Yellow Card Reporting System

Vaccine Safety Update

This is the ninth of the regular round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the eighth one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with the Daily Sceptic‘s other posts on vaccines, which include both encouraging and not so encouraging developments. At the Daily Sceptic we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr Tess Lawrie recently wrote an open letter to Dr June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been “fact checked” here.) We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • Norway has announced vaccine injury compensation for at least three claims following AstraZeneca vaccination. An Oxford man has called for a review of U.K. Government vaccine injury compensation after he developed Guillain-Barré Syndrome following AstraZeneca vaccination. 
  • A 16 year old boy in Singapore suffered a cardiac arrest when exercising after his Pfizer vaccination.  
  • Some new medical reports exploring endocrine issues following Pfizer vaccination: one looking at a case of necrotising pancreatitis following the second dose of vaccine, and two looking at the development of Graves’ disease in two health care workers in Mexico.
  • The U.K. VITT Organ Donor Study Group has published a report of an analysis of organ donation and transplantation from U.K. donors with VITT (blood clots) to understand the implications. It concludes that transplantation from VITT donors should only proceed with caution due to a variety of possible complications in multiple organs. 
  • The Daily Mail reports that the MHRA has quietly added warnings on Moderna and Pfizer vaccines that they can cause heart damage in rare cases.
  • The Government has uploaded its Technical Briefing for Variants of Concern Number 18, which continues to show that despite rising cases the Delta variant is not currently causing as many fatalities or hospitalisations as the Alpha variant (case fatality rate 0.2% vs 1.9%).
  • Following a FOI request to the MHRA for all vaccine associated deaths between 2010 and 2020, the Daily Expose reports that deaths from Covid vaccines are 407% higher than all cumulative previously reported deaths from other vaccines.
  • ‘Breakthrough’ cases are being reported in Las Vegas, Wales and aboard HMS Queen ElizabethMyLondon reports that London Hospitals are refusing to provide this data.  
  • The Daily Mail reports that Johnson & Johnson and AstraZeneca are both seeking to modify their vaccines to reduce the incidence of life-threatening blood clots. 
  • VAERS – the American version of the Yellow Card reporting system – released new data bringing the total to 463,457 reports of adverse events following Covid vaccines, including 10,991 deaths and 48,385 serious injuries between December 14th 2020 and July 9th 2021.
  • Suspected adverse events in the U.K. as reported in the media: Kent radio host Jules Serkin and Anthony Shingler (57).

Summary of Adverse Events in the U.K.

According to an updated report published on July 16th (covering the period up to July 7th), the MHRA Yellow Card reporting system has recorded a total of 1,059,307 events based on 314,043 reports. The total number of fatalities reported is 1,470.

  • Pfizer (19.7 million first doses, 11.6 million second doses) now has one Yellow Card in 357 doses, 2.8 adverse reactions per card. Deaths: 1 in 68,640 (456 deaths)
  • AstraZeneca (24.7 million first doses, 22.3 million second doses) has one Yellow Card in 214 doses, 3.6 adverse reactions per card. Deaths: 1 in 47,813 (983 deaths)
  • Moderna (1.1 million first doses) has one Yellow Card in 123 doses, 2.9 adverse reactions per card. Deaths: 1 in 157,143 (7 deaths). (This is a high rate of Yellow Card reports but lower fatal reports compared to the other two vaccines.)

Vaccine Safety Update

This is the eighth of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the seventh one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr Tess Lawrie recently wrote an open letter to Dr June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans,” a claim that has been “fact checked” here.) We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • Correspondence in the BMJ from nurse Marco T. Suadoni calculating that, as far as vaccinating the under-25s is concerned, “for every single prevention of a hospital admission, at least 22 to 23 individuals will experience at least one serious adverse event”.
  • Article in the Telegraph quoting JCVI member Professor Robert Dingwall suggesting that it is safer to let children catch COVID-19 than vaccinate them.
  • UKMFA has written an open letter requesting that informed consent be properly addressed at vaccination centres.
  • The peer-reviewed paper in Vaccines that we mentioned recently claiming that two deaths result from COVID-19 vaccinations for every three deaths prevented has been retracted by the journal, citing serious concerns with the use of adverse event data. The paper’s authors have issued a statement in which they say: “The true reason seems to have been pressure on the part of some editors of the journal,” and “The timeline suggests that the journal was not really interested in our response and that our response was irrelevant to the retraction”.
  • Report of a blood clotting death following Moderna vaccination.
  • Newsweek reports that the CDC is investigating the death of a 13 year-old Michigan boy in his sleep days after receiving the second dose of the Pfizer vaccine.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 16,535 people have died and 1,750,275 have suffered injuries following receipt of the Covid vaccines in the EU.
  • VAERS – the American version of the Yellow Card reporting system – released new data bringing the total to 441,931 reports of adverse events following Covid vaccines, including 6,985 deaths and 34,065 serious injuries between December 14th 2020 and June 25th 2021.

