Sunday, February 11, 2024


House Oversight Panel to Assess Efficacy of Vaccine Injury Reporting, Compensation Systems

The continued fallout from the COVID-19 vaccines’ introduction has raised questions about the effectiveness of the United States’ existing vaccine injury reporting and compensation systems.

On Feb. 15, a panel of the House Oversight and Accountability Committee will hold a hearing to examine those systems and how they might be improved for future victims. Witnesses will include officials at the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA).

“Vaccine safety systems were designed to protect public health. Unfortunately, the COVID-19 pandemic—and resulting vaccine mandates—appear to have exceeded the capabilities of these systems,” Subcommittee Chairman Brad Wenstrup (R-Ohio) said in announcing the hearing on Feb. 9.

“All the while, the Biden administration coerced healthy Americans into compliance with unscientific vaccine mandates, seemingly without having a sufficient system in place to protect and compensate individuals who were potentially harmed. This hearing is an important step to increase vaccine transparency and to ensure that victims of future vaccine injuries are properly compensated,” he said.

Caught Unawares

Since 1990, the nation’s early warning system for reporting vaccine injuries has been the Vaccine Adverse Event Reporting System (VAERS). The system is co-managed by the FDA and CDC, but anyone can submit a report, regardless of medical expertise.

And report they have. As of Jan. 26, more than 1.6 million adverse event reports have been submitted to VAERS in connection with the COVID-19 vaccines, according to OpenVAERS, a private organization that compiles and publishes VAERS data online.

Documents obtained through a Freedom of Information Act (FOIA) request also show that the sheer volume of those reports—though downplayed by health agencies—surprised officials in the months following the first vaccines’ rollout in December 2020.

More COVID-19 Vaccinations Linked to Higher Infection Risk: Study

“Two vaccines have been released since the last report. Since release the number of incoming COVID-19 reports has significantly exceeded the estimated maximum of 1,000 reports per day,” General Dynamics Information Technology (GDIT), a contractor hired to process VAERS reports, notified the CDC in a status report on Jan. 15, 2021. “As a result, GDIT is unable to meet processing and other timeframes (data processing, telephone inquiries, clinical [inquiries], etc.).”

A chart included in the report shows that the number of daily reports was substantially higher than predicted, even topping 4,500 on Jan. 10, 2021. The trend also continued for several months, resulting in a backlog of nearly 94,000 reports that took until the end of May to clear.

‘Don’t Want to Appear Alarmist’

At around the same time those reports began rolling in, the CDC was warned of a potential link between the Pfizer-BioNTech and Moderna COVID-19 vaccines and a “large number” of cases of myocarditis, a type of heart inflammation among healthy, young Israelis.

While the CDC initially planned to notify doctors and public health officials of that emerging link through its Health Alert Network (HAN), the alert was never sent.

The reason for the delay, according to an email recently obtained by The Epoch Times, was that officials did not want to incite a panic.

“The pros and cons of an official HAN are what the main discussion are right now,” wrote Dr. Sara Oliver in the May 25, 2021, missive. “I think it’s likely to be a HAN since that is CDC’s primary method of communications to clinicians and public health departments, but people don’t want to appear alarmist either.”

Other emails from that same week show that the FDA also played a role in canceling the alert in favor of issuing clinical considerations, which were published on the CDC website on May 28, 2021.

The considerations advised that “increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna),” but still recommended COVID-19 vaccination for everyone aged 12 and older.

Compensation Complications

Cody Flint, an agricultural pilot in his 30s, was young and healthy when he received Pfizer’s COVID-19 vaccine.
That changed within an hour of getting the shot.

Mr. Flint soon began to experience intense head pressure—pressure that only worsened when he boarded a flight two days later.

“One second, I went from having burning in the back of my neck and tunnel vision to the very next second, I was slumped over in my airplane. The best way I know to describe it—it was like a bomb went off inside my head,” he said.

Four doctors diagnosed Mr. Flint as having a severe adverse reaction to the Pfizer vaccine. But for the U.S. Countermeasures Injury Compensation Program (CICP), which compensates those who can prove they have a COVID-19 vaccine injury, those diagnoses were not enough.

CICP administrators told Mr. Flint that “compelling, reliable and valid medical and scientific evidence does not support a causal association” between the Pfizer vaccine and the condition doctors diagnosed him with, perilymphatic fistula, which is a defect in the membranes separating the middle and inner ear.

They also wrote off his claim of having been injured by the vaccine as implausible “given the timeline of symptoms.”

“It’s just all comical to me,” Mr. Flint told The Epoch Times last April. “I get the shot, I’m injured within 48 hours, and they say that that makes it implausible.”

And Mr. Flint is not alone in his experience. Of the 2,214 COVID-19 vaccine injury claims the CICP had reviewed as of Jan. 1, only 40 were deemed eligible for compensation—just 11 of which have been compensated.

