Vaccine Safety
Background:
Soon after mass vaccinations began in January 2021, reports of serious adverse reactions following the injections began to surface worldwide and still more are being documented.[1] [2]
Over time more individual testimonies have been gathered and turned into the documentaries Anecdotals and The Testimonies.
The government acknowledged that there would be significant amounts of people with mild short-term side effects but that it was better to take the shot anyway.[3] The more serious adverse reactions were dismissed as having no proven link to the vaccination.[4]
As time passed, doctors began voicing their concerns.[5] [6] [7] The adverse effects on younger people were of particular concern, since they are at a much lower risk from COVID. The Israeli Public Council of experts, a group of physicians from Sweden,[8] and America's Frontline Doctors (AFLDS)[9] in the U.S., all called for suspending vaccinations for people under 30.[10]
An international group of doctors, healthcare professionals and scientists issued a policy declaration calling for, among other actions, a stop to the worldwide vaccination campaign and a full investigation. The declaration has accumulated over 25,000 signatures.[11]
Early on, experts warned that these vaccines could cause significant damage to people’s health.[12] [13] [14] [15]
Data showing significant adverse events:
A German study found that German states with higher vaccination rates had higher excess mortality than less vaccinated states.[16]
During the vaccine campaign, England,[17] Scotland,[18] Israel,[19] and Queensland, Australia,[20] saw 25%–40% increases in ambulance calls for cardiovascular events among young people.
Germany's largest health insurer Techniker Krankenkasse revealed that 1 in 25 clients underwent medical treatment for COVID vaccine side effects, an increase of 3000% over previous years’ vaccine side effects. The insurer only made this information public following a freedom of information request.[21]
The U.S. Bureau of Labor Statistics records the number of Americans 16 years and over with disabilities. This population remained stable from 2016 to 2020 but jumped sharply in early 2021[22] coinciding with the rollout of COVID injections.
Anecdotally, there has been an increase in sudden and unexplained deaths worldwide even among athletes[23] [24] [25] with many captured on video.[26] This increase has since been documented by the KBV in Germany.[27] The graph below shows the dramatic increase in sudden and unspecified death starting with the vaccine rollout.
The Israel Ministry of Heath conducted a survey[28] of those who received a COVID booster. It revealed significant adverse reactions; 0.29% had to be hospitalized, while 29% reported difficulty performing daily activities, and 4.5% reported neurological issues.[29]
The German Heath Ministry reported that the rate for serious reactions is 0.2 reports per 1,000 vaccine doses (1 in 5000 doses).[30]
One study looked at data collected from vaccine recipients in 11 European countries. According to the data 0.2%–0.3% reported at least one serious adverse reaction (SAR) after receiving the first and/or the second dose. Similar percentages reported SARs after the first booster.[31] This study showed SAEs (serious adverse events) in about 1 in 500–1 in 350 per dose.
The CDC's vaccine monitoring program called V-Safe is a voluntary, smartphone-based U.S. vaccine safety surveillance system that tracks users and seeks to identify trends in adverse event reporting. The CDC refused to release V-Safe data until compelled by a court order in October 2022. ICAN created a dashboard to better understand the raw data.[32]
The data show that of the approximately 10 million V-Safe users 782,913 individuals, representing over 7.7% of V-Safe users, had a health event requiring medical attention, emergency room intervention, and/or hospitalization. Another 25% of V-Safe users had an event that required them to miss school or work and/or prevented normal activities.[33]
A study published by the BMJ looked at the risk-benefit analysis for mandating boosters for college students. The study found that it would take an average of 37,000 students getting boosted in order to prevent one COVID hospitalization, and concluded, “[O]ur estimate shows that university COVID-19 vaccine mandates are likely to cause net expected harms to young healthy adults—for each hospitalisation [from COVID] averted [due to vaccination] we estimate approximately 18.5 SAEs and 1430–4626 disruptions of daily activities."[34] This means that for every COVID hospitalization saved, more than 18 students would experience a serious adverse event. The study concluded that the damage caused by COVID boosters is "not outweighed by a proportionate public health benefit."
The State of Florida, in a statement recommending against vaccinating males aged 18 to 39 cited their own investigation[35] that showed an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days of an mRNA vaccination.[36]
A CDC report that studied the effects of boosters in 5–11 years olds found that 13%–14% were unable to attend school or perform daily tasks, 1.9% needed medical care, and 0.2% experienced a serious adverse event.[37]
The pedia provides a separate examination of the increase in all-cause mortality, fertility, and vaccine-related increases in cases of COVID.
