(VeDDRA) list of clinical terms for reporting suspected adverse

243 Pages·2017·1.04 MB·English

by  European Medicines Agency

13 September 2022
EMA/CVMP/PhVWP/10418/2009-Rev.13-corr*
Committee for Veterinary Medicinal Products
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) 24-25 May 2022
Adoption by CVMP 14-15 June 2022
Date for coming into effect 1 October 2022

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
LLT term types:
A: animal
C: common
H: human
*: High level term key for Administration errors and issues corrected to 3020

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© European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged.
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Application site
1 1 1 Application site blister 3 Application site blister 4 C
disorders reactions
Application site Application site
2 1 1 Application site burn 934 Application site burn 2063 C
disorders reactions
Application site Application site Application site
3 1 1 4 Application site erythema 5 C
disorders reactions erythema
Application site Application site Application site
4 1 1 4 Application site reddening 1332 C
disorders reactions erythema
Application site Application site Application site
5 1 1 4 Application site rubra 6 C
disorders reactions erythema
Application site Application site Application site feather
6 1 1 1016 Application site feather change 2603 A
disorders reactions change
Application site Application site Application site feather
7 1 1 1016 Application site feather loss 2604 A
disorders reactions change
Application site Application site
8 1 1 Application site fibrosis 917 Application site fibrosis 2003 C
disorders reactions
Application site Application site Application site
9 1 1 5 Application site granuloma 7 C
disorders reactions granuloma
Application site Application site Application site
10 1 1 7 Application site bleeding 12 C
disorders reactions haemorrhage
Application site Application site Application site
11 1 1 7 Application site bruising 8 C
disorders reactions haemorrhage
Application site Application site Application site
12 1 1 7 Application site haematoma 10 C
disorders reactions haemorrhage
Application site Application site Application site
13 1 1 7 Application site haemorrhage 11 C
disorders reactions haemorrhage
Application site Application site Application site
14 1 1 7 Application site petechiae 9 C
disorders reactions haemorrhage
Application site Application site Application site hair
15 1 1 2 Application site alopecia 2 C
disorders reactions change
Application site Application site Application site hair
16 1 1 2 Application site greasy fur 2057 A
disorders reactions change
Application site Application site Application site hair
17 1 1 2 Application site hair change 1878 C
disorders reactions change
Application site Application site Application site hair Application site hair coat
18 1 1 2 2519 A
disorders reactions change discolouration
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.13 Page 2/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Application site Application site hair
19 1 1 2 Application site hair loss 3 C
disorders reactions change
Application site Application site Application site hair
20 1 1 2 Application site leukotrichia 2148 C
disorders reactions change
Application site Application site Application site hair
21 1 1 2 Application site residue 2191 C
disorders reactions change
Application site Application site Application site
22 1 1 918 Application site abscess 2004 C
disorders reactions infection
Application site Application site Application site
23 1 1 918 Application site infection 2005 C
disorders reactions infection
Application site Application site Application site
24 1 1 8 Application site dermatitis 1934 C
disorders reactions inflammation
Application site Application site Application site
25 1 1 8 Application site eczema 2064 C
disorders reactions inflammation
Application site Application site Application site
26 1 1 8 Application site inflammation 13 C
disorders reactions inflammation
Application site Application site Application site
27 1 1 8 Application site moist eczema 2065 C
disorders reactions inflammation
Application site Application site Application site
28 1 1 8 Application site rash 1331 C
disorders reactions inflammation
Application site Application site Application site
29 1 1 8 Application site warmth 2406 C
disorders reactions inflammation
Application site Application site
30 1 1 Application site lesion 9 Application site crust 16 C
disorders reactions
Application site Application site
31 1 1 Application site lesion 9 Application site lesion 14 C
disorders reactions
Application site Application site
32 1 1 Application site lesion 9 Application site scab 15 C
disorders reactions
Application site Application site
33 1 1 Application site lesion 9 Application site scar 2518 C
disorders reactions
Application site Application site
34 1 1 Application site lesion 9 Application site sore 2602 C
disorders reactions
Application site Application site Application site mass
35 1 1 1152 Application site lump 21 C
disorders reactions NOS
Application site Application site Application site mass
