Covid in Norway: Injection Safety Edition, pt. 1: 1 in every 200 injections caused an adverse event and a paper on menstrual disturbances after injection

The share of Norwegian women 18-30yo who reported 'more heavy bleeding' almost doubled after getting injected, a recent pre-print by Trogstad et al. reveals

So, I’ve been meaning to write about a particular facet of all matters Covid-19 for quite some time now, but since the Institute of Public Health (IPH) has come out with a brief bespoke news item on 9 Feb. 2022, here’s a couple of brief, if acid, notes on drug safety.

Entitled ‘low likelihood of long-term side effects after Covid injection’, the IPH appears to have taken a page out of the playbook by many (western) politicians—and resorted to policy-making by press statement.

It is now over a year since the first Covid-19 injections became available. More than 11 million doses have been set in Norway, and over 10 billion doses world-wide. This provides valuable insights and knowledge about side effects after injection.

Context matters: Norway has approx. 5.4m inhabitants, hence 11m I injections correspond to 4,326,847 first doses, 4,015,436m second doses, and 2,858,704 third doses as of 17 Feb. 2022, the most recently-available data (as per the IPH; note that the below visualization says 18 Feb., but the numerical data—click on ‘tabell’—only incl. data as of the day before).

The numbers per 18 Feb. (the most recent ones) are:

Here’s more from the IPH’s press release (emphases mine):

It is common for both Covid-19 injections and other vaccines that side effects occur in the first few days and within the first two weeks. If a side effect occurs more than 6 weeks after injection, it is often referred to as a late side effect or long-term side effect, however, it is very unusual for reactions to occur so long after the produce has been administered.

This knowledge is based on broad and long experience from the use of many different vaccines over several decades. Every year since 1952, hundreds of thousands of doses are administered by the Norwegian childhood vaccination program. In addition, large segments of the adult population receives annual flu shots, and adults are recommended regular booster doses of several vaccines, e.g. for travel abroad.

With the stage thus set, the news item then switches to ‘long-term adverse events after injection’, with a short segment on the failure of a product by the name of Pandemrix, which was manufactured by GlaxoSmithKline (GSK) to fight the (largely imaginary swine) flu outbreak in 2009.

Of all vaccines administered in Norway, only one product has been registered with a serious side effects more than 6 weeks after injection. This product was Pandemrix, which was offered during the swine flu pandemic in 2009/2010 and which caused some children and young people to develop narcolepsy. 700,000 doses were administered to individuals under the age of, of whom 56 were diagnosed with narcolepsy. 60,000 individuals among the same age group were registered with influenza, and 16 of the unvaccinated also developed narcolepsy.

There are two links below the quote sections, one leading to the dedicated website on the ‘influenza pandemic’ and Pandemrix tragedy of 2009/10 and the other to the over guidelines ‘on adverse reactions after vaccination’.

11.2m jabs = 56,479 AEs, of which 5,386 were ‘severe’

Regulatory oversight and pharmaceutical compliance in Norway is carried out by the National Medicines Agency (States Legemiddelverket), in close collaboration with its EU/EEC partner institutions.

On 15 Feb. 2022, the NMA came out with an update on ‘possible side-effects of the Covid injections’, and this is what we’re going to look at here. According to their website,

after about 11.2m injections administered, the NMA has received 56,479 notes of suspected side-effects. Of these, 28,899 notifications required the attention of a physician or hospitalisation. 5,386 are classified as severe, and 23,513 are classified as other adverse events [lite alvorlig]

On the upside (face of it), this ratio (56,479 AEs / 11.2m injections) means that an adverse event occurred in 0.5% of all injections. Doesn’t sound like much, does it? In other words, though, the same ratio may also be described as 1 in 200 injections led to an AE.

Hence, it’s quite likely, statistically speaking, that every Norwegian resident actually knows at least a few, if not more than a handful of, people out of every slightly more than 100 of their social contacts who, sadly, experienced such AEs.

Sidenote: personally, anecdotal evidence attests to that very low threshold, for I know of at least two other individuals (both in their early 40s) who were out of order for about 1 week after these injections, one of whom was a woman who took the AstraZeneca product (twice) and was ‘sick for a week’ after the second injection, which was ‘much worse than after the first one’. One of my US-based friends, to also note an mRNA product (Moderna) was suffering from ‘head-splitting headaches’ for two days after the second injection. Both instances would count as ‘severe’, for it definitely prevented the normal daily functioning of these individuals, according to the IPH’s classification of AEs.

