

2328

C

1025

Hepato-biliary disorders

9

Hepatic disorders

66

Hepatopathy

308

Small liver

2017

C

1026

Hepato-biliary disorders

9

67

C

9

923

2018

C

1028

Hepato-biliary disorders

9

69

312

507

C

1029

Hepato-biliary disorders

9

69

Hepatic neoplasm

312

Hepatic tumour

506

C

1030

Hepato-biliary disorders

9

Hepato-biliary neoplasms Hepato-biliary neoplasms Hepato-biliary

Hepatic vascular disorder Hepato-biliary disorder NOS Hepatic neoplasm

502

Hepato-biliary disorders

Hepatic vascular disorder Hepato-biliary disorder NOS Hepatic neoplasm

310

1027

Hepatic vascular disorders Hepato-biliary disorders

69

Hepatic neoplasm

312

Liver tumour

505

C

233

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2329

C

2576

C

neoplasms 1031

Hepato-biliary disorders

9

Hepato-biliary neoplasms

69

Hepatic neoplasm

312

1032

Hepato-biliary disorders

9

69

Hepato-biliary disorders

9

1009

Hepato-biliary neoplasm

2574

C

1034

Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders

10

72

Hepato-biliary neoplasm Hepato-biliary neoplasm Allergic oedema

1009

1033

Hepato-biliary neoplasms Hepato-biliary neoplasms Allergic conditions

NT - hepatic or biliary tumour (hepatocarcinoma/chola ngiocarcinoma/ adenoma/cholangioma) Biliary neoplasm

320

Allergic oedema

515

C

10

Allergic conditions

72

Allergic oedema

320

Anal oedema

2239

C

10

Allergic conditions

72

Allergic oedema

320

Angioedema

516

C

10

Allergic conditions

72

Allergic oedema

320

1462

C

10

Allergic conditions

72

Allergic oedema

320

Face and neck swelling (see also 'Skin') Facial oedema

1110

C

10

Allergic conditions

72

Allergic oedema

320

517

C

10

Allergic conditions

72

Allergic oedema

320

1577

C

10

Allergic conditions

72

Allergic oedema

320

Facial swelling (see also 'Skin') Lip oedema (see also 'Skin') Quincke's oedema

1111

C

10

Allergic conditions

72

Allergic oedema

320

Rectal oedema

2240

C

10

Allergic conditions

72

Allergic oedema

320

1811

C

10

Allergic conditions

72

Allergic oedema

320

Swollen face (see also 'Skin') Swollen lip (see also 'Skin')

1817

C

1035 1036 1037 1038 1039 1040 1041 1042 1043 1044

69

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1045

Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders

10

Allergic conditions

72

Allergic oedema

320

Vulvar oedema

2121

C

10

Allergic conditions

72

Allergic rhinitis

706

Allergic rhinitis

1305

C

10

Allergic conditions

72

Allergy to food

707

Allergy to food

1308

C

10

Allergic conditions

72

Allergy to food

707

Food allergy

1481

C

10

Allergic conditions

72

Anaphylaxis

317

Anaphylactic shock

1112

C

10

Allergic conditions

72

Anaphylaxis

317

1114

C

10

Allergic conditions

72

Anaphylaxis

317

Anaphylactic-type reaction Anaphylactoid reaction

1113

C

10

Allergic conditions

72

Anaphylaxis

317

Anaphylaxis

512

C

10

Allergic conditions

72

Anaphylaxis

317

1115

C

10

Allergic conditions

72

Atopic allergy NOS

318

513

C

10

Allergic conditions

72

319

2076

C

10

Allergic conditions

72

319

Allergic reaction

1304

C

10

Allergic conditions

72

319

Allergic skin reaction

1306

C

10

Allergic conditions

72

319

Allergy NOS

1307

C

10

Allergic conditions

72

319

Hypersensitivity NOS

514

C

10

Allergic conditions

72

Hypersensitivity reaction Hypersensitivity reaction Hypersensitivity reaction Hypersensitivity reaction Hypersensitivity reaction Hypersensitivity reaction

Generalised allergic reaction NOS Atopic allergy NOS (see also 'Skin') Allergic pruritus

319

Hypersensitivity reaction

2241

C

1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1061

Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders Immune system disorders

10

Allergic conditions

72

Urticaria

321

Hives (see also 'Skin')

1525

C

10

Allergic conditions

72

Urticaria

321

519

C

10

Allergic conditions

72

Urticaria

321

1645

C

10

Allergic conditions

72

Urticaria

321

Nettle rash (see also 'Skin') Nettle-like rash (see also 'Skin') Urticaria

521

C

10

Allergic conditions

72

Urticaria

321

Urticarial erythema

1859

C

10

Allergic conditions

72

Urticaria

321

Urticarial rash

1860

C

10

Allergic conditions

72

Urticaria

321

Welt

1875

C

10

Allergic conditions

72

Urticaria

321

Wheal

520

C

10

Autoimmune disorders

70

313

C

Autoimmune disorders

70

1896

C

10

Autoimmune disorders

70

2009

C

10

Autoimmune disorders

70

314

Autoimmune disorder NOS Immune mediated haemolytic anaemia Immune mediated thrombocytopenia Pemphigus

508

10

Autoimmune disorder NOS Immune mediated haemolytic anaemia Immune mediated thrombocytopenia Pemphigus

509

C

10

Autoimmune disorders

70

Pemphigus

314

Pemphigus foliaceus

1225

C

10

Autoimmune disorders

70

835

Polymyalgia rheumatica

1700

H

10

Bursal disorders

71

315

A

Bursal disorders

71

Bursa of Fabricius degeneration Bursa of Fabricius inflammation

510

10

Polymyalgia rheumatica Bursa of Fabricius degeneration Bursa of Fabricius inflammation

511

A

1062 1063 1064 1065 1066 1067 1068 1069 1070 1071 1072 1073 1074 1075 1076

882 941

316

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1077

Immune system disorders Immune system disorders Immune system disorders Immune system disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders

10

Other immune system disorders Other immune system disorders Other immune system disorders Other immune system disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland neoplasms Mammary gland neoplasms Milk production disorders Milk production disorders

73

322

Demodicosis

2587

C

322

522

C

322

Other immune system disorder NOS Persistent infection

1897

C

73

Other immune system disorder NOS Other immune system disorder NOS Other immune system disorder NOS Sarcoidosis

323

Sarcoidosis

523

C

74

Acute mastitis

324

Acute mastitis

525

A

74

Acute mastitis

324

Erythema of the teat

524

A

74

Acute mastitis

324

Gangrenous mastitis

2526

A

74

Chronic mastitis

325

Chronic mastitis

526

A

74

Mammary gland disorder NOS Mammary gland disorder NOS Mammary gland oedema Mastitis NOS

326

Galactorrhoea

2464

C

326

Mammary gland disorder NOS Mammary gland oedema Mastitis NOS

527

A

528

A

1988

A

328

A

329

Mammary gland neoplasm NOS Mammary hyperplasia

529

75

Mammary gland neoplasm NOS Mammary hyperplasia

530

A

76

Lactation change

950

Agalactia

531

A

76

Lactation change

950

Alteration of milk quality

533

A

1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092

10 10 10 11 11 11 11 11 11 11 11 11 11 11 11

73 73

74 74 74 75

327 914

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1093

Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Mammary gland disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders

11

76

Lactation change

950

Milk drop

534

A

76

Lactation change

950

535

A

76

Lactation change

950

Milk production decrease Milk production increase

536

A

76

Lactation change

950

Onset of lactation

2122

C

11

Milk production disorders Milk production disorders Milk production disorders Milk production disorders Teat disorders

77

External teat disorder

334

External teat disorder

537

A

11

Teat disorders

77

External teat disorder

334

Teat discolouration

1116

A

11

Teat disorders

77

External teat disorder

334

Teat nodules

1117

A

11

Teat disorders

77

External teat disorder

334

Teat ulcer

2628

A

11

Teat disorders

77

Teat canal disorder

335

Teat canal disorder

538

A

12

Congenital metabolic disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders

78

336

C

337

Congenital metabolic disorder Acid-base disorder

539

79

Congenital metabolic disorder Acid-base disorder

540

C

79

Acid-base disorder

337

Acidosis

1898

C

79

Acid-base disorder

337

Alkalosis

2075

C

79

Electrolyte disorder

951

Cervical ventroflexion

2123

C

79

Electrolyte disorder

951

Electrolyte disorder

2144

C

79

Electrolyte disorder

951

High sodium-potassium ratio (Na:K ratio)

2629

C

1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 1105 1106 1107 1108

11 11 11

12 12 12 12 12 12

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1109

Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders

12

Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Electrolyte and fluid balance disorders Food intolerance syndromes Food intolerance syndromes Food intolerance syndromes Metabolism and nutrition disorders Nutritional and vitamin disorders Nutritional and vitamin disorders Nutritional and vitamin disorders Nutritional and vitamin disorders Nutritional and vitamin disorders

79

Electrolyte disorder

951

Hyperchloraemia

2577

C

79

Electrolyte disorder

951

Hyperkalaemia

1944

C

79

Electrolyte disorder

951

Hypernatremia

2511

C

79

Electrolyte disorder

951

Hypochloraemia

2578

C

79

Electrolyte disorder

951

Hypokalaemia

2418

C

79

Electrolyte disorder

951

Hyponatremia

2512

C

79

Electrolyte disorder

951

2630

C

80

340

1302

H

548

C

547

C

2019

C

550

A

341

Food allergy diarrhoea and/or constipation Food intolerance syndrome Metabolism and nutrition disorder NOS Selenium deficiency syndrome Selenium toxicity signs

2020

A

341

Trace element disorder

549

C

81

Food intolerance syndrome Food intolerance syndrome Food intolerance syndrome Metabolism and nutrition disorder NOS Trace element disorder Trace element disorder Trace element disorder Vitamin disorder

Low sodium-potassium ratio (Na:K ratio) Alcohol intolerance

342

Vitamin deficiency

552

C

81

Vitamin disorder

342

Vitamin disorder

551

C

1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 1122 1123 1124

12 12 12 12 12 12 12 12 12 12 12 12 12 12 12

80 80 234 81 81 81

340 340 924 341

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1125

Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Metabolism and nutrition disorders Musculoskeletal disorders

12

Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Other metabolic disorders Bone and joint disorders

82

Changes in blood phosphorous Changes in blood phosphorous Copper deficiency signs Copper toxicity signs

930

Hyperphosphataemia

2046

C

930

Hypophosphataemia

2242

C

348

Copper deficiency signs

561

A

344

Copper toxicity signs

554

A

Hypercalcaemic condition Hyperglycaemia

343

Hypercalcaemia

553

C

903

Hyperglycaemia

1946

C

Hypocalcaemic condition Hypocalcaemic condition Hypocalcaemic condition Hypoglycaemia

347

Eclampsia

558

C

347

Hypocalcaemic condition

560

C

347

Milk fever

559

C

904

Hypoglycaemia

1947

C

349

564

C

349

Hypomagnesaemic condition Staggers (grass)

563

A

82

Hypomagnesaemic condition Hypomagnesaemic condition Ketosis

351

Acetonaemia

566

C

82

Ketosis

351

Ketosis

567

C

82

Other metabolic disorder Arthritis

823

Other metabolic disorder Arthritis

1668

C

569

C

1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140

12 12 12 12 12 12 12 12 12 12 12 12 12 12 13

82 82 82 82 82 82 82 82 82 82 82

83

352

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1141

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

13

Bone and joint disorders

83

Arthritis

352

Haemarthrosis

2527

C

13

Bone and joint disorders

83

Arthritis

352

Joint effusion

570

C

13

Bone and joint disorders

83

Arthritis

352

Joint inflammation

571

C

13

Bone and joint disorders

83

Arthritis

352

Joint oedema

572

C

13

Bone and joint disorders

83

Arthritis

352

Joint stiffness

573

C

13

Bone and joint disorders

83

Arthritis

352

Joint swelling

568

C

13

Bone and joint disorders

83

Arthritis

352

Polyarthritis

574

C

13

Bone and joint disorders

83

Arthritis

352

Septic arthritis

1899

C

13

Bone and joint disorders

83

Arthritis

352

Stiff knee

1792

C

13

Bone and joint disorders

83

Arthritis

352

Swollen joint

1816

C

13

Bone and joint disorders

83

Arthritis

352

Swollen wrist

1821

H

13

Bone and joint disorders

83

Arthropathy NOS

722

Arthropathy NOS

1335

C

13

Bone and joint disorders

83

Arthrosis

353

Arthrosis

575

C

13

Bone and joint disorders

83

Arthrosis

353

Polyarthrosis

576

C

13

Bone and joint disorders

83

354

C

Bone and joint disorders

83

Bone and joint disorder NOS Joint cartilage disorder NOS

577

13

Bone and joint disorder NOS Bone and joint disorder NOS

2243

C

1142 1143 1144 1145 1146 1147 1148 1149 1150 1151 1152 1153 1154 1155 1156

354

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1157

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

13

Bone and joint disorders

83

354

A

Bone and joint disorders

83

354

Joint ligament disorder NOS Knuckling

2465

13

578

C

13

Bone and joint disorders

83

354

Panosteitis

1948

C

13

Bone and joint disorders

83

354

Polyarthropathy

1118

C

13

Bone and joint disorders

83

355

Cartilage degeneration

579

C

13

Bone and joint disorders

83

Bone and joint disorder NOS Bone and joint disorder NOS Bone and joint disorder NOS Bone and joint disorder NOS Cartilage degeneration Crystal arthropathy

356

Crystal arthropathy

580

C

13

Bone and joint disorders

83

Crystal arthropathy

356

Gout

581

C

13

Bone and joint disorders

83

357

Delayed fracture union

583

C

13

Bone and joint disorders

83

357

Mal union

582

C

13

Bone and joint disorders

83

357

Pseudoarthrosis

584

C

13

Bone and joint disorders

83

Delayed fracture union Delayed fracture union Delayed fracture union Fracture

358

Fracture

585

C

13

Bone and joint disorders

83

Joint pain NOS

359

Joint ache

587

C

13

Bone and joint disorders

83

Joint pain NOS

359

Joint pain

588

C

13

Bone and joint disorders

83

Joint pain NOS

359

Joint pain NOS

586

C

13

Bone and joint disorders

83

360

Metaphyseal osteopathy

589

C

13

Bone and joint disorders

83

Metaphyseal osteopathy Osteochondritis

361

Osteochondritis

590

C

1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1173

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

13

Bone and joint disorders

83

Osteochondritis

361

591

C

13

Bone and joint disorders

83

Osteomyelitis

362

Osteochondritis dissecans Osteomyelitis

592

C

13

Bone and joint disorders

83

Spondylopathy

857

Spondylitis

2244

C

13

Bone and joint disorders

83

Spondylopathy

857

Spondylopathy

2379

C

13

Bone and joint disorders

83

Spondylopathy

857

Spondylosis

1788

C

13

Bone and joint disorders

83

363

Subchondrial bone cyst

593

C

13

Bone and joint disorders

83

Subchondrial bone cyst Torticollis

364

Lateral neck deviation

596

C

13

Bone and joint disorders

83

Torticollis

364

Torticollis

594

C

13

Bone and joint disorders

83

Torticollis

364

Wry neck

595

C

13

84

597

C

598

C

366

Congenital musculoskeletal disorder Connective tissue disorder NOS Fasciitis

2467

C

1010

Discus prolapse

599

C

1010

C

368

Intervertebral disc disease Jaw disorder

2579

87

Congenital musculoskeletal disorder Connective tissue disorder NOS Connective tissue disorder NOS Intervertebral disc disease Intervertebral disc disease Jaw disorder

365

13

Congenital musculoskeletal disorders Connective tissue disorders NOS Connective tissue disorders NOS Intervertebral disc disorders Intervertebral disc disorders Jaw disorders

600

C

13

Jaw disorders

87

Jaw disorder

368

Jaw pain

1949

C

1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 1188

13 13 13 13

85 85 86 86

366

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1189

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

13

Ligament disorders

245

Ligament rupture

1011

Ligament rupture

2580

C

13

Ligament disorders

245

Ligament rupture

1011

Torn ligament

2581

C

13

88

802

C

369

2124

C

88

Osteodystrophy

369

Metabolic bone disorder NOS Hypertrophic osteodystrophy Osteodystrophy

1613

88

Metabolic bone disorder NOS Osteodystrophy

601

C

88

Osteodystrophy

369

Rubber beak/jaw

602

A

88

Osteomalacia

370

Osteomalacia

603

C

13

Metabolic bone disorders Metabolic bone disorders Metabolic bone disorders Metabolic bone disorders Metabolic bone disorders Muscular disorders