Summary of Adverse Events in the U.K.

According to an updated report published on July 1st (covering the period up to June 23rd), the MHRA Yellow Card reporting system has recorded a total of 1,007,253 events, based on 298,081 reports. The total number of fatalities reported is 1,403.

  • Pfizer: 18 million first doses, 11 million second doses.
  • AstraZeneca: 24.5 million first doses, 20.7 million second doses.
  • Moderna: 0.88 million first doses.

Vaccine Safety Update

This is the seventh of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the sixth one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all the news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as reporting the facts, not advocating for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr Tess Lawrie recently wrote an open letter to Dr June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans”, a claim that has been “fact checked” here.) We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • An article in the peer-reviewed journal Vaccines discusses the balance of benefits and risks of COVID-19 vaccines. Based on analysis of data from Israel and Europe, the study finds that for every three Covid deaths vaccines prevent they cause two deaths through adverse reactions, leading the authors to question the lack of clear benefit of the current vaccination policy. The journal has subsequently published an “expression of concern” about the paper to notify readers that it is reviewing the numerous complaints it has received about the article.
  • A preliminary review of VAERS reports (the U.S. equivalent of Yellow Card reports) has found that 86% of the first 250 deaths reviewed were correctly reported as involving an adverse reaction to the vaccine.
  • There have been reports of “breakthrough” infections among the fully vaccinated in a Cornwall care home, though all were reportedly asymptomatic. Massachusetts has reported 4,000 infections among the fully vaccinated, also said to be mainly asymptomatic or mild with a low viral load. Half of Israelis in the most recent outbreak are also reported to have been fully vaccinated.
  • Further reports of Guillain-Barré syndrome linked with the vaccines, particularly AstraZeneca, in India and the UK.
  • The American Journal of Ophthalmology Case Reports has released a study that looks at “acute-onset central serous retinopathy after immunisation with COVID-19 mRNA vaccine”, finding that there may be a causal link in a 33 year-old male case study. 
  • Reuters reports on the recent decision of the FDA to add warnings of possible heart inflammation following vaccination with Pfizer and Moderna Vaccines and JAMA reports on 23 cases of heart inflammation among members of the U.S. military following vaccination with mRNA vaccines, which was “higher than expected among male military members after a second vaccine dose”.
  • The Mirror reports on a case of a 48 year-old male writer and filmmaker who died of blood clots associated with the AstraZeneca vaccine, raising questions over access to the Vaccine Damage Payment Scheme for the families of victims of vaccine injury who have died as a result of the vaccine.
  • Suspected adverse events in the U.K. as reported in the media: the latest victim is Lucy Taberer, a 47 year-old mum of three.

Summary of Adverse Events in the U.K.

According to an updated report published on June 24th (covering the period up to June 16th), the MHRA Yellow Card reporting system has recorded a total of 970,696 events, based on 285,219 reports. The total number of fatalities reported is 1,356.

  • Pfizer (16.8 million first doses, 10.9 million second doses) now has one Yellow Card in 375 doses, 2.8 adverse reactions per card. 
  • AstraZeneca (24.6 million first doses, 19.6 million second doses) has one Yellow Card in 196 doses, 3.6 adverse reactions per card.
  • Moderna (0.73 million first doses) has one Yellow Card in 140 doses, 2.8 adverse reactions per card. (It’s possible the continuing very high rate of Yellow Cards with Moderna is to do with skin reactions.)

