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AstraZeneca vaccine adverse reports

That some people will get infection after vaccination is not a surprise as that was not the even a secondary endpoint in the trials. I note from a large trial of HCWs in California of the mRNA vaccines that they also found some reinfections.
Anecdotally I had my first AZ shot 3 weeks ago and had no reaction for 12hrs and then within a few minutes 12hrs later suddenly felt as if I had hypothermia and could not stop shivering despite going to bed fully clothed with 3 duvets which lasted about 3 hours and had a headache all of the following day after which I was fine. I never had any pain at the infection site and could not even feel which arm it was in after about an hour. I have been fairly critical of the UK COVID response but the vaccination was brilliantly organised and speaking to friends and family all have reported how impressed they were with how well organised it was in their location.
 
Great to hear you had a good experience with the vaccine JJackson. I was not really clear in what I was trying to articulate in my post - sorry - people can be sick and not show it and have their vaccine - impossible to sort out what was caused by what. Chicken and egg situation.
 
https://edition.cnn.com/2021/03/25/india/india-covid-double-mutant-variant-intl-hnk/index.html

New Delhi (CNN)India has discovered a new "double mutant" variant of Covid-19, as the country struggles to contain a spike in cases that's raising fears of a second wave.

"VOCs (variants of concern) and a new double mutant variant have been found in India," the country's Ministry of Health said in a news release on Wednesday, adding that "genomic sequencing and epidemiological studies are continuing to further analyze the situation."
A "double mutant" variant is a virus strain that carries two mutations. It's not yet clear how many infections have been linked to this double mutant variant, or whether the strain is any more dangerous, but the ministry said "such mutations confer immune escape and increased infectivity."According to the ministry, the number of known cases linked to the double mutation was not high enough to explain the current nationwide surge in infections,
Click to expand...
 
The description "double mutants" is not very helpful as all the VOC have a lot more than 2 mutations.

mutants.JPG
 
Chills and shaking seem fairly common after all the pandemic vaccines. Someone in a trial for one of the mRNA vaccines shook so bad he cracked a tooth. Maybe he was in a high dose group.
The concern about deaths and serious reactions would be this, IMO:
https://flutrackers.com/forum/forum...tly-had-or-currently-have-covid-19-infections

In those cases it would be not an either/or effect - just bad policy. HCW's would be more at risk since they get exposed so much to the natural disease.
Immunologist has concerns about safety of vaccinating people who recently had or currently have COVID-19 infections
 
 
https://qz.com/india/1985742/is-india-analysing-deaths-reported-after-coronavirus-vaccines/

AFTER THE VACCINE

Is India adequately assessing the deaths reported after Covid-19 vaccines?
By Manavi KapurCulture and lifestyle reporter
March 18, 2021

India has administered 36.4 million shots of the Covid-19 vaccine to its people. But healthcare experts now worry that these numbers are incomplete without looking at vaccine side-effects.
A group of 29 doctors, researchers, and healthcare professionals have written to India?s health minister and those on the committee for the Covid-19 vaccines expressing their worry over the lack of data on adverse events after immunisation (AEFIs) and deaths related to the vaccine.
This letter comes in the context of various European nations stopping the use of the AstraZeneca vaccine after reported AEFIs included incidents of clotting. In India, Covishield, manufactured by Serum Institute of India, is made from the master seed of the AstraZeneca vaccine. A large majority of India?s Covid-19 vaccine initiative depends on Covishield....

https://www.ibtimes.com/woman-has-m...-getting-astrazeneca-covid-19-vaccine-3165358
Woman Has 'Major Bleeding', Dies 1 Week After Getting AstraZeneca COVID-19 Vaccine
By Danielle Ong
03/19/21 AT 7:10 AM

KEY POINTS
  • A woman developed ?major bleeding? a week after getting a COVID-19 vaccine shot
  • Three countries in the EU suspended administration of the AstraZeneca vaccine
  • A team of Norwegian medical experts found a link between blood clotting and the vaccine
A previously healthy woman in Sweden died from severe bleeding a week after getting the first dose of AstraZeneca?s COVID-19 vaccine, the Swedish Medical Products Agency said on Thursday.

?This is a case of blood clots in the arteries and veins and major bleeding, ie the unusual disorder that is the focus of the EMA investigation,? Veronica Arthurson, head of drug safety at the Swedish Medical Products Agency, said at a news conference. Her death follows a suspension of the AstraZeneca vaccine by Norway, Sweden and Denmark that began Tuesday...
 
16 reports of blood clots following AZ vaccine - HPRA

Updated / Tuesday, 6 Apr 2021



The Health Products Regulatory Authority (HPRA) has said it has received 16 reports of blood clots occurring following vaccination with the AstraZeneca Covid-19 vaccine.

It said that none describe a rare blood clot.

The figures are up to the end of March.

The HPRA said that none of the reports describe cerebral venous sinus thrombosis, which is a rare type of blood clot in the brain, nor the occurrence of a blood clot associated with low platelets.

It said that any suspected reports received are being closely monitored and will be considered in the context of the ongoing review with the European Medicines Agency.

It comes as the EU drug regulator said it is still deciding whether the AstraZeneca coronavirus vaccine causes blood clots, after a top official said there was a clear link.

