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CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older – FDA

Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.

https://web.archive.org/web/20230113214706/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cdc-and-fda-identify-preliminary-covid-19-vaccine-safety-signal-persons-aged-65-years-and-older

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News

CDC identifies possible ‘safety concern’ for certain people receiving COVID vaccines – Fox News

The Centers for Disease Control and Prevention (CDC) says that a preliminary COVID-19 vaccine “safety signal” has been identified and is investigating whether the Bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people 65 and older.

In the Friday statement, the CDC said that the preliminary signal hasn’t been identified with the Bivalent Moderna COVID-19 vaccine.

https://archive.today/2023.01.13-203714/https://www.foxnews.com/health/cdc-identifies-possible-safety-concern-certain-people-receiving-covid-vaccines

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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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Alternative Media Opinion

Heart Problems After Covid Are Much Worse for the Vaccinated, Nature Study Shows – But It’s Hidden in the Appendix – The Daily Sceptic

Nature published a comprehensive study this week on cardiovascular risk including a total of over 11 million patients that has made a few headlines. The aim was to identify the cause of increased cardiac pathology. It should have been a very simple study comparing four groups:

Not infected and never vaccinated 
Not infected and vaccinated 
Infected but not vaccinated
Infected and vaccinated 

It is hard to believe the authors did not look at these groups, but whatever was found when comparing them remains a mystery.

Instead, the following groups were compared:

Not infected and never vaccinated data from 2017
Not infected, including vaccinated and not vaccinated
Infected but not vaccinated
Infected with vaccinated people included but using modelled adjustments

When studies with huge datasets use modelling and fail to share data prior to their adjustments alarm bells should start ringing. Therefore, I took a deeper dive to see what else was questionable.

https://dailysceptic.org/2022/02/09/heart-problems-after-covid-are-much-worse-for-the-vaccinated-nature-study-shows-but-its-hidden-in-the-appendix/

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Publications

Long-term cardiovascular outcomes of COVID-19 – Nature

The cardiovascular complications of acute coronavirus disease 2019 (COVID-19) are well described, but the post-acute cardiovascular manifestations of COVID-19 have not yet been comprehensively characterized. Here we used national healthcare databases from the US Department of Veterans Affairs to build a cohort of 153,760 individuals with COVID-19, as well as two sets of control cohorts with 5,637,647 (contemporary controls) and 5,859,411 (historical controls) individuals, to estimate risks and 1-year burdens of a set of pre-specified incident cardiovascular outcomes. We show that, beyond the first 30 d after infection, individuals with COVID-19 are at increased risk of incident cardiovascular disease spanning several categories, including cerebrovascular disorders, dysrhythmias, ischemic and non-ischemic heart disease, pericarditis, myocarditis, heart failure and thromboembolic disease. These risks and burdens were evident even among individuals who were not hospitalized during the acute phase of the infection and increased in a graded fashion according to the care setting during the acute phase (non-hospitalized, hospitalized and admitted to intensive care). Our results provide evidence that the risk and 1-year burden of cardiovascular disease in survivors of acute COVID-19 are substantial. Care pathways of those surviving the acute episode of COVID-19 should include attention to cardiovascular health and disease.

Commentary by Dr. Clare Craig: Heart Problems After Covid Are Much Worse for the Vaccinated, Nature Study Shows – But It’s Hidden in the Appendix

http://archive.today/2022.02.08-054001/https://www.nature.com/articles/s41591-022-01689-3

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News

Family’s agony as dad ‘trapped in his own body’ following rare reaction from Covid jab – The Mirror

A dad has become ‘trapped in his body’ after a stroke caused by the AstraZeneca vaccine.

John O’Neill, 42, from Essex, is one in 50,000 to suffer an extreme reaction to the Covid vaccine.

The IT engineer was hit with vaccine-induced immune thrombocytopenia and thrombosis (VITT) only nine days after he received his first dose in May, the family wrote on a JustGiving page.

http://archive.today/2021.12.14-145910/https://www.mirror.co.uk/news/uk-news/familys-agony-dad-trapped-body-25681253

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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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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.

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News

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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Videos

Dr. Roger Hodkinson – Investigative Corona Committee Germany Session 56

Dr Hodkinson is the CEO of Western Medical Assessments, and has been the Company’s Medical Director for over 20 years. He received his general medical degrees from Cambridge University in the UK, and then became a Royal College certified pathologist in Canada (FRCPC) following a residency in Vancouver, BC.

Source: Western Medical Assessments
  • Dr Hodkinson’s interview is at 2h49m.

Find out more about the Investigative Corona Committee Germany.

The video at https://youtu.be/OjhM3XRN5js?t=10145 has been removed from YouTube

Backup mirrors:

A shortened version of the video Session 56 has been uploaded to Bitchute by Coronavirus Plushie.

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Videos

Investigative Corona Committee Germany Session 56 (Full video)

Dr. Michael Dykta, Dr. Wolfgang Wodarg, Professor Arne Burkhardt, Dr. Peter McCullough and Dr. Roger Hodkinson speak with Dr. Reiner Fuellmich on Germany’s Investigative Corona Committee Session 56.

  • Dr McCullough’s is at around 1h35m.
  • Dr Hodkinson’s interview is at 2h49m.

Find out more about the Investigative Corona Committee Germany.

The full video has been removed from YouTube. You can find a backup mirror below:

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News

Now AstraZeneca vaccine is linked to strokes: One British patient dies and two are hospitalised after receiving Covid jab as doctors are told to look out for signs of brain-damaging clots – Daily Mail

Doctors are now being told to look out for signs of the most common type of stroke following the Oxford coronavirus vaccine, after three British patients were admitted to hospital and one died.

Two women in their 30s and a man in his 40s suffered ischaemic strokes after having the vaccine. 

Previous reports of rare blood clots from the jab have specifically involved cerebral venous thrombosis – a rare form of stroke caused by the blockage of specific veins.

https://www.dailymail.co.uk/news/article-9618837/Oxford-vaccine-linked-strokes-One-patient-dies-two-hospitalised-receiving-Covid-jab.html

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News

Woman, 35, dies from brain blood clot caused by AstraZeneca vaccination – The Telegraph

A woman in her 30s has died from a stroke after the Oxford/AstraZeneca Covid vaccination caused a blood clot to form in an artery in her brain.

The patient, a 35-year-old Asian woman, went to hospital six days after her vaccine appointment, and died two weeks after being admitted following “extensive hemorrhaging”. 

https://www.telegraph.co.uk/news/2021/05/25/woman-35-dies-brain-blood-clot-caused-astrazeneca-vaccination/

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Publications

5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021 – Pfizer

Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.

The download link is available from Public Health and Medical Professionals for Transparency.

Important points from this report include:

  • A seven-year-old experienced a stroke.
  • One child and one infant suffered facial paralysis.
  • One infant had a kidney adverse event, either kidney injury or failure.
  • Of the 34 cases, 24 (71%) were classified as serious.
  • Predominantly female patients were affected — at least 25 of 34 (73.5%) patients.
  • Table 6 reports 34 cases of use in pediatric individuals. However, 28 additional cases were excluded because details such as height and weight were “not consistent with pediatric subjects.”
  • Ages ranged from two months to nine years, with median 4.0 years, which means half the children were under four years of age.
  • 132 adverse events were reported in the 34 children – i.e., an average of 3.88 AEs per child.

Summary from Daily Clout journalists:

https://archive.today/2022.12.29-231302/https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf