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Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

Our early warning safety system is the first to identify-four new statistical signals for modestly elevated risks (RR less than 2) of four serious outcomes of AMI, PE, DIC, and ITP following BNT162b2 vaccination. This FDA and CMS COVID-19 vaccine safety study is one of the largest studies of elderly persons aged 65 years and above including approximately 34 million doses administered to more than 17 million Medicare insured persons. Our surveillance monitoring did not detect statistical signals for the mRNA-1273and Ad26 COV2.S vaccines for any of the 14 monitored outcomes.

Analysis from The Epoch Times can be found here: Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA

http://archive.today/2022.12.19-065727/https://www.sciencedirect.com/science/article/pii/S0264410X22014931

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News

Strokes, blood clots, wheelchairs: B.C. patients describe rare reactions to COVID vaccines – Vancouver Sun

As British Columbians were starting to get COVID-19 vaccinations in December 2020 and the first half of 2021, health officials were behind-the-scenes carefully tracking serious side-effects from the shots, according to documents recently released under the Freedom of Information Act.

Although the 42-page released contains few examples of severe reactions, those that were flagged sparked immediate responses from health leaders who were monitoring the millions of Canadians getting the new vaccinations.

http://archive.today/2022.06.20-174916/https://vancouversun.com/health/strokes-blood-clots-wheelchairs-bc-patients-describe-rare-reactions-covid-vaccines

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US restricts use of Johnson & Johnson Covid vaccine over rare blood clot risk

FDA officials said in a statement that they decided to restrict Johnson & Johnson’s vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination.

http://archive.today/2022.05.06-145106/https://www.theguardian.com/world/2022/may/05/us-johnson-johnson-covid-vaccine-blood-clot

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News

Student paramedic, 18, died of clot two weeks after having Covid vaccine – Grimsby Telegraph

An 18-year-old died two weeks after having her Covid vaccination when a blood clot caused a ‘thunder clap’ headache. Kasey Turner was admitted to hospital two weeks after having the AstraZeneca vaccine.

An inquest this week heard her severe and sudden headache was the result of a thrombosis in her sinus cavity. Kasey was admitted to Barnsley Hospital’s A&E department on the morning of September 23, 2021 with the “worst headache” that she had ever experienced. Partly because of a low platelet count in her blood doctors ruled out a brain hemorrhage.

https://web.archive.org/web/20220324071701/https://www.grimsbytelegraph.co.uk/news/uk-world-news/student-paramedic-18-died-clot-6852296

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News

Covid-19 Vaccines Were Deadly in Rare Cases. Governments Are Now Weighing Compensation – Wall Street Journal

[Ms. Spit] is part of a very small, little-discussed community of pandemic victims: those who have suffered—or had family or loved ones suffer—from rare but serious vaccine side effects recognized by doctors, regulators and researchers. They say they feel lost in wider Covid-19 statistics, which have shown vaccines to be extremely safe and effective for most of the population.

Faced with the gravest health crisis in memory, governments deployed newly developed vaccines in record time. Many countries indemnified pharmaceutical companies that made the shots, with some governments promising to consider compensation for suspected Covid-19 vaccine-related injuries.

Now governments, including the U.S. and U.K., are trying to live up to that pledge. They are in the very early stages of applying existing vaccine-injury programs to hundreds of claims of injury alleged from Covid-19 shots.

…The U.K.’s National Health Service has received more than 720 claims requesting Covid-19 vaccine-related compensation. The country’s vaccine-injury compensation program entails a one-size-fits-all cash payment of £120,000, equivalent to around $163,000. The volume of Covid-related claims has grown by about 20 a week, toward a projected 1,500 to 1,800 new claims this year, according to U.K. government projections.

http://archive.today/2022.02.22-001537/https://www.wsj.com/articles/covid-19-vaccines-were-deadly-in-rare-cases-governments-are-now-weighing-compensation-11645266603

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News

Healthy mother-of-three, 43, died from blood clots in ‘rare complication’ after she had AstraZeneca Covid-19 vaccine, coroner finds – Daily Mail

A mother-of three died of multiple blood clots weeks after having a Covid-19 vaccine, an inquest has found.