89

Muscle ischaemia

372

Muscle anaemia

606

C

13

Muscular disorders

89

Muscle ischaemia

372

Muscle ischaemia

607

C

13

Muscular disorders

89

Muscle pain

373

Muscle pain

608

C

13

Muscular disorders

89

Muscle stiffness

374

Muscle stiffness

609

C

13

Muscular disorders

89

Muscle stiffness

374

Stiffness limb

1793

C

13

Muscular disorders

89

Muscle weakness NOS

806

Muscle weakness NOS

1629

C

13

Muscular disorders

89

Myoglobinuria

371

Azoturia

605

C

13

Muscular disorders

89

Myoglobinuria

371

Equine myoglobinuria

604

A

13

Muscular disorders

89

Myoglobinuria

371

Myoglobinuria

2056

C

1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200 1201 1202 1203 1204

13 13 13 13

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1205

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

13

Muscular disorders

89

Myopathy

375

Muscle contracture

2468

C

13

Muscular disorders

89

Myopathy

375

Muscle degeneration

1119

C

13

Muscular disorders

89

Myopathy

375

Muscle wasting

611

C

13

Muscular disorders

89

Myopathy

375

Myopathy

610

C

13

Muscular disorders

89

Myositis

376

2245

C

13

Muscular disorders

89

Myositis

376

Elevated creatine-kinase (CK) Muscle inflammation

613

C

13

Muscular disorders

89

Myositis

376

Muscle necrosis

1245

C

13

Muscular disorders

89

Myositis

376

Myositis

612

C

13

Muscular disorders

89

Myositis

376

Polymyositis

2631

C

13

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

90

Hyperextension

377

Hyperextension

614

C

90

Lameness

378

Lameness

615

C

90

Lameness

378

Limping

1990

C

90

Laminitis

379

Founder

616

C

90

Laminitis

379

Laminitis

617

C

90

Musculoskeletal disorder NOS Musculoskeletal disorder NOS

640

Gait abnormality

1989

C

640

Head down

2397

C

1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220

13 13 13 13 13 13

90

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1221

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders

13

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal neoplasms Musculoskeletal neoplasms Musculoskeletal neoplasms Musculoskeletal neoplasms Synovial and bursa disorders Synovial and bursa disorders Synovial and bursa disorders

90

Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Musculoskeletal disorder NOS Chondrosarcoma

640

Limb weakness

1121

C

640

Lumbar pain

2390

C

640

1120

C

640

Musculoskeletal disorder NOS Musculoskeletal pain

2021

C

640

Plantigrade posture

2632

A

640

Stiff gait

1950

C

640

Stiffness NOS

1794

C

640

Unable to jump

2394

C

640

Walking on tiptoes

2389

C

380

Chondrosarcoma

618

C

641

C

381

Musculoskeletal neoplasm NOS Osteosarcoma

1122

91

Musculoskeletal neoplasm NOS Osteosarcoma

619

C

91

Rhabdomyosarcoma

382

Rhabdomyosarcoma

620

C

92

Bursitis

383

Bursitis

621

C

92

Synovitis

384

Synovitis

623

C

92

Synovitis

384

Windgall

622

A

1222 1223 1224 1225 1226 1227 1228 1229 1230 1231 1232 1233 1234 1235 1236

13 13 13 13 13 13 13 13 13 13 13 13 13 13 13

90 90 90 90 90 90 90 90 91 91

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1237

13

92

Synovitis

384

Windpuff

624

A

13

Synovial and bursa disorders Tendon disorders

93

Tendinitis

385

Tendinitis

625

C

13

Tendon disorders

93

Tendon injury

386

Tendon injury

626

C

13

Tendon disorders

93

Tendon rupture

387

Tendon rupture

627

C

1241

Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Musculoskeletal disorders Neurological disorders

14

Amnestic conditions

201

Amnesia

710

Amnesia

1312

H

1242

Neurological disorders

14

Amnestic conditions

201

Amnesia

710

Memory loss

1603

H

1243

Neurological disorders

14

Amnestic conditions

201

Memory impaired NOS

797

Forgetfulness

1482

H

1244

Neurological disorders

14

Amnestic conditions

201

Memory impaired NOS

797

Memory impaired NOS

1602

H

1245

Neurological disorders

14

Amnestic conditions

201

Memory impaired NOS

797

Short term memory loss

1747

H

1246

Neurological disorders

14

Amnestic conditions

201

Memory impaired NOS

797

Transient memory loss

1851

H

1247

Neurological disorders

14

system

94

Amaurosis

662

C

Neurological disorders

14

system

94

388

628

C

1249

Neurological disorders

14

system

94

389

629

C

1250

Neurological disorders

14

system

94

389

Brain disorder NOS

1356

C

1251

Neurological disorders

14

system

94

389

C

Neurological disorders

14

system

94

2400

C

1253

Neurological disorders

14

system

94

389

Central nervous system disorder NOS Extrapyramidal syndrome Fly biting behaviour

631

1252

2469

C

1254

Neurological disorders

14

system

94

Central system Central system Central system Central system Central system Central system Central system

Amaurosis (see also PT Impaired vision) Central nervous system depression Brain damage NOS

410

1248

Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders

389

Head bobbing

2022

C

1238 1239 1240

nervous depression nervous disorder NOS nervous disorder NOS nervous disorder NOS nervous disorder NOS nervous disorder NOS nervous disorder NOS

389

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1255

Neurological disorders

14

94

C

14

Head tilt - neurological disorder Head tremor

2523

Neurological disorders

1900

C

1257

Neurological disorders

14

C

Neurological disorders

14

system

94

1372

C

1259

Neurological disorders

14

system

94

391

633

C

1260

Neurological disorders

14

system

94

Encephalitis

391

Viral encephalitis

1868

C

1261

Neurological disorders

14

system

94

Encephalopathy NOS

404

Encephalopathy NOS

666

C

1262

Neurological disorders

14

system

94

Headache

773

Headache

1511

H

1263

Neurological disorders

14

system

94

Headache

773

Migraine-like headache

1615

H

1264

Neurological disorders

14

system

94

Headache

773

Sinus headache

1751

H

1265

Neurological disorders

14

system

94

Cerebral oedema

635

C

Neurological disorders

14

system

94

392

Head pressing

636

C

1267

Neurological disorders

14

system

94

392

C

Neurological disorders

14

system

94

393

Increased intracranial pressure Meningitis

634

1268

Increased intracranial pressure Increased intracranial pressure Increased intracranial pressure Meningitis

392

1266

637

C

1269

Neurological disorders

14

system

94

Migraine

803

Cluster headache

1380

H

1270

Neurological disorders

14

Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders Central nervous disorders

Central nervous system infection and inflammation Central nervous system infection NOS Encephalitis

632

1258

Central nervous system disorder NOS Central nervous system disorder NOS Central nervous system infection and inflammation Central nervous system infection NOS Encephalitis

389

1256

Central nervous system disorders Central nervous system disorders Central nervous system disorders

system

94

Migraine

803

Migraine

1614

H

94 94

389 390

730

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1271

Neurological disorders

14

94

Motor neurone disease

1621

C

Neurological disorders

14

94

Motor neurone disease Multiple sclerosis

804

1272

805

Multiple sclerosis (MS)

1626

H

1273

Neurological disorders

14

94

Multiple sclerosis

805

H

Neurological disorders

14

94

Myelitis

642

Multiple sclerosis (MS) aggravated Myelitis

1627

1274

1123

C

1275

Neurological disorders

14

94

Myelitis

642

Transverse myelitis

1124

C

1276

Neurological disorders

14

94

Writing impaired

874

Writing impaired

1877

H

1277

Neurological disorders

14

95

C

14

Cerebral vascular accident Stroke

638

Neurological disorders

639

C

1279

Neurological disorders

14

395

Congenital neurological disorder NOS

640

C

1280

Neurological disorders

14

96

396

Hydrocephalus

641

C

1281

Neurological disorders

14

97

Convulsion

397

Clonic seizure

1125

C

1282

Neurological disorders

14

97

Convulsion

397

Convulsion

642

C

1283

Neurological disorders

14

97

Convulsion

397

Convulsive disorder NOS

1397

C

1284

Neurological disorders

14

97

Convulsion

397

Emprosthotonus

2023

C

1285

Neurological disorders

14

97

Convulsion

397

Fit

643

C

1286

Neurological disorders

14

Congenital neurological disorders Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy

Cerebral vascular accident Cerebral vascular accident Congenital neurological disorder NOS Hydrocephalus

394

1278

Central nervous system disorders Central nervous system disorders Central nervous system disorders Central nervous system disorders Central nervous system disorders Central nervous system disorders Central nervous system vascular disorders Central nervous system vascular disorders Congenital neurological disorders

97

Convulsion

397

Opisthotonus

644

C

95 96

394

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1287

Neurological disorders

14

97

Convulsion

397

Paddling

1226

C

1288

Neurological disorders

14

97

Convulsion

397

Seizure NOS

645

C

1289

Neurological disorders

14

97

Convulsion

397

Tonic seizure

1126

C

1290

Neurological disorders

14

97

Convulsion

397

Tonic-clonic seizure

646

C

1291

Neurological disorders

14

97

Epileptic seizure

398

Absence seizure

1295

C

1292

Neurological disorders

14

97

Epileptic seizure

398

Epilepsy

647

C

1293

Neurological disorders

14

97

Epileptic seizure

398

Epileptic fit

1443

C

1294

Neurological disorders

14

97

Epileptic seizure

398

Epileptic seizure

648

C

1295

Neurological disorders

14

97

Epileptic seizure

398

C

Neurological disorders

14

97

Epileptic seizure

398

Increased seizure frequency Petit mal epilepsy

2528

1296

1694

C

1297

Neurological disorders

14

97

Epileptic seizure

398

Status epilepticus

2473

C

1298

Neurological disorders

14

97

Myoclonus

399

Extensor rigidity

1127

C

1299

Neurological disorders

14

97

Myoclonus

399

Muscular hypertonicity

1128

C

1300

Neurological disorders

14

97

Myoclonus

399

Myoclonic jerk

1631

C

1301

Neurological disorders

14

97

Myoclonus

399

Myoclonus

650

C

1302

Neurological disorders

14

Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Convulsions and epilepsy Coordination and balance signs

98

Abnormal movement NOS

643

Abnormal movement NOS

1131

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1303

Neurological disorders

14

98

Ataxia

400

Ataxia

654

C

1304

Neurological disorders

14

98

Ataxia

400

Balance impaired

1341

C

1305

Neurological disorders

14

98

Ataxia

400

Balance problem

372

C

1306

Neurological disorders

14

98

Ataxia

400

C

Neurological disorders

14

98

Ataxia

400

Central vestibular disorder Cerebellar ataxia

2471

1307

2634

C

1308

Neurological disorders

14

Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs

98

Ataxia

400

652

C

1309

Neurological disorders

14

98

Ataxia

400

2466

A

1310

Neurological disorders

14

98

Ataxia

400

Drunken gait

1133

C

1311

Neurological disorders

14

98

Ataxia

400

Equilibrium disorder

371

C

1312

Neurological disorders

14

98

Ataxia

400

Falling

651

C

1313

Neurological disorders

14

98

Ataxia

400

Hind limb ataxia

1134

A

1314

Neurological disorders

14

98

Ataxia

400

Incoordination

1901

C

1315

Neurological disorders

14

Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs

Circling - neurological disorder (see also 'Behavioural disorders') Clumsy

98

Ataxia

400

656

C

1316

Neurological disorders

14

98

Ataxia

400

1248

C

1317

Neurological disorders

14

Coordination and balance signs Coordination and balance signs

Lack of coordination (see also 'Ear' vestibular disorder) Locomotor disturbance

98

Ataxia

400

Paradoxical vestibular syndrome

2472

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1318

Neurological disorders

14

98

Ataxia

400

Staggering

655

C

1319

Neurological disorders

14

98

Ataxia

400

Stumbling gait

657

C

1320

Neurological disorders

14

98

Ataxia

400

Unable to stand

653

C

1321

Neurological disorders

14

98

Ataxia

400

Unsteady gait

1858

C

1322

Neurological disorders

14

98

Ataxia

400

Walking difficulty

1902

C

1323

Neurological disorders

14

98

Dizziness

750

Dizziness

1422

H

1324

Neurological disorders

14

98

Dizziness

750

Dizzy on standing

1423

H

1325

Neurological disorders

14

98

Dizziness

750

Dizzy spell

1424

H

1326

Neurological disorders

14

98

Dizziness

750

Felt giddy

1473

H

1327

Neurological disorders

14

98

Dizziness

750

Giddiness

1498

H

1328

Neurological disorders

14

98

Dizziness

750

Light headedness

1576

H

1329

Neurological disorders

14

98

Dizziness

750

Vertigo

1865

H

1330

Neurological disorders

14

98

Dysmetria

402

Dysmetria

1137

C

1331

Neurological disorders

14

98

Dysmetria

402

Goose stepping

663

C

1332

Neurological disorders

14

98

Dysmetria

402

High leg gait

661

C

1333

Neurological disorders

14

Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs Coordination and balance signs

98

Dysmetria

402

Hypermetria

662

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1334

Neurological disorders

14

Impaired consciousness

99

Coma

403

Coma

664

C

1335

Neurological disorders

14

Impaired consciousness

99

Coma

403

Vegetative state

665

C

1336

Neurological disorders

14

Impaired consciousness

99

663

Dullness

126

C

1337

Neurological disorders

14

Impaired consciousness

99

663

Impaired consciousness

1217

C

1338

Neurological disorders

14

Impaired consciousness

99

663

C

Neurological disorders

14

Impaired consciousness

99

663

Reduced level of consciousness Semi-conscious

1724

1339

1738

C

1340

Neurological disorders

14

Impaired consciousness

99

663

Star-gazing

2246

C

1341

Neurological disorders

14

Impaired consciousness

99

663

Staring

2635

C

1342

Neurological disorders

14

Impaired consciousness

99

663

Vacant

2636

C

1343

Neurological disorders

14

Impaired consciousness

99

Impaired consciousness Impaired consciousness Impaired consciousness Impaired consciousness Impaired consciousness Impaired consciousness Impaired consciousness Loss of consciousness

405

Blackout

1345

C

1344

Neurological disorders

14

Impaired consciousness

99

Loss of consciousness

405

668

C

1345

Neurological disorders

14

Impaired consciousness

99

Loss of consciousness

405

Collapse (see also 'Cardio-vascular' and 'Systemic disorders') Eyes rolling back

2084

C

1346

Neurological disorders

14

Impaired consciousness

99

Loss of consciousness

405

Loss of consciousness

667

C

1347

Neurological disorders

14

Impaired consciousness

99

Loss of consciousness

405

Unconscious

1857

C

1348

Neurological disorders

14

Impaired consciousness

99

Loss of consciousness

405

Unresponsive to stimuli

2247

C

1349

Neurological disorders

14

Impaired consciousness

99

Sedation

664

Prolonged anaesthesia

1218

C

1350

Neurological disorders

14

Impaired consciousness

99

Sedation

664

Recovery prolonged

1904

C

1351

Neurological disorders

14

Impaired consciousness

99

Sedation

664

Sedation

111

C

1352

Neurological disorders

14

Impaired consciousness

99

Sedation

664

Sedation prolonged

1903

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1353

Neurological disorders

14

Impaired consciousness

99

Somnolence

68

127

C

1354

Neurological disorders

14

Impaired consciousness

99

Somnolence

68

Sleepiness neurological disorder Somnolence

110

C

1355

Neurological disorders

14

Mental impairment

217

734

C

Neurological disorders

14

Mental impairment

217

734

Cognitive and attention disorders NOS Cognitive disorder NOS

1381

1356

1382

C

1357

Neurological disorders

14

Mental impairment

217

734

Cognitive disturbance

1383

C

1358

Neurological disorders

14

Mental impairment

217

734

Cognitive impairment

1384

C

1359

Neurological disorders

14

Mental impairment

217

734

C

Neurological disorders

14

Mental impairment

217

401

Drowsiness neurological disorder Confusion

1282

1360

Cognitive disorder NOS Cognitive disorder NOS Cognitive disorder NOS Cognitive disorder NOS Cognitive disorder NOS Disorientation

659

A

1361

Neurological disorders

14

Mental impairment

217

Disorientation

401

Disorientation

660

A

1362

Neurological disorders

14

Mental impairment

217

Disorientation

401

Disoriented state

1418

C

1363

Neurological disorders

14

Mental impairment

217

748

Concentration impaired

1392

C

1364

Neurological disorders

14

Mental impairment

217

748

Disturbance in attention

1420

C

1365

Neurological disorders

14

Mental impairment

217

748

Loss of concentration

1589

C

1366

Neurological disorders

14

Mental impairment

217

748

Poor concentration

1701

C

1367

Neurological disorders

14

Mental impairment

217

Disturbance in attention Disturbance in attention Disturbance in attention Disturbance in attention Mental confusion

747

Confused

1393

C

1368

Neurological disorders

14

Mental impairment

217

Mental confusion

747

Mental confusion

1609

C

1369

Neurological disorders

14

Mental impairment

217

801

C

Neurological disorders

14

Mental impairment

217

Mental function decreased Mental impairment NOS

1611

1370

Mental impairment NOS Mental impairment NOS

1612

C

801

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1371

Neurological disorders

14

100

C

14

Nervous system neoplasm Motor dysfunction NOS

669

Neurological disorders

1620

C

1373

Neurological disorders

14

C

Neurological disorders

14

Nervous system disorder NOS Neurological signs NOS

1642

1374

630

C

1375

Neurological disorders

14

C

Neurological disorders

14

219

813

Neurological symptoms NOS Nerve pain NOS

1648

1376

Nervous system neoplasm Neurological disorder NOS Neurological disorder NOS Neurological disorder NOS Neurological disorder NOS Neurological pain

