Covid in Norway: Injection Safety Edition, pt. 3: deaths, severe AEs, menstrual disturbances among teens, cardiac events

Lots of wrongs here, ranging from significant questions about injections in nursing homes to high rates of menstrual disturbances among 12-17yo, and high rates of pericarditis and myocarditis

In the first instalment of this mini-series, we’ve explored whatever drug safety data is published by the Norwegian Medicines Agency (NMA), incl. a recent pre-print on menstrual disturbances. In the second part, we’ve looked in more detail at the age and gender profile of severe adverse events (AE), as well as taken a foray into modelling AE incidence ratio per injection as Norwegian AE reports took off during the late-spring roll-out of the injections: while correlation doesn’t imply causation, it is interesting to note that individually-reported AEs surged as the pace of injections surged in June and July 2021.

In this third part, we shall wrap up the NMA’s current AE report, so let’s get to it.

Deaths

So far, 254 AE reports that, sadly, resulted in deaths have been processed by the NMA, which further holds that

Some deaths occurred in close temporal proximity with injections, while other deaths occurred in fully vaccinated many months later. Most deaths affected elderly people in need of care and nursing home residents…of these 254 deaths, 16 reports concern deaths of fully vaccinated who also tested positive for Covid-19. The cases of patients who died after testing positive for Covid-19 between 2 weeks up until 10 months after vaccination have been included because of suspected vaccine failure [vaksinesvikt].

Speaking of injection product failure, this is something that was admitted to exist by the NMA in its report on 28 Sept. 2021 (see here, pp. 8-9). As of 27 Sept. 2021, healthcare workers (HCW) had filed reports on a mere 32 breakthrough cases, which occurred between 2 weeks after the second injection up to 7 months later. Interestingly, ‘less than 5’ such breakthrough cases had occurred among ‘partially vaccinated’ HCW.

There’s another facet we need to talk about, and it concerns deaths among ‘fully vaccinated’ who contract Covid-19, and this is on p. 8 in the late September report: back then, there were ‘9 reports of deaths among fully vaccinated individuals’ whose average age was 89 (i.e., some 7-8 years above the average life expectancy).

Sidenote on Covid-associated deaths: both Joel Smalley (here) and I have written about the unusually high mortality Norway (and other countries) are experiencing since August or September 2021. Note further that most deaths in the past 6-7 weeks occurred among the ‘all-cause vaccinated’ who are dying by now at 3X the rate of ‘unvaccinated’ (table 8, p. 19) in the past four weeks, but note that both ‘groups’ do so literally at the same (median) age of 82. We need to talk about the remaining sales pitch that these products impact the death (they don’t).

This is also borne out by the NMA’ ‘admission’ that most of the 300 deaths that occur every week in Norway’s nursing and retirement homes are ‘(very) infirm and/or terminally ill’ (p. 7, emphases mine):

It was therefore expected that there would be deaths in close temporal proximity to vaccination without there having to be a causal relationship with the vaccine. In several of the AR reports, it is noted that they there is no suspected connection [with the injections], but that the report was filed to be on the safe side.

The highlighted section is both true—as well as horrific: we’re talking about elderly, infirm, and/or terminally ill patients, many of whom may be on painkillers and a whole variety of other drugs that affect cognition. I have a number of questions, which include, but are not limited to, the following:

• Why were they given an experimental injection of unknown properties?

• True, these individuals may already have been on experimental drugs, but how about informed consent? (This comes to the fore in the ‘let’s report it to be on the safe side’ part of the above quote, if ‘only’ for liability issues, I’d suspect.)

• Is it really necessary to administer this product to terminally ill patients who may not be able to understand—or care—about such a product?

• How would HCW or nursing home staff react, if one said ‘no’ to the injection?

• I mean, there’s so many potential wrongs here, where does one stop to ponder these possibilities?

