Skip to main content

COVID Vaccines: Adverse Event Info from Germany, The Netherlands

There's a new article called "The Safety of COVID-19 Vaccinations--We Should Rethink the Policy." While the methodology is kind of questionable (focusing on the European country with the most reported vaccine events, assuming that reported deaths were all caused by the vaccines, not considering herd immunity) and their results very imprecise, it does attempt to answer how much risk and reward the vaccines provide in the short term. 

The European reporting system is even more unwieldy than VAERS in the US--but Germany and The Netherlands have their own reporting systems with events broken out by age groups. Malcolm Kendrick writes in Doctoring Data that he thinks the Germans have the most thorough vaccine event reporting system, while the article above says the Dutch have reported the most events for COVID vaccines. 

Below are Google translations straight from these countries' websites on vaccine event reports, with some information highlighted. I've omitted minor and particularly rare side effects; to read about them, you can go to the country's website and copy and paste text into Google translator. Germany in particular provides detailed information.

Summary

The Netherlands reports 30 deaths per million following (not necessarily caused by) vaccination, most of whom were over age 65. 

Germany reports 17 deaths per million; the median age was 81 years. There were also 85 per million serious adverse reactions following vaccination. Deaths per million vaccinations are close to what the VAERS system in the US reports. 

Worldometer shows COVID deaths per million population at over 1,000 per million for the US, Germany and the Netherlands. Obviously, the risks vary with age, health and exposure. Minors have a one in a million chance from dying of COVID, so the vaccine has only downside risks for them if they're healthy. 

The COVID vaccines are very new and use a novel technology. We don't know what the long-terms risks are, if any. And not all events get reported.

Corminaty is the Pfizer vaccine. 

The Netherlands

This update concerns all reports received at the Lareb Side Effects Center of suspected adverse reactions to corona vaccines, which have been reviewed by experts up to and including June 20, 2021.

The reports concern about 13.6 million vaccines given. This concerns approximately 9.6 million vaccines from Pfizer/BioNTech (Comirnaty), 2.4 million from AstraZeneca (Vaxzevria), 1 million from Moderna and 450,000 from Janssen. These figures are based on the Corona dashboard of the central government.

We show an update of the reported side effects once every two weeks. If there are new insights in the meantime, we will of course report on them. For more information about side effects of the corona vaccines, view our frequently asked questions

Inflammation of the heart muscle or the pericardium

Lareb now has 10 reports of heart inflammation (myocarditis) and 22 of inflammation of the pericardium (pericarditis). This concerns 13 reports on the Pfizer/BioNTech vaccine, 7 on the AstraZeneca vaccine, 8 on the Moderna vaccine and 3 on the Janssen vaccine. In 1 report it is not clear which vaccine was involved. It concerns 19 men and 13 women, 14 of whom are between 20-50 years old and 18 older than 50 years. A large part of these reports were received recently and are still under investigation at Lareb. And will also be passed on to the EMA. The EMA is further investigating reports of myocarditis or pericarditis. At the moment there is not enough data to determine whether there is a connection with the injections.

The inflammation can be caused by an infection or immune disease. They occur annually in 1 to 10 in 100,000 people. Complaints include shortness of breath, chest pain and palpitations that are sometimes irregular. The complaints usually go away on their own or can be treated well with medication. Anyone who has these complaints should contact a doctor.

Systemic Capillary Leak Syndrome (SCLS)

People who have previously had systemic capillary leak syndrome should not receive an AstraZeneca vaccination, the EMA reports. The capillary leak syndrome is also included in the package insert as a side effect. The Side Effects Center has not received any reports of this syndrome with the AstraZeneca vaccine, but one with the Janssen vaccine. It concerns a man between the ages of 50 and 60 who has died. Read our news item to learn more about systemic capillary leak syndrome after corona vaccination.

Extensive thrombosis in combination with a low platelet count

A combination of extensive thrombosis and low platelet count has been described as a rare side effect in the package inserts of the AstraZeneca vaccine (Vaxzevria) and the Janssen vaccine. It is now referred to as “thrombosis with thrombocytopenia syndrome” (TTS).

Lareb has so far received 29 reports with the AstraZeneca vaccine and 1 report with the Janssen vaccine in which there was a combination of thrombosis and a low platelet count. In one report on the Janssen vaccine and in 14 reports on the AstraZeneca vaccine, it is almost certain that it concerns the rare side effect. This concerns 9 women and 6 men. Of these, 4 were between 20 and 40 years, 1 between 40 and 60 years and 10 older than 60 years. The symptoms appeared within 7-20 days after the first vaccination. In these reports, this was demonstrated with a special test or it concerned very extensive or multiple thromboses. In the other reports, a connection with the vaccination is also possible, but it is less clear that it concerns the specific side effect. Four people have died, two of which are almost certainly the rare side effect of the AstraZeneca vaccine.

