Authored by Zachary Stieber via The Epoch Times (emphasis ours),
The U.S. Centers for Disease Control and Prevention (CDC) and its partners uncovered signs that the Pfizer-BioNTech and Moderna COVID-19 vaccines might cause the persistent condition called tinnitus but never disclosed the findings to the public, The Epoch Times can report.
The signs were found while analyzing data from the CDC’s Vaccine Safety Datalink (VSD), which has been described as one of the stronger CDC surveillance systems because it utilizes health care records.
The detection of the signs came just after the CDC told a reporter that there were no signs of large numbers of cases of tinnitus, which commonly manifests as a constant ringing in the head, following COVID-19 vaccination, documents obtained by The Epoch Times show.
The CDC never updated the reporter, whose story reported that the CDC had not found a clustering of cases.
The CDC declined to comment.
The documents “prove that they were aware of a safety signal of tinnitus after the COVID-19 shots as early as 2022,” Dr. Joel Wallskog, co-chair of the advocacy group React19, told The Epoch Times via email. “However, to my knowledge, this safety signal was never communicated to the public and no further epidemiological study on tinnitus in VSD was ever completed.”
The Epoch Times obtained the documents through a Freedom of Information Act (FOIA) request.
Previous requests have yielded other evidence the CDC knew about possible safety problems with the COVID-19 vaccines but did not alert the public. That includes the detection in May 2022 of a safety signal for tinnitus and the Pfizer and Moderna vaccines, in an analysis of data from another CDC system, which is based on reports filed by doctors and others.
“As time passes and more FOIA requests are executed, how many more safety signals will we learn about that the CDC knew about years ago? When does this nightmare end? When will the American public know the whole truth and nothing but the truth? Is the CDC evil or incompetent? Or maybe both,” Dr. Wallskog added.
Detection
A CDC spokeswoman, according to one of the emails obtained by The Epoch Times, told a reporter on Sept. 21, 2022, that the CDC was aware of reports of tinnitus after COVID-19 vaccination lodged with the Vaccine Adverse Event Reporting System (VAERS). That CDC-run system accepts reports from anybody, although most are filed by health care workers.
“Because so many people have been vaccinated, and because tinnitus is so common in the population, temporally-associated cases are expected, with some expected to occur shortly after vaccination,” Martha Sharan, the spokeswoman, said.
The CDC opted to explore potential links in VSD.
“Unlike VAERS, which relies primarily on voluntary reports ... the VSD uses data from electronic health records,” Ms. Sharan said. “Consequently, the VSD data are less likely to be affected by the reporting biases and other biases that impact spontaneous reporting patterns to VAERS and data quality.”
The analysis of VSD data showed that “to date, no clustering of tinnitus diagnoses have been observed post-vaccination,” she added.
Katherine Yih, PhD, leads analyses of VSD data to monitor vaccine safety. She’s an assistant professor at the Harvard Pilgrim Health Care Institute’s Department of Population Medicine and receives funding from the CDC.
Ms. Yih informed CDC officials on Sept. 29, 2022, that analyses of VSD data turned up “statistically significant temporal clusters” for tinnitus following receipt of the Pfizer and Moderna vaccines, another email obtained by The Epoch Times shows. Both vaccines utilize messenger RNA (mRNA) technology.
“Both strongest clusters for the mRNA vaccines start around 12-13 days after when dose 2 would likely have been received,” she said. “The relative risks are quite low and certainly it’s hard to see anything on visual inspection of the graphs, especially for Moderna, so this seems to be a subtle effect if it is truly a VAE, unless you’re one of the unlucky ones who got tinnitus.”
VAE stands for vaccine adverse event.
Ms. Yih told the officials they could discuss the matter during an upcoming call.
No Disclosure
Tara Haelle, the reporter who contacted the CDC about VSD and tinnitus, asked for an interview with one of the officials, Dr. Tom Shimabukuro, in August 2022, after a study found “overwhelming statistical support in VAERS” for tinnitus being a possible side effect of the mRNA shots.
Ms. Sharan informed Ms. Haelle that the VSD analysis did not show any clustering of tinnitus after COVID-19 vaccination. In a follow-up email on Sept. 29, 2022, attributed to Dr. Shimabukuro, he repeated the statement.
Hours later, Ms. Yih alerted Dr. Shimabukuro and others to the clustering that was found.
The CDC appears to have never alerted Ms. Haelle, or the general public, to the discovery.
Dr. Shimabukuro wanted to delay the interview, Ms. Sharan added soon after, because the CDC was going to conduct additional analyses of VSD data. The analyses would be done “relatively soon,” according to Dr. Shimabukuro.
On Nov. 10, 2022, Ms. Sharan told Ms. Haelle that “vaccine safety monitoring efforts in CDC have identified no evidence of a causal association between COVID-19 vaccination and tinnitus or other hearing loss,” conveying a statement from Dr. John Su, another CDC official, and that the VSD analysis was “in progress.”