You know, back in January and February 2021, i.e., at the beginning of the injection roll-out—which, as we all know, began with the elderly and infirm—there was ‘a large outbreak of Covid-19’ among precisely the infirm and nursing home residents. Public health authorities scrambled and appointed an expert panel—on 23 Feb. 2021, i.e., some two months into the injection campaign—to investigate these matters in a transparent and independent fashion.

The group’s report was ready by mid-May and published in the Journal of the Norwegian Medical Association on 19 May 2021; you can find it here. It’s actually a quite solid piece of work, which notes the following data points:

Between 27 Dec. 2020 and 15 Feb. 2021, 29,400 of Norway’s approx. 35,000 nursing and retirement home population had been offered the BioNTech/Pfizer product (injection uptake of c. 84%).

There were 100 AE reports that were filed on the suspicion of a causal relationship between the injection and death. The panel consisted of 4 experts who assessed 20 AE reports (distributed randomly) independently and then compared notes; for this, McNemar’s criteria of symmetry was used.

The average age of patients in these AE reports was 87.7 year, and the experts considered 10 cases (out of 100) ‘probable’, 26 were deemed ‘possible’, and 59 considered ‘unlikely’; five were impossible to classify.

The main conclusion reads:

For the majority of care home residents, there was no obvious connection between vaccination and death.

Some patients with a high degree of frailty experience AEs that probably accelerated an already ongoing death process.

As you read this, keep in mind that the expert panel carefully hedged its wording. Out of 100 cases, 10 (‘probable’) plus 26 (’possible’)—equal to 36% of the sample—had some AE quite likely tied to the injection. Yes, that leaves ‘the majority’ outside this particular segment, but it’s more than a third.

As a follow-up: this was a study commissioned literally a year ago. Haven’t they followed up on this since then? (The answer is, sadly, no.) As one reads through that paper, there are indicators of a massive undercount of injection-associated (-derived) incidents. Writing specifically about the period and sample, the authors hold that (ref’s omitted, emphases mine):

The adverse reaction reports were submitted within approx. 50 days, a period of time in which it can be assumed that 2,000-2,500 nursing home patients died in Norway Whether it is assumed that 10 or 36 [percent, it should read here] of these deaths were accelerated by the vaccine, the proportion is still low. In the same period, close to 30,000 nursing home patients were vaccinated, which means that there will most likely have been far more than 100 deaths in nursing homes in close temporal relation to vaccination in the relevant time period. Therefore, our findings can not be used to estimate the incidence of vaccine-related deaths.

Still, what is said is telling enough, and I’d argue that it does make a difference if, of the approx. 30,000 care home residents injected with the experimental gene therapy, there were 3,000 (10%) or 10,000+ (36%) injection-related (-derived) deaths, wouldn’t it?

There’s also a short section in the NMA’s report on 20 deaths affecting people under 60, four of whom came down with thrombocytopenia syndrome (TTS) after receiving the AstraZeneca product, but ‘for the rest of them, the correlation with vaccination is unclear’.

Severe AEs, Menstrual Disturbances among Teens, Myocarditis, and Pericarditis

The one (so far) admitted significant AE to these injections concern cardiac incidents, most notably myocarditis and pericarditis (NMA report, pp. 8). So far, there are 267 AEs concerning pericarditis and 141 AEs concerning myocarditis, all of which concern the two available mRNA products by BioNTech/Pfizer and Moderna, respectively (and 5 more AEs of pericarditis after administration of the AstraZeneca product).

Tables 4 and 5 (p. 8) show how these AEs break down by sex and age:

Now, we’d need context and a more detailed break-down of esp. the age brackets to derive at any meaningful conclusion, however tentative it may be. Alas, the NMA’s reporting—like the IPH’s—is seriously lacking in this regard.

What we do know from a news item at the NMA’s website, though, is that the teen cohort (12-17yo) has received 461,000 injections between 28 Dec. 2020 and 15 Feb. 2022.