Vaccine Safety Update

This is the sixth of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the fifth one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. (Dr Tess Lawrie recently wrote an open letter to Dr June Raine, head of the MHRA, arguing that: “The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans“, a claim that has been “fact checked” here.) We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • Dr Robert Malone, the inventor of mRNA and DNA vaccine technology, has expressed concern about the safety profile of the current Covid vaccines and the censorship of discussing the issues, and called for them to be properly investigated as a matter of urgency. See also his appearance on Bret Weinstein’s podcast (deleted from YouTube) along with Steve Kirsch, who has written of his concerns about the vaccines here.
  • The UKMFA has written an open letter objecting to a report on BBC Newsround (a children’s television news programme) by Professor Devi Sridhar, Chair of Global Public Health at the University of Edinburgh, about vaccine efficacy and safety.
  • Researchers at RCSI have published a study in the Journal of Thrombosis and Haemostasis in which they show that COVID-19 patients had higher levels of pro-clotting VWF molecules and lower levels of the anti-clotting ADAMTS13. This has yet to be applied to clots in vaccinated patients but may have implications.
  • A study in the British Journal of Ophthalmology noted the occurrence of corneal transplant rejection after vaccination with COVID-19 mRNA vaccines.  
  • In Public Health England’s latest Variants of Concern Technical Briefing, the fully vaccinated have a 0.64% chance of death after testing positive for the Delta Variant whereas unvaccinated individuals have a 0.096% chance of death – a seventh of the risk. However, this is likely to be primarily a result of the much younger age profile of the unvaccinated.
  • Dr. Diego Rubinowicz, a Urologist in Palm Beach County Hospital, has observed increased PSA levels in vaccinated men, leading to possible misdiagnosis of prostate cancers.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 15,472 people have died and 1,654,407 have suffered injuries following receipt of the Covid vaccines in the EU.
  • VAERS – the American version of the Yellow Card reporting system – released new data on June 11th bringing the total to 358,379 reports of adverse events following Covid vaccines, including 5,993 deaths and 29,871 serious injuries between December 14th 2020 and June 11th 2021.
  • Suspected adverse events in the U.K. as reported in the media: Vanessa Newton (45); Lucy Taberer (47); Sophia Gomes (43).

Summary of Adverse Events UK

According to an updated report published on June 17th (covering the period up to June 9th), the MHRA Yellow Card reporting system has recorded a total of 949,287 events, based on 276,867 reports. The total number of fatalities reported is 1,332.

  • Pfizer (15.6 million first doses, 10.8 million second doses) now has one Yellow Card in 372 doses, 2.9 adverse reactions (i.e., symptoms) per card. 
  • AstraZeneca (24.6 million first doses, 17.7 million second doses) has one Yellow Card in 211 doses, 3.6 adverse reactions per card.
  • Moderna (0.56 million first doses) has one Yellow Card in 130 doses, 2.8 adverse reactions per card.

Vaccine Safety Update

This is the fifth of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the fourth one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • Questions have been raised by Trial Site News on whether Pfizer failed to perform industry standard animal testing prior to the start of human trials, following a worrying response to a Freedom of Information request from a group of Canadian physicians.
  • According to the FDA, in the Pfizer clinical trials on children aged 12-15, of the 1,127 children who received a first dose, no fewer than 86% experienced an adverse reaction. Of the 1,097 children who received a second dose, 78.9% experienced an adverse reaction. Several children also developed deep vein thrombosis (resulting in pulmonary embolism) post-vaccination. 
  • Does the SARS-CoV-2 spike protein trigger certain forms of cancer? An exploration of the data after autopsies found two of eight COVID-19 sufferers with undetected thyroid cancer.
  • Dr Tess Lawrie of the Evidence-based Medicine Consultancy wrote an open letter to Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), calling for the “cessation of the vaccination roll out while a full investigation is conducted” as “the MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans”.
  • A pre-print study from Cleveland, Ohio, reported in the Washington Examiner, finds that vaccination offers no additional protection from COVID-19 infection after a person has been previously infected.
  • The first post-mortem of a patient vaccinated against COVID-19, reported in the Journal of Infectious Diseases, found that the 86 year-old man had viral RNA present in all organs of his body.
  • The BMJ reports on a Norwegian review that finds the Pfizer Vaccine is “likely” responsible for the some of the deaths in the elderly post-vaccination.
  • Switzerland has approved the vaccination of children as young as 12 without their parents permission from July.
  • The BMJ reports further concerns regarding immune thrombocytopenic purpura (ITP) after vaccination with AstraZeneca (also reported in the Daily Mail).  
  • A report from Australia of a probe launched by the medicines regulator after eight people developed Guillain-Barré Syndrome following an AstraZeneca vaccination.
  • Italy has halted use of the AstraZeneca vaccine for the under-60s after the death of a teenager with blood clots following vaccination.
  • There have been further reports of heart inflammation following vaccination with the mRNA vaccines (Pfizer and Moderna). The Daily Mail reports on the CDC calling an urgent meeting over 226 cases of heart inflammation in teenage boys who have had the Pfizer or Moderna shots.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 13,867 people have died and 1,354,336 have suffered injuries following receipt of the Covid vaccines in the EU (as of June 5th).
  • Suspected adverse events in the U.K. as reported in the media: Laura Hamilton (39); Jennifer Rose (65).

