Has the novel vaccine for a novel coronavirus led to a novel case of hiding something bad in plain sight? We are constantly told by the authorities and mainstream media that the novel coronavirus vaccines are exceptionally effective and safe. Yet at the same time there is a constant drip feed, now running more like a torrent, of reports of numerous and sometimes serious side effects from the vaccines. Dan Astin-Gregory of the Pandemic Podcast recently received, but failed to publish, a “113 page report documenting the tragic accounts of people who had sadly died following the COVID-19 vaccination”. Mr Astin-Gregory’s heart is clearly in the right place, but the mind needs data. An anecdote of anecdotes? Without seeing the report, it is impossible to make any assessment of it.

Others have behaved more reprehensibly. Joel Smalley, a quantitative data analyst, member of HART and constant thorn in the side of the authorities, published a tweet, now unavailable on twitter but captured by the Wayback Machine, that claimed 0.2% of children vaccinated against covid in the US subsequently died. Dr No was able to verify, using VAERS, the US equivalent of the UK’s yellow Card scheme, that there were nine reported deaths in children aged 17 and under who had been vaccinated, but the Smalley denominator of 4,000 vaccinated is ludicrously small. The real number, for those aged 17 and under, is 2,216,504, giving a rate of reported deaths following vaccination of 0.0004%. To put the nine deaths in context, there were 34,602 deaths in the US in 2019 in those aged 17 and under. The majority of those deaths (20,921) were in infants aged under one year of age, but even so, nine deaths set against tens of thousands is hardly a call to lock up your daughters. Sorry folks, nothing to see here.

Or perhaps there is. The real story here isn’t how many deaths there have been in US children after covid vaccination, it is how few deaths have been reported. The 34,602 deaths work out as a crude rate of 474 death per million population, which means that of the 2.2 million vaccinated children, around 1,050 can be expected to die every year from non-covid related causes, or let’s say 350 for the four months or so covered by the VAERS covid vaccine data. Yet only nine of the expected deaths got reported. Even allowing for the fact that many of the deaths are caused by prematurity, accidents and violence, there are still many deaths due to medical causes including diseases of heart, influenza and pneumonia, septicaemia and chronic lower respiratory diseases (1,654 of the 34,602 deaths), all of which might reasonably be in some shape or form possible adverse reactions to vaccination. Yet only nine deaths following covid vaccination got reported.

What this tells us is that the passive surveillance schemes, like VAERS in the US and the Yellow Card scheme in the UK, are hopelessly and woefully incapable of providing effective surveillance. Our Yellow Card scheme here in the UK is even more inadequate than the VAERS scheme. No demographic data at all is reported, because the electronic reporting system does not require this data: the key fields are marked ‘optional’. All we have is crude numbers of adverse events, and even these are derisory. The three commonest side effects for adults after pain at the injection site reported in clinical trials for the Pfizer/Biontech vaccine were fatigue (> 60%), headache (> 50%) and myalgia (> 30%); for the Oxford/AstraZeneca vaccine the figures are headache (52.6%), fatigue (53.1%) and myalgia (44.0%). According to the latest Yellow Card scheme data, to 28th April 2021, reported rates of these side effects for the Pfizer/Biontech vaccine are fatigue (0.05%), headache (0.08%) and myalgia (0.03%). For the Oxford/AstraZeneca vaccine, the Yellow Card rates are headache (0.25%), fatigue (0.13%) and myalgia (0.08%). Some of these rates are several orders of magnitude less than the expected rates.

These figures confirm that the Yellow Card scheme is hopelessly and woefully incapable of providing effective surveillance. To be fair to the scheme, it was never really intended to provide true surveillance; instead, it is an alert system, intended to provide a signal that something might be amiss. But being a voluntary scheme greatly compromises its capabilities, and the failure to collect demographic data is little short of wilful neglect. Most importantly, the Yellow Card scheme can only ever be an alert system that might, with a following wind, generate a signal of potential concern meriting further investigation. It can never, of itself, prove, or indeed disprove, causation. It is a necessary scheme, but nowhere near a sufficient scheme.  