36 1 1 1152 Application site mass NOS 2832 C
disorders reactions NOS
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.13 Page 3/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site
Application site Application site Application site mucopurulent
37 1 1 mucopurulent 10 17 C
disorders reactions discharge
discharge
Application site Application site Application site
38 1 1 11 Application site necrosis 18 C
disorders reactions necrosis
Application site Application site Application site
39 1 1 12 Application site oedema 19 C
disorders reactions oedema
Application site Application site Application site
40 1 1 12 Application site swelling 20 C
disorders reactions oedema
Application site Application site
41 1 1 Application site pain 13 Application site burning sensation 2555 H
disorders reactions
Application site Application site
42 1 1 Application site pain 13 Application site pain 22 C
disorders reactions
Application site Application site
43 1 1 Application site pain 13 Immediate pain upon application 2408 C
disorders reactions
Application site Application site Application site
44 1 1 948 Application site numbness 2192 C
disorders reactions paraesthesia
Application site Application site Application site
45 1 1 948 Application site paraesthesia 2112 C
disorders reactions paraesthesia
Application site Application site Application site
46 1 1 948 Application site tingling 2193 H
disorders reactions paraesthesia
Application site Application site Application site
47 1 1 14 Application site itching 23 C
disorders reactions pruritus
Application site Application site Application site
48 1 1 14 Application site pruritus 25 C
disorders reactions pruritus
Application site Application site Application site
49 1 1 14 Application site scratching 26 C
disorders reactions pruritus
Application site Application site Application site
50 1 1 15 Application site hot spot 2407 A
disorders reactions pyoderma
Application site Application site Application site
51 1 1 15 Application site pustule 27 C
disorders reactions pyoderma
Application site Application site Application site
52 1 1 15 Application site pyoderma 28 C
disorders reactions pyoderma
Application site Application site Application site
53 1 1 16 Application site irritation 24 C
disorders reactions reaction NOS
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.13 Page 4/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Application site Application site
54 1 1 16 Application site reaction NOS 29 C
disorders reactions reaction NOS
Application site Application site Application site self-
55 1 1 18 Application site excoriation 2194 C
disorders reactions trauma
Application site Application site Application site self-
56 1 1 18 Application site self-trauma 31 C
disorders reactions trauma
Application site Application site Application site self-
57 1 1 18 Licking at application site 1973 A
disorders reactions trauma
Application site
Application site Application site Application site serosanguinous
58 1 1 serosanguinous 19 33 C
disorders reactions discharge
discharge
Application site
Application site Application site Application site weeping (see also
59 1 1 serosanguinous 19 32 C
disorders reactions Skin)
discharge
Application site Application site Application site serous
60 1 1 20 Application site serous discharge 34 C
disorders reactions discharge
Application site Application site Application site skin
61 1 1 963 Application site dry skin 2514 C
disorders reactions change
Application site Application site Application site skin
62 1 1 963 Application site hyperkeratosis 2516 C
disorders reactions change
Application site Application site Application site skin
63 1 1 963 Application site papule 2195 C
disorders reactions change
Application site Application site Application site skin Application site pigmentation
64 1 1 963 2517 C
disorders reactions change disorders
Application site Application site Application site skin
65 1 1 963 Application site skin change NOS 2200 C
disorders reactions change
Application site Application site Application site skin
66 1 1 963 Application site skin discolouration 2197 C
disorders reactions change
Application site Application site Application site skin
67 1 1 963 Application site skin scaling 2198 C
disorders reactions change
Application site Application site Application site skin
68 1 1 963 Application site skin squamosis 2199 C
disorders reactions change
Application site Application site Application site skin
69 1 1 963 Application site stickiness 2750 C
disorders reactions change
Application site Application site Application site skin
70 1 1 963 Application site thickening 2515 C
disorders reactions change
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.13 Page 5/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Application site Application site
71 1 1 964 Application site twitching 2196 C
disorders reactions twitching
Application site Application site
72 1 1 Application site ulcer 21 Application site ulcer 35 C
disorders reactions
Application site Application site Application site
73 1 1 1107 Application site vasoconstriction 2671 C
disorders reactions vasoconstriction
Application site Implant site