Summary of Adverse Events UK

According to an updated report published on June 10th (covering the period up to June 2nd), the MHRA Yellow Card reporting system has recorded a total of 922,596 events, based on 267,671 reports. The total number of fatalities reported is 1,295.

  • Pfizer (14.7 million first doses, 10.7 million second doses) now has one Yellow Card in 374 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 62,562 doses. 
  • AstraZeneca (24.5 million first doses, 15.7 million second doses) has one Yellow Card in 205 doses, 3.7 adverse reactions per card, one fatal reaction in 46,581 doses.
  • Moderna (0.46 million first doses) has one Yellow Card in 140 doses, 2.8 adverse reactions per card, one fatal reaction in 115,000 doses.

A curiosity is that the rate of Yellow Cards went up for Moderna from an already very high level (higher than at any point for AstraZeneca) despite there being only 60,000 shots administered this week.

Key events analysis:

Vaccine Safety Update

This is the fourth of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the third one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • A new study from the Journal of Pharmaceutical Policy and Practice on adverse events among Japanese women receiving the Pfizer vaccine (known in the study as tozinameran), in particular cerebral venous sinus thrombosis and intracranial haemorrhage (ICH), finds a “disproportionately high incidence of death by ICH in Japanese women who received tozinameran, suggesting a potential association of ICH with the vaccine”.
  • Dr Andreas Greinacher, Head of the Institute of Immunology and Transfusion Medicine at University Hospital Greifswald in Germany, has proposed a mechanism to explain the blood clotting adverse events connected with the AstraZeneca vaccine. Scottish physician Dr Malcolm Kendrick has published an article exploring the connection between the spike protein in SARS-CoV-2 and blood clotting. The UK Medical Freedom Alliance has produced a document looking into the relationship between the spike protein, cellular fusion and tissue damage.     
  • The Sun highlights the emerging link between the Pfizer vaccine and heart condition symptoms, advising people on five key symptoms to look out for post-vaccination.
  • The journal Paediatrics has an article entitled “Symptomatic Acute Myocarditis in Seven Adolescents Following Pfizer-BioNTech COVID-19 Vaccination“. 
  • The MHRA has cleared the use of the Pfizer vaccine for 12-15 year-olds in the UK. The regulator says the benefits outweigh the risks, though its analysis supporting this is awaited. In the U.S., the FDA has released its guidance on using the Pfizer vaccine in this age group. There is a petition on the Parliament website asking the U.K. Government to stop Covid vaccination in children for reasons discussed by HART’s Dr Ros Jones on the TalkRadio Mark Dolan Show (1hr 10 mins). Further petitions started this week: “Reform the VDPA 1979 to improve support for those harmed by COVID-19 vaccines“; “Do not mandate COVID-19 vaccinations for British soldiers under 25“.
  • Dr Byram Bridle, a Viral Immunologist and Associate Professor at the University of Guelph, Ontario has drawn attention to the findings of a Japanese study on the biodistribution of the Pfizer vaccine in the body, highlighting the presence of the spike protein in several organs, including the brain, liver and ovaries. (More information on this here.)  
  • International Vaccine Injury Awareness Day was marked on June 3rd with a peaceful vigil in London (close to BBC Broadcasting House) remembering the victims of all vaccine injury, including those damaged by COVID-19 vaccinations.
  • VAERS – the American version of the Yellow Card reporting system – released new data on June 4th bringing the total to 294,801 reports of adverse events following Covid vaccines, including 5,165 deaths and 25,359 serious injuries between December 14th 2020 and May 28th 2021.
  • Suspected adverse events in the U.K. as reported in the media: Tanya Smith (43).

Summary of Adverse Events UK

According to an updated report published on June 3rd (covering the period up to May 26th), the MHRA Yellow Card reporting system has recorded a total of 888,196 events, based on 256,224 reports. The total number of fatalities reported is 1,253.

  • Pfizer (14 million first doses, 10.6 million second doses) now has one Yellow Card in 382 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 62,121 doses. 
  • AstraZeneca (24.3 million first doses, 13.4 million second doses) has one Yellow Card in 200 doses, 3.7 adverse reactions per card, one fatal reaction in 45,637 doses.
  • Moderna (0.4 million first doses) has one Yellow Card in 162 doses, 2.8 adverse reactions per card, one fatal reaction in 100,000 doses.

