Jenny Brown, an independent healthcare professional with significant nursing experience, has examined and analysed each of the approximately 75 MHRA Yellow Card Covid vaccine reports (adverse events data) published since the beginning of the Covid ‘vaccine’ roll-out. It is her analyses which have informed TCW‘s MHRA Yellow Card reporting to date. We are grateful for her efforts in transforming complexity into clinically relevant and accessible information. Today she reports on changes the MHRA have made to their reporting format and her concerns about it, presenting the latest summary breakdown of the data. This includes the tragic news of a further 2,249 people negatively impacted and a further 42 fatal outcomes reported in the last five weeks.
JUST before Christmas, the Medicines and Healthcare products Regulatory Agency (MHRA) changed their manner of reporting of Yellow Card adverse events.In the first ‘Coronavirus vaccine – summary of Yellow Card reporting’ update of this year, published on January 13, the ‘suspected’ side effects of the ‘vaccines’ are presented in ‘interactive Drug Analysis Profiles’ (iDAPs), which they describe as ‘a new enhanced format of data visualisations’. They claim this provides ‘improvements in format, accessibility and data protection whilst allowing access to more data than has been published previously.’
Stripping away the jargon, charts, graphs and interactive selections have replaced the previous 387 pages of adverse event listing documents for all Covid ‘vaccines’.
Delving into this new format with anticipation, my hope was to find more useful information to continue creating reports to help raise awareness of the impact of these therapies. Would this so-called upgrade in data representation provide more clarity, reassurance and transparency or create more concerns and obfuscation of the situation? I have been surprised and disturbed in equal proportions. Several themes emerge which I discuss before presenting an overview breakdown of data as can now be gleaned.
1. The MHRA has drawn a line under the initial ‘vaccine’ campaign
Although the overall report and reaction totals are cumulative from the initial roll-out, the written information now almost solely focuses on the autumn 2022 boosters. Most of the previously regularly updated text and tables, with important historical data points from the last two years, are no longer available, meaning that important comparisons and context are archived.
This obscures the deeper picture, as the MHRA introductory text continues confidently to report that there is no cause for concern in pregnant women, for fertility, when breastfeeding or for under-18s, and acknowledges only a very rare potential association for menstrual bleeding, myocarditis/pericarditis and reports which have a fatal outcome. Given the growing body of peer-group-published scientific research that arrives at a contrary conclusion, along with ever more concerned doctors and scientists calling a halt to the entire programme, this seems incredibly misleading.
Once again, we are being asked to place blind trust in health authorities as the MHRA reassure us that ‘robust safety monitoring and surveillance continues to be carried out between publications’ and that they will ‘continue to communicate promptly on any updated safety advice when needed’ without any proof that this is happening at all, or how.
2. The MHRA finally admits that the majority of adverse effects are serious
The new interactive format does provide a new and valuable insight into, and admitting the severity of, and is a belated disclosure of, the vast majority of individual reports submitted. This runs directly counter to what MHRA have consistently maintained that ‘Safety monitoring throughout the deployment showed that the most common adverse reactions for all the Covid-19 vaccines were mild and self-limiting “reactogenicity”-type events such as fever, fatigue and injection site pain.’
More than two years of close monitoring of MHRA’s own published data and summarising the Yellow Card reports has shown the numbers of adverse events rising beyond the tens of thousands for blood and nervous system disorders, for cardiac conditions including heart attacks and peri/myocarditis, for eye conditions, infections, for respiratory and immune conditions, for skin, reproductive and breast disorders, for psychiatric distress, and thousands of cases of anaphylaxis, strokes, haemorrhages and thrombosis, seizures and paralysis. Hundreds of people have become deaf or blind. Hardly mild reactions.
In direct conflict with their ‘low risk’ reassurances, the MHRA explain their definition of ‘seriousness criteria for ADR reporting’, determined by a working group of the Council for International Organisations of Medical Sciences (CIOMS), ‘as 6 possible categories which are documented on the Yellow Card’.