406

1372

1640

C

1377

Neurological disorders

14

219

Neurological pain

813

Neuralgia

1646

C

1378

Neurological disorders

14

219

Neurological pain

813

Neurological pain NOS

1647

C

1379

Neurological disorders

14

101

Akinesia

345

Akinesia

1301

C

1380

Neurological disorders

14

101

Akinesia

345

C

Neurological disorders

14

101

Anisocoria

407

Loss of voluntary movement Anisocoria

1597

1381

670

C

1382

Neurological disorders

14

101

Anisocoria

407

Unequal pupils

671

C

1383

Neurological disorders

14

101

Cholinergic disorder

408

Cholinergic disorder

673

C

1384

Neurological disorders

14

101

Cholinergic disorder

408

C

Neurological disorders

14

101

Dyskinesia

753

Organophosphate toxicity NOS Dyskinesia

672

1385

1432

C

1386

Neurological disorders

14

Nervous system neoplasms Neurological disorders NOS Neurological disorders NOS Neurological disorders NOS Neurological disorders NOS Neurological disorders NOS Neurological disorders NOS Neurological disorders NOS Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders

101

Dyskinesia

753

Involuntary movement

1558

C

219 219 219 219

812 812 812 812

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1387

Neurological disorders

14

101

Hyperreflexia

410

Hyperreflexia

678

C

1388

Neurological disorders

14

101

Hyperreflexia

410

Increased reflexes

1532

C

1389

Neurological disorders

14

101

Hypertonia

778

Hypertonia

1529

C

1390

Neurological disorders

14

101

Hypertonia

778

Muscle rigidity

1628

C

1391

Neurological disorders

14

101

Hypertonia

778

Rigidity

1730

C

1392

Neurological disorders

14

101

Hypertonia

778

Rigidity of limbs

1731

C

1393

Neurological disorders

14

101

Hypertonia

778

Tense muscles

2248

C

1394

Neurological disorders

14

101

Hyporeflexia

409

Depressed reflexes

677

C

1395

Neurological disorders

14

101

Hyporeflexia

409

Dull reflexes

675

C

1396

Neurological disorders

14

101

Hyporeflexia

409

Hyporeflexia

1220

C

1397

Neurological disorders

14

101

Hyporeflexia

409

Reduced reflexes

676

C

1398

Neurological disorders

14

101

Hyporeflexia

409

Slow reflexes

674

C

1399

Neurological disorders

14

101

Hypotonia

971

Flaccid muscles

2250

C

1400

Neurological disorders

14

101

Hypotonia

971

Hypotonia

2251

C

1401

Neurological disorders

14

101

Hypotonia

971

Limpness

2252

C

1402

Neurological disorders

14

Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders

101

Miosis

411

Constricted pupils

679

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1403

Neurological disorders

14

101

Miosis

411

Miosis

680

C

1404

Neurological disorders

14

101

Muscle tremor

412

Chorea

683

C

1405

Neurological disorders

14

101

Muscle tremor

412

Clonic muscle spasm

1139

C

1406

Neurological disorders

14

101

Muscle tremor

412

Diaphragmatic flutter

2582

C

1407

Neurological disorders

14

101

Muscle tremor

412

Ear twitching

1138

C

1408

Neurological disorders

14

101

Muscle tremor

412

Fasciculation

688

C

1409

Neurological disorders

14

101

Muscle tremor

412

Hiccup

2090

C

1410

Neurological disorders

14

101

Muscle tremor

412

Intention tremor

2249

C

1411

Neurological disorders

14

101

Muscle tremor

412

Muscle shaking

1745

C

1412

Neurological disorders

14

101

Muscle tremor

412

Muscle spasm NOS

682

C

1413

Neurological disorders

14

101

Muscle tremor

412

Muscle tremor

684

C

1414

Neurological disorders

14

101

Muscle tremor

412

Shivering

1905

C

1415

Neurological disorders

14

101

Muscle tremor

412

Spasm

681

C

1416

Neurological disorders

14

101

Muscle tremor

412

Tic(s)

685

C

1417

Neurological disorders

14

101

Muscle tremor

412

Tonic muscle spasm

1140

C

1418

Neurological disorders

14

Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders

101

Muscle tremor

412

Trembling

687

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1419

Neurological disorders

14

101

Muscle tremor

412

Tremor

1852

C

1420

Neurological disorders

14

101

Muscle tremor

412

Tremor of limb

1853

C

1421

Neurological disorders

14

101

Muscle tremor

412

Tremor/shaking of hand

1854

H

1422

Neurological disorders

14

101

Muscle tremor

412

Twitching

686

C

1423

Neurological disorders

14

101

Myasthenia gravis

645

Myasthenia gravis

1142

C

1424

Neurological disorders

14

101

Mydriasis

413

Dilated pupils

1414

C

1425

Neurological disorders

14

101

Mydriasis

413

Enlarged pupils

689

C

1426

Neurological disorders

14

101

Mydriasis

413

Mydriasis

690

C

1427

Neurological disorders

14

101

C

14

1649

C

1429

Neurological disorders

14

1822

C

1430

Neurological disorders

14

101

Nystagmus

414

1143

C

1431

Neurological disorders

14

101

Nystagmus

414

Nystagmus

691

C

1432

Neurological disorders

14

101

Nystagmus

414

Rotatory nystagmus

2637

C

1433

Neurological disorders

14

101

Nystagmus

414

Vertical nystagmus

2638

C

1434

Neurological disorders

14

Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders

Muscle atrophy (see also 'Muscle wasting') Neuromuscular disorder NOS Symptom NOS involving neurological and muscular skeletal SOCs Horizontal nystagmus

2470

Neurological disorders

Neuromuscular disorder NOS Neuromuscular disorder NOS Neuromuscular disorder NOS

814

1428

Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders

101

Tetany

863

Lockjaw

1587

C

101 101

814 814

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1435

Neurological disorders

14

101

Tetany

863

Tetanus

1831

C

1436

Neurological disorders

14

101

Tetany

863

Tetany

1130

C

1437

Neurological disorders

14

101

Tetany

863

Trismus

1855

C

1438

Neurological disorders

14

102

Cranial nerve disorder

415

Bell's palsy

1343

C

1439

Neurological disorders

14

102

Cranial nerve disorder

415

Cranial nerve disorder

1147

C

1440

Neurological disorders

14

102

Cranial nerve disorder

415

Cranial nerve paralysis

1150

C

1441

Neurological disorders

14

102

Cranial nerve disorder

415

Droopy lower lip

2454

C

1442

Neurological disorders

14

102

Cranial nerve disorder

415

Eyelid ptosis

2392

C

1443

Neurological disorders

14

102

Cranial nerve disorder

415

Facial nerve disorder

1148

C

1444

Neurological disorders

14

102

Cranial nerve disorder

415

Facial palsy

1464

C

1445

Neurological disorders

14

102

Cranial nerve disorder

415

Facial paralysis

1144

C

1446

Neurological disorders

14

102

Cranial nerve disorder

415

Laryngeal paralysis

1991

C

1447

Neurological disorders

14

102

Cranial nerve disorder

415

Lip paralysis

1151

C

1448

Neurological disorders

14

102

Cranial nerve disorder

415

Roaring

2034

A

1449

Neurological disorders

14

102

Cranial nerve disorder

415

Tongue paralysis

2108

C

1450

Neurological disorders

14

Neuromuscular disorders Neuromuscular disorders Neuromuscular disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders

102

Cranial nerve disorder

415

Trigeminus paralysis

1149

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1451

Neurological disorders

14

paretic

102

Paralysis

668

Flaccid paralysis

695

C

1452

Neurological disorders

14

paretic

102

Paralysis

668

Hemiplegia

693

C

1453

Neurological disorders

14

paretic

102

Paralysis

668

Hind limb paralysis

2025

A

1454

Neurological disorders

14

paretic

102

Paralysis

668

Paralysis

696

C

1455

Neurological disorders

14

paretic

102

Paralysis

668

Paralysis NOS

1677

C

1456

Neurological disorders

14

paretic

102

Paralysis

668

Paraplegia

692

C

1457

Neurological disorders

14

paretic

102

Paralysis

668

Quadriplegia

694

C

1458

Neurological disorders

14

paretic

102

Paralysis

668

C

Neurological disorders

14

paretic

102

Paralysis

668

Skeletal muscle paralysis Tail paralysis

1753

1459

2170

A

1460

Neurological disorders

14

paretic

102

Paresis

416

Collapse of leg

1389

C

1461

Neurological disorders

14

paretic

102

Paresis

416

C

Neurological disorders

14

paretic

102

Paresis

416

697

C

1463

Neurological disorders

14

paretic

102

Paresis

416

Deterioration of muscle function Hemiparesis (weakness L or R side) Hind limb paresis

1409

1462

1153

A

1464

Neurological disorders

14

paretic

102

Paresis

416

C

Neurological disorders

14

paretic

102

Paresis

416

Monoparesis (paralysis of limb) Paraparesis

1617

1465

699

C

1466

Neurological disorders

14

Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders Paralytic and disorders

paretic

102

Paresis

416

Paresis

698

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1467

Neurological disorders

14

102

Paresis

416

Quadriparesis

700

C

1468

Neurological disorders

14

102

Paresis

416

Tail paresis

2171

A

1469

Neurological disorders

14

102

Paresis

416

Unilateral paresis

1154

C

1470

Neurological disorders

14

102

Spasticity

417

Spasticity

701

C

1471

Neurological disorders

14

Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Paralytic and paretic disorders Parkinsonism

222

Parkinsonism

829

Parkinsonism

1681

H

1472

Neurological disorders

14

Parkinsonism

222

Parkinsonism

829

Parkinson's disease

1680

H

1473

Neurological disorders

14

103

Horner's syndrome

418

Horner's syndrome

702

C

1474

Neurological disorders

14

103

Nerve damage NOS

1639

C

Neurological disorders

14

883

C

Neurological disorders

14

103

832

Peripheral nervous system disorder NOS Carpal tunnel syndrome

1906

1476

Peripheral nerve injury Peripheral nervous system disorder NOS Peripheral neuropathy

831

1475

1370

H

1477

Neurological disorders

14

103

Peripheral neuropathy

832

Myelopathy NOS

2173

C

1478

Neurological disorders

14

103

Peripheral neuropathy

832

Neuropathy NOS

1650

C

1479

Neurological disorders

14

103

Peripheral neuropathy

832

Peripheral neuropathy

1689

C

1480

Neurological disorders

14

103

Peripheral neuropathy

832

Polyneuritis

2102

C

1481

Neurological disorders

14

103

Peripheral neuropathy

832

Polyradiculoneuritis

2103

C

1482

Neurological disorders

14

Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Peripheral neuropathies and neuritis Sensory abnormalities

104

Hyperaesthesia

419

Hyperaesthesia

706

C

1483

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

Hypersensitivity to light

705

C

1484

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

Hypersensitivity to

707

C

103

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

movement 1485

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

Hypersensitivity to pain

703

C

1486

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

1695

C

1487

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

1534

C

1488

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

1535

C

1489

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

Increased sensitivity to light Increased sensitivity to sound Increased skin sensitivity Photophobia

704

C

1490

Neurological disorders

14

Sensory abnormalities

104

Hyperaesthesia

419

Rolling skin syndrome

2404

C

1491

Neurological disorders

14

Sensory abnormalities

104

Hypoaesthesia

905

Hypoaesthesia

1957

C

1492

Neurological disorders

14

Sensory abnormalities

104

Hypoaesthesia

905

Hyposensitivity to pain

1968

C

1493

Neurological disorders

14

Sensory abnormalities

104

Hypoaesthesia

905

1958

C

1494

Neurological disorders

14

Sensory abnormalities

104

Hypoaesthesia

905

Localised numbness (see also application site SOC) Numbness

1972

C

1495

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Burning sensation (skin)

1367

H

1496

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Paraesthesia

1674

C

1497

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

1675

C

1498

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Paraesthesia generalised Paraesthesia localised

1676

C

1499

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Pins and needles

1697

H

1500

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Pricking skin sensation

1707

H

1501

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Skin smarting

1764

H

1502

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Stinging skin

1796

H

1503

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Tingling sensation

1841

H

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1504

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Tingling skin

1842

H

1505

Neurological disorders

14

Sensory abnormalities

104

Paraesthesia

826

Tongue paraesthesia

1250

C

1506

Neurological disorders

14

Sensory abnormalities

104

646

Impaired proprioception

1156

C

1507

Neurological disorders

14

Sensory abnormalities

104

646

C

Neurological disorders

14

Sensory abnormalities

104

646

Proprioception abnormality Proprioception deficit

1155

1508

1157

C

1509

Neurological disorders

14

Sensory abnormalities

104

646

Proprioception loss

1158

C

1510

Neurological disorders

14

Sensory abnormalities

104

Proprioception abnormality Proprioception abnormality Proprioception abnormality Proprioception abnormality Sensory abnormality

843

Flehmen response

2532

A

1511

Neurological disorders

14

Sensory abnormalities

104

Sensory abnormality

843

Sensation loss

1739

C

1512

Neurological disorders

14

Sensory abnormalities

104

Sensory abnormality

843

1740

C

1513

Neurological disorders

14

Sensory abnormalities

104

Sensory abnormality

843

Sensory abnormality NOS Sensory loss

1741

C

1514

Neurological disorders

14

Sensory abnormalities

104

Smell disorder

854

Anosmia

1318

C

1515

Neurological disorders

14

Sensory abnormalities

104

Smell disorder

854

Loss of smell

1592

C

1516

Neurological disorders

14

Sensory abnormalities

104

Smell disorder

854

Parosmia

1683

C

1517

Neurological disorders

14

Sensory abnormalities

104

Smell disorder

854

Smell alteration

1776

C

1518

Neurological disorders

14

Sensory abnormalities

104

Smell disorder

854

Smell disorder NOS

1777

C

1519

Neurological disorders

14

Sensory abnormalities

104

Smell disorder

854

Smell perversion

1778

C

1520

Neurological disorders

14

Sensory abnormalities

104

Taste disorder

861

Bad taste

1340

H

1521

Neurological disorders

14

Sensory abnormalities

104

Taste disorder

861

Loss of taste

1595

H

1522

Neurological disorders

14

Sensory abnormalities

104

Taste disorder

861

Taste alteration

1823

H

1523

Neurological disorders

14

Sensory abnormalities

104

Taste disorder

861

Taste disorder

1824

H

1524

Neurological disorders

14

Sensory abnormalities

104

Taste disorder

861

Taste salty

1825

H

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1525

Neurological disorders

14

229

Aphasia

715

Aphasia

1321

H

1526

Neurological disorders

14

229

Aphasia

715

Loss of speech

1593

H

1527

Neurological disorders

14

229

Dysarthria

752

Confused speech

1251

H

1528

Neurological disorders

14

229

Dysarthria

752

Dysarthria

1431

H

1529

Neurological disorders

14

229

Dysarthria

752

Slurred speech

1775

H

1530

Neurological disorders

14

229

Dyslexia

754

Dyslexia

1433

H

1531

Neurological disorders

14

229

Speech disorder NOS

855

H

Neurological disorders

14

229

Speech disorder NOS

855

1571

H

1533

Neurological disorders

14

229

Speech disorder NOS

855

Communication disorder NOS Lack of spontaneous speech Screaming

1391

1532

1736

H

1534

Neurological disorders

14

229

Speech disorder NOS

855

Speech disorder NOS

1784

H

1535

Neurological disorders

14

229

Speech disorder NOS

855

Speech impairment NOS

1785

H

1536

Neurological disorders

14

105

Cervical spondylopathy

708

C

Neurological disorders

14

420

Wobbler

709

A

1538

Renal and urinary disorders

15

421

C

Renal and urinary disorders

15

Congenital renal and urinary tract disorders

106

Congenital renal and urinary tract disorder NOS NT - renal cysts hydronephrosis

710

1539

Cervical spondylopathy Cervical spondylopathy Congenital renal and urinary tract disorder NOS Congenital renal and urinary tract disorder NOS

420

1537

Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Speech and language abnormalities Spinal cord and spinal nerve root disorders Spinal cord and spinal nerve root disorders Congenital renal and urinary tract disorders

2315

C

105 106

421

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1540

Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders

urinary

15

Renal disorders

107

Anuria

422

Anuria

712

C

urinary

15

Renal disorders

107

Nephritis

423

Glomerulonephritis

713

C

urinary

15

Renal disorders

107

Nephritis

423

Interstitial nephritis

715

C

urinary

15

Renal disorders

107

Nephritis

423

Nephritis

714

C

urinary

15

Renal disorders

107

Nephritis

423

2359

C

urinary

15

Renal disorders

107

Nephritis

423

2360

C

urinary

15

Renal disorders

107

Nephritis

423

NT - acute glomerulonephritis NT - chronic interstitial nephritis NT - glomerulosclerosis

2361

C

urinary

15

Renal disorders

107

Nephritis

423

2362

C

urinary

15

Renal disorders

107

Nephritis

423

2363

C

urinary

15

Renal disorders

107

Nephritis

423

NT - granulomatous nephritis NT - proliferative glomerulonephritis NT - pyelonephritis

2373

C

urinary

15

Renal disorders

107

Nephritis

423

2364

C

Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders

urinary

15

Renal disorders

107

Nephritis

423

2365

C

urinary

15

Renal disorders

107

Nephritis

423

NT - renal tubulonephrosis/renal amyloidosis NT - suppurative glomerulonephritis Pyelonephritis

