‘Rare AEs’, or: Shifting Goalposts in Pharmacovigilance

Among the most insidious aspects of the Covid Mania is surely the distortion of truth in terms of the generally accepted meaning of certain terms and concepts

Among the more controversial aspects of the global response to the declaration of the Sars-CoV-2 Pandemic by WHO in spring 2020 was the decision to pursue mass vaccination. This was a decisive, if controversial, pitch as it placed yet-unapproved biological materials into the spotlight, namely DNA and modified RNA-vectored injections.

While especially the latter platform—used in the BioNTech/Pfizer and Moderna products—was ‘considered a gene therapy product by the FDA’ as late as August 2020 (as per Moderna’s 10-Q form (Q2/2020) with the SEC, p. 70) and came with several disclaimers with respect to ‘side effects’ (that ‘could negatively impact the perception of mRNA medicines’), their unlicensed nature (the ‘regulatory pathway for approval is uncertain’), and the need for additional safety testing (that ‘may be different from those required for gene therapy products’).

None of these concerns were followed up on in the second half of 2020, even though the language in these filings is crystal clear about the many things that could go wrong:

mRNA medicines are a novel approach, and negative perception of the efficacy, safety, or tolerability of any investigational medicines that we develop could adversely affect our ability to conduct our business, advance our investigational medicines, or obtain regulatory approvals (p. 75).

Hence, despite Moderna noting on 6 Aug. 2020 that ‘the length of time necessary to complete clinical trials and to submit an application for marketing approval…varies significantly from one pharmaceutical product to the next, and may be difficult to predict’ (p. 70), all of these things—including, most importantly, the deduction of a positive risk/benefit analysis—were accomplished in the third quarter of that same year.

In Q4 of 2020, public health officials, politicians, experts [sic], and legacy media were uniformly concerned with the roll-out of these DNA and mRNA-vectored injectable products, which commenced across the world (along several other so-called vaccines™) in the last days of December, with this legacy media piece by ABC News serving as pars pro toto for the spirit of the time.

4.5 Years On, The Carnage Continues

This is neither the format nor the forum to discuss the ensuing confrontations over the mass vaccination and anti-Covid measures employed by various governments, public health authorities, medical professionals, and journalists. While there is more than enough evidence for what may only be called ‘carnage’ (for a long-form discussion, see this US Senate hearing held in May 2025)—off-the-charts signals in the available pharmacovigilance systems, in particular the Vaccine Adverse Event Reporting System (USA; click here for OpenVAERS) and the EudraVigilance database run by the EU’s pharmacovigilance watchdog.

Both systems are quite cumbersome to use, yet there were significant indications in both databases that warrant attention, including thousands of adverse events in babies aged 0-2 (see here for Dr. Jessica Rose’s posting about VAERS and my own look at data from EudraVigilance). The US database also contains tens of thousands of entries from non-US rapporteurs, which the Dept. of Health and Human Services, upon request of the EU, discontinued to disclose from mid-November 2022 onwards.

By then, to cite but one example, these foreign reports from one EU member-state alone, Austria, contained more than 500 AE reports with deadly outcomes (none of which can be reliably and indisputably attributed to any of the Covid injectable products). Needless to say, official numbers stand in stark contrast to the VAERS data, admitting to less than 2,000 vaccine injuries (this author was able to acquire the last spreadsheets from before that point in time courtesy of

Jessica Rose

).

As tragic as these results of the mass vaccination campaign are, the main phase shift, however, is something else: during the similarly WHO-declared, first 21^st-century public health emergency—that is, the ‘2009 H1N1 Pandemic’ (see the CDC’s dedicated page; WHO’s dedicated page; Wikipedia entry)—all the accoutrements and measures of the Covid era were in place: a new zoonotic virus, the WHO’s declaration of a ‘pandemic’, and a mass vaccination campaign (although undertaken with GlaxoSmithKline’s approved traditional Pandemrix™ vaccine). Extensive pharmacovigilance eventually led to the discontinuation of the administration of these vaccines in summer 2010 due to the discovery of a ‘signal’.