On Dec. 19, 2022, Ms. Yih sent an “outline of tinnitus exploration” to Dr. Shimabukuro and other officials. The “outline for a possible report on COVID vaccination and tinnitus” was created at the request of one of the other officials, she said. Large portions of that and other emails were redacted.
On Dec. 16, 2022, results from analyses of the VSD data were published. The study, co-authored by Ms. Yih and others, did not mention tinnitus. Ms. Yih did not respond to a request for comment.
On Jan. 8, 2023, Ms. Sharan told Ms. Haelle that the CDC “doesn’t have enough evidence to justify an epidemiologic study on tinnitus in VSD.”
Despite Ms. Haelle’s efforts, the CDC refused to provide the results of its analyses.
Ms. Haelle’s article was published on Feb. 21, 2023. Ms. Haelle, who did not respond to an inquiry, wrote that the CDC said it “found no evidence that tinnitus diagnoses were clustered together following vaccination but hasn’t published that analysis and declined to share the preliminary report.”
“If the CDC had found a statistically significant link to tinnitus, it could have taken steps to add an official warning to the vaccine labels,” she added later.
Other Countries Find Link
Other researchers and countries have identified a link between tinnitus and COVID-19 vaccines.
U.S. researchers, for example, said in early 2022 that VAERS data “suggest an association” between the vaccines and tinnitus.
Australian and South Korean researchers later reported finding that vaccinated people faced an increased risk of tinnitus, including people who received a Moderna or Pfizer vaccine.
Some other papers, on the other hand, such as one from the United States, have not found an increase in tinnitus after COVID-19 vaccination.
Due to increasing evidence of a link, the European Medicines Agency added tinnitus to the labels for the AstraZeneca and Johnson & Johnson COVID-19 vaccines. Tinnitus may affect up to one in 1,000 people after the shots, according to the agency.
Australian regulators have also placed tinnitus on the labels for the AstraZeneca and Novavax COVID-19 vaccines. The AstraZeneca shot has never been authorized in the United States.
The method by which the vaccines may cause the condition remains unconfirmed.
Drs. Christian Rausch and Qun-Ying Yue of the Uppsala Monitoring Centre have proposed that the vestibulocochlear nerve may be involved. Others have postulated inflammation being the culprit. Treatments include ivermectin and ganglion blocks.
Authored by Zachary Stieber via The Epoch Times (emphasis ours),
The U.S. Centers for Disease Control and Prevention (CDC) and its partners uncovered signs that the Pfizer-BioNTech and Moderna COVID-19 vaccines might cause the persistent condition called tinnitus but never disclosed the findings to the public, The Epoch Times can report.
The signs were found while analyzing data from the CDC’s Vaccine Safety Datalink (VSD), which has been described as one of the stronger CDC surveillance systems because it utilizes health care records.
The detection of the signs came just after the CDC told a reporter that there were no signs of large numbers of cases of tinnitus, which commonly manifests as a constant ringing in the head, following COVID-19 vaccination, documents obtained by The Epoch Times show.
The CDC never updated the reporter, whose story reported that the CDC had not found a clustering of cases.
The CDC declined to comment.
The documents “prove that they were aware of a safety signal of tinnitus after the COVID-19 shots as early as 2022,” Dr. Joel Wallskog, co-chair of the advocacy group React19, told The Epoch Times via email. “However, to my knowledge, this safety signal was never communicated to the public and no further epidemiological study on tinnitus in VSD was ever completed.”
The Epoch Times obtained the documents through a Freedom of Information Act (FOIA) request.
Previous requests have yielded other evidence the CDC knew about possible safety problems with the COVID-19 vaccines but did not alert the public. That includes the detection in May 2022 of a safety signal for tinnitus and the Pfizer and Moderna vaccines, in an analysis of data from another CDC system, which is based on reports filed by doctors and others.
“As time passes and more FOIA requests are executed, how many more safety signals will we learn about that the CDC knew about years ago? When does this nightmare end? When will the American public know the whole truth and nothing but the truth? Is the CDC evil or incompetent? Or maybe both,” Dr. Wallskog added.
Detection
A CDC spokeswoman, according to one of the emails obtained by The Epoch Times, told a reporter on Sept. 21, 2022, that the CDC was aware of reports of tinnitus after COVID-19 vaccination lodged with the Vaccine Adverse Event Reporting System (VAERS). That CDC-run system accepts reports from anybody, although most are filed by health care workers.
“Because so many people have been vaccinated, and because tinnitus is so common in the population, temporally-associated cases are expected, with some expected to occur shortly after vaccination,” Martha Sharan, the spokeswoman, said.
The CDC opted to explore potential links in VSD.
