Yellow Card Vaccine Monitor

Background

The Yellow Card Vaccine Monitor (YCVM) was a national programme run by the Medicines and Healthcare products Regulatory Agency (MHRA) to support safety monitoring of COVID-19 vaccines during their rollout in the UK.

The programme formed part of the UK’s wider pharmacovigilance approach, building on the established Yellow Card scheme. It complemented clinical trial data by collecting real‑world information directly from members of the public after vaccination.

What was the Yellow Card Vaccine Monitor?

The Yellow Card Vaccine Monitor was a voluntary data collection platform designed to help continuously monitor the safety of COVID-19 vaccines in real-world use.

Although COVID-19 vaccines had already been shown to be safe and effective in clinical trials, the YCVM programme aimed to strengthen this evidence base by gathering additional data from individuals outside of controlled trial settings.

Information collected through the programme was used alongside other data sources to support ongoing safety monitoring and ensure that the benefits of vaccination continued to outweigh any potential risks.

Who delivered the programme

The programme was run by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator for medicines and medical devices.

The MHRA:

• Operates under the Department of Health and Social Care (DHSC)

• Is responsible for ensuring medicines and vaccines meet standards for safety, quality and effectiveness

• Continuously monitors the safety of medicines and vaccines once they are in use

How the programme worked

Some individuals invited for a COVID-19 vaccination were also invited to register with the Yellow Card Vaccine Monitor. Participation was entirely voluntary and did not affect eligibility for vaccination.

Participants were asked to provide information at key stages:

• Before vaccination

• On the day of vaccination

• After vaccination

This included details such as:

• Medical history

• Current medications

• Vaccine details (brand and batch number, where available)

• Any symptoms experienced following vaccination

Participants were contacted via email, SMS or notifications to provide updates, particularly in the early weeks following vaccination.

Parents, carers or family members could also contribute on behalf of an individual, with their consent.

Relationship to other COVID-19 tools

The Yellow Card Vaccine Monitor operated as a standalone platform. It did not directly link to other COVID-19 apps or services such as the NHS COVID-19 app or symptom tracking tools.

Individuals who were not invited to participate could still report suspected side effects through the standard Coronavirus Yellow Card reporting system.

Why vaccine safety monitoring is important

Monitoring the safety of vaccines is an essential and ongoing process. While vaccines are highly effective in preventing infectious diseases and have been rigorously tested before approval, side effects can continue to be identified when used across large populations.

Most side effects are mild and short-term; however, continued monitoring helps to:

• Detect any new or rare safety signals

• Assess benefit–risk balance over time

• Support informed regulatory decisions

Use of data and expert review

Data collected through the YCVM programme contributed to the UK’s wider safety surveillance system.

Reports of suspected side effects were:

• Reviewed by teams of medical and scientific experts

• Assessed alongside clinical trial data, medical literature and international evidence

• Used to ensure that vaccine benefits continued to outweigh risks

Findings informed regulatory advice and were shared, in anonymised form where appropriate, with expert groups including:

• The MHRA Vaccine Expert Working Group

• The Joint Committee on Vaccination and Immunisation (JCVI)

• The Department of Health and Social Care

Data protection and privacy

Participant data was handled in accordance with the General Data Protection Regulation (GDPR) and MHRA privacy policies.

Data could be analysed in combination with other health datasets (including NHS data) to support robust safety monitoring. Any outputs shared externally were anonymised.

Participation and withdrawal

Participation in the Yellow Card Vaccine Monitor was entirely voluntary.

Participants were able to withdraw at any time without providing a reason. Further information on data rights and withdrawal processes was available via the MHRA privacy policy and the Information Commissioner’s Office.

Programme closure

The Yellow Card Vaccine Monitor was developed as part of the enhanced monitoring required during the COVID-19 pandemic. With the programme now concluded, its role has ended and this page is retained for archival and transparency purposes.

Individuals can still submit reports of suspected side effects from COVID-19 vaccines via the Yellow Card scheme.