74 1 2 Implant site blister 24 Implant site blister 39 A
disorders reactions
Application site Implant site
75 1 2 Implant site erythema 25 Implant site erythema 41 A
disorders reactions
Application site Implant site
76 1 2 Implant site erythema 25 Implant site rubra 40 A
disorders reactions
Application site Implant site
77 1 2 Implant site fibrosis 919 Implant site fibrosis 2006 C
disorders reactions
Application site Implant site Implant site
78 1 2 26 Implant site granuloma 42 A
disorders reactions granuloma
Application site Implant site Implant site
79 1 2 28 Implant site bleeding 47 A
disorders reactions haemorrhage
Application site Implant site Implant site
80 1 2 28 Implant site bruising 43 A
disorders reactions haemorrhage
Application site Implant site Implant site
81 1 2 28 Implant site haematoma 44 A
disorders reactions haemorrhage
Application site Implant site Implant site
82 1 2 28 Implant site haemorrhage 46 A
disorders reactions haemorrhage
Application site Implant site Implant site
83 1 2 28 Implant site petechiae 45 A
disorders reactions haemorrhage
Application site Implant site Implant site hair
84 1 2 23 Implant site alopecia 37 A
disorders reactions change
Application site Implant site Implant site hair
85 1 2 23 Implant site hair change 2151 C
disorders reactions change
Application site Implant site Implant site hair
86 1 2 23 Implant site hair loss 38 A
disorders reactions change
Application site Implant site Implant site hair
87 1 2 23 Implant site leukotrichia 2152 C
disorders reactions change
Application site Implant site
88 1 2 Implant site infection 22 Implant site abscess 36 A
disorders reactions
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.13 Page 6/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Implant site
89 1 2 Implant site infection 22 Implant site infection 2201 A
disorders reactions
Application site Implant site Implant site
90 1 2 29 Implant site dermatitis 2007 C
disorders reactions inflammation
Application site Implant site Implant site
91 1 2 29 Implant site inflammation 48 A
disorders reactions inflammation
Application site Implant site Implant site
92 1 2 29 Implant site warmth 2409 C
disorders reactions inflammation
Application site Implant site
93 1 2 Implant site lesion 30 Implant site crust 51 A
disorders reactions
Application site Implant site
94 1 2 Implant site lesion 30 Implant site lesion 50 A
disorders reactions
Application site Implant site
95 1 2 Implant site lesion 30 Implant site scab 49 A
disorders reactions
Application site Implant site
96 1 2 Implant site mass NOS 1153 Implant site lump 54 A
disorders reactions
Application site Implant site
97 1 2 Implant site mass NOS 1153 Implant site mass NOS 2833 A
disorders reactions
Implant site
Application site Implant site
98 1 2 mucopurulent 31 Implant site mucopurulent discharge 52 A
disorders reactions
discharge
Application site Implant site
99 1 2 Implant site necrosis 32 Implant site necrosis 53 A
disorders reactions
Application site Implant site
100 1 2 Implant site oedema 33 Implant site oedema 55 A
disorders reactions
Application site Implant site
101 1 2 Implant site oedema 33 Implant site swelling 56 A
disorders reactions
Application site Implant site
102 1 2 Implant site pain 34 Implant site pain 57 A
disorders reactions
Application site Implant site
103 1 2 Implant site pruritus 35 Implant site irritation 58 A
disorders reactions
Application site Implant site
104 1 2 Implant site pruritus 35 Implant site itching 59 A
disorders reactions
Application site Implant site
105 1 2 Implant site pruritus 35 Implant site pruritus 61 A
disorders reactions
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.13 Page 7/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Implant site
106 1 2 Implant site pruritus 35 Implant site scratching 60 A
disorders reactions
Application site Implant site
107 1 2 Implant site pyoderma 36 Implant site pustule 62 A
disorders reactions
Application site Implant site
108 1 2 Implant site pyoderma 36 Implant site pyoderma 63 A
disorders reactions
Application site Implant site Implant site reaction
109 1 2 37 Implant site reaction NOS 64 A
disorders reactions NOS
Application site Implant site Implant site self-
110 1 2 39 Implant site self- trauma 66 A
disorders reactions trauma
Implant site
Application site Implant site
111 1 2 serosanguinous 40 Implant site serosanguinous discharge 68 A
disorders reactions
discharge
Implant site
Application site Implant site
112 1 2 serosanguinous 40 Implant site weeping (see also Skin) 67 A
disorders reactions
discharge
Application site Implant site Implant site serous
113 1 2 41 Implant site serous discharge 69 A
disorders reactions discharge
Application site Implant site
114 1 2 Implant site ulcer 42 Implant site ulcer 70 A
disorders reactions
Application site Implant site
115 1 2 Movement of implant 43 Movement of implant 71 A
disorders reactions
Application site Injection site
116 1 3 Injection site blister 46 Injection site blister 75 C
disorders reactions
Application site Injection site Injection site
117 1 3 782 Injection site complication NOS 1540 C
disorders reactions complication
Application site Injection site Injection site
