FDA drug safety expert Dr. David Gortler: Vaccine manufacturers, FDA not adequately warnings about myocarditis risks
The FDA's VAERS database shows a long and impersonal number of cardiovascular-related events in young healthy people. The United States alone has accumulated a list of over 700,000 reports of adverse events, but it's difficult to understand the humanity of these large numbers. Many people don't realize that cardiovascular adverse events were warned about in the FDA medical review of the Pfizer application.
We don't always know the specific details about those who died, including their ages. To give some perspective, I've data-mined a worldwide list of seemingly healthy people who died or suddenly collapsed, as reported in the news just since December 1, 2021. Most are young athletes in the prime of their careers. The list is long (and, I'm sure, badly incomplete). So as not to interrupt the flow of this post, you'll find the list at the bottom of this post.
What's clear is that there is a mysterious overall increases in adverse events following mRNA vaccines/boosters. In many cases, the reports do not mention the athlete's vaccine status. Admittedly, these are poorly documented anecdotal cases because they are not collected by regulatory or medical professionals. However, the sheer number of cases, something we've never seen before, is cause for alarm to drug safety experts like myself.
Myocarditis and pericarditis used to be considered rare conditions. They are defined as inflammation of the heart muscle or layers of the pericardial sac, respectively. Both conditions cause easily recognizable ECG changes and have nonspecific symptoms that include shortness of breath and chest pain. They can easily be diagnosed clinically with echocardiograms and can easily be treated by pharmacology. The FDA's medical officer review, which was the basis for approving the Pfizer vaccine, notes that "clinically important serious adverse reactions [were] anaphylaxis and myocarditis/pericarditis." The problem is: patients are not being adequately warned or monitored for cardiovascular symptoms. Drug epidemiologists at the FDA and Pfizer aren’t doing their jobs, neither are the many academic institutions which claim to teach drug epidemiology for which they receive federal funding.
These are also just cardiovascular cases. According to Steve Kirsch, intracranial infection cases are up 60-fold since vaccines rolled out. Additionally, there have been over four dozen cases of sudden onset of acute transverse myelitis following mRNA COVID-19 vaccination.
Image: Qatar pro-soccer player Othman Coulibaly suffered a heart attack. YouTube screen grab.
The information I gathered for the list, below, comprises individual stories I was able to data-mine over a discrete, approximately 35 day time interval. Additionally, there are tens of thousands of reports of heart attack/myocarditis/pericarditis in the USA alone. Moreover, these thousands of cases are well known to represent only 1–10% of the adverse events that occur in actuality.
It's very unlikely that these heart-related deaths in young healthy individuals are random phenomena. Pfizer should already have placed a substantial warning on the label. Additionally, the FDA, major pharmacies, and state pharmacy boards should have loudly warned pharmacists to comply with their federal Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requirements. Had they complied, they would have warned all their patients about potentially deadly cardiovascular adverse events, as well as other adverse events trending upward in VAERS that are associated with COVID vaccine and booster administration.
Even as the list of victims of the vaccine grows longer, the entire federal government and mainstream media fail to report the vaccine's shortcomings. They are shamefully complicit in ignoring science and endangering us all.
This essay was updated at 4:45 Eastern time.
Sudden, unexpected heart attacks and deaths in the seemingly healthy over the past 45 days
- December 1, 2021, Scotland: Siobhan Cattigan (age 26), a female Scottish rugby player, died. Cause of death not given.
- December 1, 2021, Russia: Arina Biktimirova (age 19), Amateur taekwondo champion died suddenly at home.
- December 1, 2021, Belgium: Keanu Breurs (age 19) a soccer player and youth coach died suddenly Wednesday morning. Cause of death not given.
- December 1, 2021, Melbourne Australia: Ben Madgen (age 36), a basketball player in hospital with pericarditis after 2nd Pfizer dose.
- December 2, 2021, Egypt: Adham El-Selhadar (age 53), Egyptian football manager collapsed and died on the sideline of a match after his team scored a winning goal.
- December 3, 2021, Australia: An unnamed Adelaide Crows football player went to hospital diagnosed with pericarditis two weeks after his first Pfizer dose.
- December 2, 2021, Germany: Ugur Tezel (age 24), FC Carl Zeiss Jena player collapsed during a soccer game.