716

C

urinary

15

Renal disorders

107

Nephropathy

424

Hydronephrosis

2066

C

urinary

15

Renal disorders

107

Nephropathy

424

Nephropathy

717

C

urinary

15

Renal disorders

107

Nephropathy

424

Nephrotic syndrome

2174

C

1541 1542 1543 1544 1545 1546 1547 1548 1549 1550

1551 1552 1553 1554 1555

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1556

Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders

urinary

15

Renal disorders

107

Nephropathy

424

Renal degeneration

2126

C

urinary

15

Renal disorders

107

Oliguria

670

Oliguria

711

C

urinary

15

Renal disorders

107

Papillary necrosis

825

Papillary necrosis

1253

C

urinary

15

Renal disorders

107

Polyuria

425

Polyuria

718

C

urinary

15

Renal disorders

107

Renal colic

841

Renal colic

1727

C

urinary

15

Renal disorders

107

Renal disorder NOS

426

Dilated renal pelvis

1993

C

urinary

15

Renal disorders

107

Renal disorder NOS

426

Enlarged kidney(s)

2253

C

urinary

15

Renal disorders

107

Renal disorder NOS

426

Renal disorder NOS

719

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Acute renal failure

1159

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Azotaemia

2182

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Chronic renal failure

1160

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Elevated BUN

2047

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Elevated creatinine

2048

C

urinary

15

Renal disorders

107

Renal insufficiency

428

2533

C

urinary

15

Renal disorders

107

Renal insufficiency

428

1992

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Elevated protein:creatinine ratio Elevated renal parameters Elevated SDMA (Symmetrical dimethylarginine)

2583

C

1557 1558 1559 1560 1561 1562 1563 1564 1565 1566 1567 1568 1569 1570 1571

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1572

Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders

urinary

15

Renal disorders

107

Renal insufficiency

428

Isosthenuria

2254

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Renal failure

720

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Renal insufficiency

721

C

urinary

15

Renal disorders

107

Renal insufficiency

428

Uraemia

722

C

urinary

15

Renal disorders

107

Renal tubular disorder

952

Fanconi syndrome

2125

C

urinary

15

Renal disorders

107

Renal tubular disorder

952

Renal tubular disorder

2145

C

urinary

15

Renal disorders

107

429

NT - renal infarcts

2366

C

urinary

15

Renal disorders

107

429

Renal vascular disorder

723

C

urinary

15

Ureteric disorders

108

Renal vascular disorder Renal vascular disorder Ureteric disorder

430

Ureteric disorder

724

C

urinary

15

109

Cystitis

431

Cystitis

725

C

urinary

15

109

Haemorrhagic bladder

433

Haemorrhagic bladder

730

C

urinary

15

109

Bladder rupture

2077

C

15

435

C

15

109

436

Urinary bladder disorder NOS Bladder incontinence

732

urinary

Urinary bladder disorder NOS Urinary bladder disorder NOS Urinary incontinence

435

urinary

1346

C

urinary

15

109

Urinary incontinence

436

Frequent micturition

734

C

urinary

15

Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders

109

Urinary incontinence

436

Frequent urination

733

C

1573 1574 1575 1576 1577 1578 1579 1580 1581 1582 1583 1584 1585 1586 1587

109

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1588

Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders

urinary

15

109

Urinary incontinence

436

Uncontrolled micturition

736

C

urinary

15

109

Urinary incontinence

436

Urinary incontinence

735

C

urinary

15

109

Urinary incontinence

436

Urination

1161

C

urinary

15

109

Urinary incontinence

436

Urine leakage

2127

C

urinary

15

109

Urinary retention

437

Bladder distension

2639

C

urinary

15

109

Urinary retention

437

Urinary retention

737

C

urinary

15

Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary bladder disorders Urinary tract disorders

110

Dysuria

432

Difficulty in micturition

1410

C

urinary

15

Urinary tract disorders

110

Dysuria

432

Dysuria

727

C

urinary

15

Urinary tract disorders

110

Dysuria

432

Pollakiuria

1994

C

urinary

15

Urinary tract disorders

110

Dysuria

432

Urinary tenesmus

726

C

urinary

15

Urinary tract disorders

110

Stranguria

438

Painful urination

2099

C

urinary

15

Urinary tract disorders

110

Stranguria

438

Stranguria

738

C

urinary

15

Urinary tract disorders

110

439

C

15

Urinary tract disorders

110

906

Urinary tract disorder NOS Abnormal urine odour

739

urinary

Urinary tract disorder NOS Urine abnormalities

1966

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Acidic urine

1951

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Alkaline urine

1952

C

1589 1590 1591 1592 1593 1594 1595 1596 1597 1598 1599 1600 1601 1602 1603

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1604

Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders Renal and disorders

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Bilirubinuria

2175

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Blood in urine

1956

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

1963

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Decreased urine concentration Discoloured urine

1964

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Glucosuria

1960

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Haematuria

1967

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Haemoglobinuria

2027

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Hypersthenuria

2477

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Hyposthenuria

2475

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

1962

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Increased urine concentration Proteinuria

1961

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Pyuria

2255

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Urinary tract bleeding

1965

C

urinary

15

Urinary tract disorders

110

Urine abnormalities

906

Urinary tract infection

2026

C

urinary

15

Urinary tract disorders

110

907

Urine abnormalities NOS

1959

C

urinary

15

Urinary tract disorders

110

Urine abnormalities NOS Urolithiasis

440

Calculi

741

C

1605 1606 1607 1608 1609 1610 1611 1612 1613 1614 1615 1616 1617 1618 1619

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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SOC key

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HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1620

Renal and urinary disorders Renal and urinary disorders Renal and urinary disorders Renal and urinary disorders Renal and urinary disorders Renal and urinary disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders

15

Urinary tract disorders

110

Urolithiasis

440

Crystalluria

2028

C

15

Urinary tract disorders

110

Urolithiasis

440

NT - pelvic lithiasis

2374

C

15

Urinary tract disorders

110

Urolithiasis

440

Uric acid crystals

2256

C

15

Urinary tract disorders

110

Urolithiasis

440

Urolithiasis

740

C

15

Urinary tract neoplasms

111

441

NT - renal lymphoma

2375

C

15

Urinary tract neoplasms

111

441

Urinary tract neoplasm

742

C

16

112

442

Egg drop

743

A

112

Egg drop

442

Egg drop syndrome

747

A

112

Egg drop

442

Loss of egg quality

744

A

112

Egg drop

442

Loss of egg quantity

745

A

112

Egg drop

442

Reduced hatchability

746

A

112

Egg peritonitis

443

Egg peritonitis

748

A

16

Avian reproductive system disorders Avian reproductive system disorders Avian reproductive system disorders Avian reproductive system disorders Avian reproductive system disorders Avian reproductive system disorders Breast disorders

Urinary tract neoplasm Urinary tract neoplasm Egg drop

207

Breast disorder NOS

726

Breast disorder NOS

1357

H

16

Breast disorders

207

Gynaecomastia

769

1358

C

16

Breast disorders

207

Gynaecomastia

769

Breast enlargement (male) Gynaecomastia

885

H

16

Cervix disorders

113

Cervix disorder

444

Abnormal cervix

749

C

1621 1622 1623 1624 1625 1626 1627 1628 1629 1630 1631 1632 1633 1634 1635

16 16 16 16 16

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1636

Reproductive system disorders Reproductive system disorders Reproductive system disorders

16

Cervix disorders

113

Cervix disorder

444

Cervix disorder

751

C

16

Cervix disorders

113

Cervix disorder

444

Failure to dilate

750

C

16

Congenital reproductive tract disorders

114

445

Congenital reproductive tract disorder NOS

753

C

1639

Reproductive system disorders

16

Congenital reproductive tract disorders

114

445

Freemartin

752

A

1640

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

Cryptorchidism

115

Congenital reproductive tract disorder Congenital reproductive tract disorder Cryptorchidism

446

Cryptorchidism

754

C

system

16

Cryptorchidism

115

Cryptorchidism

446

Cryptorchidy

755

C

system

16

of menstrual

211

Amenorrhoea

709

Amenorrhoea

1311

H

system

16

of menstrual

211

Amenorrhoea

709

Menstruation absent

1606

H

system

16

of menstrual

211

H

of menstrual

211

798

Disorders of menstrual cycle NOS Menstruation delayed

1417

16

Disorders of menstrual cycle NOS Menstruation delayed

746

system

1607

H

system

16

of menstrual

211

Menstruation delayed

798

Period delayed

1687

H

system

16

of menstrual

211

Menstruation irregular

799

Menstruation irregular

1608

H

system

16

of oestral

116

Abnormal cycling

1227

A

16

of oestral

116

647

Abnormal oestrus NOS

1162

A

system

16

of oestral

116

Abnormal oestrus NOS Abnormal oestrus NOS Anoestrus

647

system

Disorders cycle Disorders cycle Disorders cycle Disorders cycle Disorders cycle Disorders cycle Disorders cycle Disorders cycle Disorders cycle

447

Anoestrus

756

A

1637 1638

1641 1642 1643 1644 1645 1646 1647 1648 1649 1650

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1651

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

116

Anoestrus

447

Lack of heat

757

A

system

16

116

Polyoestrus

448

Continuous heat

759

A

system

16

116

Polyoestrus

448

Polyoestrus

758

A

system

16

116

Return to oestrus

972

Return to oestrus

780

A

system

16

116

Suboestrus

449

Quiet heat

761

A

system

16

116

Suboestrus

449

Suboestrus

760

A

system

16

117

C

450

Female reproductive tract neoplasm NOS Ovarian neoplasm

762

16

2176

C

system

16

450

Uterine neoplasm

2111

C

system

16

451

Abnormal spermatozoa

763

C

system

16

Fertility disorders

118

451

C

16

Fertility disorders

118

2128

C

system

16

Fertility disorders

118

2130

C

system

16

Fertility disorders

118

452

Decreased number of spermatozoa Decreased spermatozoa motility Decreased ejaculate volume Barren

2129

system

Female reproductive tract neoplasm NOS Female reproductive tract neoplasm NOS Female reproductive tract neoplasm NOS Abnormal spermatozoa Abnormal spermatozoa Abnormal spermatozoa Decreased ejaculate volume Infertility NOS

450

system

Disorders of oestral cycle Disorders of oestral cycle Disorders of oestral cycle Disorders of oestral cycle Disorders of oestral cycle Disorders of oestral cycle Female reproductive tract neoplasms Female reproductive tract neoplasms Female reproductive tract neoplasms Fertility disorders

2534

A

system

16

Fertility disorders

118

Infertility NOS

452

Infertility NOS

764

C

system

16

Fertility disorders

118

Infertility NOS

452

Male infertility NOS

2399

C

1652 1653 1654 1655 1656 1657 1658 1659 1660 1661 1662 1663 1664 1665 1666

117 117 118

451 953

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1667

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

Fertility disorders

118

Infertility NOS

452

Reduced conception rate

1163

C

system

16

Fertility disorders

118

Infertility NOS

452

Sterile

1790

C

system

16

119

High oestrogen level

954

High oestrogen level

2132

C

system

16

119

Nymphomania

453

Nymphomania

765

C

system

16

119

Pseudopregnancy

454

Pseudopregnancy

766

C

system

16

119

Pseudopregnancy

454

C

16

120

455

767

C

system

16

768

C

system

16

Male reproductive tract disorder NOS Male reproductive tract neoplasm NOS Female reproductive tract disorder NOS

Pseudopregnancy behaviour Male reproductive tract disorder NOS Male reproductive tract neoplasm NOS Female reproductive tract disorder NOS

2131

system

769

C

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

220

Genital tract pruritus

767

Genital tract licking

2478

A

system

16

220

Genital tract pruritus

767

Genital tract pruritus

1497

C

system

16

Gonadotrophin and sex hormone changes Gonadotrophin and sex hormone changes Gonadotrophin and sex hormone changes Gonadotrophin and sex hormone changes Male reproductive tract disorders Male reproductive tract neoplasms Other female reproductive tract disorders Other genital tract disorders Other genital tract disorders Ovarian disorders

123

Luteolysis

458

Luteolysis

770

C

system

16

Ovarian disorders

123

Ovarian cyst

459

Ovarian cyst

771

C

system

16

Oviduct disorders

124

Impaction of oviduct

460

Impaction of oviduct

772

C

system

16

Oviduct disorders

124

Oviduct cyst

461

Oviduct cyst

773

C

system

16

Oviduct disorders

124

Salpingitis

462

Salpingitis

774

C

1668 1669 1670 1671 1672 1673 1674 1675

1676 1677 1678 1679 1680 1681 1682

121 122

456 457

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1683

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

125

Abnormal birth weight

886

Abnormal birth weight

1911

C

system

16

125

C

125

463

Abnormal number of offspring Abortion

1912

16

Abnormal number of offspring Abortion

887

system

775

C

system

16

125

Abortion

463

Abortion spontaneous

1294

C

system

16

125

Abortion

463

Miscarriage

1616

C

system

16

125

Birth defect

464

Birth defect

776

C

system

16

125

Birth defect

464

Congenital disorder NOS

2030

C

system

16

125

Birth defect

464

Malformation NOS

1164

C

system

16

125

Dystocia

465

Dystocia

777

C

system

16

125

Dystocia

465

Foetal malpresentation

2479

A

system

16

125

Dystocia

465

Uterine atony

2133

C

system

16

125

Foetal maceration

466

Foetal maceration

778

A

system

16

125

Foetal mummification

467

Foetal mummification

779

A

system

16

125

Foetal resorption

468

Foetal death

2134

C

system

16

125

Foetal resorption

468

Foetal resorption

781

A

system

16

Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition

125

Foetal resorption

468

Oestrus following foetal resorption

1913

A

1684 1685 1686 1687 1688 1689 1690 1691 1692 1693 1694 1695 1696 1697 1698

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1699

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

125

Omphalitis

1015

Navel disease

2600

C

system

16

125

Omphalitis

1015

Navel ill

2601

C

system

16

125

Omphalitis

1015

Omphalitis

2598

C

system

16

125

Omphalitis

1015

Omphalophlebitis

2599

C

system

16

125

Perinatal mortality

830

Perinatal mortality

1686

C

system

16

125

Perinatal mortality NOS

783

C

16

125

Perinatal mortality NOS Placental abnormality

470

system

471

Placental abnormality

784

C

system

16

125

Pregnancy

472

Pregnancy

785

C

system

16

125

Premature parturition

473

Premature birth

786

C

system

16

125

Premature parturition

473

Premature parturition

787

C

system

16

125

Retained placenta

474

C

16

125

Retained placenta

474

Retained foetal membrane Retained placenta

789

system

788

C

system

16

125

Runt

475

Runt

790

A

system

16

125

Stillbirth

476

Intrauterine death

792

C

system

16

125

Stillbirth

476

Stillbirth

791

C

system

16

Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Pregnancy and parturition Prostatic disorders

126

Prostate hypertrophy

942

Prostate hyperplasia

793

C

1700 1701 1702 1703 1704 1705 1706 1707 1708 1709 1710 1711 1712 1713 1714

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1715

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

Prostatic disorders

126

Prostate hypertrophy

942

Prostate hypertrophy

2104

C

system

16

Prostatic disorders

126

Prostatic disorder NOS

648

Prostatic disorder NOS

1165

C

system

16

Prostatic disorders

126

Prostatic disorder NOS

648

Prostatitis

2135

C

system

16

Prostatic disorders

126

Prostatic tumour

478

Prostatic tumour

794

C

system

16

penile

127

Balanoposthitis

479

Balanoposthitis

795

C

system

16

penile

127

Penile disorder NOS

480

Penile disorder NOS

796

C

system

16

penile

127

Penile disorder NOS

480

Penile erection

2136

C

system

16

penile

127

Penile disorder NOS

480

Penile prolapse

2031

C

system

16

penile

127

Penile disorder NOS

480

Penile protrusion

2100

C

system

16

penile

127

Phimosis

481

Paraphimosis

797

C

system

16

penile

127

Phimosis

481

Phimosis

798

C

system

16

penile

127

Preputial discharge

482

Preputial discharge

799

C

system

16

penile

127

Preputial haemorrhage

1914

C

16

penile

127

Preputial haemorrhage Preputial oedema

888

system

998

Preputial oedema

2536

C

system

16

penile

127

Preputial oedema

998

Preputial swelling

2535

C

system

16

Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders Scrotal and disorders

penile

127

Preputial oedema

998

Sheath oedema

2640

C

1716 1717 1718 1719 1720 1721 1722 1723 1724 1725 1726 1727 1728 1729 1730

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1731

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

127

Preputial prolapse

483

Preputial prolapse

800

C

system

16

127

Priapism

484

Priapism

801

C

system

16

127

Scrotal disorder NOS

485

Scrotal disorder NOS

802

C

system

16

127

Scrotal irritation NOS

842

Scrotal irritation NOS

1737

C

system

16

127

Scrotitis

486

Scrotal oedema

804

C

system

16

127

Scrotitis

486

Scrotitis

803

C

system

16

128

Increased testicle size

2068

C

16

926

Reduced testicle size

2033

C

system

16

128

Change in testicular volume Change in testicular volume Epididymitis

926

system

487

Epididymitis

805

C

system

16

128

Orchitis

488

Orchitis

806

C

system

16

128

Orchitis

488

Testicular erythema

2032

C

system

16

128

Testicular pain

862

Testicular pain

1830

C

system

16

Scrotal and penile disorders Scrotal and penile disorders Scrotal and penile disorders Scrotal and penile disorders Scrotal and penile disorders Scrotal and penile disorders Testicular and epidydimal disorders Testicular and epidydimal disorders Testicular and epidydimal disorders Testicular and epidydimal disorders Testicular and epidydimal disorders Testicular and epidydimal disorders Uterine disorders

