This post was written by one of the readers of the Trust the Evidence Substack who would like to remain anonymous. The facts are as reported.
I reported the death of a dear friend to the MHRA’s Yellow Card Scheme back in March 2021. She had become immediately unwell following her first COVID-19 vaccination, a pain at the injection site spreading across her chest and leading to a minor heart attack nine days later. Eight days after that, she was dead.
A full 10 months elapsed before the MHRA finally got back in touch to request more details. I had assumed they were busy following up on my report, so I didn’t think to chase them.
I answered the questions as best I could. We didn’t know which vaccine brand or batch number had been administered, but the Yellow Card Service Team assured me they would contact our friend’s GP surgery and obtain those details. Once they had them, they said they would update me.
Weeks, then months, went by. I chased via email, and on April 12th, 2022, over a year since my original report, I was told they had sent a letter to the GP surgery. I waited a few more weeks before contacting them again for an update. This time, I was told:
April 27th, 2022
Unfortunately, the letter has not been posted out from the office yet. When someone from the team is next in the office it will be sent out. Please accept our apologies for the delay. If further information is received, we will be in contact.
I was astonished. Why was the Yellow Card Service Team not working in the office? This was clearly hampering their ability to respond to and thoroughly investigate suspected adverse event reports. What could be more important, at a time when extraordinary efforts were being made to induce even children as young as 5 to “grab a jab”?
I urged the Yellow Card Service Team to phone or email the GP surgery instead to speed up their investigations. To which I was told:
May 6th, 2022
We usually follow up on cases via email, however as only a postal address was provided we have written to the GP and are awaiting a response.
I supplied the GP surgery’s full postal address, website and phone number over a month before. An email address was just one click away. Were they being wilfully obtuse? Or did this illustrate the MHRA’s wholly careless approach to monitoring the safety of brand-new drugs rolled out to millions?The automatic reply from the Yellow Card mailbox said that if I was unsatisfied with the handling of my case, I could contact the Service Team Manager, Faiza Farooq. In June 2022, when my further emails and phone calls were unsuccessful, I decided to do just that. Much to my amazement, I heard from Faiza within five minutes.
June 14th, 2022
Thank you for your email. I will discuss this with my colleagues in the assessment team and get back to you.And then… nothing. More weeks and months passed. I periodically emailed but to no avail. At the beginning of October 2022, I phoned the MHRA. I was told the Benefit-Risk Team was looking into my case and should have an update within days. They did not provide an update.
I even contacted my friend’s GP surgery to see if they would tell me which vaccine and batch number our friend was given. They couldn’t. They also said they hadn’t received any correspondence on the matter, but in the MHRA’s defence, this turned out to be untrue.
I had the idea of submitting a Subject Access Request (SAR) to find out what data and information was being held on me, my adverse drug reaction report and efforts (if any) made by the MHRA to investigate my report. I submitted this on December 16th, 2022.
Their reply on January 30th, 2023 (two weeks after their response was due) was revealing.Firstly, the MHRA had incorrectly logged the age of our deceased friend on their system. Not a great start. More importantly, the SAR revealed the Yellow Card Team’s lacklustre attempts to investigate my report. They had only tried to contact the GP surgery twice – once by letter (in April 2022, after I had started to make a fuss) and once by email (October 11th, 2022, after further urging by me to do so). An email referred to someone’s intention to call the GP surgery, but as far as I can tell, it didn’t happen. Entirely missing was any attempt to contact the hospital where our friend was taken following the heart attack.
I decided to rattle more cages. After all, I’d come this far. Armed with the knowledge that they had indeed been approached, I contacted the GP surgery again. Finally, complete GP records were made available to the Yellow Card Team. After two years of trying, I finally learnt that our friend had been given AstraZeneca, batch AB0002.
I contacted the hospital and requested that complete records be sent; I was doing the MHRA’s job for them. Naturally, the hospital initially said that I would need to obtain our (deceased) friend’s written permission to proceed.
I wrote to the MHRA Chief Safety Officer, Dr. Alison Cave. In the March 2023 board meeting, I was surprised to hear Cave claim that “every single serious adverse event to a vaccine is interrogated and analysed extremely carefully” and that there is ”huge attention to detail and careful analysis of every single report that comes through”.I sent her an account of my experience and urged her to reflect on the issues I raised. She defensively replied two months later, “Our follow-up procedures are robust, and we will further enhance our ability to extract this information in the future.” She also told me about their “proactive strategy” for monitoring the COVID-19 vaccines and that “I consider that we have fulfilled our responsibilities set out under this strategy.” You can read Dr. Cave’s response by downloading the letter here.
I exchanged a few emails with the Director of Nursing at the hospital where our friend had been treated. She was helpful (if slow) and kept me updated as the wheels of MHRA pharmacovigilance slowly creaked into life. Three more months went by. Then the Director of Nursing emailed to say that a verbal discussion had occurred with Phil Tregunno, MHRA Deputy Director of Patient Safety Monitoring, no less. Two years and three months after the original Yellow Card was submitted, something vaguely resembling the ‘analysis’ of my report was finally happening.
Two things stood out from the details I was sent: firstly, the case was discussed verbally, with no records (including scans) being sent via email. Secondly, the MHRA usually requests details of concurrent medication and medical history at the time of administration and not post-administration. I assume that means they aren’t interested in any symptoms experienced after administration, which seems absurd.
This saga had a few more minor twists and turns, but you get the gist. I will just mention that the GP records show our deceased friend was invited back via text for a second jab six weeks after the first one, which potentially killed her. You couldn’t make it up.I can only conclude that the MHRA is hopelessly inept or wilfully blind. I suspect both. The Yellow Card system is supposed to “rigorously” and “continuously” “monitor information on suspected safety concerns” – ready to sound the alarm as an early warning system at the first sign of a problem. It seems pretty clear they aren’t doing even a basic evaluation of suspected lethal side effects. I’d bet my experience is not a one-off.
I wrote to a doctor with cardiac expertise to get his take on what happened to our friend. He wrote back: “It sounds more than likely the vaccine may have triggered myocarditis and led to her death. But you are never going to be able to prove this. The system is big and powerful and wants no vaccine-related deaths to mess up the ‘vaccines are wonderful’ narrative. I think you will only drive yourself nuts looking for answers here.”
I don’t think I’ve driven myself nuts quite yet, but I have accepted that we will never know for sure whether the COVID-19 vaccine killed our friend or whether the timing was simply a coincidence. There were no hugs or kisses the last time we were together because she wanted to be sensible and maintain ‘social distancing’. I think about that often. Do those who work for the MHRA ever spare a thought for the real human beings at the other end of a Yellow Card report? I doubt it.
Our friend was previously healthy and not on any other medication, so when she became immediately unwell after receiving a COVID-19 vaccine and died 17 days later, the least I would expect is that such a report would be adequately and thoroughly investigated as a matter of urgency. The fact that it was not is disturbing. The MHRA’s bombastic and repeated claims about what a good job they are doing could not sound more hollow.
This mess needs sorting out, but who in government has the power and the inclination to do it? From where I’m sitting, I see no one who fits that bill.
Dr. Carl Heneghan is the Oxford Professor of Evidence Based Medicine and Dr. Tom Jefferson is an epidemiologist based in Rome who works with Professor Heneghan on the Cochrane Collaboration. This article was first published on their Substack, Trust the Evidence, which you can subscribe to here.
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