· Patient died due to reaction
· Resulted in hospitalisation or prolonged inpatient hospitalisation
· Congenital abnormality
· Involved persistent or significant disability or incapacity
· If the reaction was deemed medically significant. In addition to this, seriousness of reaction terms has been defined by the MHRA.
According to this seriousness definition, the MHRA is now acknowledging that, overall, the Yellow Card Reports for all Covid ‘vaccines’ are classified as serious, totalling 74.3 per cent, with non- serious at just 25.2 per cent. The mismatch between this and their previous declarations that most Yellow Card reactions are mild is quite mind-boggling.
3. Data disguised under the pretext of confidentiality
Prolific throughout the new format is the use of the symbol ^. MHRA explains ‘Where there are less than 5 reports, numbers have been replaced with a ^ in order to prevent patient/reporter identification in line with our duty of confidentiality to patients and reporters’. However, as no identifiable context is disclosed it would seem highly unlikely that confidentiality could or would be breached. This retraction of numerical information means that, for example, alongside the five suicides that we can see have been reported in association with the AstraZeneca ‘vaccine’, we can no longer see the two suicides that we know are associated with Pfizer.
4. The new format obscures child data
Although the new interactive format looks good and can be used to explore different combinations of reported information, it is a lot less accessible in many ways, most critically for data relating to children.
The ‘under 18s’ category has been replaced with 0-9yrs, 10-19yrs, which mixes the outcomes for young school age children before the age of Gillick Competence (under 16), through that potential consenting framework in teen years, with the ‘fully competent’ young adult data. The under-18s category was never adequate and this is not the improvement we have been looking for. The public and medical community urgently require more transparency around the data impacting children, not least because, disturbingly, 71.3 per cent (a total of 6,673)of the 0 -19yr old reports are classified as serious against 28.6 per cent non-serious (2,675).
Also alarming is the 0.1 per cent of 0-19yr old reports classified as fatal by MHRA, equivalent to greater than ten (see below). In addition, we still have more than 370 deaths reported as being ‘Age Unknown’. Why? How can the age of a person who has died be unknown?
5. Downplaying real-world relevance of ‘people’ negatively impacted
By primarily commenting on the bivalent ‘vaccine’ reporting prevalence, the impression given is that the adverse event reporting rate is low at around 0.5 Yellow Cards per 1,000 doses administered. However, if we consider real-world terms, although 53.8million first doses have been administered across the UK, these are ‘people’ who have received one or more doses of a Covid ‘vaccine’. Although over 171million doses have been given, 476,267 Yellow Card reports – that represents nearly half a million people – have been filed, nearly 75 per cent of which, by the MHRA’s own definition, are serious. That’s nearly 354,000 people.
With the presumption that one person completes one report regardless of dose number, approximately 1-in-113 people have been negatively impacted and 1-in-152 people having an experience classified as serious. Yet this reporting rate may well be less than 10 per cent of actual figures according to MHRA itself, especially given the bureaucratic difficulties and time-consuming nature of Yellow Card reporting, as well as ignorance of its existence.
6. The MHRA still proclaims the effectiveness of the ‘vaccines’ despite the evidence
Within the latest updated Yellow Card reporting introductory text, the MHRA persists with the statement: ‘Vaccination is the single most effective way to reduce deaths and severe illness from Covid-19.’ How can this possibly be when the UKHSA’s own data summary clearly demonstrates the ‘vaccine’ effectiveness drops significantly just months after a booster dose? Surely there are other valid ways to support our health and well-being?
They also state that ‘The benefits of the vaccines in preventing Covid-19 and serious complications associated with Covid-19 far outweigh any currently known side effects in the majority of patients.’ And ‘Vaccines are the best way to protect people from Covid-19 and have already saved tens of thousands of lives.’
From our experiences in the real world, where is the evidence for these statements?
And where is the evidence that the current excess mortality, running at 20.7 per cent above the five-year average (2,493 excess deaths for the third week in December 2022), and excess all-cause mortality in the most heavily vaccinated age groups, are completely unrelated to this topic?
