In football (Soccer), a yellow card is used by the referee to discipline players for misconduct or failing to follow the rules.
The Yellow Card Reporting Scheme (MHRA) is supposed to provide an early warning that the safety of a medicine or a medical device may require further investigation. In other words, whatever you report will be assessed and logged by the MHRA.
Up until today, I didn't think there were any caveats, imagine my surprise when I open an email from Brian Burch, Signal Assessor, Vigilance Risk Management of Medicines, MHRA, who tells me reporters of adverse events can now decide whether or not they think the medicine, device or, indeed, vaccine, caused that adverse event. Upon doing so the MHRA will then take the relevant action to reflect this on their database.
So, in a nutshell, you or I could take a vaccine and some weeks later suffer with heart problems. After talking with a GP or a heart specialist we can then decide if the vaccine played a part in the heart problem or not.
We don't, it seems, even have to talk to a healthcare professional. We can make our own minds up whether we think the vaccine caused the heart problem or whether the heart problem appeared out of nowhere and isn't vaccine related.
The MHRA will accept our final word on the matter...but only if we don't wish to lay blame on the vaccine.
If we think the vaccine did cause the adverse event, the MHRA, according to Burch, will try to determine whether the reported vaccine was causal, contributory or simply coincidental.
Here's the rub (straight from the written word of Burch)
"In any individual case it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental."
Yet, they will accept a patient or healthcare professional report that suggests it wasn't vaccine related.
If it's 'very difficult, if not impossible' for the MHRA to determine a casual, contributory or coincidental link, why do they assume a layperson, such as you or I, can determine if a vaccine caused or contributed to an adverse event?
Nonetheless, you or I can do the job of the MHRA (probably after speaking with our 'pro-vax' healthcare professional) - Do we have a large number of healthcare professionals who would support our inkling that the vaccine, they may have administered, caused us injury?
One has to ask, if this poor system of reporting vaccine adverse events should be shown the red card.
Anyway, here's the FOIA follow-up response Burch sent to me earlier. It comes on the back of their original reply which can be viewed here.
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From: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>
To: Bob Fiddaman
Subject: GENQ-00150010
Follow up questions
Dear Mr Fiddaman,
Thank you for your recent correspondence where you asked the following:
1. Is a follow-up question/s sent to every single person who reports (via the yellow-card reporting system) an adverse reaction to the vaccine?
2. Is it the position of the MHRA that a UK citizen can determine whether or not an injury was caused by a pharmaceutical product?
Follow up questions are not sent to every single individual who reports a suspected adverse reaction to a Covid-19 vaccine. The MHRA assesses Yellow Card reports using an internal follow up algorithm to determine whether any additional information such as test results, other drugs and/or medical history is required. The MHRA will then contact the original reporter, where contact details are available and permission is granted, to request this information.
The nature of Yellow Card reporting means that reported events are not always proven side effects. The MHRA accepts reports of any suspected adverse reactions as determined by the reporter of the Yellow Card. In any individual case it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental. Should a reporter of a Yellow Card, upon reflection or receipt of additional information, no longer suspect that the drug or vaccine was the cause of the adverse reaction(s) reported the MHRA accepts this information and will take the relevant action to reflect this on our database.
I hope this information is of use, please do not hesitate to contact me if I can be of any further assistance.
Yours sincerely,
Brian Burch
Signal Assessor
Vigilance Risk Management of Medicines
MHRA
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Bob Fiddaman
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