EudraVigilance

Vaccine Safety Update

This is the 19th of the 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 18th 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 in June 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.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. 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.

Summary of Adverse Events in the U.K.

According to an updated report published on November 19th, the MHRA Yellow Card reporting system has recorded a total of 1,271,009 events based on 386,517 reports. The total number of fatalities reported is 1,784.

  • Pfizer (24.2 million first doses, 20.6 million second doses) now has one Yellow Card in 185 people vaccinated. Deaths: 1 in 39,607 people vaccinated (611).
  • AstraZeneca (24.8 million first doses, 24.1 million second doses) has one Yellow Card in 105 people vaccinated. Deaths: 1 in 22,103 people vaccinated (1,122).
  • Moderna (1.5 million first doses, 1.3 million second doses) has one Yellow Card in 85 people vaccinated. Deaths: 1 in 78,947 people vaccinated (19).

Overall, one in every 131 people vaccinated (0.76%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures.

Vaccine Safety Update

This is the 18th of the 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 17th 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 in June 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.) Boris Johnson said in October that being double vaccinated “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. 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.

Summary of Adverse Events in the U.K.

According to an updated report published on November 11th, the MHRA Yellow Card reporting system has recorded a total of 1,261,714 events based on 383,644 reports. The total number of fatalities reported is 1,766: 1,118 with AstraZeneca, 597 with Pfizer, 19 with Moderna, 32 unspecified. (Note: updated dose counts were not available in this week’s MHRA report so figures based on dose counts have been omitted in this update. All other data has been updated.)

Vaccine Safety Update

This is the 17th of the 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 16th 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 in June 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.) Boris Johnson said in October that the vaccine “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. 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.

Summary of Adverse Events in the U.K.

According to an updated report published on November 4th, the MHRA Yellow Card reporting system has recorded a total of 1,252,679 events based on 380,850 reports. The total number of fatalities reported is 1,739.

  • Pfizer (23.5 million first doses, 20.3 million second doses) now has one Yellow Card in 187 people vaccinated. Deaths: 1 in 40,728 people vaccinated (577).
  • AstraZeneca (24.9 million first doses, 24.1 million second doses) has one Yellow Card in 106 people vaccinated. Deaths: 1 in 22,392 people vaccinated (1,112).
  • Moderna (1.5 million first doses, 1.3 million second doses) has one Yellow Card in 87 people vaccinated. Deaths: 1 in 83,333 people vaccinated (18).

Overall, one in every 131 people vaccinated (0.76%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures.

Vaccine Safety Update

This is the 16th of the 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 15th 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 in June 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.) Boris Johnson said in October that the vaccine “doesn’t protect you against catching the disease, and it doesn’t protect you against passing it on”. 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.

  • New Zealand researchers Aleisha Brock and Simon Thornley have published a peer-reviewed paper in Science, Public Health Policy, and the Law which reanalyses a key CDC study showing mRNA vaccines are safe during pregnancy and found that the actual rate of miscarriage before 20 weeks gestation following mRNA exposure was at least 81.9% – a massive seven-fold increase over the expected background rate of 11.3%. They have called for a halt on COVID-19 vaccines for pregnant women.
  • The Brownstone Institute has collated 102 (and counting) research studies that “affirm naturally acquired immunity to COVID-19“.
  • An investigation found that 100% of deaths reported as adverse events from Covid vaccines were associated with just 5% of the vaccine batches, suggesting the most serious safety issues may be batch-related.
  • Covid vaccine damage sufferers have called for a review of the Vaccine Damages Payment Scheme (VDPS), asking the Government to “overhaul the VDPS to make it more accessible, with payments based on need rather than an arbitrary figure”.
  • The Irish county of Waterford has the highest reported infection rate in the country despite 99.7% of adults being vaccinated.
  • TV presenter Lisa Snowdon has reported suffering from Covid a second time despite being double vaccinated, and she says it was worse.
  • The Government of New South Wales in Australia has said that workers will face tighter restrictions if they don’t get vaccinated.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged (up to October 19th) 2,637,525 adverse events, including 28,103 deaths.
  • VAERS – the American version of the Yellow Card reporting system – released new data on October 22nd bringing the total to 837,595 reports of adverse events following Covid vaccines, including 17,619 deaths and 127,457 serious injuries.
  • DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to October 19th) 70,355 reports of adverse events, including 608 deaths.
  • Children (Under 18) Adverse Events U.K. – up to October 20th, MHRA report a total of 1,458 adverse event reports, comprising 1,216 Pfizer, 233 AstraZeneca, 5 Moderna and 4 unspecified. Myocarditis reports are 9 in a million doses for this age group (suggesting approximately 18 cases to date from the 1,956,481 doses administered so far). No information is provided on fatalities.

Summary of Adverse Events in the U.K.

According to an updated report published on October 28th, the MHRA Yellow Card reporting system has recorded a total of 1,243,998 events based on 378,074 reports. The total number of fatalities reported is 1,738.

  • Pfizer (23.2 million first doses, 20.1 million second doses) now has one Yellow Card in 187 people vaccinated. Deaths: 1 in 40,278 people vaccinated (576).
  • AstraZeneca (24.9 million first doses, 24.1 million second doses) has one Yellow Card in 106 people vaccinated. Deaths: 1 in 22,412 people vaccinated (1,111).
  • Moderna (1.5 million first doses, 1.3 million second doses) has one Yellow Card in 83 people vaccinated. Deaths: 1 in 75,000 people vaccinated (20).

