Published: 18 February 2021

COVID-19

Vaccine Adverse Event Reporting Form

An adverse event reporting form for COVID-19 vaccines is now available. Healthcare professionals are encouraged to use this new reporting form.

New reporting form

A new reporting form for adverse events following immunisation (AEFIs) with COVID-19 vaccines is now available. The form is published on the Centre for Adverse Reactions Monitoring (CARM) website and is designed to make reporting of AEFIs easier.

Please use this new form to report all suspected AEFIs for COVID-19 vaccines. You don’t have to be certain that the vaccine caused the event.

Although the form is downloadable and can be sent to CARM, we encourage reporters to use the online version. Direct online reporting will help provide a close to real-time safety profile of the COVID-19 vaccines.

The new reporting form includes:

  • easy selection of COVID-19 vaccines
  • tick boxes for specific adverse events following immunisation (eg, anaphylaxis)
  • reporter assessment of how serious the reaction is.

If completed online, there is the ability to attach additional documents (eg, blood test results or images). A PDF of the submitted report will also be provided for your records.

Including detailed information in the report will help CARM and Medsafe to investigate the adverse event more quickly.

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Why report adverse events?

Medsafe is actively encouraging healthcare professionals and members of the public to report suspected AEFIs for COVID-19 vaccines to:

  • add to the information we already know about the safety profile of each vaccine
  • act as an early warning system for the identification of previous unrecognised or rare side effects.

Medsafe and regulators across the globe are sharing emerging anonymised safety data.

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More information

See the data sheets and consumer medicine information for the expected reactions for approved COVID-19 vaccines.

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