About That ‘Other’ WHO-Declared Pandemic™

Contrary to the present situation with respect to Sars-CoV-2/Covid-19, however, there were after-action enquiries, many academic studies conducted, the award of compensation payments to vaccine-injured individuals, and the eventual non-renewal of Pandemrix’s marketing authorisation in 2015.

The similarities and differences between these two WHO-declared pandemics are both obvious and clearly visible, if, e.g., Peter Doshi’s question ‘Pandemrix vaccine: why was the public not told of early warning signs?’ in the British Medical Journal (2018) and the extensive follow-up enquiries by, among others, the Norwegian Institute of Public Health (Folkehelseinstituttet) into ‘the risk of narcolepsy’ that ‘increased after vaccination with Pandemrix’ are any indication (that link also includes references to published studies).

As late as mid-November 2020, Norwegian public health authorities—reference is made specifically to the Norwegian Medicines Agency (then Legemiddelverket, now the Directorate for Medicinal Products, or Direktoratet for medisinske produkter) and a piece entitled, ‘Adverse Events of Vaccines: What did We Learn from the 2009 Pandemic?’ (orig. Bivirkninger av vaksiner: hva lærte vi av pandemien i 2009?), then-head of pharmacovigilance Steinar Madsen held the following (translations of non-English texts and emphases mine):

In a pandemic situation, it’s important to get access to an effective vaccine quickly…

Based on the knowledge available at the time of authorisation, the benefits and risks of vaccines are always assessed against the risk of serious illness and death. The pandemic vaccine Pandemrix was based on a well-tested vaccine…

‘Serious side effects of vaccines are rare. Based on the knowledge and long experience we had with influenza vaccines, it was considered safe to replace the pandemic virus in the model vaccine’, says Steinar Madsen, Medical Director at the Norwegian Medicines Agency.

While the roll-out of the mass-vaccination went well enough in 2009/10, no dedicated media hype accompanied the administration of a total of about 2.2m single-dose injections in Norway.

At first, all went smoothly and ‘no side effects were detected that were serious enough’, the above lessons learned inform the reader. ‘It wasn’t until the summer of 2010 that the first indications of an increased incidence of cases of narcolepsy in Sweden and Finland emerged’, the Norwegian Medicines Agency held, adding that ‘rare side effects are difficult to detect’.

Emphasising the importance of ‘good monitoring and good studies’, however, it was warned that ‘it will never be possible to fully protect against rare side effects’ as ‘all medicines, including vaccines, can have side effects’, Madsen surmised.

‘Catastropic Damages of Pandemrix’

As a case in point—and in defence of pharmacovigilance as it once was—once these suspicions arose in summer 2010, the Institute of Public Health moved quickly and stopped the mass vaccination campaign literally overnight. In the spirit of transparency, the adverse reactions reported in context of Pandemrix administration were discussed extensively in Norwegian legacy media, including state broadcaster NRK.

Speaking with the latter’s Line Hødnebø in January 2013, Preben Aavitsland, Director of Epidemiology at the Folkehelseinitututtet, called the ‘damages of Pandemrix [a] catastrophe’, even going as far as calling it ‘the most serious vaccine catastrophe in recent history’.

How many adverse reactions are we talking, the reader may infer? Well, this is where the transformative nature of the Covid ‘pandemic’ comes to the fore. As reported by NRK, ‘Narcolepsy stops vaccination’, which occurred ‘after reports of at least 15 individuals who were vaccinated against swine flu’—in Finland. There were further 10 such reports from neighbouring Sweden, as well as an undisclosed number from Germany and the UK.

‘All these cases in Finland concerned children, and six [of these 15] were confirmed diagnostically’, NRK’s Line Hødnebø highlights. Norway halted the mass vaccination campaign on 24 August 2010—after one (!) Norwegian girl was diagnosed with narcolepsy (which is not to say that this condition is harmless, to the contrary). One of the Division Heads of the Norwegian Medicines, one Stainar Madsen—remember him?—is quoted as follows:

There is no confirmed association between narcolepsy and [the swine flu] vaccination, but we take this very seriously and follow developments closely.