Key events analysis:

Vaccine Safety Update

This is the third of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the second one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

  • The U.S. CDC is investigating reports of heart problems following vaccination with the mRNA vaccines (Pfizer and Moderna), particularly in young adults aged between 18 and 30, according to the Mail. It is estimated that around 1 in 100,000 vaccine recipients suffer myocarditis – an inflammation of the heart muscle – as an adverse event. The Israeli Health Ministry has announced further investigation into the issue while the Pentagon is reportedly monitoring it in the U.S. after 14 cases were reported following military vaccination. A study in the Lancet suggests a possible mechanism by which the virus itself could trigger such a condition.
  • The European Medicines Agency has approved the Pfizer vaccine for children of 12 years and above, the Metro reports. In Israel, 93 Doctors have signed an open letter calling for vaccines not to be offered to children on account of the low risks to them of the disease and the unknown risks of the vaccines. America’s Frontline Doctors have filed for a temporary restraining order against the use of COVID-19 vaccines in children in the Northern District of Alabama. In the U.K., the JCVI has not made a recommendation on the vaccination of children, and it will reportedly be left to Prime Minister Boris Johnson to make a decision in the coming weeks. If true, this seems a very unsatisfactory state of affairs – in the absence of a clear medical and scientific recommendation to authorise the use of a medicine on children, the default position should surely be not to authorise it?
  • A comment piece in the Lancet has raised the issue of the missing consideration of Absolute Risk Reduction (ARR) in the vaccine trials and studies. The authors, including Professor Piero Olliaro of the Centre for Tropical Medicine and Global Health at the University of Oxford, calculate an ARR of 1.3% for AstraZeneca, 1.2% for Moderna, 1.2% for Janssen and 0.84% for Pfizer.
  • A letter in the Journal of Neurology, Neurosurgery and Psychiatry (BMJ) (also reported by the Mail and ITV) highlights the risk of stroke following receipt of the AstraZeneca vaccination, linking it to the newly identified condition of Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) (blood clots).
  • The U.K. Government has released two reports on the hospitalisation rates of vaccinated people with COVID-19 over the winter and spring. One, from PHE, suggests 57% of patients admitted with Covid over the period had received at least one vaccine dose. The other, from the ISARIC4C consortium, suggested just 7.3% of Covid hospital admissions over the period had received at least one vaccine dose. This large discrepancy has not been acknowledged or explained.
  • The Johnson & Johnson vaccine has received conditional marketing authorisation in the UK. 
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 12,184 people have died and 1,196,190 have suffered injuries following receipt of the Covid vaccines in the EU.
  • Suspected adverse events in the U.K. as reported in the media: Stephanie Dubois (39); Lisa Shaw (44); Kirsty Hext (25).

Summary of Adverse Events UK

According to an updated report published on May 27th (covering the period up to May 19th), the MHRA Yellow Card reporting system has recorded a total of 859,481 events, based on 246,970 reports. The total number of fatalities reported is 1,213.

  • Pfizer (12.7 million first doses, 10.5 million second doses) now has one Yellow Card in 380 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 61,000 doses. 
  • AstraZeneca (24.2 million first doses, 10.7 million second doses) has one Yellow Card in 190 doses, 3.7 adverse reactions per card, one fatal reaction in 43,000 doses.
  • Moderna (0.3 million first doses) has one Yellow Card in 152 doses, 2.8 adverse reactions per card, one fatal reaction in 75,000 doses.

Note that these rates have dropped slightly from last week.

Is the MHRA’s Yellow Card Reporting System Fit For Purpose?

We’re publishing an original piece today by a scientist who has been involved in university teaching and research in biology and scientific enquiry for 35 years. It’s about the Yellow Card reporting system the vaccine regulator has put in place to document the adverse effects of the Covid vaccines and the author is sceptical, to put it mildly. Here’s an extract:

As a means of providing data to establish a causal relationship between vaccination and an adverse event, the Yellow Card scheme is fundamentally flawed. It does not yield data from a control group against which to compare the vaccinated group. In this situation all that can be established is a temporal association between vaccination and an adverse event and there is no means of establishing causation. Using this approach, it can always be argued that any association that is found is merely a coincidence. The Yellow Card scheme, because it is not founded on fundamental principles of good experimental design, is therefore not fit for the purpose of increasing our understanding of either the beneficial or the adverse effects of COVID-19 vaccines. It is not providing the protection from the possible harmful effects of COVID-19 vaccination that the UK public deserves.

