UK – Vaccine Adverse Drug Reactions Data
Here is the highlighted latest information on UK Covid vaccine adverse drug reactions (ADR) as reported on the Yellow Card scheme. Data taken from the UK. Gov website.
I am reporting the key data as detailed on the government website as of Tuesday 16th March 2021, as a public record on my website. I have put my review at the bottom of the post.
From Website
What is a Yellow Card Scheme?
The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse reactions (ADRs).
Vaccine doses administered.
Data from the UK Public Health agencies show that at least 20,275,451 people have received their first vaccination in the UK by week ending 28 February 2021, with 815,816 second doses administered.
Yellow Cards reported. Up to and including 28 February 2021, the MHRA received and analysed 33,207 UK Yellow Cards from people who have received the COVID-19 mRNA Pfizer/BioNTech vaccine. These reports include a total of 94,809 suspected reactions (i.e., a single report may contain more than one symptom). The first report was received on 9 December 2020.
In the same time period, the MHRA also received and analysed a total of 54,180 UK reports of suspected ADRs to the COVID-19 Oxford University/AstraZeneca vaccine. These reports include a total of 201,622 suspected reactions (a single report may contain more than one symptom). The first report was received on 4 January 2021.
Overall safety
As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction.
Comments on specific reports
The following reports reflect data up to 28 February 2021. The glossary provides an explanation of the clinical terms used.
Anaphylaxis (Severe allergic reactions)
The MHRA continues to monitor reports of serious allergic reactions with the Pfizer/BioNTech COVID-19 vaccine and has received 214 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions. The nature and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer/BioNTech vaccine remain very rare. The MHRA’s guidance remains that those with a previous history of allergic reactions to the ingredients of the vaccine should not receive it.
The MHRA also closely monitors reports of anaphylaxis or anaphylactoid reactions with the AstraZeneca vaccine. These are reported less frequently than with the Pfizer/BioNTech vaccine, with 194 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions reported and is very rare. An update to the product information has been made to reflect the fact that cases of anaphylaxis have been reported for the AstraZeneca vaccine.
Bell’s Palsy
The MHRA continues to review cases reporting Bell’s Palsy and to analyse case reports against the number expected to occur by chance in the absence of vaccination (the ‘natural rate’). The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events, including through evaluation of electronic healthcare record data.
Events with a fatal outcome
Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated in the vaccination campaign so far are very elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.
Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly.
The MHRA has received 227 UK reports of suspected ADRs to the Pfizer/BioNTech vaccine in which the patient died shortly after vaccination, 275 reports for the Oxford University/AstraZeneca vaccine and 4 where the brand of vaccine was unspecified. The majority of these reports were in elderly people or people with underlying illness. Usage of the AstraZeneca has increased rapidly and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.
A range of other isolated or series of reports of non-fatal, serious suspected ADRs have been reported. These all remain under continual review, including through analysis of expected rates in the absence of vaccine. There are currently no indications of specific patterns or rates of reporting that would suggest the vaccine has played a role.
Conclusion
At the time of this report, nearly 125,000 people across the UK have died within 28 days of a positive test for coronavirus. Rates of COVID-19 infection and hospitalisation remain high.
Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.
In clinical trials, the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines have demonstrated very high levels of protection against symptomatic infection. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness with COVID-19 in the UK.
All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.
Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines.
Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received to date, and for the cases of other medical conditions reported in temporal association with vaccination, the available evidence does not currently suggest that the vaccine caused the event.
The overall safety experience with both vaccines is so far as expected from the clinical trials. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is a continuously monitored and benefits and possible risks remain under review.
We take every report of a suspected ADR seriously and encourage everyone to report through the Yellow Card scheme.
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Peter Ragg review
The above information is taken from the government website. I have highlighted the final two paragraphs for you. Here is the link to the government website. You will also find links where you will find the breakdown of the adverse events into different symptoms.
All I am doing is giving you the information, to enable you to then make an informed decision as to whether you want to get vaccinated or not. It’s your call.
As I go to press there are 13 countries that have in the last 48 hours put on hold the use of the AstraZeneca (AZ) vaccine for further investigation due to a number of reported cases of blood clots in the brain as a result of the vaccination, countries include, Germany, France, Italy, Spain, Ireland, Netherlands, Denmark, Norway, Iceland, Austria.
The WHO and the EU have discussed the findings and concerns and are both saying, they have no concerns, and the vaccination program should continue. The UK government has never wavered, and at no point have considered putting the AZ vaccine on hold and have always said the AZ vaccine is safe.
So, what is going on here?
The people simply want to know what is the truth, and that the vaccines are safe? This is especially true in the UK because the people have put their complete trust in the science and are totally believing the government and scientists when they say that the vaccines are safe.
Nothing is straight forward with the pandemic. Vaccines and who made them and at what price has clearly become very political, and we the masses have become pawns in a Big Pharma power game to maximise profits, in my opinion.
The current outcome
Yes, the WHO and the EU (and UK) regulators after further reviewing the data after a significant number of reports of blood clotting from concerned countries are still saying that the vaccines are safe, and the vaccination program should continue. Official announcement expected from EU regulators 18.3.21. I will say here, if this is found not to be the case over time, then we have a very very serious problem.
Observations
You will all know that the vaccines have been released on emergency authorisation, they are not approved, why, because the clinical trials have not been completed. When will they be completed? 2023. Nobody knows what are the long-term side effects of these vaccines?
Therefore, to me it is perfectly acceptable to say, at this time I am not sure, we need to give it longer, simply because we don’t know. We need to be very cautious in my opinion because the bottom line here, what goes into your arm is irreversible and will affect your health in a positive or negative way for the rest of your life. It is your call.
Follow up.
I realise this post is getting a bit long. My next post will be on the vaccines themselves which I would like you to look out for, as it will give you more information on the risk that everyone is taking when the get vaccinated. Information you will not be aware of that you need to know. The post will be called, ‘Losing Your Innate Immunity.’
Thank you.
Kind regards
Peter