OUR drugs watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), have sent out the most extraordinary press release ten months into the Covid-19 vaccination campaign. They have decided it is now prudent to use social media to encourage those who have suffered serious or life-changing adverse events to report them to the MHRA’s Yellow Card scheme.
The scheme has been such a well-kept secret since the beginning of the vaccination rollout that many GPs and hospital doctors have never heard of it and virtually none of the public knows what it is. Hospital staff who want to report an adverse reaction (ADR) often find the site blocked from hospital computers. According to an NHS managerial source, who wishes to remain anonymous: ‘We have clinical colleagues who have sent videos showing that the Yellow Card website is BLOCKED from within some hospital sites . . . deliberately so that they cannot report.’
Meanwhile, the press release’s headline is clear. It says: ‘Every report counts: support the Yellow Card scheme by reporting suspected side effects.
‘People who suspect they have may have [sic] experienced a side effect from a medicine or vaccine are being encouraged to report it as part of the global #MedSafetyWeek campaign from 1-7 November 2021.
‘The social media campaign calls upon healthcare professionals, national immunisations programme staff, as well as patients, their carers and families, to report suspected side effects.
‘Healthcare professionals prescribing, dispensing or administering medicines or vaccines are encouraged to discuss side effects with their patients and to be vigilant for new or rare suspected side effects.’
The campaign is backed by healthcare regulators in 60 countries.
Yellow Card is a self-reporting system which informs the MHRA whether something is amiss with a new drug. It is funded largely by Big Pharma and has been accused of allowing the fox to guard the hen house, or to use another metaphor, to mark its own homework. Ministers often dismiss the reports as coincidental because little or no investigation is done into them. The site does not show the age of the person involved or the timeframe of reactions, so it is impossible to know whether the reaction was noticed within 12, 24, 48 hours or one to two weeks after vaccination.
These omissions in data collection mean that basic conclusions about safety cannot be drawn. We know from VAERS, the American system, that most deaths occur within 48 hours of vaccination, which should be a huge red flag. Those details are not available in the weekly summaries the MHRA produce. Therefore, the public and healthcare workers cannot rely on the system to reveal the real incidents of mortality and morbidity.
Earlier this year, this is how the MHRA responded to an inquiry as to the number of vaccine reports they received: ‘We estimate that 10 per cent of all drug reactions are reported to the Yellow Card.’
Asked how they evaluated the few reports they did receive, they said: ‘We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.’
It took a Freedom of Information request to discover that reported death rates in the UK per million doses are approximately 28 times higher for Covid-19 vaccines than for influenza vaccines. This does not support MHRA statements that the number of suspected adverse drug reactions is not unusual for an immunisation programme of this scale.
When the injured report an ADR such as the autoimmune disorder Guillain-Barré syndrome, when the immune system damages nerves causing weakness and sometimes paralysis, or vaccine-induced thrombotic thrombocytopenia (VITT) characterised by blood clots and low platelets, they receive an acknowledgement but not much else. None of the seven we spoke to who reported injuries after being injected with Oxford/AstraZeneca’s batch PV46671 has had any meaningful follow up.
One of the seven, BBC food broadcaster Jules Serkin, 63, from Canterbury, reported her serious adverse reaction in May, two months after receiving the AstraZeneca (AZ) vaccine. Since the jab, she’s had constant headaches, tested positive for blood clots, and had problems with her eyesight and pains in her legs and sinuses. Her symptoms have worsened over time and no help has been offered to her or to her GP by either the MHRA or AZ. She said: ‘I have not heard back from the MHRA. My doctor submitted a report to AstraZeneca in September but we have heard nothing since.
‘I’m bouncing from pillar to post trying to find help.’
It is vital that the MHRA see as many reports as possible to get a realistic overview.
Men’s sexual and reproductive data is particularly under-reported, even by the alternative media.
In September, Trinidadian-born singer Nicki Minaj tried to raise awareness and was ridiculed for a Twitter post that her 2million followers sent viral. It said her cousin’s friend was jilted at the altar by his fiancée because the Covid-19 vaccine had made his testicles swell. #BallGate turned into quite a drama with the White House inviting Nicki to a meeting aimed at neutralising her views and to ‘talk to one of our many doctors to answer questions about the safety and effectiveness of the vaccines’. Meanwhile, the MHRA have quietly been receiving reports of swollen testicles plus erection and ejaculation disorders.
Their data also show other disturbing reports affecting men’s sexual health.
MHRA Yellow Card reporting up to October 20 (published October 28, 2021)
Out of the 49.6million people injected the average rate of overall reporting rate for all vaccines combined is 1-in-131 people impacted.
Total fatalities – 1,738; Pfizer – 576, AstraZeneca – 1,111, Moderna – 20, Unspecified – 31
Men’s sexual/reproductive health specific data
Infections including epididymitis (swelling in one or both testicles), orchitis (inflammation of the testes) and prostate (gland located between penis and bladder)
• Pfizer = 13
• AZ = 13
• Moderna = 2
Penis injury or contusion (blood builds up under the skin and penis may become swollen and badly bruised)
• Pfizer = 1
• AZ = 4
Neoplasms (excessive tissue growth) including prostate, male breast, penile and testicular cancers
• Pfizer = 4
• AZ = 12
Erection and ejaculation disorders
• Pfizer = 78
• AZ = 135
• Moderna = 19
Penile, scrotal and prostate disorders
• Pfizer = 61
• AZ = 88
• Moderna = 9
Sperm and testicular disorders
• Pfizer = 72
• AZ = 180
• Moderna = 16
Gynaecomastia (swelling in men’s breasts)
• Pfizer = 3
• AZ = 9
The last word should go to Mick Foy, Head of Pharmacovigilance Strategy at the MHRA, who says: ‘The most important part of our work is making sure the vaccines and medicines you and your family take are effective and acceptably safe. This campaign comes at a crucial time when millions of people in the UK are vaccinated against COVID-19 but is equally applicable to all vaccines and medicines.
‘Yellow Card scheme reports play a key role in helping the MHRA monitor the safe use of all medicines and vaccines to protect public health through effective regulation.’