118 1 3 782 Injection site joint reaction 1543 C
disorders reactions complication
Application site Injection site Injection site
119 1 3 782 Injection site nerve damage 1545 C
disorders reactions complication
Application site Injection site Injection site
120 1 3 782 Injection site tenosynovitis 2834 C
disorders reactions complication
Application site Injection site Injection site
121 1 3 47 Injection site erythema 77 C
disorders reactions erythema
Application site Injection site Injection site
122 1 3 47 Injection site reddening 1552 C
disorders reactions erythema
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.13 Page 8/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Injection site Injection site
123 1 3 47 Injection site rubra 76 C
disorders reactions erythema
Application site Injection site Injection site feather
124 1 3 1017 Injection site feather change 2606 A
disorders reactions change
Application site Injection site Injection site feather
125 1 3 1017 Injection site feather loss 2607 A
disorders reactions change
Application site Injection site
126 1 3 Injection site fibrosis 920 Injection site fibrosis 2008 C
disorders reactions
Application site Injection site Injection site
127 1 3 48 Injection site granuloma 78 C
disorders reactions granuloma
Application site Injection site Injection site
128 1 3 50 Injection site bleeding 83 C
disorders reactions haemorrhage
Application site Injection site Injection site
129 1 3 50 Injection site bruising 79 C
disorders reactions haemorrhage
Application site Injection site Injection site
130 1 3 50 Injection site haematoma 80 C
disorders reactions haemorrhage
Application site Injection site Injection site
131 1 3 50 Injection site haemorrhage 82 C
disorders reactions haemorrhage
Application site Injection site Injection site
132 1 3 50 Injection site petechiae 81 C
disorders reactions haemorrhage
Application site Injection site Injection site hair
133 1 3 45 Injection site alopecia 73 C
disorders reactions change
Application site Injection site Injection site hair
134 1 3 45 Injection site hair change 2149 C
disorders reactions change
Application site Injection site Injection site hair
135 1 3 45 Injection site hair loss 74 C
disorders reactions change
Application site Injection site Injection site hair
136 1 3 45 Injection site leukotrichia 2150 C
disorders reactions change
Application site Injection site
137 1 3 Injection site infection 44 Injection site abscess 72 C
disorders reactions
Application site Injection site
138 1 3 Injection site infection 44 Injection site infection 1542 C
disorders reactions
Application site Injection site
139 1 3 Injection site infection 44 Injection site phlegmon 2835 C
disorders reactions
Application site Injection site Injection site
140 1 3 51 Injection site dermatitis 1938 C
disorders reactions inflammation
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.13 Page 9/177
New System Organ
SOC High Level Term HLT PT LLT Term
line Class (SOC) Preferred Term (PT) Low Level Term (LLT)
Key (HLT) Key Key Key Type1
no. Term
Application site Injection site Injection site
141 1 3 51 Injection site inflammation 84 C
disorders reactions inflammation
Application site Injection site Injection site
142 1 3 51 Injection site warmth 1556 C
disorders reactions inflammation
Application site Injection site
143 1 3 Injection site lesion 52 Injection site crust 87 C
disorders reactions
Application site Injection site
144 1 3 Injection site lesion 52 Injection site lesion 86 C
disorders reactions
Application site Injection site
145 1 3 Injection site lesion 52 Injection site scab 85 C
disorders reactions
Application site Injection site Injection site mass
146 1 3 1154 Injection site lump 92 C
disorders reactions NOS
Application site Injection site Injection site mass
147 1 3 1154 Injection site mass NOS 2113 C
disorders reactions NOS
Application site Injection site Injection site mass
148 1 3 1154 Injection site nodule 2605 C
disorders reactions NOS
Injection site
Application site Injection site
149 1 3 mucopurulent 53 Injection site mucopurulent discharge 88 C
disorders reactions
discharge
Application site Injection site
150 1 3 Injection site necrosis 54 Injection site gangrene 2093 C
disorders reactions
Application site Injection site
151 1 3 Injection site necrosis 54 Injection site gaseous gangrene 2094 C
disorders reactions
Application site Injection site
152 1 3 Injection site necrosis 54 Injection site necrosis 89 C
disorders reactions
Application site Injection site Injection site
153 1 3 875 Injection site neoplasm NOS 1879 C
disorders reactions neoplasm NOS
Application site Injection site Injection site
154 1 3 784 Injection site numbness 1546 C
disorders reactions numbness
Application site Injection site
155 1 3 Injection site oedema 55 Injection site oedema 90 C
disorders reactions
Application site Injection site
156 1 3 Injection site oedema 55 Injection site swelling 91 C
disorders reactions
Application site Injection site
157 1 3 Injection site pain 56 Immediate pain upon injection 2410 C
disorders reactions
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.13 Page 10/177