DearDr. Raine,
RE: Urgent preliminary report of Yellow Card data up to 26thMay 2021
As the Director of the Evidence-based Medicine Consultancy Ltd and EbMCSquaredCiC, I am writing to share with you this urgent preliminary report onthe Yellow Card data up to 26thMay 2021. Please note that EbMCSquared CiC is a Community Interest Company that conducts research mandated by the public and funded by public donations. We have no conflicts ofinterest 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.”1Furthermore, 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 6thMay2021nearly39million people have received their first dose of the Covid-19 vaccine, and 24million both doses. Sufficient data have now accumulated to get a good overview of adverse 1https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
Evidence-Based ConsultancyMedicineLtdThedrug reactions(ADRs). Iwould, 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 4thJanuary 2021 and the 26thMay 2021. In total,1,253deaths and 888,196ADRs (256,224individual reports) werereportedduring this period.To facilitate a better clinical understanding of the nature of the adverse events occurring, primarily to inform doctors at the frontline, we havesearched the Yellow Card reports using pathology-specific key wordsto group the data according to the following five broad, clinicallyrelevant categories:A.Bleeding, Clotting and Ischaemic ADRsB.Immune System ADRsC.‘Pain’ADRs D.Neurological ADRsE.ADRs involvingloss of Sight, Hearing, Speech or SmellF.Pregnancy ADRsAfter running each search, we entered theresults into an Excel spreadsheet, excludingADRs that were clearly irrelevant or appeared in duplicate.Thesespreadsheets will be used going forward to facilitate the weekly monitoring of Yellow Card data. We recognise that keywords may need expandingto capture category relevant ADRsthat 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 TERMSto identify bleeding, clotting and ischaemic ADRs: bleed, haemo*, thrombo*, emboli*, coag*, death, ischaem*, infarct*, angina, stroke, cerebrovascular, CVA. Weincluded 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, weconsidered 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 thispending a Freedom of Information (FOI) request to clarify the cause of death in these 438people.
Evidence-Based ConsultancyMedicineLtdTheUsing these search terms, 13,766bleeding, clotting and ischaemic ADRs were identified–856of which were fatal.Government reports have highlighted the occurrence of cerebral venous sinus thrombosis,apparently accounting for 24fatalities and 226ADRsup to the 26thMay 2021. However, our analysis indicates thatthromboembolic ADRs havebeen reported in almost every vein and artery, including large vesselslike the aorta,and in every organincluding otherparts of the brain, lungs, heart, spleen, kidneys, ovaries and liver,with life-threatening and life-changing consequences. The most common Yellow Card categoriesaffected by these sorts of ADRs were the nervous system (152 fatalities, mainly from brain bleeds and clots), respiratory (with 103fatalities,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 TERMSto 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, asthmaTo the 26thMay, a total of 54,870ADRs and 171fatalitiesfell 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 with19,474 ADRs)reported under the ‘INFECTIONS’ category. Among 1,187people for whom post-vaccination COVID infection was reported, there were 72 fatalities(6% of reported COVID infection ADRs). Many‘INFECTION’ categoryADRs indicatedthe 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 isstrongly 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 wasthe high number of immune-mediatedconditions reported, including Guillain-BarréSyndrome (280 ADRs, 6 deaths), Crohn’s and non-infective colitis (231 ADRs, 2 deaths) and Multiple Sclerosis(113 ADRs).
Evidence-Based ConsultancyMedicineLtdTheAllergic responses to the vaccines comprised 25,270reportedADRs, with 4 fatalities occurring among 1,001 people experiencing anaphylactic reactions.C. ‘Pain’Adverse Drug ReactionsWe used the following SEARCH TERMSto identify pain ADRs: pain, -algia. Pain ADRs accounted for at least 157,579ADRs(18%) in total.A large number of these were arthralgias (joint pains –24,902ADRs) and myalgias (muscle pains –31,168ADRs), including fibromyalgia(270 ADRs), a long-term condition that causes pain all over the body. Among Congenital Disorders (usually conditions present from birth)there were11 reports of Paroxysmal Extreme Pain Disorder (PEPD), which is an extremely rare inherited disease caused by a genetic mutationleading 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 imaginedwas reported. Headaches were reported more than 90,000timesandwereassociated withdeath in four people(excluding deaths reported to be from other causes, that may also have involved headache). D. Neurological Adverse Drug ReactionsIn addition to examining ADRsin the NERVOUS SYSTEM DISORDERS (category), we used the following SEARCH TERMSto 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, -lepsyTwenty-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 ADRsinvolving seizures and 2,357 ADRsinvolving 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 asNervous
Evidence-Based ConsultancyMedicineLtdTheSystem 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 smellWe 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 ReactionsGiven that vaccinated pregnant women comprise a small proportion of the vaccinated population in the UK up to 26thMay 2021, there appear to be a high number of Pregnancy ADRs (307ADRs), including one maternal death, 12stillbirths(reported as 6 stillbirths and 6 foetal deaths, but only 3 listed as fatal(?)), one newborn death following preterm birth, and 150spontaneous abortions. We have submitted a FOI request as to the cause of the maternal deathand will look into pregnancy and congenital ADRs in more detail in our next report.Limitations of this rapid reportThis report is not comprehensive, and analysis of Yellow Card data is ongoing. The process of defining the search terms was iterative and we trust that it provides a basis for discussion amongclinicians and scientists. We have not compared the frequencies of ADRs between different vaccines; however, our impression is thatADRs were not limited to any particular vaccine brand (AstraZenenca, Pfizer and Moderna) or type (mRNA and DNA) currently used in the UK. UK ADR data mirror data reportedon the World Health Organization’s pharmacovigilance database