129

780

H

16

Uterine disorders

129

Heavy menstrual bleeding Heavy periods

927

system

1518

H

system

16

Uterine disorders

129

H

16

Uterine disorders

129

Increased menstrual bleeding Delayed uterine involution

1531

system

Increased menstrual bleeding Increased menstrual bleeding Increased menstrual bleeding Metritis

811

C

1732 1733 1734 1735 1736 1737 1738 1739 1740 1741 1742 1743 1744 1745 1746

128

780 780 489

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1747

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

Uterine disorders

129

Metritis

489

Endometritis

808

C

system

16

Uterine disorders

129

Metritis

489

Metritis

807

C

system

16

Uterine disorders

129

Metritis

489

Mucometra

809

C

system

16

Uterine disorders

129

Metritis

489

Pyometra

812

C

system

16

Uterine disorders

129

Metritis

489

Stump pyometra

810

C

system

16

Uterine disorders

129

Uterine disorder NOS

955

2137

C

system

16

Uterine disorders

129

Uterine disorder NOS

955

Cystic endometrial hyperplasia Uterine cyst

2480

A

system

16

Uterine disorders

129

Uterine disorder NOS

955

Uterine disorder NOS

2146

C

system

16

Uterine disorders

129

Uterine haemorrhage

490

1861

H

Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders Reproductive disorders

system

16

Uterine disorders

129

Uterine haemorrhage

490

Uterine bleeding NOS (see also increased menstrual bleeding) Uterine haemorrhage

813

C

system

16

Uterine disorders

129

Uterine prolapse

491

Uterine prolapse

814

C

system

16

Uterine disorders

129

Uterine rupture

492

Uterine rupture

815

C

system

16

Uterine disorders

129

Uterine spasm

871

Menstrual cramp

1604

H

system

16

Uterine disorders

129

Uterine spasm

871

Menstrual pain

1605

H

system

16

Uterine disorders

129

Uterine spasm

871

Uterine contraction

2257

C

system

16

Uterine disorders

129

Uterine spasm

871

Uterine spasm

1863

C

1748 1749 1750 1751 1752 1753 1754 1755

1756 1757 1758 1759 1760 1761 1762

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1763

Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Reproductive system disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders

16

Uterine disorders

129

Uterine torsion

493

Uterine torsion

816

C

16

Vulvovaginal disorders

130

Vaginal haemorrhage

494

Vaginal haemorrhage

817

C

16

Vulvovaginal disorders

130

Vaginal hyperplasia

495

Vaginal hyperplasia

818

C

16

Vulvovaginal disorders

130

Vaginal prolapse

496

Vaginal prolapse

819

C

16

Vulvovaginal disorders

130

Vaginal tear

497

Vaginal tear

820

C

16

Vulvovaginal disorders

130

Vaginal vesicle

498

Vaginal vesicle

821

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Swollen vulva

825

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Vaginal discharge

1166

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Vaginal oedema

826

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Vaginal swelling

827

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Vaginitis

822

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Vulvitis

823

C

16

Vulvovaginal disorders

130

Vulvovaginitis

499

Vulvovaginitis

824

C

17

Avian respiratory disorders Bronchial and lung disorders Bronchial and lung disorders

131

Airsacculitis

500

Airsacculitis

828

A

132

Apnoea

502

Apnoea

830

C

132

Apnoea

502

Respiratory arrest

831

C

1764 1765 1766 1767 1768 1769 1770 1771 1772 1773 1774 1775 1776 1777 1778

17 17

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1779

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

and lung

132

Apnoea

502

Respiratory failure

1167

C

tract

17

and lung

132

Asthma

503

Asthma

832

C

tract

17

and lung

132

Atelectasis

991

Lung collapse

2483

C

tract

17

and lung

132

Bradypnoea

504

Bradypnoea

833

C

tract

17

and lung

132

Bradypnoea

504

C

17

and lung

132

Bradypnoea

504

Decreased respiratory rate Hypoventilation

834

tract

2058

C

tract

17

and lung

132

Bradypnoea

504

Respiratory depression

1168

C

tract

17

and lung

132

Bronchitis

505

Bronchial secretion

1169

C

tract

17

and lung

132

Bronchitis

505

Bronchitis

835

C

tract

17

and lung

132

Bronchitis

505

Wheezing

836

C

tract

17

and lung

132

C

and lung

132

2295

C

1791

Respiratory tract disorders

17

Bronchial and lung disorders

132

Bronchopulmonary inflammation

979

2296

C

1792

Respiratory tract disorders

17

Bronchial and lung disorders

132

Bronchopulmonary inflammation

979

2297

C

1793

Respiratory tract disorders

17

Bronchial and lung disorders

132

Bronchopulmonary inflammation

979

Bronchopulmonary inflammation NT - acute (interstitial) pneumonia/pleuropneu monia NT - chronic (broncho)pneumonia/pl europneumonia NT - chronic (interstitial) pneumonia/pleuropneu monia NT - fibrinous (broncho) pneumonia/fibrinous

2294

17

Bronchopulmonary inflammation Bronchopulmonary inflammation

979

tract

Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders

2298

C

1780 1781 1782 1783 1784 1785 1786 1787 1788 1789 1790

979

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2299

C

2300

C

1359

C

pleuropneumonia 1794

Respiratory tract disorders

17

Bronchial and lung disorders

132

Bronchopulmonary inflammation

979

1795

Respiratory tract disorders

17

Bronchial and lung disorders

132

Bronchopulmonary inflammation

979

1796

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

and lung

132

Bronchospasm

727

tract

17

and lung

132

Dyspnoea

506

Abnormal breathing

837

C

tract

17

and lung

132

Dyspnoea

506

Breathing difficulty

1170

C

tract

17

and lung

132

Dyspnoea

506

Breathlessness

1915

C

tract

17

and lung

132

Dyspnoea

506

C

17

and lung

132

Dyspnoea

506

Cheyne-Stokes respiration Dyspnoea

841

tract

839

C

tract

17

and lung

132

Dyspnoea

506

Hyperpnoea

2138

C

tract

17

and lung

132

Dyspnoea

506

Irregular breathing

838

C

tract

17

and lung

132

Dyspnoea

506

Laboured breathing

1171

C

tract

17

and lung

132

Dyspnoea

506

Open mouth breathing

1172

C

tract

17

and lung

132

Dyspnoea

506

Orthopnoea

2641

C

tract

17

Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders

NT - granulomatous pneumonia/pleuropneu monia NT - suppurative (broncho) pneumonia/pleuropneu monia Bronchospasm

and lung

132

Dyspnoea

506

Paradoxical breathing

1173

C

1797 1798 1799 1800 1801 1802 1803 1804 1805 1806 1807

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1808

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

and lung

132

Dyspnoea

506

Respiratory discomfort

1258

C

tract

17

and lung

132

Dyspnoea

506

Respiratory distress

840

C

tract

17

and lung

132

Dyspnoea

506

Shallow breathing

2481

A

tract

17

and lung

132

Hypoxia

501

Anoxia

829

C

tract

17

and lung

132

Hypoxia

501

C

17

and lung

132

Hypoxia

501

Decreased pulse oxygenation Hypoxia

2486

tract

2186

C

tract

17

and lung

132

Pneumonia

507

Bronchopneumonia

2139

C

tract

17

Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders

and lung

132

Pneumonia

507

2290

C

Respiratory tract disorders Respiratory tract disorders

17

Bronchial and lung disorders Bronchial and lung disorders

132

Pneumonia

507

NT caseous/granulomatous pneumonia (tuberculosis) NT - embolic pneumonia

2291

C

132

Pneumonia

507

2367

C

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

and lung

132

Pneumonia

507

2292

C

tract

17

and lung

132

Pneumonia

507

842

C

tract

17

and lung

132

Pneumonitis

973

Pneumonitis

2258

C

tract

17

and lung

132

Pulmonary congestion

508

Pulmonary congestion

843

C

tract

17

Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders

NT - pulmonary mineralisation (chronic renal failure) NT - pulmonary parasitic nodules Pneumonia

and lung

132

Pulmonary disorder NOS

509

Pulmonary disorder NOS

844

C

1809 1810 1811 1812 1813 1814 1815

1816 1817

1818 1819 1820 1821 1822

17

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1823

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

and lung

132

Bullous emphysema

1954

C

17

and lung

132

510

C

17

and lung

132

510

NT - emphysematous pneumonia Pulmonary emphysema

2293

tract

845

C

tract

17

and lung

132

Pulmonary emphysema Pulmonary emphysema Pulmonary emphysema Pulmonary fibrosis

510

tract

974

Pulmonary fibrosis

2259

C

tract

17

and lung

132

Coughing blood

1259

C

17

and lung

132

511

Coughing up blood

1970

C

tract

17

and lung

132

511

Haemoptysis

846

C

tract

17

and lung

132

511

Pulmonary haemorrhage

847

C

tract

17

and lung

132

Pulmonary haemorrhage Pulmonary haemorrhage Pulmonary haemorrhage Pulmonary haemorrhage Pulmonary oedema

511

tract

512

Bronchial oedema

850

C

tract

17

and lung

132

Pulmonary oedema

512

Lung oedema

849

C

tract

17

and lung

132

Pulmonary oedema

512

Pulmonary oedema

848

C

tract

17

and lung

132

C

and lung

132

514

Pulmonary thromboembolism Bronchial rale

851

17

Pulmonary thromboembolism Rale

513

tract

1174

C

tract

17

and lung

132

Rale

514

Crackles on auscultation

2140

C

tract

17

and lung

132

Rale

514

C

17

and lung

132

Rale

514

Crepitation on auscultation Harsh lung sounds

2147

tract

Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders Bronchial disorders

2487

C

1824 1825 1826 1827 1828 1829 1830 1831 1832 1833 1834 1835 1836 1837 1838

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 114/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1839

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

132

Rale

514

Increased lung sounds

2488

C

tract

17

132

Rale

514

Lung sound

1175

C

tract

17

132

Rale

514

Rale

852

C

tract

17

132

Rale

514

Rattling chest

853

C

tract

17

132

Rale

514

Respiratory sound

1176

C

tract

17

132

Tachypnoea

515

Hyperventilation

1177

C

tract

17

132

Tachypnoea

515

C

17

132

Tachypnoea

515

Increased respiratory rate Panting

856

tract

855

C

tract

17

132

Tachypnoea

515

Polypnoea

857

C

tract

17

132

Tachypnoea

515

Tachypnoea

854

C

tract

17

133

C

133

517

Congenital respiratory tract disorder NOS Hypoplastic trachea

858

17

Congenital respiratory tract disorder NOS Hypoplastic trachea

516

tract

859

C

tract

17

Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Bronchial and lung disorders Congenital respiratory tract disorders Congenital respiratory tract disorders Fish respiratory disorder

134

Fish asphyxia

518

Fish asphyxia

860

A

tract

17

Fish respiratory disorder

134

Fish asphyxia

518

Fish gasping

861

A

tract

17

Fish respiratory disorder

134

Gill discolouration

1001

Gill discolouration

2540

A

tract

17

Fish respiratory disorder

134

Gill disorder NOS

1000

Gill disorder NOS

2539

A

1840 1841 1842 1843 1844 1845 1846 1847 1848 1849 1850 1851 1852 1853 1854

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1855

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

Fish respiratory disorder

134

Inflammation of gill

519

Inflammation of gill

862

A

tract

17

244

992

A

17

665

Guttural pouch empyema Dry nose

2490

tract

1219

C

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

tract

17

Guttural pouch disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders Nasal cavity and disorders

1856 1857 1858 1859 1860 1861 1862 1863 1864 1865 1866 1867 1868 1869 1870

sinus

135

Guttural pouch empyema Dry nose

sinus

135

Epistaxis

520

Epistaxis

864

C

sinus

135

Epistaxis

520

Epistaxis (bilateral)

2484

C

sinus

135

Epistaxis

520

Epistaxis (unilateral)

2485

C

sinus

135

Epistaxis

520

Nasal bleeding

863

C

sinus

135

521

C

135

1634

C

sinus

135

809

Nasal cavity and sinus disorder NOS Nasal cavity disorder NOS Nasal dryness

865

sinus

1636

C

sinus

135

809

Nasal irritation

1637

C

sinus

135

809

Snoring

2506

A

sinus

135

Nasal cavity and sinus disorder NOS Nasal cavity disorder NOS Nasal cavity disorder NOS Nasal cavity disorder NOS Nasal cavity disorder NOS Rhinitis

522

Nasal congestion

1635

C

sinus

135

Rhinitis

522

Purulent rhinitis

866

C

sinus

135

Rhinitis

522

Rhinitis

869

C

sinus

135

Rhinitis

522

Rhinitis NOS

868

C

809

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 116/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1871

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

135

Rhinitis

522

Rhinorrhoea

1729

C

tract

17

135

Rhinitis

522

Sniffing

870

C

tract

17

135

Rhinitis

522

Snuffle

867

C

tract

17

135

Sinus disorder NOS

845

Sinus congestion

1749

C

tract

17

135

Sinus disorder NOS

845

Sinus disorder NOS

1750

C

tract

17

135

Sinus disorder NOS

845

Sinus pain

1752

C

tract

17

135

Sinusitis

523

Sinusitis

872

C

tract

17

135

Sneezing

524

Reverse sneezing

2178

C

tract

17

135

Sneezing

524

Sneezing

873

C

tract

17

136

C

138

889

Neonatal respiratory disorder Asphyxia

874

17

Neonatal respiratory disorder Asphyxia

525

tract

1916

C

tract

17

138

Cough

532

Cough

884

C

tract

17

138

Cough

532

Cough, productive

2260

C

tract

17

138

Cough

532

C

17

138

526

2537

C

tract

17

Foam in respiratory tract Foam in respiratory tract

Obstructive airway cough Bloody foam in mouth and nose Foam in the mouth

883

tract

Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Nasal cavity and sinus disorders Neonatal respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders

1228

C

1872 1873 1874 1875 1876 1877 1878 1879 1880 1881 1882 1883 1884 1885 1886

138

526

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 117/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1887

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

tract

138

Foam in the nose

1178

C

17

tract

138

526

Foam in the trachea

875

C

tract

17

tract

138

650

Fluid from nose

2482

A

tract

17

tract

138

650

Nasal discharge

871

C

tract

17

tract

138

650

Respiratory signs

1181

C

tract

17

tract

138

650

C

17

tract

138

1728

C

tract

17

tract

138

1953

C

Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders

17

Respiratory tract disorders Respiratory tract neoplasms Respiratory tract neoplasms

138

651

1182

C

139

Respiratory tract infection NOS Pulmonary neoplasm

Respiratory tract disorder NOS Respiratory tract irritation Stridor (Upper respiratory; for lower respiratory see also Bronchial rale) Respiratory tract infection NOS Lung tumour

1180

tract

Foam in respiratory tract Foam in respiratory tract Respiratory tract disorder NOS Respiratory tract disorder NOS Respiratory tract disorder NOS Respiratory tract disorder NOS Respiratory tract disorder NOS Respiratory tract disorder NOS

526

tract

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

1917

C

139

Pulmonary neoplasm

890

2368

C

Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders

17

Respiratory tract neoplasms Respiratory tract neoplasms Respiratory tract neoplasms

139

Pulmonary neoplasm

890

2369

C

139

Pulmonary neoplasm

890

NT - lung tumour (adenocarcinoma/adeno ma/bronchiolo/alveolar carcinoma/adenoma) NT - pulmonary metastases Pulmonary neoplasm

1918

C

139

Respiratory tract neoplasm NOS

533

NT - pleural tumour (mesothelioma)

2370

C

1888 1889 1890 1891 1892 1893 1894

1895 1896 1897

1898 1899 1900

17 17

17 17

650 650

890

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 118/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1901

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

139

C

140

731

Respiratory tract neoplasm NOS Chest discomfort NOS

888

17

Respiratory tract neoplasm NOS Chest discomfort NOS

533

tract

1263

C

tract

17

140

Chest discomfort NOS

731

Chest tightness

1376

H

tract

17

140

Haemothorax

534

Haemothorax

889

C

tract

17

140

Hydrothorax

535

Fluid in thorax

1183

C

tract

17

140

Hydrothorax

535

Hydrothorax

890

C

tract

17

140

Hydrothorax

535

Pleural effusion

1184

C

tract

17

140

Hydrothorax

535

Thoracic exudate

2642

C

tract

17

140

Hydrothorax

535

Thoracic transudate

2643

C

tract

17

140

Pleuritis

536

C

17

140

Pleuritis

536

NT - pleural mineralisation Pleural inflammation

2371

tract

891

C

tract

17

140

Pleuritis

536

Pleurisy

2141

C

tract

17

140

Pleuritis

536

Pleuritis

892

C

tract

17

140

Pneumothorax

927

Pneumothorax

2035

C

tract

17

140

Pyothorax

537

Pyothorax

893

C

tract

17

Respiratory tract neoplasms Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders Thoracic cavity disorders