Aside from this fundamental flaw, the Yellow Card scheme does not even generate a reliable summary of suspected adverse events that follow after vaccination. The reason for this is that it relies on a voluntary app-based reporting system which places the onus either on medically unqualified patients, carers and parents, or on qualified but more distantly connected medical staff to make a connection between vaccination and an adverse health event, and thereafter to file a report on this suspected connection. It takes little critical scrutiny to realise that a system based on these principles will be subject to huge underreporting either by individuals who are not medically trained to make such connections, or by medically trained staff who lack a close temporal connection with vaccinated individuals. A simple illustration of this fact is that in the Phase 2 COVID-19 vaccine trials, where individuals were comprehensively monitored for adverse events, the reported rates for symptoms such as headaches and fatigue were of the order of 30% – 50%, whereas under the Yellow Card scheme they were of the order of 0.3% – 0.5%. Only 1% of these events are being reported by the Yellow Card scheme. Not only is there huge underreporting, but we also anticipate considerable bias in a voluntary reporting scheme; those who believe that vaccines may do harm will be motivated to make a report, while those who are predisposed to dismiss a connection between vaccination and harm will not take the trouble.

Worth reading in full.

Is the MHRA’s Yellow Card Reporting System Fit For Purpose?

Since December 2020 the UK public has been unwittingly involved in a huge experiment that will reveal the clinical effects, both positive and negative, of the Pfizer/BioNTech (PF)1 and Oxford University/AstraZeneca (AZ)2 COVID-19 vaccines. Despite the absence of thorough animal trials of these products and lack of any human data beyond Phase 2 trials lasting a matter of months, they have been approved by the MHRA and are now being deployed in a programme of mass vaccination. As part of its statutory functions, as well as its legal and moral duty, the MHRA is responsible for monitoring the effects of these vaccines to ensure that their benefits to patients outweigh any risks.3

There are a number of reasons for anticipating that these particular vaccines pose more risk to the general public than traditional vaccines. Traditional vaccines contain products against which the immune system directly generates antibodies. These may, for instance, be inactivated forms of an otherwise harmful virus. Whatever their nature, they are not intimately associated with living human cells. In contrast the PF and AZ vaccines operate by hijacking the protein-producing machinery of human cells causing them to produce and display the spike protein of the SARS-CoV-2 virus. The immune system then raises antibodies against these proteins, thus providing protection against the real virus. However, the workings of the immune system are extremely complex, and it is not a simple matter to predict its manifold responses to the presentation of viral spike proteins on the surface of human cells located in multiple tissues throughout the body. A further reason for caution in deploying the novel vaccines is that during the development of vaccines against other coronaviruses it has repeatedly been found that vaccinated animals suffer more severe disease responses when challenged with the coronavirus itself, a phenomenon known as Antibody Dependent Enhancement (ADE).4, 5 We do not know whether ADE will be a problem with the COVID-19 vaccines because the relevant animal experiments have not been performed.

Given these very real risks, it is incumbent on the MHRA to put in place a professional, robust and transparent research programme in real time for quantifying the effects of the novel coronavirus on human health, allowing a rapid policy response if deleterious effects are detected. In order to do this, it is essential that the research programme is founded on sound experimental design. The objective must be to ensure that, if they occur, we can demonstrate and quantify causal relationships between the vaccine treatment and any beneficial or adverse effects.

A fundamental principle of experimental design is that if we wish to demonstrate a causal relationship between a treatment and an effect, we must have, as well as the treatment, a control against which to compare it. In the case of the COVID-19 vaccines our control population must comprise individuals who are part of the same community to whom the vaccine is being administered, but who are willing to forgo the vaccination. Within our experiment we will need to take account of factors other than vaccine treatment that could lead to a different outcome for vaccinated and control populations. Therefore, when documenting our vaccinated and control populations at the beginning of the trial, it will be essential to record as many characteristics of the individuals involved that could affect their response to vaccines. These might include sex, age, comorbidities, height, weight, ethnicity, pre-existing conditions, e.g. diabetes, etc.

The next step in the experimental design should be to decide on the nature of the measurements that we wish to make on our experimental and control populations. The primary information we are interested in is the health of the participants in the experiment. If we wish to involve a very large number of individuals in our trial, it will clearly not be feasible to make use of medical symptoms that can only be diagnosed by a physician. Therefore, for this wider trial, a list of symptoms seen in earlier trials, easily recognised and scorable by the general public, should be created, together with a common scoring system for these symptoms. Such symptoms would include headaches, fever, vomiting, chills, fatigue, muscle ache, swelling, rash, etc. The participants would be responsible for scoring their own outcomes for each health criterion, and the language used would be comprehensible to a lay audience.