By implication, it appears to be expected and acceptable for a sizeable minority of people to experience a serious adverse event up to and including death and with long-term outcomes as yet completely unknown. Just how much more ‘serious’ does it need to get?
MHRA Yellow Card reporting summary up to December 28, 2022
(Data published January 13, 2023) New interactive format
Adult & Child – Primary, Third Dose & Boosters (mono/bivalent)
Government data up to September 11, 2022 – UK-wide (latest)
· 1st doses received = 53.8million people
· 2nd doses – 50.7m people
· 3rd doses/one or more booster – 40,576,925 people
All boosters = 66.86million doses
· Pfizer – 33.1m (monovalent) & 11.1m (bivalent)
· AstraZeneca – 60,800
· Moderna – 13.3m (monovalent) & 9.3m (bivalent)
Yellow Card Adverse Event Reports – 175,724 (Pfizer-mono) + 3,538 (Pfizer-bivalent) + 247,157 (AZ) + 42,706 (Moderna-mono) + 4,860 (Moderna-bivalent) + 52 (Novavax) + 2,230 (Unknown brand) = 476,267 people impacted (increase of 2,249 in 5 weeks)
Reports classified as serious by MHRA = 74.3 per cent
124,114 (Pfizer-mono) + 2,667 (Pfizer-bivalent) + 191,252 (AZ) + 30,825 (Moderna-mono) + 3,472 (Moderna-bivalent) + 34 (Novavax) + 1,592 (Unknown) = 353,956
Reports classified as non-serious by MHRA = 25.2 per cent
50,757 (Pfizer-mono) + 852 (Pfizer-bivalent) + 54,557 (AZ) + 11,796 (Moderna-mono) + 1,356 (Moderna-bivalent) + 18 (Novavax) + 571 (Unknown) = 119,907
Overall 1 in 113 people injected experiences a Yellow Card Adverse Event, 1 in 152 classified as SERIOUS* which may be less than 10 per cent of actual figures according to MHRA.
Total doses administered (approx) = 171,360,000 including all booster programmes
Reactions – 506,216 (Pfizer-mono) + 9,319 (Pfizer-bivalent) + 875,826 (AZ) + 139,933 (Moderna-mono) + 13,131 (Moderna-bivalent) + 106 (Novavax) + 6,838 (Unknown) = 1,551,263
Fatal – 853 (Pfizer-mono) + 19 (Pfizer-bivalent) + 1348 (AZ) + 85 (Moderna-mono) + 32 (Moderna-bivalent) + 67 (Unknown) = 2,404 (increase of 42 reports with fatal outcome in 5 weeks)
370 of the above fatalities are of ‘Unknown Age’
Children & young people special report
Last available dose numbers dataset for under-18s in November 2022
· 4,213,500 children (1st doses) – majority Pfizer
· 2,910,500 (2nd doses) – majority Pfizer
· 485,900 boosters
Yellow Card adverse events reported now 0-9yrs : 10-19yrs segments
Below Combined 0-19yrs – many categories retracted (^) due to less than 5 reports ‘in line with MHRA duty of confidentiality to patients and reporters’
0-19yr old reports classified as serious by MHRA = 71.3 per cent
4,634 (Pfizer-mono) + >26 (Pfizer-bivalent) + 1,457 (AZ) + 518 (Moderna-mono) + >6 (Moderna-bivalent) + >32 (Unknown) = 6,673
0-19yr old reports classified as non-serious by MHRA = 28.6 per cent
1,989 (Pfizer-mono) + >5 (Pfizer-bivalent) + 400 (AZ) + 265 (Moderna-mono) + <5 (Moderna-bivalent) + 16 (Unknown) = 2,675
0-19yr old reports classified as fatal by MHRA = 0.1 per cent
>10 (Pfizer-mono) + zero (Pfizer-bivalent) + <5 (AZ) + <5 (Moderna-mono) + zero (Moderna-bivalent) + <5 (Unknown brand) = greater than 10
Full reports are here.