- December 4, 2021, Holland: Wouter Betjes (age 14), a student hockey player collapsed walking to the dugout. Team physician tried to resuscitate him on scene continuing in the ambulance and at hospital in Amsterdam but they were not successful and he died.
- December 4, 2021, England: Fabio Pedretti (age 24), died while running the Uno di Monticelli, a night trail running event. In the final km of the 20 km race, he collapsed and could not be resuscitated.
- December 5, 2021, Iran: Navid Khosh Hava (age 30), former Iranian soccer team defender died of cardiac arrest
- December 5, 2021, Alabama: John Wolfe (age 20), three-time state tennis champion in high school, died.
- December 6, 2021, England: Rob Woodward (age 36), Double vaccinated. "It is with great sadness that the club announces that Rob Woodward our manager passed away suddenly yesterday."
- December 6, 2021, France: Xavier Ziani (age 49), French professional volleyball player and coach at Charenton-le-Pont died following a cardiac arrest.
- December 7, 2021, Croatia: Pavel Karpf (age 52), former Swiss soccer goalkeeper was on his sailboat in Croatia on Tuesday when he suddenly collapsed. He died three days later in hospital.
- December 7, 2021, USA: Matt Scherer (age 38), former Oregon Ducks professional runner dies suddenly and mysteriously.
- December 10, 2021, Serbia: Ricardo Gomes (age 29) Cape Verde soccer player collapsed during training, 45 days after his COVID vaccination.
- December 11, 2021, England: Victor Lindelof (age 27), Manchester United soccer player, collapsed clutching his chest and pointing to his heart, complained of chest pain and racing pulse. His wife confirmed they were both vaccinated.
- December 12, 2021, Pennsylvania: Branson King (age 23), University of Pennsylvania Ice Hockey player died suddenly. No cause of death given.
- December 12, 2021, Portugal: Edgar Marques (age 20), Pedrógão de São Pedro football player collapsed during a match.
- December 12, 2021, Italy: Piotr Zielinski (age 27), a soccer player went to the sideline, 19 minutes into the game, struggled to breathe, pointing to his neck and chest.
- December 12, 2021, France: Martin Terrier (age 24), a Rennes soccer player, was substituted after chest pains in the game.
- December 12, 2021, Australia: Kane van Dierman (n/a), Sydney Convicts rugby player, dies. Reason for death not announced
- December 12, 2021, France: An unnamed soccer player (age 34), playing for Olympique FC de Reims suffered a cardiac arrest mid-match. He was resuscitated on the pitch and then taken to hospital by ambulance.
- December 13, 2021, England Maxwell Harrison (age 21), an International ballroom dancer, developed pericarditis five days after his second Pfizer COVID-19 vaccine and was hospitalized.
- December 14, 2021, Miami, Florida, USA: Andres Melendez (age 20), Cleveland Guardians minor league Baseball player, died unexpectedly—no further details available
- December 14, 2021, Zinswiller, Alsace, France: Aurélie Hans (age 21), female soccer goalkeeper (since she was 12), suffered a sudden cardiac arrest and died Tuesday, December 14.
- December 15, 2021, Russia: Alexander Frolov (age 63), an ice hockey player was on the sidelines during a match in the Russian amateur night hockey league when he suddenly fell ill and collapsed. He died on the way to intensive care unit, with an apparent heart problem.
- December 16, 2021, Rhode Island, USA: Meaghan McGonagle (age 41), Cranston High School East boys and girls Volleyball coach and business teacher. Cranston Mayor Ken Hopkins said "This is a young woman, 41 years old, in good health, that had the early vaccinations." She "had been hospitalized for about a week prior to her death."
- December 16, 2021, New Zealand: Taniela Moa (age 36), a former rugby player, died suddenly. No cause of death.
- December 16, 2021, Murcia, Spain: José Javier Ros (aka Monas) (age 22), UCAM Murcia footballer, withdrew from the rest of the season after being diagnosed with pericarditis.
- December 16, 2021, Spain: Dani Chabrera (age 29), Lokomotiv Tashkent football goalkeeping coach in Uzbekistan. He returned to Spain but became ill and died.
- December 17, 2021, Los Angeles USA: Donald Parham (age 24) Los Angeles Chargers (NFL) tight end player, collapsed in mid-air while taking a flying touchdown catch. He had received two Covid-19 vaccines and a booster. His arms were shaking as he was wheeled off. It appears that his left arm locked up before his helmet hit the ground, which may be why he didn't handle the recovery well. The Chargers report he suffered a concussion, but the video tells a different story.
