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Vaccine Safety Update

by Will Jones
6 May 2022 6:56 PM

This is the 31st 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 30th 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 was 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.

  • The U.S. FDA has limited access to Johnson & Johnson’s COVID-19 vaccine because of the risk of blood clots, making it available now only to over-18s who cannot take one of the mRNA vaccines for medical reasons or are not willing to take one.
  • A family GP practice in the USA has said it is not able to sign off vaccinated student athletes for sport without lab work to check their heart.
  • Data released by the U.K. Government show the all-cause mortality rate is substantially higher in those who have received one or two doses of the Covid vaccine than in the unvaccinated.
  • The U.K. Government has launched an urgent investigation into an increase in severe hepatitis amongst children. Hepatitis is a known vaccine side-effect, though any potential link of this outbreak with the vaccines would be indirect as almost all the children affected are unvaccinated (most are too young).
  • A study has shown that Covid vaccination can elicit a distinctive form of hepatitis (liver inflammation) which is “CD8 T-cell dominant”.
  • Case report on severe and fatal rhabdomyolysis (muscle tissue damage) after Covid vaccination.
  • A piece in Spectator Australia asks questions about adverse events in the country linked to the Covid vaccines.
  • Pfizer has submitted an application to the FDA for U.S. Emergency Use Authorisation for a COVID-19 vaccine booster dose in children aged five to 11.
  • A study has found significant menstrual issues related to Covid jabs including a massive increase in the previously rare event of “decidual cast shedding”.
  • Geert Vanden Bossche says he has informed the WHO of the dangers associated with continuing the Covid vaccine campaign.
  • Adverse events reported in the U.K. press: Mollie Brown, 21; Oli Akram Hoque, 26; Peter Jackson, 96; Dawn Wooldridge, 36.
  • Eudravigilance – the European version of the Yellow Card Reporting system – as of April 30th has reported 4,241,317 reactions from 1,755,775 reports of which 1,933,161 were deemed as serious. 44,161 fatal reactions were reported with an approximate actual number of deaths being 14,379. This is due to a 3.07 reporting rate in fatalities across multiple reactions.
  • VAERS – the American version of the Yellow Card reporting system – as of April 29th reports a total of 1,247,131 reports of adverse events following Covid vaccines, including 27,532 deaths and 226,340 serious injuries. For children up to the age of 17 there have been 48,033 reports, of which 4,296 were deemed serious and 106 fatalities. 
  • DAEN Australia – the equivalent of the Yellow Card reporting system – has logged (up to April 20th) 124,087 reports of adverse events, including 828 deaths.
  • Children (Under 18) Adverse Events U.K. – up to April 20th, the MHRA reports a total of 3,873 adverse event reports, comprising 3,558 Pfizer, 263 AstraZeneca, 26 Moderna and 26 unspecified from 3,613,500 children vaccinated with 5,926,600 doses. This includes 76 reported cases with Pfizer of myocarditis/pericarditis, suggesting a current reported risk of 14 cases per million first doses and 11 per million second doses for this age group.
  • Booster Doses – 48,612 adverse events have been reported across all vaccines up to March 30th from 39,108,473 people vaccinated.

Summary of Adverse Events in the U.K.

According to an updated report, as of April 20th the MHRA Yellow Card reporting system has recorded a total of 1,485,059 events based on 453,680 reports. The total number of fatalities reported is 2,096.

  • Pfizer (26.5 million first doses, 24.1 million second doses, 29.9 million third doses) now has one Yellow Card in 156 people vaccinated. Deaths: one in 35,475 people vaccinated (747).
  • AstraZeneca (24.9 million first doses, 24.0 million second doses, 56,000 third doses) has one Yellow Card in 102 people vaccinated. Deaths: one in 19,715 people vaccinated (1,263).
  • Moderna (1.7 million first doses, 1.5 million second doses, 9.2 million third doses) has one Yellow Card in 44 people vaccinated. Deaths: one in 37,778 people vaccinated (45).

Overall, one in every 117 people vaccinated (0.85%) have experienced a Yellow Card adverse event. Reported adverse events are not necessarily caused by the vaccine and further investigation is required to establish causality. The MHRA has previously estimated that the Yellow Card reporting rate may be approximately 10% of actual figures. Note that sometimes in Yellow Card reporting, the numbers of adverse events (including fatalities) will be lower than the previous week. The Yellow Card system is a passive reporting system, so in theory this should not happen as all reports should be cumulative. However, the MHRA says it analyses the data prior to publication, with deaths and pregnancy conditions being notably investigated. It does not state criteria by which reports would be removed and to date has not clarified why these data vary. It is therefore unclear how many reported adverse events have been removed from the reports since reporting began in February 2021.

  • Blood Disorders = 27,469
  • Anaphylaxis = 1,632
  • Acute Cardiac = 27,940
  • Eye Disorders = 24,602
  • Blindness = 529
  • Deafness = 794
  • Hepatic (liver) Disorders = 840
  • Infections = 35,268
  • Spontaneous Abortions = 797 miscarriages
  • Nervous System Disorders = 284,984
  • Strokes and CNS haemorrhages = 3,230
  • Gastrointestinal Disorders = 134,726
  • Immune System Disorders = 6,401
  • Seizures = 3,487
  • Paralysis = 1,525
  • Pericarditis/Myocarditis = 2,112
  • Psychiatric Disorders = 31,290
  • Respiratory Disorders = 56,167
  • Epistaxis (nosebleeds) = 3,609
  • Metabolic Disorders = 12,498
  • Nausea & Vomiting = 73,117
  • Guillain-Barré Syndrome = 620
  • Reproductive/Breast Disorders = 57,565

Further analysis can be found via the U.K. Freedom Project.

Source: Pfizer; Moderna; AstraZeneca; Unspecified. “F” denotes fatal.
Tags: Adverse eventsDAEN AustraliaEudraVigilanceSafetySide-effectsVaccinesVAERSYellow Card Reporting System

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