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Current Food and Drug Administration (FDA)-approved labels for the Pfizer and Moderna COVID-19 vaccines are obsolete, misleading and out of touch with regulators elsewhere. Take the ongoing uncertainty over whether vaccines reduce viral transmission. We asked the FDA to clarify in labeling that there isn't substantial evidence that mRNA vaccines reduce viral transmission. The FDA also failed to warn about the documented risk of sudden death, even though myocarditis is now a well-recognized side effect, particularly among young men. To support adding "sudden death" to product labeling, we pointed to multiple autopsy studies on lethal vaccination-associated myocarditis. We asked the FDA to add seven adverse event types to product labeling: multi system inflammatory syndrome in children (MIS-C), pulmonary embolism, sudden cardiac death, neuropathology and autonomic disorders, decreased sperm concentration, heavy menstrual bleeding and detection of vaccine mRNA in breast milk. Current and former FDA advisers and academics from around the country ... tried to fix this problem by asking the FDA to make critical changes to official product labels. But four months later, in a 33-page response letter, the agency denied almost every single request. In doing so, the FDA failed to follow the lead of regulators elsewhere. We cited the European regulator's addition of heavy menstrual bleeding to product information as a potential vaccine adverse reaction. The FDA's response was a sophisticated version of "who cares!"
Note: Explore a deeper look into why medical experts are calling for more accurate COVID-19 vaccine labeling. For more along these lines, see concise summaries of deeply revealing news articles on government corruption and coronavirus vaccines from reliable major media sources.
On April 27, 2021, then-director of the CDC, Rochelle Walensky stated, “we have not seen any reports” of post-vaccination myocarditis, but this was a false statement. When Walensky claimed to have “not seen any reports,” there were dozens of reports in the US Vaccine Adverse Event Reporting System (VAERS). “The CDC,” notes [journalist Zachary] Stieber, “was warned by Israel on Feb. 28, 2021, about a ‘large number’ of myocarditis cases after Pfizer COVID-19 vaccination. Internally, the warning was designated as ‘high’ importance and set off a review of US data.” The Israeli Ministry of Health requested a joint meeting with the Food and Drug Administration (FDA) and the CDC to respond to this trend. “The Israeli National Focal Point is noticing a large number of reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccines,” the email stated. Even when more information about myocarditis became public, [Walensky's] agency continued to downplay the risks. Stieber also found that the CDC’s V-Safe self-reporting system did not include a category for myocarditis reports. To this day, the CDC has not released complete, updated data on myocarditis. The agency’s cover-up of adverse cardiac events has had profound consequences and represents a major breach of trust and abuse of authority. Due to the higher risks of myocarditis after Moderna, Sweden, Norway, Finland, Germany, and France suspended the use of the Moderna vaccine for people under 30 two years ago.
Note: When current and former FDA advisers and academics asked the FDA to improve COVID vaccine labeling given the significant risk of severe vaccine injuries, the agency denied almost every single request. For more along these lines, see concise summaries of deeply revealing news articles on government corruption and coronavirus vaccines from reliable major media sources.
What if I told you one in 50 people who took a new medication had a “medically attended adverse event” and the manufacturer refused to disclose what exactly the complication was — would you take it? And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline? And what if we told you the Food and Drug Administration cleared it without any human-outcomes data. That’s what we know about the new COVID vaccine the Biden administration is firmly recommending. COVID vaccines are very different from flu vaccines. COVID vaccines have higher complication rates, including severe and life-threatening cardiac reactions. Flu shots have a 50-plus-year safety record whereas COVID vaccines have been associated with a serious adverse event rate of one in 5,000 doses, according to a German study by the Paul-Ehrlich-Institut. Another study, published last year in the medical journal Vaccine, estimated the rate of serious adverse events to be as high as one in 556 COVID vaccine recipients. And for young people, the incidence of myocarditis is six to 28 times higher after the vaccine than after infection, even for females, according to a 2022 JAMA Cardiology study. That’s one of the reasons a study that we and several national colleagues published last year found that college booster mandates appear to have resulted in a net public health harm.
Note: The above was written by Marty Makary, MD, a professor at the Johns Hopkins School of Medicine. Anecdotals is a powerful documentary that follows the lives of many people who stepped up to get vaccinated for themselves or the greater good, yet whose lives changed drastically as a result. Instead of having their stories of vaccine injuries heard and seen, they were discredited and abandoned by the medical system and our media systems.
