Summary of adverse experience reports made to the APVMA about Hendra virus vaccine

The information presented below is collected by the Adverse Experience Program (AERP) of the APVMA as part of its ongoing surveillance of the registered product.

How the APVMA classifies an adverse experience

The APVMA makes an independent assessment about the causal relationship between exposure to or use of a product and a reported adverse experience—the likelihood that the product was involved in causing the adverse experience. The outcome of the assessment is a four-tiered classification of probable, possible, unlikely or unknown.

Read further information about the classification process.

The following table presents the number of APVMA classified reports grouped in time periods in which the adverse events occurred.

Number of equine reports classified by the APVMA to 30 June 2016 (grouped by the year of reaction)

Reaction year Possible Possible/off-label Probable Probable/off-label Unlikely Unknown Total
2012 26   4   8 4 42
2013 261 1 52 3 33 31 381
2014 366 1 76 1 32 42 518
2015 191 1 46   31 40 309
1 January—30 June 2016 39   20 2 7 16 84
Total 883 3 198 6 111 133 1334

* Please note that as the APVMA continues to classify adverse reports received, the individual figures in the above table may also continue to rise, depending on the date of the adverse event and the date of its classification.

What do the classifications mean?

Probable

A ‘probable’ classification is given when there is a reasonable association between exposure to a product and the onset of the reported adverse experience, and the description of the presenting signs is consistent (or plausible) with the known pharmacology and toxicology of the product and there are no other alternative explanations.

Possible

A ‘possible’ classification is given when there is a reasonable association between the exposure to the product and the onset of the reported adverse experience. Therefore, it is reasonable to include the adverse reaction as a differential diagnosis, and it is one of the possible explanations for the adverse experience (for example, the use of concurrent medication), or the association is reasonable but does not meet the criteria for a probable classification.

Probable or possible off-label

This classification is given as per the classifications of ‘probable’ or ‘possible’, but where there is evidence of off-label use. That is, use that is not in accordance with the label instructions approved by the APVMA.

Unlikely

An ‘unlikely’ classification is given when sufficient information exists to establish that the adverse experience was not likely to have been associated with a product.

Count of presenting signs: equine reports classified by the APVMA as probable and possible to 30 June 2016

The data in the table below relates to the number of reports in which a presenting sign was identified. A single report may describe a presenting sign in multiple horses. Reports reflect the count rather than the severity of presenting signs.

Presenting signs Probable Possible
Injection site reaction 579 22
Oedema 261 23
Lethargy 255 62
Pain 253 24
Anorexia 151 32
Pyrexia 135 34
Stiffness 123 16
Swelling (local) 122 9
Lump (local) 65 6
Muscle stiffness 52 3
Urticaria 41 12
Ataxia 30 11
Sweating 28 11
Listless 26 1
Colic 22 20
Depression 15 4
Lame 15 3
Site reaction 2 0
Malaise 13 12
Behavioural change 10 6
Abdominal pain 9 6
Coat colour change 9 2
Nasal discharge 7 13
Recumbency 7 8
Disorientation 6 1
Walking (difficult) 6 1
Adipsia 5 0
Alopecia (localised) 4 7
Tachypnoea 4 2
Distress 4 1
Shaking 4 1
Panting 4 0
Pruritis 4 0
Restless 4 0
Laminitis 3 4
Hives 3 2
Lymphadenopathy 3 2
Tachycardia 3 2
Aggression 3 1
Coughing 2 4
Alopecia 2 3
Tremor 2 2
Hypersalivation 2 0
Hypersensitivity reaction 2 0
Rash 2 0
Site reaction (swelling) 2 0
Welts 2 0
Weight loss 1 5
Abnormal breathing 1 2
Dermatitis 1 2
Polydipsia 1 2
Agitation 1 1
Anaphylaxis 1 1
Epistaxis 1 1
Facial oedema 1 1
Pale mucous membranes 1 1
Paresis 1 1
Stranguria 1 1
Bradycardia 1 0
Conjunctivitis 1 0
Constipation 1 0
Haematoma 1 0
Hyperaesthesia 1 0
Incoordination 1 0
Inflammation 1 0
Laryngitis 1 0
Lesions 1 0
Polymyositis 1 0
Weakness 1 0
Death 0 7
Diarrhoea 0 5
Dyspnoea 0 3
Coat discoloration 0 2
Lymphadenitis—107 0 2
Preputial swelling 0 2
Respiratory problems 0 2
Abortion 0 1
Allergy 0 1
Anuria 0 1
Atrophy 0 1
Azoturia 0 1
Colitis 0 1
Confusion 0 1
Eczema 0 1
Fasciculation 0 1
Hepatopathy 0 1
Hyperactivity 0 1
Hypersensitive to stimuli 0 1
Periorbital swelling 0 1

Reaction incidence %: equine reports classified by the APVMA as probable and possible to 30 June 2016

Reaction Incidence calculated on the understanding that 440,438 doses of vaccine have been administered from launch to 30 June 2016.

Reaction Incidence % = Total number of animals where a presenting sign has been classified as probably or possibly linked to the administration of the Hendra vaccine/number of doses sold*100

The data in the table below relates to the number of horses for which a reaction has been reported that has been assigned a classification of possible or probable.

Presenting signs Reaction %
Injection site reaction 0.2
Oedema 0.10
Lethargy 0.10
Pain 0.09
Pyrexia 0.06
Anorexia 0.05
Swelling (local) 0.05
Stiffness 0.04
Muscle stiffness 0.01
Urticaria 0.01
Lump (local) 0.02
Colic 0.009
Ataxia 0.01
Sweating 0.01
Behavioural change 0.009
Malaise 0.007
Listless 0.009
Abdominal pain 0.004
Alopecia (localised) 0.004
Lame 0.005
Depression 0.004
Coat colour change 0.003
Recumbency 0.004
Site reaction 0.003
Nasal discharge 0.004
Coughing 0.002
Disorientation 0.002
Laminitis 0.002
Alopecia 0.002
Death 0.002
Lymphadenopathy 0.002
Tachypnoea 0.002
Weight loss 0.002
Agitation 0.001
Pruritis 0.001
Restless 0.001
Tachycardia 0.001
Walking (difficult) 0.002
Diarrhoea 0.001
Distress 0.001
Polydipsia 0.001
Shaking 0.001
Stranguria 0.001
Tremor 0.001
Hives 0.002
Adipsia 0.001
Panting 0.001

The following presenting signs each had a reaction incidence of <0.001%:

Aggression, dermatitis, dyspnoea, lymphadenitis, paresis, respiratory problems, abnormal breathing, facial oedema, site reaction (swelling), welts, allergy, anaphylaxis, coat discoloration, confusion, epistaxis, hypersalivation, hypersensitivity reaction, lesions, pale mucous membranes, preputial swelling, rash, abortion, anuria, atrophy, azoturia, bradycardia, colitis, conjunctivitis, constipation, eczema, fasciculation, haematoma, hepatopathy, hyperactivity, hyperaesthesia, hypersensitive to stimuli, incoordination, inflammation, laryngitis, periorbital swelling, polymyositis, scrotitis, urine (abnormal), weakness

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