Decisions on CICP claims are made by the HRSA, which is housed under the Department of Health and Human Services—a fact some researchers have pointed to as a potential conflict of interest.

At its hearing next week, the House Oversight Committee will likely seek input from Dr. George Reed Grimes, director of the HRSA Division of Injury Compensation Programs, on whether that’s the case.

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Adverse effects following COVID-19 vaccinations as reported in the Pubmed/Medline literature: Update and Expansion

Dr. Ronald N. Kostoff

On 24 December 2023, I published an Op-ed in Trial Site News titled “Adverse effects following COVID-19 vaccinations as reported in the Pubmed/Medline literature”. Its purpose was to demonstrate that, even with the extreme censorship of the biomedical literature (especially concerning papers that counter the official government narratives on Covid-19 issues), there exist sufficient papers in the premier biomedical literature that show the extent of myriad adverse effects following Covid-19 vaccinations. The query developed for this Op-ed retrieved ~6,200 Pubmed records.

The Gold Standard for biomedical publications focused on adverse effects following Covid-19 vaccinations is the REACT19 database. Currently, this database contains 3,580 records. My previous Op-ed (referenced above) analyzed the ~6,200 records that were retrieved from Pubmed/Medline as part of the study, and were focused on adverse effects from Covid-19 vaccinations. In the present Op-ed, I developed an expanded query to retrieve the relevant articles from Pubmed (based on lessons learned from the previous Op-ed). Use of the expanded query retrieved over 13,000 articles, of which over 90% were deemed relevant (by sampling) to adverse effects following the Covid-19 vaccinations.

The 12,000+ relevant articles retrieved for the present Op-ed and focused on adverse events following the Covid-19 vaccinations should be viewed as a very low “floor” of what exists in Pubmed. More articles could have been retrieved from a well-resourced study. Additionally, because of Pubmed proximity search limitations, the Abstracts were not searched to the full extent possible.

Because of the aforementioned censorship of the biomedical literature, credible papers on Covid-19 vaccination side-effects were retracted or rejected by the journal Editors. The number of Editorial rejections is unknown, since the public does not have access to what is submitted to the journals, and what fraction is accepted. Thus, the Pubmed published literature represents a fraction of the post-Covid-19 vaccination adverse events research has identified.

For additional background on this issue of Pubmed/Medline articles on Covid-19 vaccination after-effects, especially the limitations of the Pubmed/Medline database, see the previous Op-ed on this topic. The present Op-ed will focus on the structure of the expanded query that was developed to retrieve additional relevant articles, and will provide 1) estimates of numbers of Pubmed/Medline papers in different post-Covid-19 vaccination symptom/disease categories and 2) incidence frequencies of specific symptoms/disease terms that occurred following Covid-19 vaccinations. These results should complement the results from the text clustering categories that were generated in the previous Op-ed on this topic.

METHODOLOGY

Development of the query used to retrieve Pubmed/Medline biomedical articles on post-Covid-19 vaccination adverse effects is described in detail in Appendix 1. The 13,000+ articles that were retrieved from Pubmed were imported into Excel. Approximately 25 umbrella categories were identified by a combination of visual inspection and the text clustering categories from the previous Op-ed on this topic. A query was developed consisting of mainly root terms characteristic of each of the 25 umbrella categories, and applied to each category to extract the records from the total download that could be credibly assigned to that category. For example, if one of the 25 categories is Blood Clotting, then two of the query terms used to identify records related to blood clotting would be Thromb and Embol. If these terms are entered into the Excel filter “Contains” option, then all the records in the total download containing phrases that had a root of Thromb or Embol would be identified and selected for the Blood Clotting category. Assignment of records to multiple categories was allowed, if the records had multiple themes.

Using an excellent online N-Gram generator, Unigrams, Bigrams, 3-Grams, and 4-Grams of the Titles and Abstracts of the 13,000+ records were generated. Using visual inspection of these N-Grams, thousands of symptoms/diseases phrases in the downloaded records were identified.

The 25 categories are shown in the results, along with the titles of records in each category, the phrases used to generate these records for each category, and the main specific symptoms/diseases associated with each category (see Appendix 2, Tables 2A-1 to 2A-25, for each category). For the reader who wants to search the 13,000+ downloaded Pubmed/Medline articles for information not presented in this Op-ed, the Titles and Abstracts of the full download are contained in Table 3A-1 of Appendix 3)

RESULTS AND DISCUSSION

Table 1 summarizes the 25 umbrella categories, and the number of Pubmed records in each category. The number of records in each category should be viewed as a “floor”. The queries were developed, and the records retrieved, before the N-Grams were generated (because of the timing of major upgrades to the N-Gram generator). Some additional terms from the N-Gram results could have been added to the queries for retrieving records, resulting in greater numbers of records in each category. However, the hundreds or thousands of records that were identified for each of the 25 categories are more than enough to demonstrate the breadth of adverse events in each category that occurred post-Covid-19 vaccination.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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