One remarkable aspect of the Covid-19 pandemic has been how often unpopular scientific ideas, from the lab-leak theory to the efficacy of masks, were initially dismissed, even ridiculed, only to resurface later. Another reversal in thinking may be imminent. Some scientists have raised concerns that the safety risks of Covid-19 vaccines have been underestimated. But the politics of vaccination has relegated their concerns to the outskirts of scientific thinking. The Vaccine Adverse Event Reporting System, or Vaers ... is a database that allows Americans to document adverse events that occur after receiving a vaccine. Vaers data for Covid-19 vaccines shows an interesting pattern. Among the 310 million Covid-19 vaccines administered, several adverse events are reported at high rates in the days immediately following vaccination, then drop sharply thereafter. The silence around these potential signals of harm reflects the policy surrounding Covid-19 vaccines. The stigma of such concerns is bad for scientific integrity and could harm patients. Four serious adverse events follow this arc, according to data directly from Vaers: low platelet count (thrombocytopenia); non-infectious myocarditis or inflammation of the heart, especially in those under 30; deep vein thrombosis. The implication is that the risks of a Covid-19 vaccine may outweigh the benefits for some low-risk populations, such as children, young adults, and people who have recovered from Covid-19.
Note: This article is also available here. Read a revealing article on how the WHO is flip flopping on the safety of vaccines for children. For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
The Centers for Disease Control and Prevention (CDC) V-safe website quietly stopped collecting adverse event reports with no reason or explanation. The V-safe website simply states: “Thank you for your participation. Data collection for COVID-19 vaccines concluded on June 30, 2023.” If you go there today, V-safe directs users to the FDA’s VAERS website for adverse event reporting, even though officials continually derided VAERS as “passive” and “unverified.” VAERS and V-safe are mutually exclusive safety collection databases operated by the FDA and CDC, respectively. According to the FDA Vaccine Adverse Event Reporting System (VAERS) database, mRNA “vaccines” have been named the primary suspect in over 1.5 million adverse event reports, of which there are >20,000 heart attacks and >27,000 cases of myocarditis and pericarditis just in the USA alone. VAERS reports represent fewer than 1 percent of vaccine adverse events. Based on VAERS and previous V-safe findings, adverse events from mRNA shots in the USA alone could be considered a humanitarian crisis. Despite those alarming clinical findings, the CDC has concluded that collecting new safety reports is somehow no longer in the interest of America’s public health. Existing data from the V-safe site showed around 6.5 million adverse events/health impacts out of 10.1 million users, with around 2 million of those people unable to conduct normal activities of daily living.
Note: For more along these lines, see concise summaries of deeply revealing news articles on government corruption and coronavirus vaccines from reliable major media sources.
Dr. Peter Gøtzsche is a well known Danish physician with four decades of research experience, publishing 97 papers in the “big five” (BMJ, Lancet, JAMA, Annals of Internal Medicine, and New England Journal of Medicine) and 19 Cochrane reviews. He is a co-founder of the Cochrane Collaboration. Gøtzsche, along with ... Maryanne Demasi, PhD, have published a new paper titled “Serious harms of the COVID-19 Vaccines: A Systematic Review.” It’s been a task for academics to look into this phenomenon given the fact that vaccine manufacturers and drug regulators never allowed independent researchers to examine the raw trial data, forcing transparency advocates to sue the FDA for access to the documents. The adenovirus vector vaccines increased the risk of venous thrombosis and thrombocytopenia. (Authorities have responded by suspending the use of AstraZeneca’s vaccine across many European countries, and in the US, regulators have advised restricted use of Janssen’s vaccine). The mRNA-based vaccines increased the risk of myocarditis, with a mortality of about 1-2 per 200 cases. It was more common in younger males. We found evidence of serious neurological harms, including Bell’s Palsy, Guillain-Barré syndrome, myasthenic disorder and stroke, which are likely due to an autoimmune reaction from mRNA and adenoviral vector vaccines. Severe harms, i.e. those that prevent daily activities, were underreported in the randomized trials.