Given that particular potential risks of the COVID-19 vaccines have already been identified (e.g. ADE) it would also seem imperative to include symptoms commonly associated with these conditions, even though they may not have been detected in earlier trials. To complement these measurements, it would also seem wise to undertake some targeted measurements of health outcomes that require more sophisticated analysis in a random subset of the participants in the vaccinated and control cohorts. An example might be estimates of lymphocyte counts that are already known, from Stage 2 trials, to be significantly reduced by the PF COVID-19 vaccination.6 Finally, it should be recognised that a number of the potentially adverse effects, e.g. ADE, may take several years to manifest. Therefore, from the outset, the reporting of symptoms by a cohort of participants should be planned for a timescale of 10 or more years, with more intensive reporting in the earlier period of the trial.

In summary, an appropriate experimental design for studying and measuring the health effects of COVID-19 vaccines on the UK population would comprise matched vaccinated and control populations documented for relevant characteristics that reported relevant health outcomes systematically over a continuous period of years. This large-scale trial would be supplemented with a smaller trial involving a random subset of individuals measured for critical tests requiring more sophisticated laboratory protocols.

Having outlined the framework needed comprehensively to monitor and measure the effects of the COVID-19 vaccines on the health of the UK population, we can now consider the programme that has been put in place by the MHRA and ask whether it is adequate for the task. The MHRA programme centres around the Yellow Card scheme that has an entirely descriptive brief, to compile a list of suspected adverse events from individuals who have been vaccinated either with the PF or the AZ product.

As a means of providing data to establish a causal relationship between vaccination and an adverse event, the Yellow Card scheme is fundamentally flawed. It does not yield data from a control group against which to compare the vaccinated group. In this situation all that can be established is a temporal association between vaccination and an adverse event and there is no means of establishing causation. Using this approach, it can always be argued that any association that is found is merely a coincidence. The Yellow Card scheme, because it is not founded on fundamental principles of good experimental design, is therefore not fit for the purpose of increasing our understanding of either the beneficial or the adverse effects of COVID-19 vaccines. It is not providing the protection from the possible harmful effects of COVID-19 vaccination that the UK public deserves.

Aside from this fundamental flaw, the Yellow Card scheme does not even generate a reliable summary of suspected adverse events that follow after vaccination. The reason for this is that it relies on a voluntary app-based reporting system which places the onus either on medically unqualified patients, carers and parents, or on qualified but more distantly connected medical staff to make a connection between vaccination and an adverse health event, and thereafter to file a report on this suspected connection. It takes little critical scrutiny to realise that a system based on these principles will be subject to huge underreporting either by individuals who are not medically trained to make such connections, or by medically trained staff who lack a close temporal connection with vaccinated individuals. A simple illustration of this fact is that in the Phase 2 COVID-19 vaccine trials, where individuals were comprehensively monitored for adverse events, the reported rates for symptoms such as headaches and fatigue were of the order of 30% – 50%, whereas under the Yellow Card scheme they were of the order of 0.3% – 0.5%. Only 1% of these events are being reported by the Yellow Card scheme. Not only is there huge underreporting, but we also anticipate considerable bias in a voluntary reporting scheme; those who believe that vaccines may do harm will be motivated to make a report, while those who are predisposed to dismiss a connection between vaccination and harm will not take the trouble.

Further barriers to accurate reporting of suspected adverse events are associated with the functioning of the Yellow Card app itself. In the first place, this does not demand basic information on the individual who has experienced the adverse event. Data like age, sex, height, weight, ethnicity, date of vaccination are all optional. This means that serious interrogation of the data to determine the effects of these factors in later analyses is precluded. Secondly, the app is set up in such a way that considerable medical experience is required to register an adverse reaction. There is no drop-down menu of possible adverse events to choose from. Instead, the reporter must type in a medical term that can be recognised by the system, which then provides a list of subsets of that medical condition to choose from. Thus, if the term headache is entered, some 50 different types of headache are listed, one of which must be chosen. Needless to say, this is likely to deter all but the most confident or medically informed from ever filing a report. Finally, experience has shown that the app itself is completely unreliable. After successfully filing a single report, it proved impossible to file a subsequent report because the app would not accept data on the nature of the adverse reaction. This level of malfunction is completely unacceptable in an official Government app.

Given that the Yellow Card scheme is so comprehensively flawed, is there yet something that can be salvaged from the data that it has provided? I have indicated that in general it is true that mere descriptive data on the frequency of adverse events following vaccination is insufficient to allow any causal relationship to be drawn between vaccination and the adverse event. All that can be established is an association, and the existence of a causal link can be easily dismissed. In this vein the latest report from MHRA6 and a summary of earlier data in the BMJ7 concludes that the COVID-19 vaccines have not played a role in the death of any vaccinated patients.