Death

So far, there have been 409 reports of death after corona vaccination. This concerns 259 people aged 80 or older, 109 people between the ages of 65 and 79 and 39 people under the age of 65. The exact age of 2 people is unknown.

Most reports were about the vaccine from Pfizer/BioNTech (Comirnaty). This is the most commonly used corona vaccine and also the vaccine that is mainly used in the elderly population.

Death after vaccination does not mean that a side effect of the vaccine is the cause of death.

Vaccine Death Reports

after 1st vaccination Notifications of death

after 2nd vaccination Total

Pfizer/BioNtech 224 94 318

Moderna vaccine     24     15     39

AstraZeneca  38 6 44

Janssen vaccine 3 - 3

Vaccine brand unknown 4 1 5

Many reports required more information about the cause of death, side effects that occurred and underlying health problems. This information has been requested. Unfortunately, in several reports, there is still not enough known for a good insight. In the reports with sufficient information, health problems are the most obvious explanation for the deaths for a large part. In a number of reports, side effects may have contributed to the worsening of an already fragile health situation or dormant underlying condition, whether or not due to old age. These are known side effects of the corona vaccines such as fever, nausea and general malaise. Four patients died after thrombosis in combination with a low platelet count. Lareb has made an overview of deaths in the first 8 weeks of the vaccination campaign.

Germany

Here are excerpts from the 35-page SECURITY REPORT: Suspected cases of side effects and vaccination complications after vaccination to protect against COVID-19 from the Paul Ehrlich Institute. The report also addresses serious but less-common side effects and medical information that might be useful to patients and health care providers. 

Suspected cases of side effects and vaccination complications after vaccination to protect against COVID-19 since the start of the vaccination campaign on December 27, 2020 until May 31, 2021
The Paul Ehrlich Institute (PEI) reports on 79,106 suspected cases of side effects or vaccination complications reported from Germany in connection with vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), COVID-19 vaccine Moderna (MODERNA BIOTECH SPAIN, SL ), the vector vaccines Vaxzevria (formerly: COVID-19 vaccine AstraZeneca; AstraZeneca AB) and COVID-19 vaccine Janssen to protect against COVID-19 from the start of the vaccination campaign on December 27, 2020 to May 31, 2021. According to the Robert Koch Institute, 50,541,084 vaccinations were carried out by May 31, 2021, of which 36,865,276 vaccinations with Comirnaty, 3,972,764 vaccinations with the COVID-19 vaccine Moderna, 9,230,103 vaccinations with Vaxzevria and 472,941 vaccinations with the COVID-19 vaccine Janssen. 34,735 suspected cases of vaccination with Comirnaty were reported, 8,319 suspected cases of the COVID-19 vaccine Moderna, 34,870 suspected cases of Vaxzevria and 733 reports of the COVID-19 vaccine Janssen. In 449 reported suspected cases, the COVID-19 vaccine was unspecified. The reporting rate for all vaccines together was 1.6 per 1,000 vaccine doses, for reports of serious reactions 0.2 per 1,000 vaccine doses in total.

Venous and / or arterial thrombosis

A new syndrome characterized by venous and / or arterial thrombosis in combination with thrombocytopenia (thrombosis with thrombocytopenia syndrome, TTS) and which can be accompanied by bleeding is very rarely seen as a serious side effect of the vector vaccines Vaxzevria and COVID-19 vaccine Janssen observed, whereby the thromboses often occur in unusual locations such as cerebral cerebral veins or spleen, liver or mesenteric veins. Other cases present with deep vein thrombosis, pulmonary embolism and acute arterial thrombosis. In several of the affected patients, high levels of antibodies against platelet factor-4 (PF-4) and strong activation of platelets were detected in corresponding tests.1-5 This pattern is similar to "atypical" or "autoimmune" heparin-induced thrombocytopenia (aHIT) .6

Most TTS cases reported to date occurred within three weeks of vaccination. So far, no specific risk factors for the development of TTS have been identified. TTS is a serious side effect that has been fatal in some cases. Therefore, early diagnosis and treatment is important. Corresponding information is made available on the website of the Paul Ehrlich Institute (www.pei.de). Two-stage events of a TTS, i.e. a further thrombotic event with thrombocytopenia after initial recovery from a first TTS event, cannot be ruled out. How long PF-4 antibodies can be detected in patients with TTS is currently unknown.

Healthcare professionals should look out for the first signs and symptoms of thrombosis and / or thrombocytopenia. Vaccinated persons should be informed to see a doctor immediately if they develop symptoms such as shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain, nausea or vomiting a few days after vaccination. In addition, anyone who has neurological symptoms such as severe or persistent headache, blurred vision, seizures, or who bruises on the skin (petechiae) outside the injection site after a few days should contact a doctor immediately after the vaccination.
Individuals diagnosed with thrombocytopenia within three weeks of vaccination with Vaxzevria should be actively evaluated for signs of thrombosis. Likewise, people who develop thrombosis after vaccination should be examined immediately for thrombocytopenia. It is important that patients with thrombosis and normal platelet counts or patients with thrombocytopenia without detectable thrombosis after vaccination may have an early stage of TTS. Therefore, repeated examinations for TTS may be required in these cases. Data on the time interval to the occurrence of TTS after the second vaccination are currently only available to a very limited extent. A case of TTS after the second vaccination with Vaxzevria with an unusually short latency period of less than one day has been reported to the Paul Ehrlich Institute. Whether TTS may occur after the second vaccination with a shorter interval to the vaccination is currently not conclusive be assessed. Here, attention should be paid to complaints that may indicate a TTS.

The very rare but serious side effect of TTS must always be seen in the context of the proven benefit of vaccination, namely protection against serious and fatal COVID-19 diseases. As shown in an analysis by the European Medicines Agency (EMA), the individual benefit of vaccination increases with age and the number of infections

On the basis of the currently available data and taking into account the current pandemic situation, the Standing Vaccination Commission (STIKO) recommended on April 1, 2021 to use the Vaxzevria vaccine for people aged ≥ 60 years, both for the first and for the second vaccination. The use of Vaxzevria for a first or second vaccine dose below this age limit, however, remains possible at the discretion of the physician and after careful consultation with individual risk tolerance. So far there are insufficient data on the risk of a second vaccination. With regard to the second dose of vaccine for younger people who have already received a first dose of Vaxzevria, STIKO recommends that people <60 years of age receive a dose of mRNA vaccine instead of the second dose of Vaxzevria vaccine twelve weeks after the first vaccination. Vaccination with the COVID-19 vaccine Janssen is therefore recommended for people aged 60 and over. 14

Myocarditis or Perimyocarditis

In recent weeks, the Paul Ehrlich Institute has received increasing reports of suspected myocarditis or perimyocarditis in connection with the administration of COVID-19 mRNA vaccines, especially in adolescents and young adults. In agreement with other international data, the reported cases occurred predominantly in male adolescents and young adults aged 16 and over. If the course of the disease was sufficiently documented, the patients who were presented for medical care mostly responded well to medication and rest and showed rapid improvement in symptoms. The first symptoms of the disease typically appeared within a few days after the mRNA COVID-19 vaccination.

In several cases, the clinical information on diagnosis, differential diagnoses, the course of the disease as well as concomitant diseases and concomitant medication is currently incomplete. The Paul Ehrlich Institute will try to provide further information For a comprehensive assessment of the reports, it is important to rule out other possible causes of myocarditis and perimyocarditis; in particular, infectious (including infection with SARS-CoV-2) or rheumatic causes should be clarified.

Output of Reported Reactions

39.5% of the adverse reactions had completely subsided at the time of reporting and 21.0% of the adverse reactions had improved. 25.5% were reported as not yet resolved and the outcome of 12.2% of the adverse reactions was not known at the time of reporting. A fatal outcome was reported in 1.1% of the individual case reports (see below). In 1.0% of the suspected cases, permanent damage was reported in relation to various diseases (e.g. myocardial infarction, retinal detachment, scar after scratching the injection site).

Serious Adverse Reactions

Serious adverse reactions were reported in 8,134 suspected cases. Serious reactions are those in which the person is being treated in hospital or reactions that have been classified as medically important. 4,283 of these suspected cases occurred after vaccination with Comirnaty, 380 serious suspected cases after vaccination with the COVID-19 vaccine Moderna, 3,329 serious suspected cases occurred after vaccination with Vaxzevria and 14 serious suspected cases after vaccination with the COVID-19 vaccine Janssen. The vaccine was not reported in 128 suspected cases. In 873 of these suspected cases, the people died at different times before the vaccination. Figure 4 shows the proportions of serious and non-serious adverse reactions after vaccination with the various COVID-19 vaccines.

Deaths

The Paul Ehrlich Institute was reported to have died of 873 deaths (0.0024% of the vaccinated persons) at different times after the vaccination in persons between the ages of 24 and 102 years. The median age was 81 years and the mean age was 77 years. 674 deaths occurred in people who had been vaccinated with Comirnaty. In 13 reported deaths, it was not specified which COVID-19 vaccine had been vaccinated. In 19 cases people died after vaccination with the COVID-19 vaccine Moderna, in 162 cases people died after vaccination with Vaxzevria and in five cases after vaccination with the COVID-19 vaccine Janssen. 73 of the 873 reported deaths were not related to a vaccine side effect, but to a COVID-19 disease, 49 of them according to Comirnaty, 24 according to Vaxzevria.

The vast majority of the deceased had multiple previous illnesses, such as B. carcinoma, renal insufficiency, heart disease and arteriosclerotic changes that were presumably the cause of death. A younger patient presumably died after vaccination with Comirnaty as a result of drug use.

21 patients vaccinated with Vaxzevria died as a result of TTS (see below). Fatal bleeding is shown separately below (see below).

Comments

Popular posts from this blog

An Objective Book about Other Childhood Vaccines

Today's decision by the CDC to add COVID shots to the schedule of childhood vaccines has some people concerned about the rest of the vaccines on the schedule. Contrary to fact-checker claims, adding COVID shots to the schedule means children will be required in about a dozen states to get a COVID shot to attend public school. Indiana isn't one of them--our childhood vaccination law doesn't mention the CDC and such a requirement could run afoul of our ban on COVID vaccine passports. But even freewheeling Indiana has some vaccine requirements and this kerfuffle has people wondering how safe those vaccines are.  There's a book called Vaccines: Truth, Lies and Controversy  by Peter C. Gotzsche, DrMedSci and co-founder of the Cochrane Collaboration, about the safety and efficacy of all those vaccines, including COVID and others. Cochrane was founded to "to organise medical research findings to facilitate evidence-based choices about health interventions involving healt

Blog Lineup Change

Bye-bye, Fathead. I've enjoyed the blog, but can't endorse the high-fat, high-carb Perfect Health Diet that somehow makes so much sense to some otherwise bright people. An astrophysicist makes some rookie mistakes on a LC diet, misdiagnoses them, makes up "glucose deficiency," and creates a diet that's been shown in intervention studies to increase small LDL, which can lead to heart disease. A computer programmer believes in the diet and doesn't seem eager to refute it because, perhaps, scientists are freakin' liars and while he's good at spotting logical inconsistencies, lacks some intermediate knowledge of human biology. To Tom's credit, he says it's not the right diet for everyone, but given the truckload of food that has to be prepared and eaten, impracticality of following it while traveling (or even not traveling), and unsuitability for FODMAPs sufferers, diabetics and anyone prone to heart disease (i.e., much of the population), I'm

This Just In: Yogurt Doesn't Improve Health

A recent study from Spain finds "In comparison with people that did not eat yogurt, those who ate this dairy product regularly did not display any significant improvement in their score on the physical component of quality of life, and although there was a slight improvement mentally, this was not statistically significant," states López-García. Most yogurt is pretty much pudding with a little bacteria . Pudding is a sugar bomb. Hard to believe the stuff doesn't improve health outcomes, isn't it? But as usual, researchers are calling for...more research. "For future research more specific instruments must be used which may increase the probability of finding a potential benefit of this food."

Not Only Cheaper, But Easier

A while back, I wrote about saving money on break time coffee and snacks. I haven't done very well putting it into practice. But a post by James Clear today got me thinking about it again: Warren Buffett uses a two-list system to prioritize things. Check it out --and follow the instructions. Using Buffett's two-list system, two of the goals I ended up with were taking care of myself and saving $400 more per month than I already am. As I said, I've been wanting to save money, and the system made me really focus on this. I came up with 11 money-saving ideas, six of which had to do with food. Buying hamburger in bulk. Ranch Foods Direct sells one-pound packages of 80% lean pastured ground beef in bundles of 20 for a lot less than Whole Foods. Sprouts only carries super-lean beef that's grass-fed, and it's more expensive, too.  Not driving to Whole Foods. Whole Foods is out of my way, and saving a weekly trip saves gas. Coffee at home, tea at work. Tea is fr

1972: Carole King, M*A*S*H and...Food for 2014?

I feel well enough to try Atkins induction again. The palpitations are gone, even without taking potassium. My energy level is back to normal--no more trucking on the treadmill early in the morning  to burn off nervous energy or emergency meat, cheese and mineral water stops after yoga. It's back to lounging around to Chopin and Debussy in the morning and stopping at the wine bar for pleasure. I'm using the original Atkins book: Dr. Atkins' Diet Revolution from 1972. While looking in the book for a way to make gelatin (which is allowed on induction, but Jello(TM) and products like it have questionable ingredients), I felt the earth move under my feet : those recipes from 42 years ago look delicious and they're mostly real food. It makes sense, though: the cooks who wrote the recipes probably didn't have had a palette used to low-fat food full of added sugar or a bag of tricks to make low-fat food edible. Anyone who writes a recipe called "Cottage Cheese and