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

The information presented below was collected under a mandatory reporting regime that was required as a condition of the permit authorising the supply and use of the product. A mandatory reporting regime may yield a higher reporting incidence than would be the case under a voluntary reporting arrangement.

How the APVMA classifies an adverse experience

The APVMA makes an independent assessment about the 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 classification of probable, possible, unlikely or unknown.

Read further information about the classification process.

Number of equine reports classified by the APVMA to 31 December 2015 

Reaction year Possible Possible/off-label Probable Probable/off-label Unknown Unlikely Total
2012 4   25   4 8 41
2013 52 3 252 1 29 32 369
2014 76 1 351 1 41 28 498
2015 34   155 1 35 22 247
Total 166 4 783 3 109 90 1155

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 December 2015

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 502 17
Oedema 251 19
Lethargy 233 51
Pain 215 21
Anorexia 139 24
Pyrexia 124 28
Stiffness 85 14
Swelling (local) 104 4
Muscle stiffness 51 3
Urticaria 40 12
Lump (local) 58 5
Ataxia 29 6
Sweating 25 10
Colic 22 20
Lame 13 2
Site reaction 13 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
Pruritus 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 1
Aggression 3 1
Laminitis 2 4
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 5 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 1
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 1
Scrotitis 0 1

Reaction incidence %: equine reports classified by the APVMA as probable and possible to 31 December 2015

Reaction Incidence calculated on the understanding that 416,267 doses of vaccine have been administered from launch to 31 December 2015.

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 0.18
Oedema 0.10
Lethargy 0.10
Pain 0.08
Pyrexia 0.06
Anorexia 0.05
Swelling (local) 0.04
Stiffness 0.03
Muscle stiffness 0.02
Urticaria 0.02
Lump (local) 0.02
Colic 0.01
Ataxia 0.01
Sweating 0.01
Behavioural change 0.01
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 0.003
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) 0.001
Diarrhoea 0.001
Distress 0.001
Polydipsia 0.001
Shaking 0.001
Stranguria 0.001
Tremor 0.001

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

Hives, panting, site reaction, abnormal breathing, aggression, anaphylaxis, confusion, dermatitis, dyspnoea, hypersalivation, hypersensitivity reaction, pale mucous membranes, adipsia, anuria, atrophy, azoturia, bradycardia, coat discoloration, colitis, conjunctivitis, eczema, epistaxis, facial oedema, fasciculation, haematoma, hepatopathy, hyperactivity, hyperaesthesia, hypersensitive to stimuli, inflammation, laryngitis, sesions, periorbital swelling, polymyositis, respiratory problems, site reaction (swelling), urine (abnormal), walking (difficult), welts.

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