Note: For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
Of more than 8,000 people who filed claims with the federal government alleging injuries from COVID-19 vaccines, three have now received cash payouts, new government data shows. Their combined compensation? Less than $5,000. One person who had an anaphylactic reaction to the shot received $2,020 from the government’s Countermeasures Injury Compensation Program, or CICP. Another who got myocarditis – an inflammation of the heart muscle – from the jab received $1,583, while a second myocarditis sufferer got $1,033, according to the data, which was released last week. A third myocarditis patient’s claim was approved but the person was denied compensation due to lack of eligible expenses. The CICP has doled out just three small awards confirms [that] the government program is ill-suited to adjudicate these cases. The no-fault tribunal run by the Health Resources and Services Administration is stymied by statute in the relief it can offer, with compensation limited to unreimbursed medical expenses and up to $50,000 a year in lost wages. A death benefit of up to $422,035 may also be available. There’s no allowance for pain and suffering, no punitive damages, no attorneys’ fees, no public hearings or opinions, no right to judicial appeal. But it’s the only legal recourse available for the unlucky few who have experienced serious adverse effects from the vaccines. The COVID-19 vaccine makers are indemnified by the government and are not party to CICP proceedings.
Note: This article attributes vaccine injuries to the "unlucky few." However, an increasing amount of evidence makes it clear that vaccine injuries are more common than what we're told, as revealed in countless anecdotal stories of those significantly harmed from the vaccine and Pfizer's very own disclosed documents. For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
The New York Times (NYT) issued a correction to one of its stories this week, which significantly overstated the number of U.S. children who have been hospitalized for COVID-19. The article discussed how countries were moving to "revisit the one-dose strategy" due to concerns over health data suggesting myocarditis was more common in children who receive the COVID-19 vaccine than previously thought. The U.S. has not changed its guidance on the issue since June. The Centers for Disease Control and Prevention voted that month to recommend the vaccine for children older than 12 because "the benefits far outweighed the risk." The NYT used the misstated statistic as background information meant to describe the extent of COVID-19's effect on U.S. children. The Oct. 7 correction read: "The article also misstated the number of Covid hospitalizations in U.S. children. It is more than 63,000 from August 2020 to October 2021, not 900,000 since the beginning of the pandemic." Other errors from the article were also discussed in the correction placed at the end of the article. Those errors include incorrectly describing "actions taken by regulators in Sweden and Denmark," who halted the use of pharmaceutical manufacturer Moderna's vaccine for children. The NYT reported the two countries had only halted booster shots, not the vaccine entirely. The article also misstated the timing of a Food and Drug Administration meeting on the authorization of the Pfizer-BioNTech vaccine for children.
Note: These corrections are generally issued as a footnote, which practically no one reads. Note that the original article overstated the number of children hospitalized by nearly 1,500%. How could the respected "newspaper of record" get such important information so wrong? For more along these lines, see concise summaries of deeply revealing news articles on the coronavirus and mass media from reliable sources.
A CDC safety group said there’s a “likely association” between a rare heart inflammatory condition in adolescents and young adults mostly after they’ve received their second Covid-19 vaccine shot, citing the most recent data available. There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received Pfizer’s or Moderna’s Covid vaccine, according to a series of slide presentations published Wednesday for a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the membrane surrounding the heart. The agency said there have been 267 cases of myocarditis or pericarditis reported after receiving one dose of the mRNA vaccines and 827 reported cases after two doses through June 11. Roughly 300 million of the shots had been administered as of June 11. Men under 30 make up the bulk of the cases, the CDC said. Of the 295 people who have developed the condition and have been discharged, 79% of them have fully recovered. Nine people were hospitalized, with two in intensive care as of June 11. The CDC is coordinating its investigation with the Food and Drug Administration, which last month authorized the Pfizer-BioNTech vaccine for adolescents ages 12 to 15. Symptoms, which include chest pain and shortness of breath, typically develop within a week of receiving the shot with most developing within four days, the agency said.
Note: For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
An FDNY firefighter says he was forced to retire on half his salary after the city-mandated COVID-19 vaccine left him with permanent heart damage. O’Brian Pastrana now wants a judge to award him a more lucrative disability pension, which would pay three-quarters of his final salary tax-free, according to court papers. Pastrana, 37, got the jab in October 2021 because the city required it, and had an immediate allergic reaction, including swollen lips, chills and body aches. Despite three trips to the emergency room, he claims he was forced to get the second Pfizer shot a month later. “I thought I was going to die after that second dose,” Pastrana [said], adding he was again rushed to the ER after the second shot. By February 2022, the married father of two was diagnosed with myocarditis, which results in potentially fatal inflammation of the cardiac muscle, and was nearly in heart failure, court records show. The heart condition is a rare side effect of the vaccine, according to the Centers for Disease Control and Prevention. Pastrana was then told he could never be a firefighter again, and forced to retire in March after over a decade on the job. “I was completely blindsided,” he wrote in a statement to the court. The FDNY Uniformed Firefighter Association called his injury “totally avoidable.” The city “held his job over his head and forced him to choose between a vaccine that he did not want, and feeding his family,” Andrew Ansbro, the union’s president, said.