To sum up: in August 2010, less than a year after the mass vaccination campaign had commenced, there was one (!) Norwegian girl with narcolepsy—which, let’s not forget, was but one of the serious AEs associated with Pandemrix—, and there were ten such cases in Sweden, and fifteen in Finland. Public health authorities stopped the injection campaign, commissioned countless follow-up studies, and transparently spoke about the lessons learned.

Pandemrix vs. the Covid Poison/Death Juices

How do these actions compare to the Covid debacle using Norwegian data as an example? The most obvious lesson learned—in late March 2025, the Directorate of Medicinal Products announced the winding down of their dedicated Covid injectable products adverse reporting program (see their last such report)—is that the goalposts for reactions by public health officialdom have shifted massively: setting aside the fact that many more Covid-19 injectable products were administered (2.2m single-dose vaccines in 2009/10 vs. the almost 14m since late 2020), the sheer number of reported adverse reactions by far exceeds their relative numerical discrepancies).

As the Norwegian Medicines Agency does not break down the Covid-19 injectable products by dose number, we must, in a first step, resort to some back-of-the-envelope estimates: there were 57,858 AE reports files, of which 5,589 were classified as severe or serious; even if we allowed for the quantitative differences, the AE reports for the Covid injectable products exceed anything ever recorded. Both ‘normal’ and ‘serious’ AEs are way higher than any of the numbers for Pandemrix (1,449 and 584), which was ‘a catastrophe’ (Preben Aavitsland)—and there were ‘only’ slightly less than twice the number of first-dose recipients of the Covid-19 products.

If, in a second step, one looks at the official AE Report of 18 May 2021, there were 1,581,000 (first dose) plus 611,000 (second dose) injections administered, which make for a combined total of 2,192,900 injections. This is close enough to the 2.2m Pandemrix injections (leaving aside the issue of a one-dose product like Pandemrix vs. a two-dose regimen). Compared with Pandemrix, roughly the same amount of injections with the Covid-19 products caused (as of spring 2022, which is also roughly in line with the time elapsed between the roll-out of Pandemrix and the cessation of its administration; for further particular, see here):

• 9,175 AE reports, or 633% of the 1,449 AEs associated with Pandemrix

• 8,060 light AE reports, or almost a magnitude more (932%) than the 865 light AEs associated with Pandemrix

• 950 severe AEs (excl. deaths), or 63% more than the number of AEs associated with Pandemrix

• 165 deaths (none that I learned about with Pandemrix), of which almost all were due to the BioNTech/Pfizer product that was also ‘offered’ to children over 5 years and pregnant women

On 5 March 2025, the Norwegian Directorate of Medicinal Products published a final report that contains several additional data points—plus the disclaimer that ‘Data for the different corona vaccines is not directly comparable. The vaccines are given to people with different disease profiles and ages.’ We note, further, that the formulations and composition are also different, although this is not mentioned, and the numbers of adverse reactions for especially young adults (aged 18-49) are particularly off the charts.

Experts™ To The Rescue of Big Pharma

Then there is a discussion of 288 dead (the same disclaimer as before applies) on pp. 8-9, which is done in the following way:

We have received 288 reports of deaths where the reporter suspects that the death is related to vaccination. Most of the deaths have been among the elderly and nursing home residents…

Especially the early deaths were carefully analysed by public health experts and appeared soon after thereafter under the title ‘Dødsfall i sykehjem etter covid-19-vaksine’ [Deaths in Hospitals/Care Homes After the Covid-19 Vaccine]’. The paper was co-authored by Torgeir Bruun Wyller, Bård Reiakvam Kittang, Anette Hylen Ranhoff, Pernille Harg, and Marius Myrstad, and it appeared in the Tidsskr Nor Legeforen [Journal of the Norwegian Medical Association], 141 (2021), doi: 10.4045/tidsskr.21.0383. Here are its main findings:

Among 100 reported deaths, an association with the vaccine was considered probable in 10 cases, possible in 26, and unlikely in 59 cases. Five were unclassifiable.

