Clinical Incident/ADR Reporting

COVID-19 incident and ADR reporting

National teams are monitoring level of incidents relating to the COVID vaccination programme and also reporting of vaccine related adverse effects.

Reporting suspected COVID-19 vaccine side effects, and potential product defects or counterfeit products – SPS – Specialist Pharmacy Service – The first stop for professional medicines advice

The level of reporting from Staffordshire and Stoke-on-Trent PCN vaccination sites is relatively low and so we have simplified how you can report incidents/adverse effects. The attached document explains this in detail but in summary this is the process:

  • All vaccination sites should use DATIX for reporting all clinical and non-clinical incidents in relation to COVID-19 vaccination programme
  • All vaccination sites should report adverse drug reactions and any defects with the product (e.g. particulate contamination in vial) via yellow card https://coronavirus-yellowcard.mhra.gov.uk/ and download a PDF extract of the report and send to SSOTCovidPMO@staffsstokeccgs.nhs.uk
  • All clinicians should report any post vaccination adverse effects via yellow card https://coronavirus-yellowcard.mhra.gov.uk/ and download a PDF extract of the report and send to SSOTCovidPMO@staffsstokeccgs.nhs.uk
  • Patients who think they have suffered a side effect are encouraged to report it/them on a Yellow Card. Reporting information can be found at the coronavirus Yellow Card reporting site. Patients should include the vaccine brand and batch/lot number if available.

Standard Operating Procedure-Management of covid-19 vaccination clinical incidents and enquiries   – 18th December 2020