Note: For more along these lines, see concise summaries of deeply revealing news articles on government corruption and COVID vaccines from reliable major media sources.
Since U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf began his second tenure as the agency’s head in February 2022, he has made combating “misinformation” one of his top priorities, arguing it is “a leading cause of preventable death in America now” — though “this cannot be proved,” he said. In an interview ... Califf, who also headed the FDA between 2016 and 2017, reiterated his pledge to “save lives” by policing online content. The FDA may be facing an uphill battle, as multiple factors are combining to foster public mistrust toward the agency. For instance, in January, Frank Yiannas, the FDA’s deputy commissioner for food policy and response, resigned over concerns about the FDA’s oversight structure. A 2022 study by The BMJ found that the FDA gets 65% of its funding for drug evaluation from industry user fees, while another 2022 study found that 95% of the members of an HHS committee that establishes dietary guidelines for Americans have one or more conflicts of interest with industry actors. Members of the FDA’s Vaccines and Related Biological Products Advisory Committee have also been found to have conflicts of interest with the very pharmaceutical companies and vaccine manufacturers they are meant to be regulating. And while public health authorities in other countries have begun to come forward with admissions that the COVID-19 vaccines resulted in cases of myocarditis and death, no such admissions appear to be forthcoming from the FDA at this time.
Note: For more along these lines, see concise summaries of deeply revealing news articles on government corruption and media manipulation from reliable sources.
Elon Musk said he had 'major side effects' from his second Covid-19 booster shot that left him feeling like he 'was dying'. Musk, 51, took to Twitter to share his experience of the Covid-19 vaccine in response to a retweet of a poll that said 7 percent of adults claimed they experienced major side effects from the Covid vaccine. The Twitter and Tesla CEO said the second booster 'crushed me'. Musk also shared that his younger cousin, who he said was in 'peak health', had to be hospitalized after his jab suffering from myocarditis. 'I had major side effects from my second booster shot. Felt like I was dying for several days. Hopefully, no permanent damage, but I dunno,' Musk tweeted over the weekend. He added: 'And my cousin, who is young & in peak health, had a serious case of myocarditis. Had to go to the hospital.' Myocarditis is an inflammation of the heart and is named as a possible, but very rare, side effect of Covid-19 vaccinations. A large study published in JAMA Network of more than 192 million people who received Covid vaccines found there were 1,626 cases of myocarditis - a rate of 8.5 cases per million people (0.000845 per cent). Many people have reported side effects from Covid shots, including headaches, a temperature, fatigue and injection site soreness, but in most cases the symptoms only last a few days. When asked why he had gotten the second booster, Musk said that it was not his choice but because it was a requirement fly to Germany.
Note: Explore a list of recent news articles we've summarized that reveal how vaccine-induced myocarditis is not as rare as we're told to believe. For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccine problems from reliable major media sources.
The CDC announced Thursday that it will convene a meeting of its advisers on June 18th to discuss rare but higher-than-expected reports of heart inflammation following doses of the mRNA-based Pfizer and Moderna COVID-19 vaccines. So far, the CDC has identified 226 reports that might meet the agency's "working case definition" of myocarditis and pericarditis following the shots, the agency disclosed Thursday. The CDC first described the panel's session as an "emergency meeting," but later changed it to merely a "COVID-19 meeting." Previous times the advisors convened to discuss the pandemic — like their May 12th gathering to mull recommendations for Pfizer's COVID-19 vaccine in adolescents — were also described as "emergency meetings." The new details about myocarditis and pericarditis emerged first in presentations to a panel of independent advisers for the Food and Drug Administration, who are meeting Thursday to discuss how the regulator should approach emergency use authorization for using COVID-19 vaccines in younger children. The CDC previously disclosed that reports of heart inflammation were detected mostly in younger men and teenage boys following their second dose, and that there was a "higher number of observed than expected" cases in 16- to 24-year-olds. "Risk-benefit considerations … will need to account for this information,” [said] Dr. Marion Gruber, director of the FDA's vaccine office.”