Vaccinating an entire adult population in less than a year with a novel vaccine for a novel disease is a colossal undertaking of huge public health importance. The medium to long term side effects of the vaccine are not, and cannot be known, unless and until we have an adequate post marketing surveillance scheme in place. Instead of relying on a quaint but demonstrably inadequate voluntary scheme, we need the same effort put into post rollout surveillance as has been put into the vaccination programme itself. The current government/PHE COVID-19 Post-implementation vaccine surveillance strategy remains vaguely weak and largely aspirational on vaccine safety: “Safety surveillance will be undertaken in collaboration with the MHRA, further details on the MHRA proactive vigilance of COVID19 vaccines are available here” — only they are not, there is no link. The nearest document online appears to be here, and again it is also vaguely weak and largely aspirational. Were Dr No a cynic rather than a sceptic, he might be sorely tempted to opine that the whole Yellow Card scheme and the post-implementation vaccine safety surveillance strategy look rather like duds hiding in plain sight, all set up fail. Just the ticket to keep vaccinations on track. With such low reported rates of adverse events, there is nothing to see here, nothing at all.

Comments

  1. Annie Davenport Turner Reply

    Thanks for this piece, Dr No; sorely needed.
    This link to Dan Astin-Gregory’s ‘Coincidences’ broadcast contains a wealth of data. https://www.facebook.com/danjgregory/videos/10159278647242402/

    In one day (yesterday) I heard of yet another bunch of friends who have had severe adverse reactions: including 2 with clots in eyes, 1 with TIA (collapsed in garden, unconscious 20 minutes), one with A&E for 24 nose bleed, extremely high temperatures, shaking, and one with double lung embolisms; all touch and go and one point. It’s not good – not good at all.

  2. dearieme Reply

    Dear God, Annie, either you have many more friends than we have or you select your friends from among the desperately frail.

    Separate issue: I have consulted Dr Wiki – “The most common cause of acute myalgia is the overuse of a muscle or group of muscles; another likely cause is viral infection, especially when there has been no trauma.”

    To go off-piste for a moment – I have long wondered whether the former epidemic of heart attacks in middle-aged men was caused by an infective agent (an idea I picked up from a doctor somewhere online) – maybe a virus? How about cancers: could any of those be caused by infective agents?

  3. H W Tsudnim Reply

    The tiniest fraction of the costs of the vaccination program could have been put towards proper surveillance of post vaccine patients, it seems clear than this information was unwanted and therefore best not unearthed.
    Best not undermine the “rollout”.
    Pick up the pieces later.

  4. Tom Welsh Reply

    “What this tells us is that the passive surveillance schemes, like VAERS in the US and the Yellow Card scheme in the UK, are hopelessly and woefully incapable of providing effective surveillance”.

    By design, I fancy. No one likes the person who spoils things for everyone by warning of danger. Especially danger to people who are not deemed to matter.

    The corporate world (and large parts of government) has vast experience in subtle ways of shutting down criticism. One of the best methods is to set up a reporting system that is calculated not to produce many reports.

    Every vaccination should be performed by a doctor, or at least under the direct supervision of a doctor. That doctor should have legal responsibility for making a formal record of the vaccination, the reasons for giving it, and the manufacturer, type and batch number. That information should be added to the patient’s records, and consulted in case of any future illness – for the rest of the patient’s life.

    Moreover, doctors should have a legal duty to report any illness or signs and symptoms that could be due to vaccination.

    The gaping hole in even such a scheme is, of course, that it relies on the doctor’s judgment to decide whether a given sign or symptom is connected with a previous vaccination.

    In the last analysis, there is no substitute for personal and professional honesty.