- December 19, 2021, Spain Oscar Cabrera (age 26), a basketball player, took the ball but collapsed face-first before he could make a pass. He can be seen twitching in the video. He was transferred to hospital.
- December 21, 2021, Croatia: Marin Čačić (age 23), a soccer player, suddenly collapsed with cardiac arrest during training. He was diagnosed with heart failure from myocarditis. He is in a coma.
- December 22, 2021: Jordanian soccer player Mukhaled Al-Raqadi, (age 29) died after collapsing during a warm-up match. The reason for his death was a heart attack, Oman observer reported.
- December 22, 2021: Ahmed Amin (age 24) suffered cardiac arrest and lost consciousness in the locker room after soccer practice. The medical team tried unsuccessfully to revive him and promptly rushed him to the hospital. He was pronounced dead on arrival and the cause of death was cardiac arrest.
- December 25, 2021: Algerian soccer player Soufiane Loukar (age 30) was hurt after running into his goalkeeper during the team's match. Loukar received medical treatment but collapsed around 10 minutes after. He was rushed to a hospital for treatment, but died of a heart attack while in transit.
- January 3, 2022: Marcos Menaldo (age 25) died of a heart attack after he complained of breathing difficulties during a training session. He initially received emergency CPR at the club's home stadium but was unable to be revived.
- January 3, 2022: Carlos Tejada (age 49), an otherwise healthy New York Times Deputy Asia Editor, died of a heart attack less than a day after posting to social media that he had received a Moderna booster vaccination.
- On January 6, 2022, New Jersey:: Jack O'Drain (age 13), an otherwise healthy child, died following his second booster from "Unexplained Cardiac Arrest"
- On January 4, 2022, Brazil: Rafael Silva, (age 36), a television reporter had a heart attack during a live news broadcast, followed by four more myocardial infarctions while being transported to the hospital. He had earlier tweeted in Portuguese: "My 3rd dose will give me a long life" and "I am privileged to have this opportunity for a vaccine" and that "vaccines save lives."
- January 4, 2022, United States: Derek A. McIntosh (age 41) passed away unexpectedly, six days after receiving his COVID Vaccine. Derek had been vigorously opposed to taking the COVID vaccine but his employer forced him to do so.
- January 7, 2022: Sarah Jessica, a young girl with no cardiac history, complained of "strong heart beats" and suddenly being unable to walk or stand after receiving the vaccine. Physicians stated she died of a heart attack in her sleep.
- January 8, 2022: Othman Coulibaly from Qatar (age 32), a soccer player, suffered a heart attack in the middle of a soccer game.
- January 8, 2022: Fabienne Schlumpf, a 31-year-old triple vaccinated Swiss marathon record holder and Olympian was diagnosed with myocarditis and may never be able to compete again.
- January 8, 2022: 29-year-old double-vaccinated Georgian tennis star Nikoloz Basilashvili was forced to drop out of the Sydney Cup in Australia due to breathing difficulties. Basilashvili stated: "every shot I'm out of breath" and then told medical staff that he was "struggling to breathe." Australia's strict vaccination rules caused Novak Djokovic and Czech tennis player Renata Voracova to have their visa canceled and be thrown in the immigration detention facility despite already having been allowed into the country.
- January 9, 2022: 65-year-old comedian Bob Saget was pronounced dead in his hotel room while on tour. Free-speech social media website owner Andrew Torba was the first to report that Saget had stated in an online video that he had very recently gotten his booster while mocking the front-line pharmacist who administered his shot. Saget appeared to be in good health and, the night before his death, had just finished performing at a comedy show in Jacksonville, Florida.
- January 9, 2022, Argentina: Ámbar Suárez (age 3), died of a heart attack the day after receiving a COVID vaccine, a requirement for her to enter kindergarten. Her mother, Miryam Suárez said her daughter, had otherwise been healthy and "full of life."
Dr. David Gortler is a pharmacologist, pharmacist, and FDA and health care policy scholar at the Ethics and Public Policy Center think-tank in Washington, D.C. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale's Bioethicist Center, and was an FDA medical officer who was later appointed by the White House to serve on the FDA's Senior Executive Leadership Team as senior adviser to the FDA commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs. He is a regular columnist at Forbes and writes on drug safety, health care, and FDA policy.