140

Thoracic cavity disorder NOS

981

Thoracic cavity disorder NOS

2372

C

1902 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 1916

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1917

Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders Respiratory disorders

tract

17

140

Thoracic irritation

866

Thoracic irritation

1264

C

tract

17

140

Thoracic irritation

866

Thoracic pain

1265

C

tract

17

137

Aphonia

716

Aphonia

1266

C

tract

17

137

Aphonia

716

Loss of voice

1267

C

tract

17

137

Dysphonia

756

Dysphonia

1268

C

tract

17

137

Dysphonia

756

Voice alteration

1269

C

tract

17

137

Laryngeal irritation

792

H

17

137

Laryngeal irritation

792

Burning sensation of the throat Laryngeal irritation

1270

tract

1573

C

tract

17

137

Laryngeal irritation

792

Throat irritation

1836

C

tract

17

137

Laryngeal irritation

792

Throat pain

1837

C

tract

17

137

Laryngeal irritation

792

Throat tingling

1272

H

tract

17

137

Laryngeal spasm

999

Laryngeal spasm

2538

C

tract

17

137

Laryngitis

527

Laryngeal oedema

1574

C

tract

17

137

Laryngitis

527

Laryngitis

876

C

tract

17

Thoracic cavity disorders Thoracic cavity disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders

137

869

Tracheal and laryngeal disorder NOS

1849

C

Respiratory tract disorders

17

Tracheal and laryngeal disorders

137

Tracheal and laryngeal disorder NOS Tracheal and laryngeal disorder

869

Tracheal rales

2489

C

1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931

1932

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

NOS 1933 1934 1935 1936 1937 1938 1939 1940 1941 1942 1943 1944 1945

1946 1947

Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Respiratory tract disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

17

Skin and appendages disorders Skin and appendages disorders

18

17 17 17 17 17 17 17 17 18 18 18 18

18

Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Tracheal and laryngeal disorders Claw / hoof / nail disorders Claw / hoof / nail disorders Congenital skin disorders Cornification and elastic tissue disorders

137

Tracheal bleeding

528

Blood in trachea

878

C

137

Tracheal bleeding

528

Tracheal bleeding

877

C

137

Tracheal collapse

529

Tracheal collapse

879

C

137

Tracheal obstruction

530

Choke

2584

C

137

Tracheal obstruction

530

Tracheal obstruction

880

C

137

Tracheitis

531

Mucus in trachea

881

C

137

Tracheitis

531

Positive tracheal pinch

2585

C

137

Tracheitis

531

Tracheal oedema

2644

C

137

Tracheitis

531

Tracheitis

882

C

160

Claw / hoof / nail disorder NOS Claw / hoof / nail loss

891

Claw / hoof / nail disorder NOS Claw / hoof / nail loss

1919

C

1185

C

538

Congenital skin disorder NOS Cornification and elastic tissue disorder NOS

894

C

895

C

Cornification and elastic tissue disorders Cornification and elastic tissue disorders

142

Congenital skin disorder NOS Cornification and elastic tissue disorder NOS Delayed cicatrisation

653

Delayed cicatrisation

1186

C

142

Hyperkeratosis

540

Hyperkeratosis

896

C

160 141 142

652

539

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1948

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders

and dermal

237

Bullous disorder

728

1347

C

and dermal

237

Bullous disorder

728

Blistering (see also Application site SOC) Bullae

925

C

and dermal

237

Bullous disorder

728

Bullous dermatitis

1362

C

and dermal

237

Bullous disorder

728

Bullous disorder NOS

1363

C

and dermal

237

Bullous disorder

728

Bullous eruption

1364

C

and dermal

237

Bullous disorder

728

Erythema multiforme

1197

C

and dermal

237

Bullous disorder

728

1848

C

and dermal

237

Bullous disorder

728

Toxic epidermal necrolysis Vesicle

1866

C

and dermal

237

Bullous disorder

728

Vesicular rash

1867

C

and dermal

237

Burn

562

Burn

926

C

and dermal

237

Burn

562

Chemical burn

928

C

and dermal

237

Dermal mass

975

Dermal mass

2262

C

and dermal

237

Dermal thickening

564

Dermal thickening

930

C

and dermal

237

Dermal thickening

564

Lichenification

2037

C

and dermal

237

938

Allergic dermatitis

1303

C

and dermal

237

Dermatitis and eczema Dermatitis and eczema

938

Blotchy rash

1354

C

1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 1963

18 18 18 18 18 18 18 18 18 18 18 18 18 18 18

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1964

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders

and dermal

237

and

938

Contact dermatitis

1396

C

and dermal

237

and

938

Crust

1189

C

and dermal

237

and

938

Dermatitis

932

C

and dermal

237

and

938

Eczema

934

C

and dermal

237

and

938

Eruption

1190

C

and dermal

237

and

938

Exacerbated eczema

1450

C

and dermal

237

and

938

C

237

and

938

Facial rash (For urticaria see Immune SOC) Generalised rash

1465

and dermal

1493

C

and dermal

237

and

938

Generalised red spot

1494

C

and dermal

237

and

938

C

237

and

938

Generalised skin reaction Infected eczema

1495

and dermal

1537

C

and dermal

237

and

938

Itchy rash

1563

C

and dermal

237

and

938

Localised rash

1584

C

and dermal

237

and

938

Localised skin reaction

1585

C

and dermal

237

and

938

Macular rash

1599

C

and dermal

237

Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema Dermatitis eczema

and

938

Maculo-papular rash

1600

C

1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979

18 18 18 18 18 18 18 18 18 18 18 18 18 18 18

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1980

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders

and dermal

237

938

Miliary dermatitis

2261

C

and dermal

237

938

Moist dermatitis

937

C

and dermal

237

938

Moist eczema

931

C

and dermal

237

938

Papular rash

1673

C

and dermal

237

938

Papule

953

C

and dermal

237

938

Perivascular dermatitis

2495

C

and dermal

237

938

Pimples

935

C

and dermal

237

938

Pododermatitis

1192

C

and dermal

237

938

Pruritic rash

1709

C

and dermal

237

938

Pustular skin eruption

1715

C

and dermal

237

938

Pustules

938

C

and dermal

237

938

Rash

939

C

and dermal

237

938

Skin inflammation NOS

1759

C

and dermal

237

938

Suppurative dermatitis

2494

C

and dermal

237

938

Ulcerative dermatitis

936

C

and dermal

237

Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Dermatitis and eczema Desquamation

568

Desquamation

942

C

1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995

18 18 18 18 18 18 18 18 18 18 18 18 18 18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

1996

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders

and dermal

237

Desquamation

568

Flaking skin

1474

C

and dermal

237

Desquamation

568

Peeling skin

944

C

and dermal

237

Desquamation

568

Scale

1196

C

and dermal

237

Desquamation

568

Scaly condition NOS

1735

C

and dermal

237

Desquamation

568

Skin slough

943

C

and dermal

237

Erythema

570

948

C

and dermal

237

Erythema

570

Erythema (for urticaria see Immune SOC) Erythematous rash

1449

C

and dermal

237

Erythema

570

Oedematous erythema

1655

C

and dermal

237

Erythema

570

Red face

1722

H

and dermal

237

Erythema

570

Reddening of the skin

946

C

and dermal

237

Erythema

570

Rubra

947

C

and dermal

237

Erythema

570

Skin hyperaemia

949

C

and dermal

237

Erythema

570

Skin warmth

2398

C

and dermal

237

761

C

237

761

Erythemato-squamous condition Psoriasis

1448

and dermal

1710

C

and dermal

237

Erythematosquamous condition Erythematosquamous condition Photosensitivity

576

Photosensitivity

955

C

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

18 18 18 18 18 18 18 18 18 18 18 18 18 18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2012

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal and dermal disorders Epidermal and dermal disorders Epidermal and dermal disorders

237

Photosensitivity

576

Photosensitization

956

C

237

Photosensitivity

576

Sunburn

957

C

237

Pruritus

577

2608

C

2015

Skin and appendages disorders

18

Epidermal and dermal disorders

237

Pruritus

577

2618

C

2016

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders Epidermal disorders

and dermal

237

Pruritus

577

Biting - pruritus (see also 'Behavioural disorders') Chewing - pruritus (see also 'Oral cavity disorders') Excoriation

1198

C

and dermal

237

Pruritus

577

Generalised itching

1492

C

and dermal

237

Pruritus

577

Itching

958

C

and dermal

237

Pruritus

577

Itchy skin

1145

C

and dermal

237

Pruritus

577

Licking

1997

A

and dermal

237

Pruritus

577

Localised itching

1582

C

and dermal

237

Pruritus

577

Pruritus

960

C

and dermal

237

Pruritus

577

Rubbing

2496

A

and dermal

237

Pruritus

577

Scratching

959

C

and dermal

237

Pruritus

577

Self trauma

125

C

and dermal

237

Pruritus

577

Skin irritation

1760

C

2013 2014

2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

18 18

18 18 18 18 18 18 18 18 18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2027

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Epidermal and dermal disorders Epidermal and dermal disorders Epidermal and dermal disorders Epidermal and dermal disorders Epidermal and dermal disorders Epidermal and dermal disorders Fish skin disorders

237

Skin textural change

864

Chapped skin

1374

C

237

Skin textural change

864

Creased skin

2541

C

237

Skin textural change

864

Cutaneous calcinosis

2079

C

237

Skin textural change

864

Dry skin

1998

C

237

Skin textural change

864

Skin dryness

1428

C

237

Skin textural change

864

Skin textural change

1832

C

143

Fish skin disorder

541

Fish skin disorder

897

A

144

Alopecia

708

Alopecia

1309

C

2035

Skin and appendages disorders

18

144

Alopecia

708

Alopecia general

898

C

2036

Skin and appendages disorders

18

144

Alopecia

708

Alopecia local

900

C

2037

Skin and appendages disorders

18

144

Alopecia

708

Alopecia NOS

1310

C

2038

Skin and appendages disorders

18

144

Alopecia

708

General hair loss

1490

C

2039

Skin and appendages disorders

18

Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders

144

Alopecia

708

Hair loss NOS

1507

C

2028 2029 2030 2031 2032 2033 2034

18 18 18 18 18 18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2040

Skin and appendages disorders

18

144

Alopecia

708

Hair shedding

1971

C

2041

Skin and appendages disorders

18

144

Alopecia

708

Localised hair loss

1581

C

2042

Skin and appendages disorders

18

144

Dermal cyst(s)

563

Dermal cyst(s)

929

C

2043

Skin and appendages disorders

18

144

Dry coat

545

Dry coat

1995

A

2044

Skin and appendages disorders

18

144

Folliculitis

546

Acne

905

C

2045

Skin and appendages disorders

18

144

Folliculitis

546

Comedo/Blackhead

2382

C

2046

Skin and appendages disorders

18

144

Folliculitis

546

Follicular casts

2543

C

2047

Skin and appendages disorders

18

144

Folliculitis

546

Folliculitis

904

C

2048

Skin and appendages disorders

18

144

Hair change

771

Hair change

1506

C

2049

Skin and appendages disorders

18

144

Hair change

771

Hair modification NOS

1508

C

2050

Skin and appendages disorders

18

Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders

144

Hair change

771

Hypertrichosis

2180

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2051

Skin and appendages disorders

18

144

Hair change

771

Lack of hair regrowth

2586

C

2052

Skin and appendages disorders

18

144

Hair change

771

Salivary staining

2542

A

2053

Skin and appendages disorders

18

144

Malodour

549

Malodour

908

C

2054

Skin and appendages disorders

18

144

Piloerection

550

Hair standing on end

909

C

2055

Skin and appendages disorders

18

144

Piloerection

550

Piloerection

910

C

2056

Skin and appendages disorders

18

144

Seborrhoea

551

Greasy skin

912

C

2057

Skin and appendages disorders

18

144

Seborrhoea

551

Seborrhoea

911

C

2058

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Hair follicle and sebaceous gland disorders Nail disorders

218

Nail discolouration

807

Nail discolouration

1632

C

18

Pigmentation disorders

145

Pigmentation disorder

552

2177

C

18

Pigmentation disorders

145

Pigmentation disorder

552

Depigmentation of nasal plane Hair coat discolouration

1187

A

18

Pigmentation disorders

145

Pigmentation disorder

552

Hyperpigmentation

913

C

18

Pigmentation disorders

145

Pigmentation disorder

552

Hypopigmentation

915

C

18

Pigmentation disorders

145

Pigmentation disorder

552

Melanosis

914

C

2059 2060 2061 2062 2063

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2064

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Pigmentation disorders

145

Pigmentation disorder

552

Pigmentation disorder

1188

C

18

Skin and appendages neoplasms Skin and appendages neoplasms Skin and appendages neoplasms Skin and appendages neoplasms Skin and appendages neoplasms Skin and appendages neoplasms Skin and appendages neoplasms

146

Histiocytoma

555

Histiocytoma

917

C

146

Melanoma

556

Melanoma

918

C

146

Myofibrosarcoma

557

Myofibrosarcoma

919

C

146

Papilloma

558

Papilloma

920

C

146

Papilloma

558

Papillomatosis

952

C

146

Papilloma

558

Wart

1199

C

146

559

Dermoid cyst

1407

C

2072

Skin and appendages disorders

18

Skin and appendages neoplasms

146

559

Skin and/or appendage neoplasm NOS

922

C

2073

Skin and appendages disorders

18

Skin and appendages neoplasms

146

559

Skin sarcoma NOS

921

C

2074

Skin and appendages disorders

18

Skin and appendages neoplasms

146

559

Skin tumour NOS

923

C

2075

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Skin and appendages neoplasms Skin and appendages neoplasms Skin and subcutaneous tissue disorders

146

Skin and/or appendage neoplasm NOS Skin and/or appendage neoplasm NOS Skin and/or appendage neoplasm NOS Skin and/or appendage neoplasm NOS Skin fibrosarcoma

554

Skin fibrosarcoma

916

C

146

Spindle cell tumour

560

Spindle cell tumour

924

C

238

Panniculitis

572

Panniculitis

951

C

2065 2066 2067 2068 2069 2070 2071

2076 2077

18 18 18 18 18 18

18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2078

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders Skin and tissue infections

238

Skin emphysema

655

Cutaneous emphysema

1202

C

238

Skin emphysema

655

Skin emphysema

1201

C

238

Skin haemorrhage

848

Bruising

1360

C

238

Skin haemorrhage

848

Ecchymosis

2038

C

238

Skin haemorrhage

848

Purpura

1714

C

238

Skin haemorrhage

848

Skin haematoma

1757

C

238

Skin necrosis

583

Cutaneous necrosis

1203

C

238

Skin necrosis

583

Gangrene

2085

C

238

Skin necrosis

583

Gaseous gangrene

2086

C

238

Skin necrosis

583

Skin necrosis

967

C

238

Skin oedema

584

Cellulitis

970

C

238

Skin oedema

584

Cutaneous oedema

1204

C

238

Skin oedema

584

2491

A

238

Skin oedema

584

Juvenile cellulitis (puppy strangles) Skin oedema

968

C

238

Skin oedema

584

Skin swelling

969

C

225

Bacterial skin infection

725

Bacterial skin infection NOS

1338

C

2079 2080 2081 2082 2083 2084 2085 2086 2087 2088 2089 2090 2091 2092 2093

18 18 18 18 18 18 18 18 18 18 18 18 18 18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2094

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections

225

725

Boil

1355

C

725

Epidermal collarette

2263

C

725

Furuncle

1485

C

725

Furunculosis

1486

C

725

1200

C

725

Hot spot (pyotraumatic dermatitis) Impetigo

1274

C

725

Paronychia

1682

C

725

Pimple

1696

C

725

Purulent lesion(s)

1193

C

725

Pyoderma

961

C

725

Septic spot

1742

C

725

Skin abscess

1754

C

225

Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Bacterial skin infection Fungal skin infection

765

Dermatomycosis

940

C

225

Fungal skin infection

765

Dermatophytosis

1406

C

225

Fungal skin infection

765

Fungal paronychia

1275

C

225

Fungal skin infection

765

Fungal skin infection NOS

1484

C

2095 2096 2097 2098 2099 2100 2101 2102 2103 2104 2105 2106 2107 2108 2109

18 18 18 18 18 18 18 18 18 18 18 18 18 18 18

225 225 225 225 225 225 225 225 225 225 225

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2110

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

225

Fungal skin infection

765

Ringworm

1733

C

225

Fungal skin infection

765

Tinea NOS

1840

C

225

846

C

872

Skin and tissue infection NOS Cold sore

1755

225

Skin and tissue infection NOS Viral skin infection

1387

H

225

Viral skin infection

872

Herpes simplex

1522

H

225

Viral skin infection

872

Herpes zoster

1523

H

225

Viral skin infection

872

Orf

1661

C

225

Viral skin infection

872

Shingles

1746

H

225

Viral skin infection

872

Viral skin infection NOS

1869

C

18

Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin and tissue infections Skin disorders NOS

