(VeDDRA) list of clinical terms for reporting suspected adverse PDF
Preview (VeDDRA) list of clinical terms for reporting suspected adverse
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 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Union Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © 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
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