In this period from Dec. 2020 through 15 Feb. 202[2], we’ve received and processed 468 reports of suspected adverse events among this cohort. Of these, 68 were classified as severe, incl. five reports on cardiac inflammation, pericarditis, and myocarditis.

80% of the suspected AE in this age bracket concern menstrual disturbances, of which most are classified as non-severe.

For context, it’s necessary to note that this age cohort is ‘eligible’ for two injections, hence we must divide by two to arrive at 230,500 individuals (based on the—at least questionable—assumption that every single teen who received one injection also took the second one). Furthermore, we may also assume a perfect 50 : 50 ratio between teenage girls and boys, hence, we’re talking about 115,250 girls and boys each.

In a second step, we may now look at the above ‘data’ to see that the above-mentioned 468 AEs (divided by 2,305) yield a ‘vanilla’ adverse event incidence rate per injection (AEIR/I) of 0.3% (based on the—equally questionable, if necessary, assumption of each injection carrying the same risk, which it apparently doesn’t); using the same method for ‘severe’ AEs, we get an AEIR/I of 0.03%, and given that there are 68 severe AEs mentioned (which are slightly less than 15% of the total no. of AEs in this age bracket), this is a lower risk ratio than the absolute numbers would suggest.

Menstruation Disturbances among Teens

Yet, keep in mind that these rates are so generic that they are almost meaningless, due to two major confounders: first, ‘80% of the suspected AEs in this age bracket concern menstrual disturbances’, which means that the data put out by Trogstad et al. (discussed here) on these AEs among 18-30yo Norwegian women is, sadly, significantly underpowered, incomplete, and of very, very limited informational value. Here’s the main issue:

the Norwegian study—which was about the same size as the British one (with 5,000 participants, but neither was randomised) is much more in line with ‘a US web-based survey’ that showed 42% of participants (injected-only) ‘bled more heavily than usual’ (see here).

Yet for the age bracket of 12-17yo, the NMA holds that ‘80% of the suspected AEs in this age bracket concern menstrual disturbances’, which is either a data artefact or a truly concerning finding. In the absence of useful data on the number of girls vs. boys in the AE reporting and the relationship to overall injection uptake, here’s my 2 cents worth of speculation:

• If we assume a 50 : 50 relationship between girls and boys,

• And if we subtract the no. of severe AEs (68) from the overall no. (468),

• We may arrive at 200 AE reports of/by teenage girls.

So, 80% of them would be 160 out of 200, right? (I know, the above-quote news item said ‘most’ of these were non-severe, but hear me out on this one.) In other words: if this is even possibly true—and even if the numbers were slightly lower due to that caveat—shouldn’t this be a ‘signal’ in the ‘noise’ that raises some eyebrows among public health authorities, the affected girls (though I’m unsure about how much teens would talk about such issues), and their parents (provided their daughters talk about this)?

Maybe I’m wrong about this (as a father of two girls of even younger age, I sure as hell hope I am), but to me it looks as if the BioNTech/Pfizer injection is even worse in this regard among teens than it is among young adults, as detailed in the paper by Trogstad et al.

Myocarditis and Pericarditis

The second major confounding variable concerns myocarditis and pericarditis, which are never ‘mild’, whatever anyone claims in the media. Yet, agit-prop isn’t the only problem here, with crappy data being a much bigger problem. The NMA report shows (in Table 4, above) the overall numbers for a variety of age brackets, but only gives the number of 62 cases of pericarditis and myocarditis each—for the bracket from 12-29.

So, from the above NMA news item, we learn that of the 68 severe AEs in the system, 5 would relate to pericarditis and myocarditis among the 12-17yo, hence we now subtract these 5 cases from the 12-29yo overall no. (134 = 62 cases of pericarditis and myocarditis each) to arrive at 129 cases of pericarditis and myocarditis among the 18-29yo. Based on Table 2 (p. 4), we may now calculate the risk ratios for girls and boys for these conditions. Keep in mind, though, that the sex distribution between girls and boys for both conditions is 40 (female) : 60 (male), which provides the following risk ratios:

5 cases of pericarditis and myocarditis among 12-17yo, of which 2 were girls (assuming an equal distribution of severe AEs across sex), hence teenage girls have an overall risk of either AE of 6.25%.