239

Granuloma

571

Granuloma

950

C

18

Skin disorders NOS

239

Granuloma

571

Lick granuloma

2264

A

18

Skin disorders NOS

239

Hygroma

993

Hygroma

2493

A

18

Skin disorders NOS

239

Seroma

579

Seroma

963

C

18

Skin disorders NOS

239

Skin disorders NOS

847

2497

C

18

Skin disorders NOS

239

Skin disorders NOS

847

Cyanotic spots/blotchy skin Dermatosis NOS

941

C

18

Skin disorders NOS

239

Skin disorders NOS

847

Lump

1191

C

2111 2112 2113 2114 2115 2116 2117 2118 2119 2120 2121 2122 2123 2124 2125

18 18 18 18 18 18 18 18

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2126

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders

18

Skin disorders NOS

239

Skin disorders NOS

847

Skin disorders NOS

1756

C

18

Skin disorders NOS

239

Skin disorders NOS

847

Skin scab

2179

C

18

Skin disorders NOS

239

Skin disorders NOS

847

Skin sore

962

C

18

Skin disorders NOS

239

Skin disorders NOS

847

Skin thinning

2181

C

18

Skin disorders NOS

239

Skin lesion NOS

582

Scar

2544

C

18

Skin disorders NOS

239

Skin lesion NOS

582

Skin lesion NOS

966

C

18

Skin disorders NOS

239

Skin ulceration

943

Erosion

945

C

18

Skin disorders NOS

239

Skin ulceration

943

Mucocutaneous ulcer

1920

C

18

Skin disorders NOS

239

Skin ulceration

943

Skin ulcer

1194

C

18

Skin vascular disorders

148

587

C

Sweating disorders

149

712

Skin vascular disorder NOS Anhidrosis

973

18

Skin vascular disorder NOS Anhidrosis

1316

C

18

Sweating disorders

149

Hyperhidrosis

588

Clamminess

1379

H

18

Sweating disorders

149

Hyperhidrosis

588

Cold and clammy skin

1385

H

18

Sweating disorders

149

Hyperhidrosis

588

Cold sweat

1388

H

18

Sweating disorders

149

Hyperhidrosis

588

Excessive perspiration

1452

H

18

Sweating disorders

149

Hyperhidrosis

588

Excessive sweating

1453

C

2127 2128 2129 2130 2131 2132 2133 2134 2135 2136 2137 2138 2139 2140 2141

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2142

18

Sweating disorders

149

Hyperhidrosis

588

Heavy sweating

1519

C

18

Sweating disorders

149

Hyperhidrosis

588

Hyperhidrosis

975

C

18

Sweating disorders

149

Hyperhidrosis

588

Increased sweating

974

C

18

Sweating disorders

149

Hyperhidrosis

588

Night sweat

1651

H

18

Sweating disorders

149

Hyperhidrosis

588

Sudation

1206

C

18

Sweating disorders

149

Miliaria

553

Heat rash

1517

C

18

Sweating disorders

149

Miliaria

553

Prickly heat

1708

C

2149

Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Skin and appendages disorders Systemic disorders

19

150

A

19

978

A

2151

Systemic disorders

19

589

Avian general disorder NOS Avian systemic disorder NOS Unable to fly

977

Systemic disorders

976

A

2152

Systemic disorders

19

150

Avian systemic disorder NOS Avian systemic disorder NOS Avian systemic disorder NOS Dropped wings

589

2150

590

Dropped wings

979

A

2153

Systemic disorders

19

150

Ruffled feathers

591

Ruffled feathers

980

A

2154

Systemic disorders

19

Avian systemic disorders Avian systemic disorders Avian systemic disorders Avian systemic disorders Avian systemic disorders Bee systemic disorders

241

960

A

Systemic disorders

19

Bee systemic disorders

241

960

Bee systemic disorder NOS Bees absconding

2185

2155

2184

A

2156

Systemic disorders

19

Bee systemic disorders

241

960

Brood removal

2183

A

2157

Systemic disorders

19

Death

151

Bee systemic disorder NOS Bee systemic disorder NOS Bee systemic disorder NOS Death

592

Death

984

C

2158

Systemic disorders

19

Death

151

Death

592

Death by euthanasia

981

A

2143 2144 2145 2146 2147 2148

150 150

589

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2159

Systemic disorders

19

Death

151

Death

592

Found dead

983

C

2160

Systemic disorders

19

Death

151

Death

592

Increased culls

2513

C

2161

Systemic disorders

19

Death

151

Death

592

Increased mortality rate

2092

A

2162

Systemic disorders

19

Death

151

Death

592

Sudden death

982

C

2163

Systemic disorders

19

Death

151

Death

592

Unexplained death

985

C

2164

Systemic disorders

19

Death

151

Death

592

Unrelated death

2110

C

2165

Systemic disorders

19

Dwarfism

152

Dwarfism

593

Dwarfism

986

C

2166

Systemic disorders

19

Fish systemic disorders

153

Fish body deformity

594

Fish acquired dwarfism

989

A

2167

Systemic disorders

19

Fish systemic disorders

153

Fish body deformity

594

Fish body deformity

987

A

2168

Systemic disorders

19

Fish systemic disorders

153

Fish body deformity

594

Fish malformation

988

A

2169

Systemic disorders

19

Fish systemic disorders

153

Fish body deformity

594

Fish pinhead

990

A

2170

Systemic disorders

19

Fish systemic disorders

153

Fish colour change

595

992

A

2171

Systemic disorders

19

Fish systemic disorders

153

Fish colour change

595

Fish chromatophage disorder Fish colour change

991

A

2172

Systemic disorders

19

Fish systemic disorders

153

Fish colour change

595

Fish discolouration

993

A

2173

Systemic disorders

19

Fish systemic disorders

153

Sinking, fish

596

Sinking, fish

994

A

2174

Systemic disorders

19

Fish systemic disorders

153

Torpor, fish

597

Torpor, fish

995

A

2175

Systemic disorders

19

or

154

Abdominal mass

976

Abdominal mass

2277

C

2176

Systemic disorders

19

or

154

Abnormal posture NOS

1132

C

Systemic disorders

19

or

154

644

Wide-base stance

2633

C

2178

Systemic disorders

19

or

154

Abnormal posture NOS Abnormal posture NOS Abnormal test result

644

2177

666

Abnormal cytology

2588

C

2179

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Abnormal test result

666

Abnormal necropsy finding

2142

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2180

Systemic disorders

19

or

154

Abnormal test result

666

C

Systemic disorders

19

or

154

Abnormal test result

666

Abnormal radiograph finding Abnormal test result

2070

2181

1221

C

2182

Systemic disorders

19

or

154

Abnormal test result

666

C

Systemic disorders

19

or

154

Abnormal test result

666

2265

C

2184

Systemic disorders

19

or

154

Abnormal test result

666

2266

C

2185

Systemic disorders

19

or

154

Abnormal test result

666

2267

C

2186

Systemic disorders

19

or

154

Abnormal test result

666

Abnormal ultrasound finding Decreased cholesterol (total) Elevated cholesterol (total) Elevated C-reactive protein Elevated fibrinogen level

2069

2183

2268

C

2187

Systemic disorders

19

or

154

Abnormal test result

666

Elevated insulin

2545

C

2188

Systemic disorders

19

or

154

Abnormal test result

666

C

Systemic disorders

19

or

154

Abnormal test result

666

Elevated lactic acid dehydrogenase (LDH) Elevated SAP

2269

2189

2055

C

2190

Systemic disorders

19

or

154

Abnormal test result

666

Elevated triglyceride

2508

C

2191

Systemic disorders

19

or

154

Abnormal test result

666

Lipaemia

2421

C

2192

Systemic disorders

19

or

154

Abnormal test result

666

Low fibrinogen level

2270

C

2193

Systemic disorders

19

or

154

Abnormal test result

666

C

Systemic disorders

19

or

154

Abscess NOS

937

Sick euthyroid syndrome Abscess NOS

2507

2194

2074

C

2195

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Adipsia

338

Adipsia

542

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2196

Systemic disorders

19

or

154

Adipsia

338

Decreased drinking

2500

A

2197

Systemic disorders

19

or

154

Adipsia

338

Not drinking

541

C

2198

Systemic disorders

19

or

154

Adipsia

338

Partial adipsia

2590

C

2199

Systemic disorders

19

or

154

Anorexia

598

Anorexia

996

C

2200

Systemic disorders

19

or

154

Anorexia

598

Appetite loss

997

C

2201

Systemic disorders

19

or

154

Anorexia

598

Decreased appetite

998

C

2202

Systemic disorders

19

or

154

Anorexia

598

Food refusal

2401

C

2203

Systemic disorders

19

or

154

Anorexia

598

Inappetence

999

C

2204

Systemic disorders

19

or

154

Anorexia

598

Not eating

1207

C

2205

Systemic disorders

19

or

154

Anorexia

598

C

Systemic disorders

19

or

154

Anorexia

598

Not sucking (see also ‘Digestive’) Partial anorexia

2548

2206

2591

C

2207

Systemic disorders

19

or

154

Appetite disorder NOS

718

Appetite disorder NOS

1323

C

2208

Systemic disorders

19

or

154

Appetite disorder NOS

718

Dysorexia

2271

C

2209

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Collapse NOS

599

1001

C

2210

Systemic disorders

19

154

1007

C

Systemic disorders

19

Congested mucous membrane Congested mucous membrane

600

2211

General signs or symptoms General signs or symptoms

Collapse NOS (see also 'Cardio-vascular' and 'Neurological disorders') Congested mucous membrane Congestion of mucous membrane

1002

C

154

600

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2212

Systemic disorders

19

or

154

Hyperaemia

1008

C

Systemic disorders

19

or

154

600

Hyperaemic mucosae

1005

C

2214

Systemic disorders

19

or

154

600

C

Systemic disorders

19

or

154

600

Hyperaemic mucous membrane Inflamed mucosae

1006

2215

1004

C

2216

Systemic disorders

19

or

154

600

Red mucosae

1003

C

2217

Systemic disorders

19

or

154

Congested mucous membrane Congested mucous membrane Congested mucous membrane Congested mucous membrane Congested mucous membrane Cyanosis

600

2213

601

Cyanosis

1009

C

2218

Systemic disorders

19

or

154

Dehydration

657

Decreased skin turgor

2549

C

2219

Systemic disorders

19

or

154

Dehydration

657

Dehydration

1208

C

2220

Systemic disorders

19

or

154

Dehydration

657

Dry mucous membrane

1210

C

2221

Systemic disorders

19

or

154

Dehydration

657

Exsiccosis

1209

C

2222

Systemic disorders

19

or

154

Dehydration

657

Haemoconcentration

2272

C

2223

Systemic disorders

19

or

154

Dehydration

657

Sunken eyes

2273

C

2224

Systemic disorders

19

or

154

Discomfort NOS

994

Discomfort NOS

2498

A

2225

Systemic disorders

19

or

154

Discomfort NOS

994

Feet shifting

2547

C

2226

Systemic disorders

19

or

154

Discomfort NOS

994

Neck writhing

2546

C

2227

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Discomfort NOS

994

Pawing

2592

A

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2228

Systemic disorders

19

154

Discomfort NOS

994

Uncomfortable

2499

A

2229

Systemic disorders

19

154

Dysphoria

997

Dysphoria

2531

C

2230

Systemic disorders

19

General signs or symptoms General signs or symptoms General signs or symptoms

154

Emphysema NOS

602

1010

C

2231

Systemic disorders

19

or

154

Endotoxaemia

1013

2595

C

2232

Systemic disorders

19

or

154

Exercise intolerance

617

Exercise intolerance

1042

C

2233

Systemic disorders

19

or

154

General pain

603

C

Systemic disorders

19

or

154

General pain

603

General pain (see other SOCs for specific pain) Pain NOS

1011

2234

1012

C

2235

Systemic disorders

19

or

154

Glazed eye

658

Glazed eye

1211

C

2236

Systemic disorders

19

or

154

Haematoma NOS

940

Haematoma NOS

2088

C

2237

Systemic disorders

19

or

154

Hot flush

892

Hot flush

1924

H

2238

Systemic disorders

19

or

154

Hyperthermia

604

Elevated temperature

1033

C

2239

Systemic disorders

19

or

154

Hyperthermia

604

Febrile

1034

C

2240

Systemic disorders

19

or

154

Hyperthermia

604

Fever

1032

C

2241

Systemic disorders

19

or

154

Hyperthermia

604

Heat stroke

2504

A

2242

Systemic disorders

19

or

154

Hyperthermia

604

Hyperthermia

1014

C

2243

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

Emphysema NOS (see 'Respiratory' for pulmonary emphysema) Endotoxaemia

or

154

Hyperthermia

604

Influenza-like symptoms

1930

H

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2244

Systemic disorders

19

or

154

Hyperthermia

604

Malignant hyperthermia

1013

C

2245

Systemic disorders

19

or

154

Hyperthermia

604

Pyrexia

1031

C

2246

Systemic disorders

19

or

154

Hypothermia

605

C

Systemic disorders

19

or

154

Hypothermia

605

Decreased body temperature Hypothermia

1016

2247

1015

C

2248

Systemic disorders

19

or

154

Increased appetite

779

Excessive appetite

136

C

2249

Systemic disorders

19

or

154

Increased appetite

779

Increased appetite

1530

C

2250

Systemic disorders

19

or

154

Increased appetite

779

Polyphagia

137

C

2251

Systemic disorders

19

or

154

Jaundice

309

Acute jaundice

1297

C

2252

Systemic disorders

19

or

154

Jaundice

309

Haemolytic jaundice

1279

C

2253

Systemic disorders

19

or

154

Jaundice

309

Hepatic jaundice

1278

C

2254

Systemic disorders

19

or

154

Jaundice

309

Icterus

499

C

2255

Systemic disorders

19

or

154

Jaundice

309

Jaundice

501

C

2256

Systemic disorders

19

or

154

Jaundice

309

C

Systemic disorders

19

or

154

Lethargy

606

Yellow mucous membranes Apathy

500

2257

1212

C

2258

Systemic disorders

19

or

154

Lethargy

606

Asthenia

1277

C

2259

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Lethargy

606

Chronic fatigue syndrome

1378

H

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2260

Systemic disorders

19

or

154

Lethargy

606

Decreased activity

2039

C

2261

Systemic disorders

19

or

154

Lethargy

606

Depression

1024

C

2262

Systemic disorders

19

or

154

Lethargy

606

Devitalisation

1046

C

2263

Systemic disorders

19

or

154

Lethargy

606

C

Systemic disorders

19

or

154

Lethargy

606

Drowsiness - systemic disorder Dull

2530

2264

2274

C

2265

Systemic disorders

19

or

154

Lethargy

606

Fatigue

1467

C

2266

Systemic disorders

19

or

154

Lethargy

606

Feelings of weakness

1472

H

2267

Systemic disorders

19

or

154

Lethargy

606

Generalised weakness

1496

C

2268

Systemic disorders

19

or

154

Lethargy

606

Lack of awareness

1020

C

2269

Systemic disorders

19

or

154

Lethargy

606

A

Systemic disorders

19

or

154

Lethargy

606

1018

C

2271

Systemic disorders

19

or

154

Lethargy

606

Lack of response to owner Lethargy (see also Central nervous system depression in 'Neurological') Listless

2510

2270

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

1022

C

2272

Systemic disorders

19

or

154

Lethargy

606

Loss of strength

1594

C

2273

Systemic disorders

19

or

154

Lethargy

606

1630

H

2274

Systemic disorders

19

or

154

Lethargy

606

Myalgic encephalomyelitis (ME) Post viral fatigue syndrome

1705

H

General signs symptoms General signs symptoms General signs symptoms General signs symptoms

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2275

Systemic disorders

19

or

154

Lethargy

606

Reduced responses

1021

C

2276

Systemic disorders

19

or

154

Lethargy

606

Reluctant to move

1025

C

2277

Systemic disorders

19

or

154

Lethargy

606

C

Systemic disorders

19

or

154

Lethargy

606

Sleepiness - systemic disorder Stupor

2529

2278

1019

C

2279

Systemic disorders

19

or

154

Lethargy

606

Tiredness

1844

C

2280

Systemic disorders

19

or

154

Lethargy

606

Weakness

1023

C

2281

Systemic disorders

19

or

154

Lipoma

933

Lipoma

2062

C

2282

Systemic disorders

19

or

154

Localised pain NOS

607

Arched back

2275

C

2283

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Localised pain NOS

607

1026

C

2284

Systemic disorders

19

or

154

Malaise

608

2071

C

2285

Systemic disorders

19

or

154

Malaise

608

Malaise

1027

C

2286

Systemic disorders

19

or

154

Malaise

608

Off colour

1028

C

2287

Systemic disorders

19

or

154

Malaise

608

Quiet

2645

C

2288

Systemic disorders

19

or

154

Malaise

608

Subdued

2646

C

2289

Systemic disorders

19

or

154

Mass NOS

916

Palpable mass NOS

2000

C

2290

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

Localised pain NOS (see other 'SOCs' for specific pain) General illness

or

154

Oedema NOS

609

Dependent oedema

1229

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2291

Systemic disorders

19

or

154

Oedema NOS

609

Hand and arm swollen

1510

H

2292

Systemic disorders

19

or

154

Oedema NOS

609

C

Systemic disorders

19

or

154

Oedema NOS

609

1586

C

2294

Systemic disorders

19

or

154

Oedema NOS

609

Local swelling (not application site) Localised oedema (not application site) Lymphoedema