Do note, though, that the above back-of-the-envelope calculation is misleading on (at least) two counts:

1. given the staggered nature of these injection, we’re not talking 11.2m injections administered to the same number of individuals; we’re talking about 11.2m injections spread out across 4.3m (1 dose), 4m of these same individuals (2 doses), and 1.9m ‘fully vaccinated’ people who rolled up their sleeves a third time.

2. my above ‘calculation’ doesn’t account for differences in infection rates, differences across the various age brackets, the number of injections, and probably any number of other aspects. Still, the NMA’s news item similarly doesn’t break these data down any further, so I suspect this is quite fair game at this point.

Speaking of the NMA’s news item, they do offer a more detailed report (current as of 15 Feb. 2022), which offers at least some more data on these AEs. As always, all translations and emphases are mine, and the pp. numbers relate to the linked document.

Sidenote: Before we dive into the data, do note that all injections are registered via the national vaccination registry (SYSVAK), that registration is done with the unique individual identifier (the equivalent of the US Social Security No.), and that all AEs that require medical attention similarly require identification with the same unique individual identifier. This means that the Norwegian data is quite well organised (compared to other countries, such as the US), there are hardly any repeat or missing entries, and there’s also an obligation for all medical practitioners to report such AEs. In short: we’re talking about a quite solid body of evidence here.

On p. 3, we are reminded that the sheer number of AEs can have many reasons, incl. the swift roll-out of the products and their administration to a ‘large share of the population’. The Covid injections ‘resulted in severe reactions in many more people than expected, relative to our experiences with other products. Furthermore, many more also experience common side-effects.’ Another reason cited to ‘explain’ the comparatively high number of AEs is that with the advent of Sars-Cov-2, ‘it became possible to report suspected AEs electronically, while before [2020] healthcare workers had to file paper-based reports’.

So, we’re basically told that there’s an unusually high number of AEs, which also became easier to report due to a significant upgrade of the reporting system. There’s no mention of the underreporting factor (URF), which makes any of the following data (and my above as well as below comments) tentative, to say the least. The URF is particularly important as there’s a correlation between the mildness of side-effects and the unwillingness to report them, hence it’s fair to state that the URF will be lower the more severe the AEs turn out to be. Still, one works with the data one has, not with the data one wishes to have.

Here’s what the NMA considers ‘common’ side-effects (p. 3):

Headache, fatigue, malaise, fever, nausea, and body pain. These usually occur on the first or second day after vaccination and last about 48-72 hours.

‘Severe’ side-effects (ibid.) incl.:

Most of the suspected severe AEs are diseases or symptoms that occur quite frequently [opptrer ganske ofte] in the population. These AEs may therefore coincide with the administration of the injection. Reports of severe AEs are prioritised and processed before reports of common AEs.

Note, finally before we dive into the data, that these data relate almost exclusively to the mRNA injections Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna), for Norway determined both the Janssen (J&J) and Vaxzevria (AstraZeneca) products to be unsafe. Neither of the latter two DNA-based genetic injections are used in Norway.

Main Numbers as of 15 Feb. 2022

Since the first injection was administered in Norway on 27 Nov. 2720 through 15 Feb. 2022, there were 56,476 notifications of suspected AEs, of which roughly half (28,899, or 51%) required medical attention (p. 4). There’s also roughly the same numbers about the number of administered doses, which ‘must be considered in the context of these AEs’.

Here’s tables 1 (AEs by gender, or kjønn) and 2 (AEs broken down by age), but note that these data is somewhat misleading: note the asterisk (*)? It says that both tables show only those AEs ‘that are processed’, i.e., both tables basically tell you half the story. As a thought experiment, and all other things being equal, it might be that a doubling of all of these data might be a quite accurate guess at this point.

All I’m going to do here is to supply you with percentages to help you process these data.

Table 1: 80% of all AE notifications were done by women, and almost 13% of these were ‘serious’; do note that of these 23,205 AEs, a whopping 16% were ‘severe’. By contrast, 30% of the male-reported AEs were ‘severe’, which is tantamount to say that we may need to factor in gender bias in medicine as a significant issue here.

