Letter sent from Dr Tess Lawrie to MHRA re IMMEDIATE HALT of vaccine program.

EbMC Squared CiC

Medicines and Healthcare Products Regulatory Agency

Dear Dr. Raine,

RE: Urgent preliminary report of Yellow Card data up to 26th May 2021

The Evidence-Based Medicine Consultancy Ltd

Research for Impact

9 June 2021

As the Director of the Evidence-based Medicine Consultancy Ltd and EbMC Squared CiC, I am writing to share with you this urgent preliminary report on the Yellow Card data up to 26th May 2021. Please note that EbMC Squared CiC is a Community Interest Company that conducts research mandated by the public and funded by public donations. We have no conflicts of interest and do not engage in industry-funded work.

The MHRA describes the purpose of its Yellow Card system as providing “an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about.”1 Furthermore, the MHRA recognises that the conditions under which medicines are studied in clinical trials do not reflect how the medicines will be used in hospitals or clinical practice once they are rolled out. This means that some adverse drug reactions “may not be seen until a very large number of people have received the medicine.”

The Covid-19 vaccines were rolled out in the UK on the 8th of December 2020. As of the 6th May 2021 nearly 39 million people have received their first dose of the Covid-19 vaccine, and 24 million both doses. Sufficient data have now accumulated to get a good overview of adverse


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drug reactions (ADRs). I would, therefore, like to draw your attention to the high number of covid-19 vaccine-attributed deaths and ADRs that have been reported via the Yellow Card system between the 4th January 2021 and the 26th May 2021. In total, 1,253 deaths and 888,196 ADRs (256,224 individual reports) were reported during this period.

To facilitate a better clinical understanding of the nature of the adverse events occurring, primarily to inform doctors at the frontline, we have searched the Yellow Card reports using pathology-specific key words to group the data according to the following five broad, clinically relevant categories:

A. Bleeding, Clotting and Ischaemic ADRs

B. Immune System ADRs

C. ‘Pain’ ADRs

D. Neurological ADRs

E. ADRs involving loss of Sight, Hearing, Speech or Smell

F. Pregnancy ADRs

After running each search, we entered the results into an Excel spreadsheet, excluding ADRs that were clearly irrelevant or appeared in duplicate. These spreadsheets will be used going forward to facilitate the weekly monitoring of Yellow Card data. We recognise that keywords may need expanding to capture category relevant ADRs that may have been missed in this preliminary ADR scope and analysis.

A. Bleeding, Clotting and Ischaemic Adverse Drug Reactions (Table 1)

We used the following SEARCH TERMS to identify bleeding, clotting and ischaemic ADRs: bleed, haemo*, thrombo*, emboli*, coag*, death, ischaem*, infarct*, angina, stroke, cerebrovascular, CVA.

We included the term ‘death’ in this search group, as this term accounted for many reported fatalities (438) without specific details. Given the large number of fatalities without a specific cause of death, we considered that ADRs reported in this way, in particular as ‘sudden death’, would be most likely to occur from haemorrhagic, thrombo-embolic or ischaemic events. Given the seriousness of this ADR, we considered it justifiable to do this pending a Freedom of Information (FOI) request to clarify the cause of death in these 438 people.

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Using these search terms, 13,766 bleeding, clotting and ischaemic ADRs were identified – 856 of which were fatal. Government reports have highlighted the occurrence of cerebral venous sinus thrombosis, apparently accounting for 24 fatalities and 226 ADRs up to the 26th May 2021. However, our analysis indicates that thromboembolic ADRs have been reported in almost every vein and artery, including large vessels like the aorta, and in every organ including other parts of the brain, lungs, heart, spleen, kidneys, ovaries and liver, with life-threatening and life-changing consequences. The most common Yellow Card categories affected by these sorts of ADRs were the nervous system (152 fatalities, mainly from brain bleeds and clots), respiratory (with 103 fatalities, mainly from pulmonary thromboembolism) and cardiac categories (81 fatalities).