Tanya Smith, 43, received the Oxford AstraZeneca vaccine on March 21 this year at the Plymouth Argyle vaccination clinic.

The childminder from Plymouth then began suffering from severe stomach pains in the days after getting the jab, Plymouth Coroner’s Court was told on Wednesday.

She was later admitted into Derriford Hospital and died on April 3 in the Penrose intensive care unit (ICU). 

http://archive.today/2021.12.16-110753/https://www.dailymail.co.uk/news/article-10313969/Healthy-mother-three-43-died-rare-blood-clots-AstraZeneca-jab.html

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AstraZeneca uncovers ‘trigger’ of blood clots after its jab: Vaccine acts like a magnet and attracts platelets which body mistakes for a threat and attacks – Daily Mail

Scientists believe they have solved the mystery behind the extremely rare blood clots caused by the Oxford-AstraZeneca vaccine.

A team of international experts, involving researchers from AstraZeneca, say that in a very small number of cases, the vaccine can set off a chain reaction which leads to the body confusing its own blood platelets for fragments of virus.

http://archive.today/2021.12.02-123404/https://www.dailymail.co.uk/news/article-10266585/AstraZeneca-uncovers-trigger-blood-clots-jab.html

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Publications

ChAdOx1 interacts with CAR and PF4 with implications for thrombosis with thrombocytopenia syndrome – Science Advances

Vaccines derived from chimpanzee adenovirus Y25 (ChAdOx1), human adenovirus type 26 (HAdV-D26), and human adenovirus type 5 (HAdV-C5) are critical in combatting the severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic. As part of the largest vaccination campaign in history, ultrarare side effects not seen in phase 3 trials, including thrombosis with thrombocytopenia syndrome (TTS), a rare condition resembling heparin-induced thrombocytopenia (HIT), have been observed. This study demonstrates that all three adenoviruses deployed as vaccination vectors versus SARS-CoV-2 bind to platelet factor 4 (PF4), a protein implicated in the pathogenesis of HIT. We have determined the structure of the ChAdOx1 viral vector and used it in state-of-the-art computational simulations to demonstrate an electrostatic interaction mechanism with PF4, which was confirmed experimentally by surface plasmon resonance. These data confirm that PF4 is capable of forming stable complexes with clinically relevant adenoviruses, an important step in unraveling the mechanisms underlying TTS.

http://archive.today/2021.12.02-125456/https://www.science.org/doi/10.1126/sciadv.abl8213

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News

Covid vaccine: Woman who died was ‘wrongly diagnosed’ – BBC

A woman who died from “unrecognised” complications after having a Covid-19 vaccine was wrongly diagnosed with gastroenteritis, a coroner has said.

An inquest heard Michelle Barlow developed blood clots and died 16 days after having the AstraZeneca jab.

http://archive.today/2021.11.29-102246/https://www.bbc.com/news/uk-england-manchester-59434281.amp

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News

Couple in damages fight over vaccine side effects – BBC

A woman has described how she had to learn how to talk again after she said she was left partially-paralysed due to the side effects of her Covid-19 vaccine.

Kerry Hurt, from Rotherham, suffered a stroke after undergoing surgery for a blood clot two weeks after having the AstraZeneca jab.

http://archive.today/2021.11.26-215159/https://www.bbc.com/news/articles/c41nlvy5x85o

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News

Couple in damages fight over vaccine side effects – BBC News

At a glance

A woman has described how she had to learn how to talk again after she said she was left partially-paralysed due to the side effects of her Covid-19 vaccine.

Kerry Hurt, from Rotherham, suffered a stroke after undergoing surgery for a blood clot two weeks after having the AstraZeneca jab.

http://archive.today/2021.11.26-215159/https://www.bbc.com/news/articles/c41nlvy5x85o

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Johnson & Johnson COVID Vaccine Recipients Almost 4X as Likely to Get Blood Clots: Study – Newsweek

A new study conducted in one county in Minnesota has found an increased likelihood that citizens who received the Johnson & Johnson’s COVID-19 vaccine were more likely to develop blood clots.

