Reports involving adverse events in a person
Information for reporting adverse events in a person following accidental or intentional exposure to an animal medicine.
If a person has accidentally or deliberately ingested an animal’s tablets or liquid medication, or been exposed to the medication in any other way, for example, accidental splashing of liquid, enter the actual or estimated dose the person was exposed to prior to the event starting, such as number of tablets or quantity of solution, if known.
If multiple different exposures occurred to different dosages, add details in the ‘Details of adverse event’/‘Narrative of adverse event’ field located in the Adverse Event section of this form.
For medicinal products that a person was exposed to that were being administered in food or water, and where dose units are best represented by concentrations, enter the number of mg/g/kg or ml/l in the ‘Dose’ field with the appropriate unit in the ‘Dose (units)’ field, the total amount of food or water administered in the ‘Per’ field and the appropriate unit for this total amount in the ‘Per (units)’ field.
Enter the number of units, such as, 10 in the ‘Dose’ field, Milligram in the ‘Dose (units)’ field, 1 in the ‘Per’ field and Kilogram or Millilitre (or other unit as applicable) as appropriate in the per ‘Unit’ field.
An example would be a 6% premix, where the dose is 1 mg of the product per kilogram bodyweight daily. You would enter 1 in the ‘Dose’ field, milligram in the ‘Dose (units)’ field, 1 in the ‘Per’ field and ‘Kilogram’ in the per ‘Unit’ field.
If the amount or volume of this product that the person was exposed to is known, this information can be added to the ‘Details of adverse event’/’Narrative of adverse event’ field.
Describe, in chronological order, details of the event(s), including important information or explanations that you were unable to record in the other case fields.
There is a 2000-character limit, and you will not be able to continue typing once this limit is reached.
Do not include any confidential details, such as names of persons or medical facility names or any offensive language.
Avoid the use of abbreviations and acronyms.
Although every effort is made to avoid sharing confidential information or offensive language, we cannot guarantee that this information will not be shared with third parties such as Marketing Authorisation Holders, other teams within the VMD or other government organisations, as part of our routine data sharing processes.
Reporter details
If you select ‘Other’ for the field ‘Reporter category’, provide additional details about your involvement.
Patient(s) details
Details of any relevant medical history.
Post-mortem findings, if applicable.
Product details
Additional details regarding how the person was exposed to the product. Examples of exposure are accidental ingestion of an animal’s medicine, accidental exposure of skin or eyes to an animal’s medicine and contact with a treated animal or its excrement. Include whether the exposure was intentional or accidental.
Additional details regarding the dates of exposure, for example, if the report includes multiple different occasions on which the person was exposed.
Additional details regarding how often the exposure occurred and the time between exposures, if these have not already been added to the fields within the form. Provide details of how the person was actually exposed rather than how the product was prescribed or administered to the animal, if these differ. Add further information where multiple exposure intervals or frequencies occurred for the same dose.
Any additional details related to any events that occurred with previous exposure to any of the products, such as whether the events resolved and how quickly, and whether treatment was required. If a person experienced an adverse event following a previous administration of a product, but it was administered alongside other products at that time, provide details.
Adverse event details
a. All signs (symptoms) that occurred following administration of the product(s).
b. The date each sign started, and ended if applicable, and their severity. If signs occurred at a particular body location, include this information, and specifically state if signs occurred at the site of exposure to the product.
c. Test or investigation results.
d. Additional details where different events started or ended on different dates.
e. Details of the treatment for the adverse event that was received by the person, if any, including details of treatment products that were administered and whether they had a positive effect.
f. Your opinion as to whether the product(s) caused the events and specify a particular product if applicable.