Note: What this article fails to mention is that for every case reported there are very likely many that go unreported. Explore a much more in-depth article on this. For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
Twitter CEO Elon Musk on Saturday joined the growing debate on the serious side-effects of Covid-19 vaccines, saying he had "major side effects from my second booster shot". In a tweet, he said that he "felt like I was dying for several days". "Hopefully, no permanent damage, but I dunno," the billionaire said, adding that "first mRNA booster was ok, but the second one crushed me". Musk's admission about the side-effects of Covid vaccines came as Pfizer CEO Albert Bourla evaded difficult questions about the effectiveness of the company's vaccine during the World Economic Forum (WEF) meeting in Davis. Bourla refused to answer any questions and instead repeatedly responded with phrases such as "Thank you very much" and "Have a wonderful day". Musk also revealed that his cousin, who is young and in peak health, "had a serious case of myocarditis" and "had to go to the hospital" after the Covid vaccine jab.
Note: For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
The first research in the U.S. is underway, tracking adverse health effects — if any — that may appear in the years following a diagnosis of vaccine-associated heart problems. Early findings from the research could be published as early as next year, sources told NBC News. In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer's Covid vaccine. Miller was rushed to Henry Ford West Bloomfield Hospital, where he was diagnosed with myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the outer lining of the heart. His doctor advised him not to receive a second dose of either the Pfizer or the Moderna vaccines. In some cases, people who’ve developed myocarditis after a viral infection can suffer scarring along the heart’s tissue, reducing its ability to pump blood and circulate oxygen around the body, said Dr. Leslie Cooper, the chair of the department of cardiology at the Mayo Clinic. “It could be 2%. It could be 0%. It could be 20%,” he said, referring to the percentage of people with vaccine-associated myocarditis who could experience long-term heart consequences. “We don’t know the answer.” Scientists still don’t have a clear explanation yet for why the vaccines cause the condition, according to Dr. Paul Burton, Moderna's chief medical officer. He expects the virus’s spike protein, once produced in the cell after vaccination, may generate a reaction in the body that can cause inflammation in the heart.
Note: Leading medical journal JAMA published a study earlier this year showing that the risk of myocarditis “increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men.” Consider also watching an excellent video by Dr. Vinay Prasad at the University of California, San Francisco who discusses a revealing Switzerland study showing that myocardial injury is more common than previously thought, with concerning implications on the cumulative burden of myocardial injury from yearly boosters.
The European Medicines Agency (EMA) is recommending Novavax's COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation. The heart conditions - myocarditis and pericarditis - should be listed as new side effects in the product information for the vaccine, Nuvaxovid, based on a small number of reported cases, the EMA said. Novavax said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid and that more data would be gathered. "We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data," U.S. vaccine developer Novavax added. In June, the U.S. Food and Drug Administration flagged a risk of heart inflammation from the Novavax vaccine. Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, from groundbreaking messenger RNA (mRNA) vaccines made by Moderna and the Pfizer and BioNTech alliance. The EMA said on Wednesday it had asked Novavax to provide additional data on the risk of these side effects. Last month, the EU agency identified severe allergic reactions as potential side effects of the vaccine. Novavax was hoping that people who have opted not to take Pfizer and Moderna's vaccines would favour its shot because it relies on technology that has been used for decades. However, only around 250,000 doses of Nuvaxovid have been administered in Europe.
Note: For more, see this informative article. For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
The Ontario government is now recommending males aged 18 to 24 take Pfizer over Moderna as their COVID-19 vaccination due to the number of young men who have experienced myocarditis after getting the vaccine. This comes after public health officials determined there is a 1 in 5,000 risk of myocarditis — a form of heart inflammation — following a second dose of the Moderna vaccine. For any young men in that age bracket who received Moderna as their first dose and have not yet received a second dose, the government recommends they go with Pfizer. The risk of myocarditis for this demographic in Pfizer is 1 in 28,000, according to government officials. “The majority of reported cases have been mild with individuals recovering quickly, normally with anti-inflammatory medication,” explains a guidance document released by the government. “Symptoms have typically been reported to start within one week after vaccination, more commonly after the second dose.” While there are reports of myocarditis in Ontario among both males and females in all age brackets, the incidence rate among young males receiving their second Moderna shot was substantially higher than other categories. This development comes after a Public Health Ontario report released last month showed over half of the province’s approximately 200 cases of hospitalizations for myocarditis following mRNA vaccination were in people under the age of 25.
Note: Sweden, Norway, and Finland are also restricting use of the Moderna vaccine for safety reasons. For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.
