Oh adverse event

Adverse Event Report Form

Please fax or e-mail this report to Pharmacovigilance within 24 hours of becoming aware, to:
phone number: +44 746 858 28 32
E-mail: [email protected]
By completing this form, you acknowledge that all personal data provided in this form shall be processed by Ideogen for it to comply with its pharmacovigilance/ reporting obligations and for reasons of public health and public interest. Ideogen may share this personal data with competent regulatory authorities, manufacturers of the product identified in this form and its third-party licencing, distribution and pharmacovigilance service providers. All data provided in this form is treated as confidential and will only be shared with third parties where it is necessary to do so for pharmacovigilance purposes.
If you have any further questions about why or how we use the personal data collected in this form and your rights in relation to the personal data, please contact us via the details provided above.

Section A – Administrative Details


Report Type:

Section B – Event(s)


In the reporter’s opinion (if a HCP) was the event:

Serious Criteria:

Hospitalisation Dates:

Event Outcome

Event abated after the suspect product was discontinued or dose reduced:

Event reappeared after reintroduction of the suspect product

Post Mortem Performed:

If yes, please provide post mortem results (if known)

Section C- Patient Information*


Gender:

If female, Pregnant?

Relevant Lab Data

Relevant Medical History

History of Allergies

Section D – Product


Action Taken:

Reporter Causality Assessment:

Concomitant Meds

Section E – Reporter’s Details*


Reporter Position:

Permission to contact reporter for additional information:

Permission to contact Health Care Professional (HCP), if different from Reporter:

If this procedure is printed copy it shall become obsolete after 24hrs.