**FILE** Courtesy of Howard County Health Department via Twitter

SciCheck Digest

Viral claims have repeatedly misrepresented unverified data from a U.S. vaccine safety system that encourages reports of any potential side effects — whether they’re likely to be caused by the vaccine or not. Now we’re seeing the same phenomenon with a similar system in Germany. Some have wrongly claimed Germany found the COVID-19 vaccine caused “serious side effects” in a large number of people.


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We’ve written several stories about false and misleading claims that distort the Vaccine Adverse Event Reporting System. VAERS, run by the Centers for Disease Control and Prevention and the Food and Drug Administration, serves as an early warning system to detect potential safety problems with vaccines. Anyone can submit a report, and in many cases, health care providers are required to file a report of symptoms that occurred following vaccination, as we’ve explained

The reports don’t mean that the symptom was necessarily caused by the vaccine, but the reports allow government scientists to detect, and then investigate, potential safety issues. After more than 600 million vaccine doses in the U.S., serious adverse events linked to the vaccines have been rare.

Germany has a similar vaccine safety reporting system that is now being misrepresented in the U.S. by two popular purveyors of misleading information on the COVID-19 vaccines.

Former New York Times reporter Alex Berenson, who has wrongly used VAERS data in the past, said in a July 20 Substack post: “This morning, the German Federal Ministry of Health posted a stunning tweet, admitting that 1 out of every 5,000 Covid jabs cause ‘serious side effects.’” He claimed the statistic “implies that almost 300,000 Americans and Europeans have suffered severe side effects after receiving mRNA shots from Pfizer/BioNTech and Moderna.”

He also posted on Instagram: “The German government admits hundreds of thousands of people have had severe side effects following mRNA shots.”

Fox News’ Tucker Carlson similarly included the claim on his show on July 21 and 22. “Germany’s Ministry of Health found that 1 in 5,000 Germans have suffered ‘serious side effects after a COVID-19 vaccine,’” Carlson asserted on July 21. “That would mean that in the U.S., if that number holds constant across countries — and why wouldn’t it? — it would mean more than 100,000 Americans may have been seriously injured by the COVID vaccine.”

But the German Federal Ministry of Health didn’t find that the vaccines “cause” that rate of “serious side effects.” The figures come from the country’s Paul-Ehrlich-Institut, which is the Federal Institute for Vaccines and Biomedicines and is responsible for overseeing the safety of medicines, much like the FDA. The institute publishes periodic reports on side effects “regardless of the causal link to the vaccination,” as it says in an FAQ on its website. The individual reports on suspected side effects can come from public health officials, doctors or “vaccinated persons or their relatives,” the FAQ says.

The ministry’s initial July 20 tweet, highlighted by Berenson, was incorrect, though it clearly referred to the work of the Paul-Ehrlich-Institut. The tweet, which was later deleted and corrected, said, per Google Translate: “One in 5000 people is affected by a serious side effect after a COVID19 vaccination. If you suspect #side effects, get medical help and report your symptoms to @PEI_Germany,” referring to the institute.

In another tweet posted the same day, the ministry said: “Correction: According to @PEI_Germany, the reporting rate for serious reactions is 0.2 reports per 1,000 vaccine doses.”

But the ministry’s correction still didn’t make clear what this reporting rate meant. In a Twitter thread the next day, the ministry offered more explanation, saying that the “reporting rate refers to all suspicious activity reports, ie a causal connection with the vaccination has not yet been confirmed.”

In other words, the ministry was wrong to initially characterize the reporting rate in that way, implying the reported side effects were all caused by the vaccines when many of them were likely coincidental.

The Paul-Ehrlich-Institut told us that “there are a couple of persisting misunderstandings that continue to lead to misinterpretations” of these safety reports — just as we’ve seen with VAERS.

“[P]lease pay attention to the fact that the report rate refers to all suspected reports, i.e. a causal connection with the vaccination has not yet been confirmed with the report of suspicion. The reporting rate indicates how many suspected cases of adverse events have been reported and will be evaluated by the Paul-Ehrlich-Institut thereafter,” the institute told us in a statement via email.

It also noted that “one reported case of a suspected adverse event may involve several reactions (e.g fever, headache, muscle pain), and the reporting rate is calculated per vaccine dose, not per vaccinated person.”

We reached out to the Federal Ministry of Health as well, but we haven’t received a response.

The Paul-Ehrlich-Institut’s May 4 report said, as the ministry tweeted in its correction: “The reporting rate for serious adverse events was 0.2 reports per 1,000 doses of vaccine.” The time period is Dec. 27, 2020, when vaccinations began in the country, through March 31, 2022. There are five COVID-19 vaccines in use in Germany (see Section 2 of the report), including vaccines from Pfizer/BioNTech, Moderna, Johnson & Johnson, AstraZeneca and Novavax, most of which are two-dose primary vaccinations with booster doses also available. So many people received at least two doses.

But, again, as the report explains in the methodology section, the Paul-Ehrlich-Institut encourages all reports of possible side effects even if the link to vaccination is questionable. Doctors are “legally obligated” to report post-vaccination complications to public health departments if they “are not obviously the result of other causes,” the report said.