The study by the Mayo Clinic found that recipients of the Johnson & Johnson vaccine, officially designated “Janssen,” in Olmsted County, Minnesota, were about 3.7 times more likely to develop a certain variety of cerebral blood clots. Case numbers taken from February 28 to May 7, 2021, were compared to pre-pandemic levels of the blood clots from January 1, 2001, through December 31, 2015.

http://archive.today/2021.11.03-081828/https://www.newsweek.com/johnson-johnson-covid-vaccine-recipients-almost-4x-likely-get-blood-clots-study-1645100

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Age- and Sex-Specific Incidence of Cerebral Venous Sinus Thrombosis Associated With Ad26.COV2.S COVID-19 Vaccination JAMA

In this population-based cohort study, we found that the CVST incidence rate 15 days after Ad26.COV2.S vaccination was significantly higher than the prepandemic rate. However, the higher rate of this rare adverse effect must be considered in the context of the effectiveness of the vaccine in preventing COVID-19 (absolute reduction of severe or critical COVID-19 of 940 per 100 000 PY).

http://archive.today/2021.11.02-171706/https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2785610

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Videos

COVID Long Haulers follow-up with Dr. Al Johnson and Dr. Peter McCullough – Johnson Medical Associates

Dr. Al Johnson is back with Dr. Peter McCullough to discuss the problem with long COVID as well as vaccine reactions.

https://youtu.be/3AgvHVOo2Hg
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News

Lisa Shaw: Presenter’s death due to complications of Covid vaccine – BBC

Lisa Shaw, who worked for BBC Radio Newcastle, died at the age of 44 in May after developing headaches a week after getting her first dose of the vaccine.

…The coroner said: “Lisa died due to complications of an AstraZeneca Covid vaccination.”

http://archive.today/2021.08.27-025930/https://www.bbc.com/news/uk-england-tyne-58330796

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Pfizer vaccine: Rates of deep vein thrombosis and thrombocytopenia after vaccine increase – The Express

Millions of Britons will be offered the Pfizer vaccine as a booster shot next month. As more jabs make their way into arms, researchers continue to carefully study their potential adverse effects – some of which have already become a source of concern. A new study has observed higher rates of deep vein thrombosis and thrombocytopenia – both conditions that affect the blood – among those who receive the Pfizer vaccine.

https://www.express.co.uk/life-style/health/1473409/pfizer-vaccine-deep-vein-thrombosis-risk

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British health chiefs quietly sneak out warning that Pfizer and Moderna’s vaccines may cause heart damage in ‘extremely rare’ cases – The Mail

British health chiefs have quietly released a warning that Pfizer and Moderna’s Covid vaccines may cause heart damage, MailOnline can reveal.

Fears about the mRNA jabs’ links to myocarditis have grown in recent weeks, following a string of cases in young adults and children in Israel and the US.

https://www.dailymail.co.uk/news/article-9765259/British-health-chiefs-sneak-warnings-Pfizer-Modernas-Covid-vaccines.html

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Family heartbroken as mum-of-three dies after receiving AstraZeneca Covid vaccine – The Express

Lucy Taberer, 47, tragically died after suffering a rare reaction to the AstraZeneca Covid vaccine. After her vaccination, the mum-of-three from Leicester developed blood clots on the brain which is believed to have sparked a massive stroke. Her family said they did not want to put people off vaccinations but wanted to raise awareness so people can spot danger signs.

https://www.express.co.uk/news/uk/1455438/covid-vaccine-mum-dies-astrazeneca-leicester

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FDA Approves First Oral Blood Thinning Medication for Children – FDA

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.

http://archive.today/2021.11.03-234924/https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-blood-thinning-medication-children

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Videos

AstraZeneca shots should be halted for over-60s- EMA official – Reuters

Countries should also avoid giving the Astrazeneca coronavirus vaccine to people over 60, the head of the EU drug regulator’s COVID-19 task force was quoted on Sunday as saying, amid fears over rare blood clotting and as more vaccines become available. Emer McCarthy reports.

https://www.reuters.com/video/watch/idRCV009UM3