COVID-19 VACCINES
Yellow CARD analysis

Data is a precious thing and will last longer than the systems themselves.

– Tim Berners-Lee

Introduction

Our analysis of the Medical & Healthcare products Regulation Agency (MHRA) Yellow Card Scheme for COVID-19 vaccines uses the publicly available reports that are released by the MHRA.

The MHRA recommends that any analysis of or commentary on its reports include its guidelines.

The MHRA has changed the format and frequency of reporting several times. It now releases compiled data monthly and takes several days from the “cut off” date to update its website.

Due to the limitations of the data and the guidelines, we have deliberately held back from drawing conclusions based on the data we have.  Instead, we aim to provide insights into what we do know so that we, and you, can ask more meaningful questions of the MHRA, the government, vaccine manufacturers – and your own healthcare providers.

What We Do Know

  • How many 1st, 2nd & 3rd/booster doses of each vaccine brand have been administered
  • How many adverse reactions have been reported
  • How many deaths have been reported
  • How each reaction & death has been classified in fine detail

What We Don't Know

  • Whether a death or reaction reported was caused by the vaccine or a coincidence
  • Whether a death or reaction report relates to a 1st, 2nd or booster dose
  • Time between dose and death or reaction
  • Time between death or reaction & reporting
  • Demographic information of patient (gender, age, health status)*
  • If a patient has had multiple reactions*
  • Patterns of combinations of reactions*
  • How many deaths & reactions haven't been reported
  • Whether vaccine mixing has taken place
  • If changes in storage guidance for vaccines have impacted reactions
  • Whether patients reporting adverse reactions had previously had or tested positive for COVID-19

* From November 2022, MHRA is issuing the data in a new format and we will be exploring whether we can glean any new insights.

In early January 2023, MHRA reissued the data to 23/11/22 in a new format, claiming it was the same data, however we have compared the two datasets and found an additional 83,056 reactions and 2 deaths in the reissued reports. We have made the assumption that the reissued dataset is the more accurate and therefore all charts reflect these figures going forward.

Yellow Card Summary to 22nd February 2023

Pfizer/ BioNTech AstraZeneca Moderna Novavax Unspecified Totals
Rollout Start Date 08/12/20 04/01/21 07/04/21 03/02/22 n/a n/a
First Doses Administered 27.2 million 24.9 million 1.7 million unknown n/a 53.8 million
Second Doses Administered 25.0 million 24.2 million 1.6 million unknown n/a 50.8 million
Boosters Administered 44.6 million 0.1 million 22.6 million 1,000 n/a 67.3 million
Adverse Reactions 544,439 927,512 161,794 183 7,429 1,641,357
Deaths 897 1,364 130 0 68 2,459

New reactions this report = 2,449

New deaths this report = 23

Data Source: MHRA

How The Brands Compare

  • Pfizer/BioNTech
  • AstraZeneca
  • Moderna
  • Unspecified
Due to the small quantities currently associated with the Novavax brand, they do not show up on the pie charts

Doses

Adverse Reactions

Deaths

Top 20 Adverse Reactions

wdt_ID Condition No of Reactions No of Deaths
1 Headache 130,345 1
2 Fatigue 93,518 1
3 Pyrexia 91,749 1
4 Chills 64,000 0
5 Nausea 57,734 0
6 Pain in extremity 46,144 2
7 Myalgia 45,668 0
8 Dizziness 43,338 0
9 Arthralgia 41,073 0
10 Pain 32,937 0

Top 20 Causes of Death

wdt_ID Condition No of Deaths
1 Death (no further information available) 631
2 Pulmonary embolism 176
3 Myocardial infarction 136
4 Cardiac arrest 113
5 Cerebrovascular accident 86
6 Cerebral haemorrhage 82
7 Sudden death 80
8 COVID-19 75
9 Thrombosis 61
10 Pneumonia 58

REACTIONS & DEATHS BY TYPE (SOC)

wdt_ID Type of Reaction (System Organ Class) Reactions Deaths
1 Blood disorders 29,954 28
2 Cardiac disorders 33,944 465
3 Congenital disorders 273 6
4 Ear disorders 21,413 1
5 Endocrine disorders 1,043 1
6 Eye disorders 26,695 0
7 Gastrointestinal disorders 147,217 36
8 General disorders 460,820 780
9 Hepatic disorders 964 11
10 Immune system disorders 7,249 7

Further Research & Resources

MHRA Resources

The MHRA now provides interactive charts to allow the public to explore the Yellow card data in more depth for themselves. Unfortunately the MHRA persists in siloing each vaccine variation (brand/type) into its own dataset so exploring consolidated data or comparing brands remains a challenge. Not all variations have the same reporting options available either.