Table 2: as Norway is ‘offering’ injections to children aged 5-11 by now, take a good look at the thankfully few cases (>5) in that age bracket: 100% of these AEs were ‘severe’. Also note the following share of ‘severe’ AEs among the age brackets given:

• 12-17yo: 15% of all reported AEs were ‘severe’;

• 18-29: 13%

• 30-39: 13%

• 40-49: 16.5%

• 50-59: 22%

• 60-69: 30%

• 70-79: 43%

• 80-89: 47%

• 90+: 50%

• For the sake of completeness: the overall rate is 19%.

On p. 5, there’s a ‘commentary on table 2’, which holds that there are 21 reports of AEs related to Covid-19 injections ‘even though the children themselves are not vaccinated’.

The following symptoms have been reported in these children after the mother has received the vaccine, such as, fever, abdominal pain, nausea, restlessness, rashes, or cold. In most people, symptoms appeared 0-3 days after the mother had been vaccinated. The above symptoms are very common in infants and young children, thus they are probably not due to the mother receiving an mRNA vaccine. mRNA from the vaccines does not pass into breast milk.

As any parent can testify, these symptoms are somewhat ‘generic’, that much I’d buy into. Yet, the odd thing is the last two lines: ‘probably not due’ is a very weak way of formulating this, esp. since no source whatsoever is given. It’s just a statement without any evidence.

Furthermore, I find the following sentence about ‘mRNA from the [injections…] not pass[ing] into breast milk’ also concerning to say the least, not ‘just’ because no source or references are given—how, then, would the mRNA pass into these 21 children? Would that be due to, say, spit via kissing one’s child good night? Or shall we talk about ‘shedding’ of these genetic particles by, say, exhalation or touching the skin of somebody who’s recently been injected?

• 10 AE reports relate to symptoms of children whose mother received the AstraZeneca product [which Norway has discontinued in May 2021, as per p. 3]

• 9 AE reports relate to symptoms of children whose mother received the Pfizer/BioNTech product (Comirnaty)

• 2 AE reports relate to symptoms of children whose mother received the Moderna product

Sideshow: Helsenorge, Pregnancy, and Covid-19

There’s a brief disclaimer informing the reader that ‘all these reports are filed upon the suspicion of a relationship, but that the filing such a report does not indicate a causal relationship’. There’s only a link to ‘find out more over at the IPH’s website’, which offers two further linked choices related to nursing (amming):

No Sars-Cov-2 virus has been detected in mother’s milk among women who tested positive for Covid-19 infection. Women with Covid-19 infection may therefore breastfeed like normal. Do see also the advice offered by the WHO.

Breast-feeding [women] can get vaccinated.

Now, the first link (Advice on Sars-Cov-2 for Pregnant and Nursing Women) takes you to the national health service’s dedicated website, which, in a somewhat un-reassuring way reads ‘this website is being updated’

The section on ‘Covid-19 Injections and Pregnancy’ holds that ‘so far, data on vaccination of pregnant women indicate that the vaccines do not have an adverse effect on the course of pregnancy for either the mother or the fetus’.

Well, I’m quite certain data nerds (which I mean lovingly) like Jessica Rose might disagree with that statement.

Moving on, Helsenorge explains that ‘we don’t know for sure if Sars-Cov-2 can pass from mother to child before or during birth’, but ‘after birth, we know for certain that the mother may infect her new-born child. Children born to mothers infected with Covid-19 or who were infected during pregnancy have had either mild or no symptoms.’

Sidenote: idiotically, the section ‘what else can I do?’ informs women of child-bearing age in the following way: ‘you may optimise your pregnancy and reduce bespoke risks by not ingesting alcohol, tobacco, and other narcotics. If you need pharmaceutical products, consult with your GP.’ This is followed by nutritional advice etc., but there’s nothing, nada, zilch, zip, zero on the risks posed by experimental genetic injections, such as the ones by BioNTech/Pfizer or Moderna. Still in fairness, there’s a section entitled ‘is it safe for pregnant women to wear face-masks’, which I refuse to translate (it’s simply too outlandish at this point).