The European Medicines Agency's safety committee "has not yet reached a conclusion and the review is currently ongoing", the Amsterdam-based EMA said in a statement.

"We will communicate and hold a press briefing as soon as the review is finalised. This is currently expected tomorrow (Wednesday, 7 April) or on Thursday, 8 April," it added.

The statement came after the EMA's head of vaccine strategy Marco Cavaleri was quoted in Italian media as saying that there was a "clear" connection and that the agency would announce it within hours.

"In my opinion, we can say it now, it is clear there is a link with the vaccine. But we still do not know what causes this reaction," Mr Cavaleri told Italy's Il Messaggero newspaper in an interview.

After several countries, including Ireland, paused the use of the vaccine, the EMA said that the benefits outweigh the risks and it should remain in use.

But it has said that a causal link between clots and the vaccine is possible and is expected to provide an updated assessment this week.

"We are trying to get a precise picture of what is happening, to define in detail this syndrome due to the vaccine," Mr Cavaleri said.

He added: "Among the vaccinated, there are more cases of cerebral thrombosis ... among young people than we would expect."

UK regulators are also examining potential links between the Oxford/AstraZeneca vaccine and rare blood clots.

Reports suggest that the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals to restrict the use of the vaccine in younger people.

If confirmed, the roll-out of the UK's vaccination programme could be slowed significantly as more than a fifth of its vaccine supply is tied up in the AstraZeneca jab.
 
AstraZeneca?s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

News 07/04/2021

EMA confirms overall benefit-risk remains positive


EMA?s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.

EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.

People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets (see below).

The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

The Committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.[SUP]1[/SUP] The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine.

COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

EMA?s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State.

One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and will take any further actions necessary.

The PRAC stresses the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications. [TABLE="border: 1, cellpadding: 1, cellspacing: 1"]
[TR]
[TD]Patients should seek medical assistance immediately if they have the following symptoms
  • shortness of breath
  • chest pain
  • swelling in your leg
  • persistent abdominal (belly) pain
  • neurological symptoms, including severe and persistent headaches or blurred vision
  • tiny blood spots under the skin beyond the site of injection
[/TD]
[/TR]
[/TABLE]
Vaxzevria is one of four vaccines authorised in the EU for protecting against COVID-19. Studies show that it is effective at preventing the disease. It also reduces the risk of hospitalisation and deaths from COVID-19.

As for all vaccines, EMA will continue to monitor the vaccine?s safety and effectiveness and provide the public with the latest information.


READ MORE
 
Women under 60 face higher risk of rare clotting after AstraZeneca shot - German official

APRIL 7, 202110:03 AM UPDATED 3 HOURS AGO
By Douglas Busvine, John Miller

BERLIN/ZURICH (Reuters) - Instances of a very rare clotting condition in women aged under 60 who received AstraZeneca?s COVID-19 vaccine were 20 times higher than would normally be expected, Christian Bogdan, a member of Germany?s vaccine committee, said on Wednesday.

His comments came as the European Medicines Agency (EMA) and Britain?s medical regulator acknowledged a possible link between the AstraZeneca vaccine to rare blood clots with low blood platelet counts. The EMA conducted an in-depth review of 86 cases, including 18 fatalities.

Most were in women, but with just 169 total cases reported to the EMA after 34 million doses had been given, they appear to be extremely rare.

https://www.reuters.com/article/us-...them&utm_medium=trueanthem&utm_source=twitter
 
AstraZeneca to flag possible blood clot side-effect of COVID-19 vaccine on labelling

APRIL 7, 20211:23 PM UPDATED AN HOUR AGO
By Reuters Staff

LONDON (Reuters) - AstraZeneca on Wednesday said it was working with European and British regulators to change the product information on its COVID-19 shot after authorities said they suspected possible brain blood clots were a rare side-effect of the shot.

https://www.reuters.com/article/us-...tent&utm_medium=trueAnthem&utm_source=twitter
 
Press release: MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clo

From: Medicines and Healthcare products Regulatory Agency
Published: 7 April 2021

...
  • By 31 March 20.2 million doses of the COVID-19 Vaccine AstraZeneca had been given in the UK meaning the overall risk of these blood clots is approximately 4 people in a million who receive the vaccine.
  • Anyone who did not have these side effects should come forward for their second dose when invited.
  • The data suggest there is a slightly higher incidence reported in the younger adult age groups and the MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine. ...
... Up to and including 31 March 2021, the MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca:
  • 44 of the 79 cases were of CVST with thrombocytopenia
  • 35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia
  • 79 cases occurred in 51 women and 28 men, aged from 18 to 79 years. It should be noted that more women have been vaccinated with COVID-19 Vaccine AstraZeneca than men.
  • Sadly, 19 people have died out of the 79 cases ? 13 females and 6 males. 11 out of the 19 people who died were under the age of 50, 3 of whom were under 30. 14 of these 19 cases were of CVST with thrombocytopenia and 5 were of thrombosis with thrombocytopenia.
  • All 79 cases occurred after a first dose of the vaccine.
https://www.gov.uk/government/news/...-extremely-rare-unlikely-to-occur-blood-clots
 
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