“The reporting of suspected cases of adverse events and vaccine-related complications is a central pillar of assessments of vaccine safety because it enables the rapid detection of new safety signals,” the May 4 report said. “It should still be noted here that the reported adverse events are chronologically, but not necessarily causally, linked to vaccination. The reporting of such reactions with a questionable link to vaccination is expressly welcomed. However, this also means that not all reported reactions are actually adverse events. The Paul-Ehrlich-Institut summarises all submitted reports in its safety reports, regardless of the causal link to the vaccination.”

As for what constitutes a “serious” adverse event, the definition is broader for the COVID-19 vaccines than other vaccines. In addition to standard “serious” events, such as fatal and life-threatening events and those requiring hospitalization, reports on “adverse events of particular interest” are classified as “serious” for these vaccines. The institute pointed us to a European Union document listing those events of particular interest, which include dermatological, respiratory, gastrointestinal, liver, eye disorder and pregnancy-related issues, among others (see the AESI, or “adverse events of special interest,” list on page 13). For this reason, the May 4 report says, “a direct comparison with the reports on other vaccines is not possible.”

The institute’s report also gives information on “known adverse events,” such as myocarditis and pericarditis, inflammation of the heart muscle or the outer lining of the heart. As has been found in the U.S., the conditions have been “a very rare side effect” of the Pfizer/BioNTech and Moderna vaccines, mainly affecting young men and adolescents. The “suspected,” but not confirmed, cases showed a reporting rate of under 2 suspected cases per 100,000 doses of those vaccines in Germany. 

The institute said the “very rare” cases of anaphylaxis, a severe allergic reaction, have been reported at a frequency of 0.4 or less per 100,000 doses, depending on the vaccine.

The report also said that while fatalities were cited at various times post-vaccination in 2,810 suspected case reports, the institute found that 116 cases had a “probable or possible causal relationship” to COVID-19 vaccination. The reason for that assessment, the institute told us, is the same as explained in the Feb. 7 report on suspected adverse events. These were cases “in which patients died from known vaccination risks such as thrombosis with thrombocytopenia syndrome (TTS), bleeding due to immune thrombocytopenia, or myocarditis occurring within a logical time frame after vaccination,” that report said. TTS is a serious blood clotting disorder coupled with low platelets that is a rare risk associated with the Johnson & Johnson and AstraZeneca vaccines, the latter of which is available in Europe.

During this time period, through March 31, 172 million vaccine doses were administered in Germany.

The May report went on to say that when comparing the total reports of suspected adverse events ending in death up to six weeks after vaccination with the number of statistically expected deaths during the same time period, that comparison “did not indicate a safety signal for any of the five COVID-19 vaccines used so far in Germany.”

In the U.S., there has been a large number of VAERS reports following COVID-19 vaccination, compared with other vaccines, due to expanded reporting requirements and the hundreds of millions of doses given amid intense scrutiny and awareness of the vaccines, as we’ve explained.


Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over our editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

Paul-Ehrlich-Institut. Official Duties. Pei.de. accessed 3 Aug 2022.

Paul-Ehrlich-Institut. Safe­ty Re­ports / Safe­Vac 2.0 App. Pei.de. accessed 3 Aug 2022.

German Federal Ministry of Health (@BMG_Bund.) “Korrektur: Die Melderate für schwerwiegende Reaktionen beträgt laut @PEI_Germany
0,2 Meldungen pro 1.000 Impfdosen.” Twitter. 20 Jul 2022.

German Federal Ministry of Health (@BMG_Bund.) “Die Melderate bezieht sich auf alle Verdachtsmeldungen, d. h. ein ursächlicher Zusammenhang mit der Impfung ist mit der Verdachtsmeldung noch nicht bestätigt, es wird erstmal ein zeitlicher Zusammenhang festgestellt.” Twitter. 21 Jul 2022.

German Federal Ministry of Health (@BMG_Bund.) “Eine von 5000 Personen ist von einer schweren Nebenwirkung nach einer COVID19-#Impfung betroffen. Sollten Sie den Verdacht auf #Nebenwirkungen haben, holen Sie sich ärztliche Hilfe und melden Sie Ihre Symptome ans @PEI_Germany.” Deleted tweet. Internet Archive. 20 Jul 2022.

Paul-Ehrlich-Institut press office. Emails to FactCheck.org. 29 Jul – 3 Aug 2022.

Paul-Ehrlich-Institut. Safety Report. 4 May 2022.

Paul-Ehrlich-Institut. Safety Report. 7 Feb 2022.

European Medicines Agency. COVID-19 vaccines: authorised. accessed 3 Aug 2022.

European Medicines Agency. “Consideration on core requirements for RMPs of COVID19 vaccines.” 8 Feb 2022.

Jaramillo, Catalina. “Benefits of COVID-19 Vaccination Outweigh the Rare Risk of Myocarditis, Even in Young Males.” FactCheck.org. 1 Mar 2022.

McDonald, Jessica. “Increase in COVID-19 VAERS Reports Due To Reporting Requirements, Intense Scrutiny of Widely Given Vaccines.” FactCheck.org. 22 Dec 2021.

Centers for Disease Control and Prevention. “Safety of COVID-19 Vaccines.” CDC.gov. updated 1 Aug 2022.

Berenson, Alex. “The German government admits hundreds of thousands of people have had severe side effects following mRNA shots.” Unreported Truths. 20 Jul 2022.

Tucker Carlson Tonight.” Transcript. FoxNews.com. 21 Jul 2022.

Department of Health and Human Services. VAERS Frequently Asked Questions. HHS.gov. accessed 3 Aug 2022.

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