The section on ‘nursing and Covid-19’ reiterates that ‘even if you [the nursing mother] are infected with Sars-Cov-2, it is recommended you breast-feed or ensure breast-feeding by someone else [a wet-nurse]. There is no evidence of viral transmission via breastmilk.’ (Screen grab below.)

Similarly, the section on ‘injection and breast-feeding’ simply

Breast-feeding women can get vaccinated, like everyone else.

There is no known risk of viral transmission via breast milk for non-live vaccines, such as mRNA vaccines and viral vector vaccines.

It is not recommended to stop breast-feeding after vaccination.

There’s also a recent pre-print by Line Trogstad et al. (see here) on a 5,688-strong study on menstrual disturbances in 18-30yo Norwegians, which were remotely interviewed (p. 3) in October 2021. This data was then coupled to the national vaccination registry (SYSVAK), which revealed that almost 92% of respondents received two injections. As explained in Tables 2 and 3 (pp. 8 and 9, respectively, with the following quote on p. 4, my emphases):

Table 2 shows that the prevalence of more heavy bleeding during menstruation was 7.6% in the last menstrual cycle prior to the first vaccine dose compared to 13.6% in the first cycle after vaccination. Similarly, Table 3 shows that the prevalence of heavy bleeding was 8.2% before and 15.3% after the second vaccine dose.

In other words: getting injected with an experimental genetic product roughly doubled the share of women with ‘heavy bleeding’. In their discussion, Trogstad et al intimate that (p. 4)

On average, menstrual disturbances after the first dose returned to normal by the time the second vaccination was given, approximately two months after the first dose, suggesting that in most cases the menstrual disturbances associated with the first vaccination were transient…

Vaccine uptake for the second dose was high also for women who had reported more heavy bleeding than usual after the first dose, implying that the menstrual disturbance did not influence willingness to accept a second dose.

There’s but two more snippets in that study that I’d like to highlight right now: in a section entitled ‘comparison with other studies’ (p. 5), Trogstad et al. mention that ‘menstrual disturbances are common’, noting a British study (see here) that found a report rate of

20%…up to four months post-vaccination, whereas in our study, almost four out of ten reported one or more among seven predefined menstrual disturbances both prior to and after vaccination.

In other words: 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).

The above Norwegian paper, though, is flawed in terms of its design. Yes, they also included ‘unvaccinated’ women in their sample, at around their share among the general population (8.4%, as per Table 1), but none of the data presented in Tables 2-4 (pp. 9-11) relate the findings to the ‘background’ of ‘unvaccinated’ women. Hence, in the absence of these data, we may speculate that the ‘unvaccinated’ women—the only relevant, or possible, kind of control group, were excluded.

In light of these issues, we may only note that the prevalence of heavy bleeding increased markedly after the injections, as shown in Table 2 (p. 9), to 13.6% (first cycle after injection), up from 7.6% (last cycle before the first injection). There’s also a major flaw, which we also noted in a recent Israeli pre-print concerning safety and efficacy of a fourth injection, that is: Table 3 (p. 10) only compares the subset of the overall sample that took a first injection to those who went on and take a second injection.

In other words, what is compared is the last cycle before with the first cycle after the second injection, that is none of these women were ‘injection-naïve’ to begin with, hence it’s another case of studying the marginal changes after the fact. And the paper shows another drastic increase to 15.3% who reported ‘more heavy bleeding’ after the second injection, up from 8.2% in the last pre-second injection cycle.

In short: women of child-bearing ages who got injected with these Covid-19 products had much higher rate of menstrual disturbances than those, presumably, who elected to forego injection.

Yet, keep in mind what this study was actually about (p. 5):

Although menstrual disturbances are not a contraindication for vaccination, we do not know if such events may have influenced vaccination behaviour. Recent anecdotal reports of menstrual changes after vaccination for COVID-19 may have given rise to vaccine hesitancy or refusal.

If you thought that Trogstad et al. actually performed this research to inform the female population of child-bearing age, I must, however regretfully, inform you that they did so to push, and irresponsibly so, even more women of that segment of the population into getting injected with an experimental genetic product.

Shame on them.

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And with that finding, we shall continue with the AE report from Norway, which I shall dissect in part 2, though, due to the sheer length of this post.

Any comments or thoughts?