Boys 12-17yo = 3 cases equal an overall risk of either AE of 9.4%.

Caveat: thankfully, these are very small numbers, but the risk ratio is insanely high, as in as high as the AE incidence for the AstraZeneca injection, which was cancelled in March 2022.

How would these data be for the 18-29yo? We have 62 instances of either condition, and we need to subtract the unhelpfully non-specific 5 cases. For my calculations, I’ll use 60 as point of departure in each instance.

60 cases of pericarditis and myocarditis each, of which 40% occurred among women, hence I’m using 24 cases among women : 36 cases among men.

As per Table 2, there were a total of 5,922 AE reports filed in the 18-29yo bracket, of which 766 were classified as ‘severe’. Both pericarditis and myocarditis fall into the ‘severe’ category, which we’ll now use as our point of departure.

Assuming an equal distribution between male and female AE reports, we get 383 AEs for two injections per ‘vaccinee’.

Then we must further account for the 40 : 60 ratio between female : male and the fact that we’re dealing with two conditions, pericarditis and myocarditis.

Hence, the risk ratio for either of these conditions for women aged 18-29 would be somewhere in the range of 6.3% vs. 9.4% for men.

Caveat: apparently, the risk for injected individuals aged 12-17 vs. 18-29 thankfully doesn’t increase significantly, but keep in mind that, statistically speaking, these are insanely high risk ratios.

Furthermore, mention must be made that if we want to calculate, however tentatively, the AEIR/I, we may use the 129 AEs for both pericarditis and myocarditis in the age bracket 18-29 and divide it by the total number of severe AEs (766). If we do this (129 / 7.66), we learn that the share of severe AEs of both pericarditis and myocarditis is 16-17%.

That said, let’s see if we can find out about the AEIR/I, for which we may turn to the national injection registry SYSVAK. Turns out that this wonderful database has yet another way of breaking down data by in yet another unhelpful set of age brackets

So, here’s my work-around: since the 25-39 bracket contains 15 years, I divided the number of injections (2,418,245) by 15 and multiplied the result by 5, which yielded 80,415. I then added this number of injections among 25-29yo to the 1,033,308 injections for the 18-24yo, which yielded 1,113,723 injections.

This number, however problematically arrived at, finally allows us to calculate the AEIR/I for the age bracket 18-29, but keep in mind that this is a very generic calculation since SYSVAK doesn’t break these data down according to how many first vs. second injections. We may, however, assume that the overall ratio of an approx. equal numbers of first and second injections (which we’ve used in pt. 2 of this mini-series). That said, here are the results:

• Overall AEIR/I for ‘all-cause AEs’ (total no.) = 0.53%.

• Overall AEIR/I for severe AEs = 0.07%.

Note that this doesn’t allow for a differentiation between risk ratios for injection 1 vs. injection 2. Hence, if you use these numbers, do so very, very carefully and with a couple of salt mines.

More Context via the CDC

For more indications of the incidence and plausibility of the Norwegian reporting on these AEs, we may turn to a recent report released by the CDC. Entitled ‘Updates on myocarditis and pericarditis following Moderna COVID-19 vaccination’, these data come from Tom Shimabukuro, MD, MPH, MBA, who serves on the CDC’s Covid-19 Vaccine Task Force, and it was presented at the meeting of the Advisory Committee on Immunization Practices on 4 Feb. 2022. The slides are found here, and on slide #2 we see this:

Reporting rates of myocarditis following Moderna COVID-19 primary series vaccination in the Vaccine Adverse Event Reporting System (VAERS) among persons ages 18 years and older

Care and outcomes of persons ages 18 years and older with myocarditis after Moderna COVID-19 primary series vaccination reported to VAERS

Vaccine Safety Datalink (VSD) subgroup analysis of confirmed myocarditis and pericarditis cases after primary series Moderna COVID-19 vaccination among persons ages 18-39 years

So, here’s reporting rates per 1m doses for males (slide #5) and females (slide #6):

Note that the ‘reporting rates exceed background incidence’, but that these were ‘consistently higher’ for males ‘after dose 2 vs. dose 1.