“Unlike VAERS, which relies primarily on voluntary reports … the VSD uses data from electronic health records,” Ms. Sharan said. “Consequently, the VSD data are less likely to be affected by the reporting biases and other biases that impact spontaneous reporting patterns to VAERS and data quality.”
The analysis of VSD data showed that “to date, no clustering of tinnitus diagnoses have been observed post-vaccination,” she added.
Katherine Yih, PhD, leads analyses of VSD data to monitor vaccine safety. She’s an assistant professor at the Harvard Pilgrim Health Care Institute’s Department of Population Medicine and receives funding from the CDC.
Ms. Yih informed CDC officials on Sept. 29, 2022, that analyses of VSD data turned up “statistically significant temporal clusters” for tinnitus following receipt of the Pfizer and Moderna vaccines, another email obtained by The Epoch Times shows. Both vaccines utilize messenger RNA (mRNA) technology.
“Both strongest clusters for the mRNA vaccines start around 12-13 days after when dose 2 would likely have been received,” she said. “The relative risks are quite low and certainly it’s hard to see anything on visual inspection of the graphs, especially for Moderna, so this seems to be a subtle effect if it is truly a VAE, unless you’re one of the unlucky ones who got tinnitus.”
VAE stands for vaccine adverse event.
Ms. Yih told the officials they could discuss the matter during an upcoming call.
No Disclosure
Tara Haelle, the reporter who contacted the CDC about VSD and tinnitus, asked for an interview with one of the officials, Dr. Tom Shimabukuro, in August 2022, after a study found “overwhelming statistical support in VAERS” for tinnitus being a possible side effect of the mRNA shots.
Ms. Sharan informed Ms. Haelle that the VSD analysis did not show any clustering of tinnitus after COVID-19 vaccination. In a follow-up email on Sept. 29, 2022, attributed to Dr. Shimabukuro, he repeated the statement.
Hours later, Ms. Yih alerted Dr. Shimabukuro and others to the clustering that was found.
The CDC appears to have never alerted Ms. Haelle, or the general public, to the discovery.
Dr. Shimabukuro wanted to delay the interview, Ms. Sharan added soon after, because the CDC was going to conduct additional analyses of VSD data. The analyses would be done “relatively soon,” according to Dr. Shimabukuro.
On Nov. 10, 2022, Ms. Sharan told Ms. Haelle that “vaccine safety monitoring efforts in CDC have identified no evidence of a causal association between COVID-19 vaccination and tinnitus or other hearing loss,” conveying a statement from Dr. John Su, another CDC official, and that the VSD analysis was “in progress.”
On Dec. 19, 2022, Ms. Yih sent an “outline of tinnitus exploration” to Dr. Shimabukuro and other officials. The “outline for a possible report on COVID vaccination and tinnitus” was created at the request of one of the other officials, she said. Large portions of that and other emails were redacted.
On Dec. 16, 2022, results from analyses of the VSD data were published. The study, co-authored by Ms. Yih and others, did not mention tinnitus. Ms. Yih did not respond to a request for comment.
On Jan. 8, 2023, Ms. Sharan told Ms. Haelle that the CDC “doesn’t have enough evidence to justify an epidemiologic study on tinnitus in VSD.”
Despite Ms. Haelle’s efforts, the CDC refused to provide the results of its analyses.
Ms. Haelle’s article was published on Feb. 21, 2023. Ms. Haelle, who did not respond to an inquiry, wrote that the CDC said it “found no evidence that tinnitus diagnoses were clustered together following vaccination but hasn’t published that analysis and declined to share the preliminary report.”
“If the CDC had found a statistically significant link to tinnitus, it could have taken steps to add an official warning to the vaccine labels,” she added later.
Other Countries Find Link
Other researchers and countries have identified a link between tinnitus and COVID-19 vaccines.
U.S. researchers, for example, said in early 2022 that VAERS data “suggest an association” between the vaccines and tinnitus.
Australian and South Korean researchers later reported finding that vaccinated people faced an increased risk of tinnitus, including people who received a Moderna or Pfizer vaccine.
Some other papers, on the other hand, such as one from the United States, have not found an increase in tinnitus after COVID-19 vaccination.
Due to increasing evidence of a link, the European Medicines Agency added tinnitus to the labels for the AstraZeneca and Johnson & Johnson COVID-19 vaccines. Tinnitus may affect up to one in 1,000 people after the shots, according to the agency.
Australian regulators have also placed tinnitus on the labels for the AstraZeneca and Novavax COVID-19 vaccines. The AstraZeneca shot has never been authorized in the United States.
The method by which the vaccines may cause the condition remains unconfirmed.
Drs. Christian Rausch and Qun-Ying Yue of the Uppsala Monitoring Centre have proposed that the vestibulocochlear nerve may be involved. Others have postulated inflammation being the culprit. Treatments include ivermectin and ganglion blocks.
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