1580

2293

2319

C

2295

Systemic disorders

19

or

154

Oedema NOS

609

NT - polyserositis

2320

C

2296

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Oedema NOS

609

1029

C

2297

Systemic disorders

19

General signs or symptoms

154

Oedema NOS

609

518

C

2298

Systemic disorders

19

or

154

Oedema NOS

609

2276

C

2299

Systemic disorders

19

or

154

Oedema NOS

609

Swelling NOS

1214

C

2300

Systemic disorders

19

or

154

Oedema NOS

609

Swollen feet

1812

C

2301

Systemic disorders

19

or

154

Oedema NOS

609

Swollen limb

2402

C

2302

Systemic disorders

19

or

154

Pale mucous membrane

222

C

Systemic disorders

19

or

154

660

Pallor

1215

C

2304

Systemic disorders

19

or

154

Pale mucous membrane Pale mucous membrane Polydipsia

660

2303

339

Drinking a lot

545

C

2305

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

Oedema NOS (see other SOCs for specific oedemas) Oedema of the extremities (see also other SOCs for most applicable oedema) Submandibular oedema

or

154

Polydipsia

339

Excessive thirst

544

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2306

Systemic disorders

19

or

154

Polydipsia

339

Polydipsia

543

C

2307

Systemic disorders

19

or

154

A

19

or

154

947

Premature anaesthesia recovery Abnormal posture

2278

Systemic disorders

Premature anaesthesia recovery Recumbency

977

2308

2395

C

2309

Systemic disorders

19

or

154

Recumbency

947

Decubitus

2024

C

2310

Systemic disorders

19

or

154

Recumbency

947

Downer animal

2172

A

2311

Systemic disorders

19

or

154

Recumbency

947

Lateral recumbency

1135

C

2312

Systemic disorders

19

or

154

Recumbency

947

Prostration

1017

C

2313

Systemic disorders

19

or

154

Recumbency

947

Recumbency

658

C

2314

Systemic disorders

19

or

154

Recumbency

947

C

Systemic disorders

19

or

154

Recumbency

947

1136

C

2316

Systemic disorders

19

or

154

Recumbency

947

Self auscultation position Sternoabdominal recumbency Unable to rise

2396

2315

2045

C

2317

Systemic disorders

19

or

154

Rough recovery

995

Rough recovery

2503

C

2318

Systemic disorders

19

or

154

Septicaemia

611

Septicaemia

1035

C

2319

Systemic disorders

19

or

154

Steatitis

612

Necrotising steatitis

1037

C

2320

Systemic disorders

19

or

154

Steatitis

612

Steatitis

1036

C

2321

Systemic disorders

19

General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms General signs symptoms

or

154

Suspected infectious agent transmission

893

Suspected infectious agent transmission

1925

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2322

Systemic disorders

19

154

A

19

2550

C

2324

Systemic disorders

19

154

897

Suspected reversal to virulence Systemic fungal infection Abrasion

2647

Systemic disorders

Suspected reversal to virulence Systemic fungal infection Trauma NOS

1021

2323

2594

C

2325

Systemic disorders

19

154

Trauma NOS

897

Laceration

2509

C

2326

Systemic disorders

19

154

Trauma NOS

897

Trauma NOS

1932

C

2327

Systemic disorders

19

154

Trauma NOS

897

Wound

2593

C

2328

Systemic disorders

19

154

Ulceration NOS

613

Ulceration NOS

1038

C

2329

Systemic disorders

19

154

Weight fluctuation

1014

Weight fluctuation

2596

C

2330

Systemic disorders

19

154

Weight gain

620

Increased weight

1049

C

2331

Systemic disorders

19

154

Weight gain

620

Weight gain

1050

C

2332

Systemic disorders

19

154

Weight loss

946

Weight loss

1043

C

2333

Systemic disorders

19

General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms General signs or symptoms Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy

1039

A

2334

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2648

A

2335

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2551

A

2336

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2492

A

2337

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2436

A

2338

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (bacteria NOS) Lack of efficacy (distemper virus) Lack of efficacy (ectoparasite NOS) Lack of efficacy (endoparasite NOS) Lack of efficacy (flea)

2649

A

154

1002

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2339

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (fly)

2650

A

2340

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2430

A

2341

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (heartworm) Lack of efficacy (lice)

2651

A

2342

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (mite)

2652

A

2343

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2653

A

2344

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2654

A

2345

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2554

A

2346

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2552

A

2347

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2655

A

2348

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2553

A

2349

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2656

A

2350

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2657

A

2351

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (mosquito) Lack of efficacy (mycoplasma NOS) Lack of efficacy (myxomatosis) Lack of efficacy (parvovirus) Lack of efficacy (protozoa) Lack of efficacy (rabbit haemorrhagic disease (RHD)) Lack of efficacy (roundworm) Lack of efficacy (tapeworm) Lack of efficacy (tick)

2658

A

2352

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2659

A

2353

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

2660

A

2354

Systemic disorders

19

Lack of efficacy

155

Lack of efficacy

614

Lack of efficacy (trematode) Lack of efficacy (virus NOS) Partial lack of efficacy

2001

A

2355

Systemic disorders

19

Multi-organ failure

156

Moribund

615

Moribund

1040

C

2356

Systemic disorders

19

Multi-organ failure

156

Multi-organ failure

616

Multi-organ failure NOS

1041

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

NOS 2357

Systemic disorders

19

Neoplasia NOS

240

Metastatic neoplasia

894

Metastatic neoplasia

1926

C

2358

Systemic disorders

19

Neoplasia NOS

240

Metastatic neoplasia

894

Metastatic tumour

1927

C

2359

Systemic disorders

19

Neoplasia NOS

240

Neoplasia NOS

895

Neoplasia NOS

1928

C

2360

Systemic disorders

19

Neoplasia NOS

240

Neoplasia NOS

895

NT - adenocarcinoma

2352

C

2361

Systemic disorders

19

Neoplasia NOS

240

Neoplasia NOS

895

NT - tumour (NOS)

2351

C

2362

Systemic disorders

19

Neoplasia NOS

240

Neoplasia NOS

895

Secondary malignancy

2279

C

2363

Systemic disorders

19

Neoplasia NOS

240

945

Tumour lysis syndrome

2109

C

2364

Systemic disorders

19

Performance disorders

157

Tumour lysis syndrome Loss of condition

618

Loss of condition

1044

A

2365

Systemic disorders

19

Performance disorders

157

Loss of condition

618

Loss of condition score

1045

A

2366

Systemic disorders

19

Performance disorders

157

Loss of condition

618

Reduced growth rate

2188

A

2367

Systemic disorders

19

Performance disorders

157

Poor feed conversion

619

Low weight gain

1048

A

2368

Systemic disorders

19

Performance disorders

157

Poor feed conversion

619

Poor feed conversion

1047

A

2369

Systemic disorders

19

Performance disorders

157

Poor feed conversion

619

Unthrifty

1933

A

2370

Systemic disorders

19

Residues

235

Residues

929

Residues in eggs

2040

A

2371

Systemic disorders

19

Residues

235

Residues

929

Residues in honey

2041

A

2372

Systemic disorders

19

Residues

235

Residues

929

Residues in meat/offal

2042

A

2373

Systemic disorders

19

Residues

235

Residues

929

Residues in milk

2043

A

2374

Systemic disorders

19

Residues

235

Residues

929

Residues NOS

2044

A

2375

Systemic disorders

19

Systemic disorders NOS

158

Cachexia

621

Cachexia

1051

C

2376

Systemic disorders

19

Systemic disorders NOS

158

622

Dehiscence

2080

C

2377

Systemic disorders

19

Systemic disorders NOS

158

Systemic disorder NOS Systemic disorder NOS

622

Delayed healing

2081

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2378

Systemic disorders

19

Systemic disorders NOS

158

622

Increased yawning

2501

C

2379

Systemic disorders

19

Systemic disorders NOS

158

622

Infectious disease NOS

2597

C

2380

Systemic disorders

19

Systemic disorders NOS

158

622

Poor coat condition

1996

A

2381

Systemic disorders

19

Systemic disorders NOS

158

622

Shaking

2002

C

2382

Systemic disorders

19

Systemic disorders NOS

158

622

Surgical site disorder

2107

C

2383

Systemic disorders

19

Systemic disorders NOS

158

622

C

Systemic disorders

19

Systemic disorders NOS

158

622

Surgical site haemorrhage Systemic disorder NOS

2280

2384

1052

C

2385

Systemic disorders

19

Systemic disorders NOS

158

622

Weak pulse

2187

C

2386

Uncoded signs

20

Uncoded signs

161

Systemic disorder NOS Systemic disorder NOS Systemic disorder NOS Systemic disorder NOS Systemic disorder NOS Systemic disorder NOS Systemic disorder NOS Systemic disorder NOS Uncoded sign

661

Uncoded sign

1216

C

2387

Psychological disorders

31

stress

202

Anxiety disorder

714

Agitated state of mind

1299

H

2388

Psychological disorders

31

stress

202

Anxiety disorder

714

Anxious state of mind

1319

H

2389

Psychological disorders

31

stress

202

Anxiety disorder

714

Distressed state

1419

H

2390

Psychological disorders

31

stress

202

Anxiety disorder

714

Feeling anxious

1468

H

2391

Psychological disorders

31

stress

202

Anxiety disorder

714

Feeling restless

782

H

2392

Psychological disorders

31

stress

202

Anxiety disorder

714

Feeling shell shocked

1469

H

2393

Psychological disorders

31

stress

202

Anxiety disorder

714

Feeling stressed

1471

H

2394

Psychological disorders

31

Anxiety and disorders Anxiety and disorders Anxiety and disorders Anxiety and disorders Anxiety and disorders Anxiety and disorders Anxiety and disorders Anxiety and

stress

202

Anxiety disorder

714

Nervous tension

1643

H

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

Anxiety and stress disorders Anxiety and stress disorders Anxiety and stress disorders Anxiety and stress disorders Anxiety and stress disorders Communication disorders Communication disorders Communication disorders Depressed mood disorders Depressed mood disorders Depressed mood disorders Depressed mood disorders Disturbances in thinking/perception Disturbances in thinking/perception

202

Anxiety disorder

714

Nervousness

1644

H

202

Anxiety disorder

714

Panic attack

1671

H

202

Anxiety disorder

714

Throat constriction

1835

H

202

Anxiety disorder

714

Throat tightness

1838

H

202

Nervous breakdown

811

Nervous breakdown

1641

H

209

Speech problem

856

Speech problem

1786

H

209

Speech problem

856

Stammering

1789

H

209

Speech problem

856

Stuttering

1802

H

210

741

H

742

Depressed mood disorder NOS Depressed state

1402

210

Depressed mood disorder NOS Depression

1403

H

210

Depression

742

Feeling depressed

1404

H

210

Depression

742

Mood depressions

1618

H

213

Delusion

740

Delusion

1401

H

213

749

Disturbances in thinking/perception NOS

1421

H

Disturbances in thinking/perception

213

Disturbances in thinking/perception NOS Hallucinations

772

Hallucinations

1509

H

High level term (HLT)

disorders 2395

Psychological disorders

31

2396

Psychological disorders

31

2397

Psychological disorders

31

2398

Psychological disorders

31

2399

Psychological disorders

31

2400

Psychological disorders

31

2401

Psychological disorders

31

2402

Psychological disorders

31

2403

Psychological disorders

31

2404

Psychological disorders

31

2405

Psychological disorders

31

2406

Psychological disorders

31

2407

Psychological disorders

31

2408

Psychological disorders

31

2409

Psychological disorders

31

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2410

Psychological disorders

31

213

Paranoia

828

Paranoia

1679

H

2411

Psychological disorders

31

213

Difficulty in thinking

1411

H

Psychological disorders

31

865

Thinking abnormal NOS

1833

H

2413

Psychological disorders

31

865

Thought block

1834

H

2414

Psychological disorders

31

214

Thinking abnormal NOS Thinking abnormal NOS Thinking abnormal NOS Eating disorder NOS

865

2412

Disturbances in thinking/perception Disturbances in thinking/perception Disturbances in thinking/perception Disturbances in thinking/perception Eating disorders

758

1438

H

2415

Psychological disorders

31

221

Agoraphobia

705

1300

H

2416

Psychological disorders

31

221

Mental disorder NOS

800

Mental disorder NOS

1610

H

2417

Psychological disorders

31

221

Mental disorder NOS

800

Psychophysical malfunction

1712

H

2418

Psychological disorders

31

221

Psychiatric disorder NOS

838

Psychiatric disorder NOS

1711

H

2419

Psychological disorders

31

221

Psychotic disorder

839

Psychotic disorder

1713

H

2420

Psychological disorders

31

223

Abnormal behaviour

701

H

Psychological disorders

31

223

Abnormal behaviour

701

Abnormal behaviour NOS Aggressive behaviour

1291

2421

1298

H

2422

Psychological disorders

31

Other psychiatric/mental disorders Other psychiatric/mental disorders Other psychiatric/mental disorders Other psychiatric/mental disorders Other psychiatric/mental disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders

Eating disorder NOS (see Systemic for anorexia etc) Agoraphobia

223

Abnormal behaviour

701

Anger

1314

H

213 213

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 151/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2423

Psychological disorders

31

223

Abnormal behaviour

701

Bad mood

1339

H

2424

Psychological disorders

31

223

Abnormal behaviour

701

Emotional detachment

1441

H

2425

Psychological disorders

31

223

Abnormal behaviour

701

Hyperactive

1527

H

2426

Psychological disorders

31

223

Abnormal behaviour

701

Mood swing

1619

H

2427

Psychological disorders

31

223

Abnormal behaviour

701

Snappy

1780

H

2428

Psychological disorders

31

223

Abnormal behaviour

701

Tearfulness

1827

H

2429

Psychological disorders

31

223

Abnormal behaviour

701

Temper tantrum

1828

H

2430

Psychological disorders

31

223

Abnormal behaviour

701

Weeping

1874

H

2431

Psychological disorders

31

223

H

31

1743

H

2433

Psychological disorders

31

1744

H

2434

Psychological disorders

31

Sleep disorders

228

Abnormal dream

702

Personality disorder NOS Sexual arousal decreased Sexual dysfunction/disorder NOS Abnormal dream

1692

Psychological disorders

Personality disorder NOS Sexual dysfunction/disorder Sexual dysfunction/disorder

834

2432

Personality and mood disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders Personality and mood disorders Sexual dysfunctions/disorders Sexual dysfunctions/disorders

1292

H

2435

Psychological disorders

31

Sleep disorders

228

Abnormal dream

702

Nightmare

1652

H

2436

Psychological disorders

31

Sleep disorders

228

Abnormal dream

702

Sleep walking

1771

H

2437

Psychological disorders

31

Sleep disorders

228

Hypersomnia

777

Feeling sleepy

1772

H

2438

Psychological disorders

31

Sleep disorders

228

Hypersomnia

777

Hypersomnia

1528

H

2439

Psychological disorders

31

Sleep disorders

228

Hypersomnia

777

Somnolent state

1252

H

2440

Psychological disorders

31

Sleep disorders

228

Insomnia

787

Difficulty sleeping

1412

H

224 224

844 844

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

Page 152/153

New line no.

System organ class (SOC) term

SOC key

High level term (HLT)

HLT key

Preferred term (PT)

PT key

Low level term (LLT)NT

LLT key

LLT term type1

2441

Psychological disorders

31

Sleep disorders

228

Insomnia

787

Insomnia

1557

H

2442

Psychological disorders

31

Sleep disorders

228

Insomnia

787

Poor sleep

1704

H

2443

Psychological disorders

31

Sleep disorders

228

Insomnia

787

Sleeplessness

1773

H

2444

Psychological disorders

31

Sleep disorders

228

Sleep disorder NOS

853

Sleep disorder NOS

1769

H

2445

Psychological disorders

31

Sleep disorders

228

Sleep disorder NOS

853

Sleep dysfunction NOS

1770

H

2446

Psychological disorders

31

Suicidal behaviours

230

858

Suicidal behaviour NOS

1803

H

2447

Psychological disorders

31

Suicidal behaviours

230

858

Suicidal ideation

1804

H

2448

Psychological disorders

31

Suicidal behaviours

230

858

Suicidal tendency

1805

H

2449

Psychological disorders

31

Suicidal behaviours

230

Suicidal behaviour NOS Suicidal behaviour NOS Suicidal behaviour NOS Suicide attempt

859

Suicide attempt

1806

H

2450

Psychological disorders

31

Suicidal behaviours

230

Suicide completed

860

Suicide completed

1807

H

2451

No signs

32

No signs

231

No sign

884

No sign

1909

C

2452

Unclassifiable event

33

242

C

33

243

978

Environmental adverse event Counterfeit product

2189

Unclassifiable event

Environmental adverse event Product problem

961

2453

2281

C

2454

Unclassifiable event

33

243

Product problem

978

Medication error

2282

C

2455

Unclassifiable event

33

243

Product problem

978

Product problem

2283

C

2456

Unclassifiable event

33

Environmental adverse event Unclassifiable adverse event Unclassifiable adverse event Unclassifiable adverse event Unclassifiable adverse event

243

Unclassifiable adverse event

962

Unclassifiable adverse event

2190

C

NT: Necropsy term 1: A: animal; C: common; H: human Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products EMA/CVMP/PhVWP/10418/2009-Rev.9 (EudraVigilance Veterinary implementation version 14)

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