Tuesday, 19 November 2024

Earliest COVID-19 vaccine recipients wrote in tens of thousands of injuries left off CDC surveys


The earliest recipients of newly authorized COVID-19 vaccines, including healthcare workers, wrote in tens of thousands of adverse events related to the heart, ears, reproductive system and other conditions not listed as checkboxes in a federal active monitoring smartphone app.

The Centers for Disease Control and Prevention in the past two months turned over 780,000 "free text" entries from V-safe, the agency's vaccine-safety monitoring system, under a January order by U.S. District Judge Matthew Kacsmaryk in a Freedom of Information Act lawsuit by Freedom Coalition of Doctors for Choice. 

It kept holding out for more than a year after turning over the checkbox answers in a different FOIA lawsuit by the Informed Consent Action Network, which revealed nearly 8% of V-safe users said they required medical care, another 12% couldn't perform normal daily activities and yet another 13% said they missed work or school.

Kacsmaryk scolded the agency for drastically overstating how difficult it would be to redact free-text entries — 93% of which the CDC admitted had no personally identifying information — that were limited to 250 characters, which the judge compared to tweets.

ICAN, which shares lawyer Aaron Siri with FCDC, made the first two productions of free-text entries available over the past month. The group said they show "remarkable consistency" between each other in adverse events reported, specifically highlighting the frequency of symptoms associated with myocarditis – inflammation of the the heart muscle myocardium. 

The CDC has until mid-January 2025 to turn over all 7.8 million free-text entries from V-safe, which registered 8.5 million users from December 2020 to April 2021, when the vaccines became generally available to adults. 

More than 10 million participants have submitted 151 million health surveys through the app as of January, according to the agency. They answer questions at daily, then weekly and finally quarterly intervals, making it a more reliable gauge of vaccine injury than the passively monitored Vaccine Adverse Events Reporting System.

Even COVID vaccine recipients who escape injury may not be getting much protection from the latest formulations of the jabs, ongoing research suggests.

University of Washington researchers found "persistent immune imprinting" following Omicron XBB.1.5 mRNA boosters in a study published in the Cell journal Immunity last month, meaning the body mounts an immune response as if it were exposed to the original vaccine formulation.

It was partially funded by the National Institute of Allergy and Infectious Diseases and a National Institute of Health grant. One author consults with Pfizer and another is named on UW patents for coronavirus vaccines, the disclosures show.

"XBB.1.5 COVID-19 mRNA booster vaccination primarily recalls Wuhan-Hu-1 RBD [receptor-binding domain]-directed memory B cells," the authors wrote, with no "detectable plasma antibodies specific for XBB.1.5 [spike]" and a "scarcity of memory B cells binding to the XBB.1.5 RBD."

"These findings held true for at least 2 months post-vaccination and concur with observations made after Omicron BA.1, BA.2, and BA.5 breakthrough infections and with that made after the roll out of the bivalent Wuhan-Hu-1/BA.5 and Wuhan-Hu-1/BA.1 S [bivalent] vaccine boosters," they said.

This affirmed results going back nearly two years by research teams abroad, which was soon followed by the CDC's own findings that the purportedly better bivalent vaccines were less than 50% effective against symptomatic infection.

Just the News ran searches for several terms and variations in the two V-safe free-text productions, not including misspellings.

They run the gamut from brief descriptions of adverse events without elaboration on how strongly the participant suspects the condition is related to vaccination, to longer entries that express a more certain view of vaccine relation or qualify the report.

"Emergency" and "ER" show up nearly 1,300 times combined, while "ringing of the ears" and "tinnitus" together show up nearly 3,800 times. "Lymph" makes one of the most frequent appearances, about 43,000 times.

One of the angrier reports is about "EXTREMELY LOUD" tinnitus that made the participant regret getting vaccinated. "Put it this way, if I was suicidal I would be dead by now that's how bad it is."

"Heart" is listed in about 11,500 entries, 4,500 accompanied by "rate" and 1,800 "palpitations." Variations of "shortness of breath" show up 7,800 times. "Arrhythmia" is listed nearly 150 times.

One says: "Today, I experienced heart palpitations accompanied by tachycardia, dizziness, and weakness. These symptoms lasted about 4 hours and my heart rate was between 135-145. I have never experienced any of these symptoms until today."

ICAN flagged the frequency of reported heart palpitations and shortness of breath as classic symptoms of myocarditis, which only shows up a dozen times by that name in the free-text entries. One says: "Myocarditis that is unexplained. Multiple negative Covid-19 tests (antigen and PCR)."

The CDC included myocarditis and pericarditis as "adverse events of special interest" in the initial V-safe protocol but left cardiac symptoms off the final checkboxes despite knowing early they were a higher post-vaccination risk for young people, especially males.

Being pregnant is mentioned more than 1,000 times but rarely with further elaboration. "Miscarriage" shows up about 160 times, sometimes with stage of pregnancy, time following vaccination and judgment as to relevance.

"I had miscarriage after 2nd dose of Pfizer covid vaccine," one of the longer entries says. "I felt fine until I had the vaccine and within 48 hrs pregnancy symptoms ceased. I have no history of fertility issues or complications and had 2 healthy uneventful pregnancies prior to this."

"I experienced a miscarriage a week after my vaccine," says another. "I started bleeding 3 days after the vaccine and needed a D&C [dilation and curettage, also used in abortion] 7 days after the vaccine. I was 6-7wks along."

"I most like[ly] had a miscarriage following second vaccine dose. Probably a coincidence but nonetheless," another says. Other entries mention miscarriages a few days to a week later, with pregnancies ending in the sixth to 13th week.

The term "facial" shows up in 2,700 entries, paired with "paralysis" at the low end (more than 50) and "numb" at the high end (more than 600), with "flushing," "swelling" and "tingling" between. 

Variations of "inflammation" occur about 2,000 times, edema 900, Bell's palsy 400, seizure 200 and paralysis 130. 

ICAN attorney Elizabeth Brehm told The Epoch Times the group is still pressing the CDC for the submission dates on the free-text entries, but said the two productions received so far are comprised of the earliest V-safe reports on COVID vaccines.


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