However, before accepting this conclusion let us remember that a particular demographic in the UK has, over the same time period (December 9th 2020 to February 14th 2021), been vaccinated with two different COVID-19 vaccines, PF and AZ. From the Yellow Card data, we have information on the number of doses of each of the two vaccines given, and the corresponding number of deaths following vaccination. Our null hypothesis is that the vaccination of individuals has no effect on the background rate of a particular suspected adverse event, for example death. If our null hypothesis is true, the rate of death following vaccination should be the same whether the PF or the AZ vaccine is employed. We can test this null hypothesis making use of the information from the Yellow Card reporting scheme. The test is crude, because the information available in the Yellow Card report does not break down the data according to particular age groups or other relevant factors. Nonetheless, as a preliminary investigation this approach can be informative, and depending on the result, may indicate whether more rigorous analyses are warranted.

The data used were those freely available from the Yellow Card report published on February 25th 2021 covering the period December 9th 2020 to February 14th 2021 .7 According to the report, approximately 8.9M vaccinations (first and second doses) had been given using the PF vaccine, and 6.9M with the AZ vaccine. The number of suspected deaths associated with these vaccinations were 197 (PF) and 205 (AZ). From these data we can draw up the following table to test our null hypothesis that the rate of death is independent of the type of vaccine administered.

VaccineAliveDeadTotal
PF88998031978900000
AZ68997952056900000
Total157959840215800000
Table 1.
Contingency table for testing null hypothesis that rates of death following vaccination are independent of the vaccine administered

The result of a contingency χ2 test on these data indicates that the frequency of suspected death events differs highly significantly between the PF and AZ vaccines (χ2(1) = 8.7662, p<0.005). Our null hypothesis that there is no effect of the vaccine type on the rate of death is rejected. For every death associated with a PF vaccine injection, there are 1.34 deaths associated with an AZ vaccine injection.

Care is required in concluding uncritically from this result that vaccination has an effect on the rate of death of participants in the vaccination programme, since we have not had access to data that would allow us to compare the two groups who were given the PF and AZ vaccines. We are assuming in our analysis that the two groups do not differ in some systematic way which would affect their background rate of death, and this may not be true. However, the size and significance of the effect we have demonstrated indicates that it is important to pursue this question further to determine why death rate differs so markedly for the groups receiving PF and AZ vaccines in the UK to date.

The same form of analysis can be extended to determine the influence of the type of vaccine administered on suspected adverse reactions that are far more common than death. This has been summarised together with the previous analysis for a number of suspected adverse reactions that have a relatively high prevalence (Table 2).


Suspected Adverse Event
Ratio PF:AZχ2(1)P
Death1:1.348.77< 0.005
Tremor1:7.091640.7< 0.001
Vomiting1:3.05946.0< 0.001
Fever1:3.204836.7< 0.001
Headache1:4.024169.4< 0.001
Table 2.
Ratio of suspected adverse reactions following vaccination with PF and AZ vaccines, and results of χ2 testing null hypothesis of no effect of vaccine type on frequency of suspected adverse reactions.

Again, this shows highly significant differences between the vaccines in the rate of suspected less serious adverse events occurring shortly after vaccination. Such analyses should be useful for making recommendations on vaccine choice to minimise the incidence of less serious suspected adverse reactions in the vaccination programme.

We can conclude that the Yellow Card reporting scheme can provide some limited information that may be useful for alerting the UK public to possible adverse effects of the COVID-19 vaccines. However, the initial conception of the scheme as a purely descriptive rather than as an experimental undertaking means that it cannot address the real issues that are of crucial importance to the UK public. These issues are whether there are causal relationships between vaccination with the PF and AZ vaccines and serious adverse effects such as death, and if so, what are the size of these effects. To address these issues an experimental protocol such as that outlined earlier in this article is required, and should be implemented with immediate effect. Without data generated by such an approach it will not be possible to establish scientifically sound policy for COVID-19 vaccinations.

The author is a scientist who has been involved in university teaching and research in biology and scientific enquiry for 35 years.

1 Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

2 Regulatory approval of COVID-19 Vaccine AstraZeneca

3 Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance

4 Arvin, A.M. et al. (2020). A perspective on potential antibody dependent enhancement of SARS-CoV-2. Nature 584, 353-363.

5 Halstead S.B., Katzelnick, L. (2020). COVID-19 Vaccines: Should We Fear ADE? Journal of Infectious Diseases 222. DOI: 10.1093/infdis/jiaa518

6 Mulligan, M.J. et al. (2020) Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature

7 Coronavirus vaccine – weekly summary of Yellow Card reporting Updated March 4th 2021

8 Covid-19: First UK vaccine safety data are “reassuring,” says regulator BMJ 2021;372:n363