    • Jonbe Reply

      Agree with Tom.
      The professional honesty could be under inconscient influences. The educational process of a practitioner since the beginning, then during his career, is under influence of the pharmaceutical firms (from the little invitation to restaurant, to the “marketing” flyer of a product, and so on, to the convention for a congress…). Be conscient of this influences is a first step, but not enough to preserve complete integrity. How many medical practitioner have an acute knowledge of this influences and how do they decide to manage it in order to practice wisely their medical “Art” ? This is another pandemic, from my point of view … How to accept without psychic resistance / dissonance the idea that a medical product can be harmful despite the manufacturer had repeatedly say that it’s innovant and beneficial for the greater good ? It’s certainly less dualistic than that, but it’s important to acknowledge this fact in order to neutralise this tendency to scotomise the reality. The same process seems valide for institutions, hospitals… Sociology is fun, and it could generate collateral damages if not take in consideration.

  5. dr-no Reply

    Thanks you all for your comments. Another likely hindrance to reporting suspected adverse effects from vaccination is the very people administering the vaccines are likely to be if not vaccine zealots, then at least pro-vaccine, and no one likes pissing on their own parade. A text book example of cognitive dissonance.

    There’s an ‘interesting’ FOI response from the MHRA to a series of questions on covid vaccine surveillance which despite running to several pages of A4, manages to say virtually nothing, apart from all pigs have been fed, and are ready to fly. It’s a wonderful example of Whitehall-speak, peppered with waffle like “The reporting of suspected side effects is considered part of a healthcare professionals’ responsibility and as such reporting is also reinforced through relevant codes of conduct or policy and supported by their relevant healthcare professional bodies” “We have a range of resources and technology to support the proactive vigilance of any COVID-19 vaccination programme” and “The [AI] tool is not being used for assessment of data, but to help ensure that all the information from the reporter is well structured to support analysis and subject to robust quality assessment”. As such, these statements support Dr No’s robust assessment that there is nothing to see here either, except how to use twenty words when none will do.

    What is needed is systematic collection of linked denominator and numerator data: numbers vaccinated, numbers of potential side effects. There is more than enough money being wasted on pointless covid testing that could fund active surveillance. But it ain’t happening, or if it is, the results aren’t being published.

    Dearieme – there are a number of well known virus-cancer links, Hep B and liver cancer and HPV and cervical cancer being two common ones.

  6. dr-no Reply

    A red letter day for the BBC and the Yellow Card scheme…

    Yesterday: BBC ‘Reality Check’: “Period changes could be a harmless side effect of Covid vaccines” became “Covid vaccine: Period changes could be a short-term side effect” once they realised “could be a harmless side effect” carried quite the wrong message (if it only ‘could be a harmless side effect’ then it might not be a harmless side effect). Extract (emphasis added):

    “At a Covid vaccine appointment, you will probably be warned of possible side effects – fever, headache, a sore arm for a day or two afterwards. Changes to the menstrual cycle will not appear on the list.

    “But women online around the world have started asking if early, heavy or painful periods might be an unlisted reaction to the jab.

    “Dr Kate Clancy, a medical anthropologist, shared on Twitter her experience of an unusually heavy period following the Moderna vaccine, and received dozens of similar accounts in response. With former colleague Dr Katharine Lee, she launched a survey documenting people’s experiences.

    “We don’t yet know whether the vaccine is causing these changes – it hasn’t been studied. It’s possible women post-vaccination were more likely to notice or attribute changes, particularly after hearing about others’ experiences.

    “But Dr Victoria Male, a reproductive immunologist at Imperial College London, said some post-menopausal women, and people taking hormones which stop their periods, have reported bleeding. So she’s inclined to suspect there may be a physical reaction occurring.

    “A number of trans men and post-menopausal women who don’t normally have periods got in touch with Drs Clancy and Lee saying they had experienced bleeding after the jab.

    “And, though the link is unproven, there are logical reasons the vaccine could be causing changes to periods – but these changes are not anything to worry about, reproductive specialists say. While painful or unexpected periods can be distressing, they’re not a sign of any long-term harm.”

    Only the BBC could use a Dr Male to provide quotes on period problems without batting an eyelid. You might even say they failed to do a Reality Check…

    Yellow Card Reality Check: Pfizer and AZ Yellow Card reports for menstrual abnormalities. Nothing to see here, folks…

    Pfizer reports:

    AstraZeneca reports:

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