There you have it in writing: ten per cent fatal outcomes following administration of the mRNA injectable products were considered ‘probable’, yet the professor of geriatric medicine Bruun Wyller, in the interpretation of these data, called for the elderly ‘still [to] be prioritised for vaccination’.

In the paper’s introduction we also learn that ‘frail elderly and people with many chronic diseases were poorly represented in the vaccine trials…in the study that forms the basis for the authorisation of the Pfizer/BioNTech vaccine BNT162b2 (Comirnaty)…information about frail individuals was not provided’. Yet public health officials determined to start administering these injections with the elderly.

Here are the early results of Norway’s vaccination campaign, which began on 27 Dec. 2020, as per that paper:

The first report of a possible vaccine-related death was sent to the Norwegian Medicines Agency on 4 January 2021 [i.e., eight days after the first possible injection], and by 15 February, 100 such reports had been submitted through the spontaneous adverse drug reaction reporting system. As of 12 May 2021, the number of such reports had reached 142 [nothing to see here, folks, move on].

At that point in time—it’s early January 2021—these AEs caught the eye of the international public (this is the reference cited in the paper), and it is well worth citing it at length.

Mainstreaming Covid Vaxx Deaths

Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination

Via BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n149 (pub. 15 Jan. 2021)

‘It may be a coincidence, but we aren’t sure’, Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told The BMJ. ‘There is no certain connection between these deaths and the vaccine.’ [of course not, but I repeat: the Science considered 10% ‘probable’]

The agency has investigated 13 of the deaths so far and concluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients.

‘There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly’, Madsen said. ‘We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease’, he emphasised. ‘We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it.’ This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.

None of the above is ‘news’. In fact, all this information is widely available, and has been available in near-real time as these products were rolled out. All the NIH’s Christine Grady and NIAID director Anthony Fauci could muster were—‘yikes’, obfuscation, lies, and massive amounts of suffering, pain, and death.

Meet Drs. Carnage and Death

Most involved public health officials were around back in 2009/10, and specifically Steinar Madsen and Preben Aavitsland cannot claim ignorance. The people in charge of the Covid debacle—Drs. Grady and Fauci, as well as Drs. Aavitsland at the Institute of Public Health and Madsen at the Norwegian Medicines Agency—are the same who declared in 2009 and 2020 that all is under control.

And these injectable products are still (!) available; doctors all over the country are still administering them. It all begs the question: how many more deaths, serious, and other adverse reactions do we deem ‘acceptable’?

In the end, as the Norwegian example illustrates, the goalposts were shifted repeatedly, words like ‘rare’ have lost its meaning with respect to its use in medical research.

At this point, please consider the below-linked piece about an ‘ultra-rare’ adverse event following insertion of an IUD that made headlines a few weeks ago:

IUD Causes Serious Injury--Experts™ Call it 'Ultra-Rare'

At the same time, the public has been prepared to consider tens of thousands of (serious) adverse reactions as ‘normal’ and an ‘acceptable’ risk/benefit profile. Here’s how legacy media and the Science™ consider Oxempic, Wegowy, and other such medication™, in case you’d like yet another example:

Oxempic™ et al., According to The Science™

If these issues are not rectified in the same way, scientifically, like the Pandemrix ‘catastrophe’ (Aavitsland), drugs and other pharmaceutical products will become way more dangerous than they are today. Given the sheer amounts of (possible) malpractice, negligence, and intentional misinformation, there is likely no way around judicial and parliamentary review procedures to ensure that those who bear responsibility for this debacle explain themselves.

The same applies to whatever bioethical standards may or may not be left in the medical profession, to say nothing about public health officials and regulatory agencies.

These problems—deformations—apply to both national regulatory agencies and, perhaps more importantly, also to the EU institutions in other contexts, too.

The implications of such a stance are staggering, especially as these depraved methods and their implications—the crapification of governance—will likely spill over to many other fields.

Stay frosty.