B. Immune System Adverse Drug Reactions (Infection, Inflammation, Autoimmune, Allergic) (Table 2)

We used the following SEARCH TERMS to identify immune system ADRs: INFECTION (category), IMMUNE DISORDERS (category), -itis; immun, multiple sclerosis, lupus, myasthenia, pernicious, diabetes, Addison, Crohn’s, Coeliac, Graves, alopecia, amyloidosis, antiphospholipid, angioedema, Behcet's, pemphigoid, psoriasis, aplasia, sarcoidosis, scleroderma, thrombocytopenia, vitiligo, Miller Fisher, Guillain-Barre; allerg*, urticaria, rash, eczema, asthma

To the 26th May, a total of 54,870 ADRs and 171 fatalities fell into this category, which comprised the second most common cause of post-vaccination fatalities after ‘Bleeding, Clotting and Ischaemic ADRs’. However, only 4 associated fatalities were reported under the Yellow card ‘IMMUNE DISORDERS’ category, with the majority (141 fatalities associated with 19,474 ADRs) reported under the ‘INFECTIONS’ category. Among 1,187 people for whom post-vaccination COVID infection was reported, there were 72 fatalities (6% of reported COVID infection ADRs).

Many ‘INFECTION’ category ADRs indicated the occurrence of re-activation of latent viruses, including Herpes Zoster or shingles (1,827 ADRs), Herpes Simplex (943 ADRs, 1 fatal), and Rabies (1 fatal ADR) infections. This is strongly suggestive of vaccine-induced immune-compromise. Bell’s palsy, also associated with latent virus re-activation, is reported in the Neurological ADRs section of this report (D). Also suggestive of vaccine-induced immunocompromise was the high number of immune-mediated conditions reported, including Guillain-Barré Syndrome (280 ADRs, 6 deaths), Crohn’s and non-infective colitis (231 ADRs, 2 deaths) and Multiple Sclerosis (113 ADRs).

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Allergic responses to the vaccines comprised 25,270 reported ADRs, with 4 fatalities occurring among 1,001 people experiencing anaphylactic reactions.

C. ‘Pain’ Adverse Drug Reactions

We used the following SEARCH TERMS to identify pain ADRs: pain, -algia.

Pain ADRs accounted for at least 157,579 ADRs (18%) in total. A large number of these were arthralgias (joint pains – 24,902 ADRs) and myalgias (muscle pains – 31,168 ADRs), including fibromyalgia (270 ADRs), a long-term condition that causes pain all over the body. Among Congenital Disorders (usually conditions present from birth) there were 11 reports of Paroxysmal Extreme Pain Disorder (PEPD), which is an extremely rare inherited disease caused by a genetic mutation leading to dysfunction of voltage-gated sodium channels. The head was the most common location for pain, but abdominal pain, eye pain, chest pain, pain in extremities, and anywhere else that pain can be imagined was reported. Headaches were reported more than 90,000 times and were associated with death in four people (excluding deaths reported to be from other causes, that may also have involved headache).

D. Neurological Adverse Drug Reactions

In addition to examining ADRs in the NERVOUS SYSTEM DISORDERS (category), we used the following SEARCH TERMS to identify neurological ADRS specifically involving paralysis, neurological degeneration, and convulsive ADRs as follows: (paralysis), palsy, paresis, neuropathy, incontinence, Guillain-Barre, Miller Fisher, multiple sclerosis; (neurodegeneration) encephalopathy, dementia, ataxia, spinal muscular atrophy, delirium, Parkinson; (seizure), convuls, seizure, fit, -lepsy

Twenty-one percent (185,474) of ADRs were categorized as Nervous System Disorders in the Yellow Card system. A wide variety of neurological ADRs were noted, including 1,992 ADRs involving seizures and 2,357 ADRs involving some form of paralysis, including Bell’s palsy (626 ADRs). Other ADRs involving encephalopathy (18), dementia (33), ataxia (34), spinal muscular atrophy (1), Parkinson’s (18) and delirium (504) may reflect post-vaccination neurodegenerative pathology.

The majority of fatalities associated with Nervous System ADRs occurred as a result of central nervous system haemorrhages – 127 fatalities out of the 186 fatalities reported as Nervous

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System fatalities. These 127 have been counted in group A (Bleeding, clotting and Ischaemic ADRs).

More information is needed to determine the extent of the morbidity associated with this alarmingly large category of ADRs. Access to the full Yellow Card database and consultation with clinical specialists, along with follow up of these reports, is urgently needed.

E. Adverse Drug Reactions involving loss of sight, hearing, speech or smell

We used the following SEARCH TERMS: speech, taste, smell, olfactory, blind, sight, visual, vision, deaf, hearing.

There were 4,771 reports of visual impairment including blindness, 130 reports of speech impairment, 4,108 reports of taste impairment, 354 reports of olfactory impairment, and 704 reports of hearing impairment.

F. Pregnancy Adverse Drug Reactions

Given that vaccinated pregnant women comprise a small proportion of the vaccinated population in the UK up to 26th May 2021, there appear to be a high number of Pregnancy ADRs (307 ADRs), including one maternal death, 12 stillbirths (report