Evidence-Based ConsultancyMedicineLtdThe(www.Vigiaccess.org). On the latter, most reported ADRs to date (941,774 ADRs and 5,474 deaths) have occurred among individuals in the 18 to 44 years and 45 to 64 years of age categories (38% and 35%, respectively); the vast majority (72%) of reported ADRs have occurred among women. Unfortunately, we have been unable to examine the UK Yellow Card data accordingto age and gender due to lack of data availability.We are aware of the limitations of pharmacovigilance data and understand that information on reported Adverse Drug Reactions should not be interpreted as meaning that themedicine in question generally causes the observed effect or is unsafe to use. We are sharing this preliminary report due to the urgent need to communicate information that should lead to cessation of the vaccination roll out while a full investigation is conducted. According to the recent paper by Seneff and Nigh (1), potential acute and long-term pathologies include:•Pathogenic priming, multisystem inflammatory disease and autoimmunity•Allergic reactions and anaphylaxis•Antibody dependent enhancement•Activation of latent viral infections•Neurodegeneration and prion diseases•Emergence of novel variants of SARSCoV2•Integration ofthe spike protein gene into the human DNAThe nature and variety of ADRs reported to the Yellow Card System are consistent with the potential pathologies described in this paper and supported by otherrecent scientific papers onvaccine-induced harms, which are mediated through the vaccine spike proteinproduct(2,3). It is now apparent that these products in the blood streamare toxic to humans.An immediate halt to the vaccination programme is required whilst a full and independent safety analysis is undertaken to investigate the full extent of the harms, which the UK Yellow Card data suggest include thromboembolism, multisystem inflammatory disease, immune suppression, autoimmunity and anaphylaxis, as well asAntibody Dependent Enhancement (ADE). Due to the need for expedience, we have not detailed all ADRs in this preliminary report.The existing Yellow Card data covering just under a five-month period indicate that the extent of morbidity and mortality associated with the COVID-19 vaccines is unprecedented. Ageand gender specific data, as well as the time from vaccination,are requiredto further our analysis of these data and we have sent Freedom of Information Requests (FOIRs)to the MHRA in this regard.
Evidence-Based ConsultancyMedicineLtdTheInaddition, urgent independent expert evaluation and discussion is required to assess whether the novel vaccines may be causinggene mutations among recipients, as suggested by the occurrence of usually extremely rare geneticdisorders, such as Paroxysmal Extreme Pain Disorder(PEPD). In addition to the 11 cases of PEPD on the Yellow Card system, there are currently 12 reports of this extremely rare condition on the WHO’s Vigiaccess.orgdatabase and 10 on the European Medicines Agency’s (EUDRA) pharmacovigilance database. Are these ADRs occurring in babies of vaccinated pregnant women, or spuriously among vaccinated adults? This question needs urgent attention.As pharmacovigilance data are known to be substantiallyunder-reported, werecommend that the MHRA urgently publicises these ADR data and assists people with their ADR reporting, to facilitate full elucidation and clarification of the extent of the problem.The MHRA now has more than enough evidence on the Yellow Card system todeclare the COVID-19 vaccines unsafe for use in humans. Preparation should be made to scale up humanitarian efforts to assist those harmed by the COVID-19 vaccines and to anticipate and ameliorate medium to longer term effects. As the mechanism for harms from the vaccines appears to be similar to COVID-19itself, this includes engaging with numerous international doctors and scientists with expertise in successfully treating COVID-19.There are at least 3 urgent questions that need to be answered by the MHRA:1How many people have diedwithin 28 days of vaccination?2How many people have been hospitalised within 28 days of vaccination?3How many people have been disabled by the vaccination?EbMCSquared CiC remains at your service to assist with further analysis.Wekindly request full access to the Yellow Card database with immediate effect to enable a comprehensive, independent and accurate evaluation of the Yellow Card data, which will be undertaken in collaboration with clinical experts.
Yours sincerely,
Dr. Tess Lawrie (MBBCh, PhD) Director, Evidence-based Medicine Consultancy Ltd and EbMC Squared CiCBath, UK
Evidence-Based ConsultancyMedicineLtd
References
1.Seneff S, Nigh G. Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, Practice, and Research. 2021;2(1):402-43.
2.Kowarz E, Krutzke L, Reis J, Bracharz S, Kochanek S, Marschalek R. “Vaccine-induced covid-19 mimicry” Syndrome: Splica reactions withing the SARS-CoV-2 spike open reading frame result in spike protein varienat that may cause thromboembolic events in patients immunized with vector-based vaccines. Research Square. DOI: https://doi.org/10.21203/rs.3.rs-558954/v1.3.Ogata AF, Cheng C-A, Desjardins M, Senussi Y, Sherm
an AC, Powell M, et al. Circulating SARS-CoV-2 vaccine antigen detected in the plasma of mRNA-1273 vaccine recipients.Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciab465.