Here is an overview of the information available from each of the menu options provided for each vaccine.

wdt_ID Menu Option Information Available
1 Information Brand Names, Data Extraction Date, Link to Safety Assessment Documents
2 Overview Summary Data - Total Reports, Reactions etc, Links to Death Registrations for each country
3 COVID-19 Vaccinations (not available for all vaccines) Weekly figures for doses administered & adverse reaction reports made - available as a chart or a table of numbers.
4 Report Profile Interactive charts for demographic information (gender, age etc) - use the settings on the left of the screen to filter the data used to build the charts
5 Reaction Profile Interactive charts for types of reactions (by System Organ Class) - use the settings on the left of the screen to filter the data used to build the charts

Here are links to each of the vaccines variations’ reporting page.

Overall Summary Page
COVID-19 Vaccine Pfizer/BioNTech monovalent
COVID-19 Vaccine Pfizer/BioNTech bivalent
COVID-19 Vaccine AstraZeneca
COVID-19 Vaccine Moderna monovalent
COVID-19 Vaccine Moderna bivalent
COVID-19 Vaccine Novavax
COVID-19 Vaccine - brand unspecified or not in routine use in the UK

UK Public Health Resources

If you’d like to find out more about COVID-19 vaccines, the weekly surveillance reports may prove useful:

UK Health Security Agency (ex Public Health England) - England COVID-19 vaccine surveillance reports
Public Health Scotland - Weekly national respiratory infection and COVID-19 statistical report
Northern Ireland Department of Health - statistics & research
Public Health Wales - Rapid COVID-19 surveillance

Overseas Reaction Reporting

If you’d like to find out about adverse reactions recorded in other countries, here are some useful links:

EudraVigilance - European database of suspected adverse drug reactions
VAERS - USA Vaccine Adverse Event Reporting System
CAEFISS - Canadian Adverse Events Following Immunization Surveillance System
SwissMedic - Reporting of Adverse Drug Reactions by Patients

Other Independent Resources

Open Letters from Dr Tess Lawrie MBBCh, DFSRH, PhD
Analysis of MHRA Reporting by Healthcare Professional for Conservative Woman Blog
UK Column's Yellow Card Interactive Database (not updated since Sep 2022?)

Essential Context for Understanding this report

These reports contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of the COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the report alone. When viewing the report, you should remember that:

  • Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the vaccine may have caused the adverse reaction. The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.

  • It may be difficult to tell the difference between something that has occurred naturally and an adverse reaction. Sometimes reactions can be part of the condition being treated rather than being caused by the vaccine.

  • Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction. When monitoring the safety of medicines and vaccines, MHRA staff carry out careful analysis of these factors.

  • It is not possible to compare the safety of different vaccines by comparing the numbers presented in the vaccine reports. Reporting rates can be influenced by many factors including the seriousness of the adverse reactions, their ease of recognition and the extent of use of a particular vaccine. Reporting can also be stimulated by promotion and publicity about a product.

For a vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people receive vaccinations without having any serious side effects.

Risks and benefits of medicines

For a medicine to be considered safe, the expected benefits of the medicine will be greater than the risk of suffering harmful reactions. It is important to note that most people take medicines without suffering any serious side effects.

All medicines can cause reactions. The patient information leaflet accompanying the medicine, or available from your pharmacist, lists the known side effects associated with the medicine. Healthcare professionals such as doctors and pharmacists can also provide this information. Information on side effects of medicines can be found on the NHS website.

Monitoring the safety of medicines and vaccines

Information collected through the Yellow Card scheme is an important tool in helping the MHRA and CHM monitor the safety of medicines. Yellow Card reports of suspected adverse reactions are evaluated, together with additional sources of evidence such as worldwide literature, in order to identify previously unidentified hazards or side effects.

If a new side effect is identified, information is carefully considered in context of the overall side effect profile for the medicine or vaccine, and how it compares with other medicines used to treat the same condition.

The MHRA will take action, if necessary, to ensure that the product is used in a way that minimises risk, while maximising patient benefit. Such changes may include, for example, restricting the indication, or special warnings and precautions. Rarely, a drug may need to be withdrawn from the market if the risk of side effects is considered to outweigh the benefits of treatment. Please see our How we monitor the safety of medicines section for further information.

Use of Yellow Card data for publication

If you wish to copy or circulate the information contained within a report to anyone else, please ensure that a copy of these guidelines is also provided.

The MHRA and CHM encourage the use of data from the Yellow Card scheme in research and for publication, but wish to ensure that the limitations of interpretation of the data are made clear.

If you propose to publish information based on Yellow Card data, the MHRA is most willing to provide advice on how the Yellow Card information might be best used and presented. The MHRA is also willing to provide feedback on manuscripts prior to publication. Please write to the Deputy Director, Safety and Surveillance Group by email.