How reliable is the CDC data in light of the above-discussed Norwegian data?

There’s 283 (male) plus 76 (female) = 359 VAERS reports that cite myocarditis after one or two Moderna injections for the age bracket 18-29. The Norwegian data, by contrast, contains 129 such reports out of a much, much smaller number of injections administered for both mRNA injections.

The US data relates to 162,412,448 injections (two injections) vs. the 1,113,723 injections in Norway, which corresponds to a difference by a factor of 146. Yet, the difference between the Norwegian number of AEs (129) vs. the AEs in VAERS (359) would be ‘only’ 64%--are the Norwegian cases over-reported or the American cases (significantly) under-reported?

The underreporting factor (URF) is one of the main problems with the VAERS data, and given the highly integrated Norwegian reporting-and-cross-referencing capabilities (you file a report, you must add your insurance number, hence the Norwegian data would be quite ‘clean’).

Yet, we cannot simply ‘adjust’ the US numbers—which relate to but the Moderna product and do not include data on the BioNTech/Pfizer product—upwards to the Norwegian levels, for that would be…insane, wouldn’t it? (And I’m afraid to ponder the question ‘what if the Norwegian numbers are more correct than the American ones…?’)

Note further that the VAERS data suggests an 79 : 21 distribution between male : female reports, which is also quite different from the Norwegian data, even though that would seem odd as well.

AEs by Category

In the NMA’s current report, we should, in closing, also mention the categorisation of AEs, which can be found on pp. 13-17). Here’s Fig. 1 (p. 13) for the mRNA injections on the number of AEs according to these categories:

Here’s Fig. 2 (p. 15) for the DNA vector injections on the number of AEs according to these categories:

Note that the leading category incl. ‘pain and injection site reactions, discomfort, fever, fatigue, general malaise’, i.e., AEs that may prevent you from functioning normally during the day. The second-most important category is ‘neurological symptoms’, i.e., ‘headache, dizziness, drowsiness, syncope, lack of sense of taste and smell’.

There’s a slight difference between the mRNA vs. the DNA vector injections in the third spot, with the former affecting the female reproductive organs and the latter the muscular-skeleton system.

Irrespective of these, here’s two final brief paragraphs on the NMA’s listing:

The DNA vector injections are way, way worse in terms of AEs compared to the mRNA injections, if only because of the much earlier warning signal. The AstraZeneca (142,872 injections) and the J&J products (6,765 injections) were administered to ‘only’ 149,637 individuals, which yielded a combined total of 8,972 AEs (Table 3, p. 7), but there are 41,895 individual symptoms recorded, which means the average injection has caused 4-5 individual symptoms.

While the NMA was correct in stopping the administration of the DNA vector injections early, the mRNA products caused a total of 70,601 symptoms spread out across 8,768,355 (BioNTech/Pfizer) plus 2,248,475 (Moderna) injections, or a combined total of 11,016,830 injections. This is an average of 0.0006 symptoms per injection, but then again, the cumulative risks of repeat injections must be considered (but I cannot provide you with a ballpark estimate as the data isn’t sufficiently detailed).

So, in terms of the lower risk of AEs for the mRNA injections we must presume that this is, in no small part, due to the overall higher safety of these products (compared to the DNA vector products), but this may be due to the sheer number of injections administered. Furthermore, given the comparatively higher incidence of (female) reproductive problems associated with the mRNA products, the long-term impacts will not be known for a number of years.

Any thoughts?