COVID-19 Adverse Event Reporting Advice

On this page you'll find the latest advice from the BADBIR team on recording suspected or confirmed cases.

Last updated 26/01/2021

Entering COVID-19 / Coronavirus events

Please specify whether the event was a suspected or diagnosed case of COVID-19. Please also specify whether the patient was admitted to hospital overnight, and how they were treated.

Recording confirmed/diagnosed cases of COVID-19 on BADBIR

A confirmed case of COVID-19 where the patient was hospitalised overnight is classed as serious under the SAE category of Overnight Hospitalisation. A serious infection ESI form also needs to be completed.

A confirmed case of COVID-19 where the patient was not admitted overnight is just a non- serious adverse event.

If in any doubt please contact the BADBIR team via email badbir@manchester.ac.uk or call 0161 306 1896 and we can provide further advice. We will also update the BADBIR website and database with further information on best practice data collection as required.

Recording suspected cases of COVID-19 on BADBIR

Suspected cases of COVID-19 should be entered as non-serious events, unless the patient was hospitalised overnight or prescribed IV antimicrobials. Details of the patient's symptoms, treatment and any clinically relevant information, should be provided:

  • Was the patient hospitalised overnight?
  • Was the patient ventilated or did they require oxygen?
  • Did the patient attend A&E?
  • What medication was the patient prescribed?
  • Did the patient self-isolate at home?
  • What COVID-19 symptoms did the patient show? Please provide a full list.
  • Did the patient have any other complications?

Help with adverse events and ESIs

If you have any queries related to adverse events, our pharmacovigilance team would be happy to assist you. You can reach them on 0161 306 1911 - or feel free to email badbir@manchester.ac.uk with details of your query.

COVID-19 vaccine

We would like to know when patients have received the COVID-19 vaccine. You can enter this onto the concomitant therapy page when you're completing a follow-up.

We would also like to know the specific type of vaccine each patient receives, so please remember to ask your patients for this information during their appointments.

PsoProtect

PsoProtect is a new international registry that health care professionals can use to report cases of COVID-19 for patients with psoriasis. Please visit psoprotect.org to learn more, and spread the word to your colleagues.

Please note that reporting to PsoProtect will not record any information on BADBIR. Details of cases will need to be entered at the participant's next BADBIR follow-up