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 31 March 2016 (grouped by the year of reaction)

Reaction year Possible Possible/off-label Probable Probable/off-label Unknown Unlikely Total
2012 4   25   4 8 41
2013 52 3 252 1 31 32 371
2014 76 1 352 1 41 30 501
2015 35   166 1 37 23 262
1 January—31 March 2016 6 1 2       9
Total 173 5 797 3 113 93 1184

* 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 31 March 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 508 18
Oedema 251 21
Lethargy 239 52
Pain 220 22
Anorexia 142 24
Pyrexia 127 30
Stiffness 88 14
Swelling (local) 111 5
Muscle stiffness 51 3
Urticaria 40 12
Lump (local) 58 7
Ataxia 29 6
Sweating 26 10
Colic 22 20
Lame 13 2
Site reaction 14 0
Abdominal pain 9 6
Coat colour change 9 2
Depression 13 4
Malaise 9 11
Behavioural change 9 6
Recumbency 5 8
Nasal discharge 5 5
Disorientation 4 1
Shaking 4 1
Restless 4 0
Pruritis 4 0
Tachypnoea 4 2
Tachycardia 3 2
Lymphadenopathy 3 2
Listless 7 1
Distress 4 1
Site reaction 13 0
Alopecia (localised) 4 7
Coughing 2 4
Tremor 2 2
Alopecia 2 2
Panting 4 0
Hypersalivation 2 0
Hypersensitivity reaction 2 0
Hives 3 2
Aggression 3 1
Laminitis 2 5
Abnormal breathing 1 1
Stranguria 1 1
Paresis 1 1
Pale mucous membranes 1 1
Dermatitis 1 1
Anaphylaxis 1 1
Agitation 1 1
Paresis 1 1
Stranguria 1 1
Site reaction (swelling) 2 0
Polymyositis 1 0
Lesions 1 0
Laryngitis 1 0
Inflammation 1 0
Hyperaesthesia 1 0
Haematoma 1 0
Facial oedema 1 1
Epistaxis 1 1
Conjunctivitis 1 0
Bradycardia 1 0
Adipsia 4 0
Polymyositis 1 0
Walking difficult 6 1
Welts 1 0
Death 0 7
Weight loss 1 5
Diarrhoea 0 5
Dyspnoea 0 3
Urine (abnormal) 0 1
Respiratory problems 0 2
Polydipsia 1 2
Anuria 0 1
Periorbital swelling 0 1
Hypersensitive to stimuli 0 1
Hyperactivity 0 1
Hepatopathy 0 1
Fasciculation 0 1
Eczema 0 1
Confusion 0 1
Coat discoloration 0 2
Colitis 0 1
Azoturia 0 1
Atrophy 0 1
Incoordination 1 0
Inflammation 1 0
Vomiting 1 0
Weakness 1 0
Allergy 0 1
Lymphadenitis 0 2
Scrotitis 0 1
Preputial swelling 0 2

Reaction incidence %: equine reports classified by the APVMA as probable and possible to 31 March 2016

Reaction Incidence calculated on the understanding that 440,438 doses of vaccine have been administered from launch to 31 March 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 0.17
Oedema 0.10
Lethargy 0.09
Pain 0.08
Pyrexia 0.06
Anorexia 0.05
Swelling (local) 0.04
Stiffness 0.03
Muscle stiffness 0.01
Urticaria 0.01
Lump (local) 0.02
Colic 0.01
Ataxia 0.009
Sweating 0.009
Behavioural change 0.009
Malaise 0.006
Listless 0.005
Abdominal pain 0.005
Alopecia (localised) 0.005
Lame 0.004
Depression 0.004
Coat colour change 0.003
Recumbency 0.003
Site reaction 0.003
Nasal discharge 0.002
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 0.001

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

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

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