Overall, one in every 131 people vaccinated (0.76%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures.

Vaccine Safety Update

This is the 14th of the 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 13th 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 in June 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.

Summary of Adverse Events in the U.K.

According to an updated report published on October 14th, the MHRA Yellow Card reporting system has recorded a total of 1,228,991 events based on 372,878 reports. The total number of fatalities reported is 1,719.

  • Pfizer (22.7 million first doses, 19.8 million second doses) now has one Yellow Card in 188 people vaccinated. Deaths: 1 in 40,391 people vaccinated (562).
  • AstraZeneca (24.9 million first doses, 24 million second doses) has one Yellow Card in 106 people vaccinated. Deaths: 1 in 22,514 people vaccinated (1,106).
  • Moderna (1.5 million first doses, 1.2 million second doses) has one Yellow Card in 90 people vaccinated. Deaths: 1 in 75,000 people vaccinated (20).

Overall, one in every 132 people vaccinated (0.76%) have experienced a Yellow Card adverse event. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures.

Vaccine Safety Update

This is the tenth 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 ninth 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.

  • There have been international reports of adverse events following COVID-19 vaccines in Indonesia (reporting the deaths of 131 health care workers post Sinovac vaccine), India and Canada (reporting 22 cases of heart inflammation).
  • Further reports of Bell’s Palsy developing following vaccination, including a featured case report in the BMJ. Immunologist Dr. J. Bart Classen has written in the Journal of Medical – Clinical Research & Reviews on the risk of Parkinson’s disease following Covid vaccination, especially AstraZeneca (summarised here).
  • A study in the Lancet suggests that antibody responses wane rapidly and are low within two months of vaccination (though the authors note that protection via cellular immunity may remain).
  • A report on ‘breakthrough’ cases from NBC Boston, reporting 5,100 cases in Massachusetts and 80 subsequent deaths. 
  • The Royal College of Paediatrics and Child Health has said that it supports the recommendations of the JCVI on not vaccinating children below the age of 18 unless they have underlying health conditions.
  • The inventor of mRNA technology, Dr. Robert Malone, has spoken of his fear that current data shows a worrying trend of possible ADE (Antibody-Dependent Enhancement) as the vaccine may cause the virus to be more dangerous in the vaccinated than the unvaccinated.
  • Lawyers have warned that ‘ethical veganism’ is a protected belief that would be among those that would have to respected in any effort to introduce mandatory vaccination in workplaces, the Telegraph reports
  • Chief Midwife for England, Jacqueline Dunkley-Bent, has penned a letter to midwives, obstetricians and GP practices, asking them to recommend COVID-19 vaccines to pregnant women.  This follows some surveillance data that suggests some increased risk to pregnant women from the Delta variant. A study interim report published in the New England Journal of Medicine concludes that while 13% of the 827 vaccinated women in the study suffered a spontaneous abortion (miscarriage), this is not an elevated number. Dr. Peter McCullough has written in TrialSiteNews detailing some serious concerns with the study, stating: “The effect of the vaccines on early pregnancy losses (<20 weeks) is concerning and remains to be determined.” To date the Yellow Card system has reported 600 adverse events relating to pregnancy conditions including 10 deaths and 381 spontaneous abortions.
  • A Spanish preprint study in the Lancet suggests that the safety profiles of Pfizer and AstraZeneca vaccines are similar in terms of blood clotting. It also suggests that the risk of blood clotting is greater for those infected with SARS-CoV-2.
  • A preprint study in Medrxiv reports no difference in viral loads when comparing unvaccinated people to those who have ‘breakthrough’ infections post-vaccine, suggesting “that if vaccinated individuals become infected with the Delta variant, they may be sources of SARS-CoV-2 transmission to others”. 
  • Report in the Telegraph that AstraZeneca may end its future development of vaccines after offering its COVID-19 vaccine at cost to contribute to the pandemic effort. Pfizer, on the other hand, has reported record profits and is discussing increasing the costs of booster shots, according to the Guardian.
  • Statistician Mathew Crawford has argued that the CDC’s definition of a safety signal prevents it from picking up safety problems with the Covid vaccines, essentially because it compares the Covid vaccines to one another rather than to an established baseline.
  • VAERS – the American version of the Yellow Card reporting system – released new data on July 23rd bringing the total to 518,581 reports of 2,426,531 adverse events following Covid vaccines, including 11,940 deaths.
  • EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged (up to July 31st) 779,048 reports of 1,940,012 adverse events, including 20,595 deaths.
  • Suspected adverse events in the U.K. as reported in the media: Gemma O’Shea (35); Natalie Simpson (38).

Summary of Adverse Events in the U.K.

According to an updated report published on July 21st, the MHRA Yellow Card reporting system has recorded a total of 1,102,228 events based on 331,240 reports. The total number of fatalities reported is 1,517.

  • Pfizer (20.4 million first doses, 12.9 million second doses) now has one Yellow Card in 215 people vaccinated. Deaths: 1 in 43,777 people vaccinated (466).
  • AstraZeneca (24.7 million first doses, 23.2 million second doses) has one Yellow Card in 110 people vaccinated. Deaths: 1 in 24,263 people vaccinated (1,018).
  • Moderna (1.3 million first doses, 0.3 million second doses) has one Yellow Card in 118 people vaccinated. Deaths: 1 in 162,500 people vaccinated (8).

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.