Interview with Dr. Clare Craig
Cardiovascular Events:
A study looking at teenagers in Thailand found that about 29% of vaccine recipients experienced documented cardiovascular events, including 17% (54 out of 301) who had abnormal electrocardiograms.[38]
An Israeli study found that "males of all ages had myocarditis occur at 0.64 cases per 100,000 persons after the first dose and 3.83 cases per 100,000 after the second dose -- with the incidence increasing to 1.34 and 15.07 per 100,000 after the first and second doses, respectively, for teenage boys ages 16 to 19."[39]
Some have suggested that the risk of myocarditis is higher after a COVID infection. Even if it were, it would need to be divided by the chances of getting infected. Nevertheless, an Israeli study found no increase after COVID infections, concluding, "we did not observe an increased incidence of neither [sic] pericarditis nor myocarditis in adult patients recovering from COVID-19 infection."[40]
While other studies have found an increase in myocarditis after COVID infections, a study for the University of California found that boys aged 12-17 are 6.1 times more likely to be hospitalized for heart conditions after a second COVID vaccine dose than they are of being hospitalized from COVID.[41]
SAEs in Moderna and Pfizer studies:
A study by the editor of the British Medical Journal looked at the risk of experiencing a Serious Adverse Event (SAE) in both the Pfizer and Moderna randomized controlled trials. These were the RCTs that were used to get Emergency Use Authorization.
The study compared the vaccine group to the placebo group and found an "absolute risk increase of serious adverse events of special interest of 12.5 per 10,000" compared to the placebo group. The study continued by stating that “The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).” [42] To put it another way, the study shows that serious adverse events occurred 1 in 800 – this is from data used to approve that vaccines[43]
Over the course of the six-month study period, Pfizer vaccine recipients had 4 times as many cardiac arrests as those in the control group.[44]
Interview with Dr Aseem Malhotra, a cardiologist who was one of the first people in the UK to take COVID vaccine and then promoted it on television. He later reassessed the evidence[45] and called for a stop to the vaccination campaign.[46]
Adverse events reporting:
The Vaccine Adverse Event Reporting System (VAERS) which is “a national early warning system to detect possible safety problems in U.S.-licensed vaccines,”[47] tallied over 34,385 deaths associated with the COVID vaccines alone.[48] Reported deaths in connection to the COVID vaccines total more than all vaccines-related deaths over the past 31 years, combined.[49]
Source: https://openvaers.com/covid-data
A similar phenomenon is observed in the European reporting system,[50] in England,[51] and at the World Health Organization (WHO).[52]
In addition to deaths, other serious adverse reactions leading to permanent disability, hospitalization, or threatening the patient’s life have been reported.[53]
In July 2021 the CDC acknowledged an error in the VAERS reporting system that led to the near doubling of COVID vaccination deaths.[54] At around the same time a whistleblower came forward with a sworn declaration stating that the actual number of reported deaths was closer to 45,000.[55]
The CDC was obligated to look into these adverse event reports, but according to a response to a Freedom of Information Act (FOIA) request, the CDC had not fulfilled its obligation.[56]
Data quality and underreporting:
Since these cases are self-reported and have not been confirmed as having been caused by the vaccination, it is difficult to say exactly how many are a result of the vaccines. However, most reports are submitted by healthcare workers[57] and false reporting is a violation of Federal law punishable by a fine and imprisonment.[58]
Another issue to consider is that adverse events are under-reported to the system, so the real number of adverse events is higher than reported. The question is by how much?
Anaphylaxis is a good example because anaphylaxis reactions occur within minutes of injection, so there is a higher chance that they would be related to the vaccine and reported. Still, they are significantly under-reported.
One study found 2.47 anaphylaxis reactions per 10,000 vaccinations occurring shortly after the vaccination, but only 0.025 - 0.11 per 10 000 vaccinations were reported to VAERS.[59] This is equivalent to 50 to 120 times more cases than what VAERS and the CDC are reporting. Put differently, only 0.8 to 2 percent of all cases of anaphylaxis are posted to the VAERS.[60]
A study from November 2012 published a systematic review of Adverse Drug Reactions (ADRs). The paper examined 37 studies and found that “the median under-reporting rate across all studies was 94%.” Even serious or severe ADRs 85% - 95% were under-reported.[61]
In the original Pfizer trial report for the COVID vaccine, 0.7% of vaccine recipients suffered SAEs (Serious Adverse Events), [62] based on that there should be 2.4 million SAEs among American vaccine recipients. However, as of August 2021, there were only around 78,000 in the VAERS database, suggesting a 30:1 underreporting rate for SAEs [63] or there were dramatically more SAEs in the Pfizer trial.
BKK ProVita, a German health insurance provider examined doctors' visits involving COVID vaccine injuries and found some 217,000 people received medical treatment for a vaccine injury. Extrapolated to the whole Germany population that would be about 2.5-3 million people. However, there were only about 243,000 official reports at the time in all of Germany. The report concludes, ". . . there is a very considerable under-recording of suspected cases of vaccination side-effects after they received the [COVID-19] vaccine."[64]
It's impossible to know how much the under-reporting rate is, but among the different estimates, all show significant under-reporting.[65]
Pfizer overwhelmed by Adverse Event reports:
Pfizer itself received over 150,000 reports of adverse reactions including 1,200 deaths by March 2021 - after only 3 months on the market.[66] So many reports were coming in that the company had to hire 1,800 more full-time employees to handle the workload according to its reports with the FDA.[67]
Causation:
Adverse events following vaccination, does not necessarily mean the vaccine caused the event. The Bradford Hill criteria which is widely used in public health research is a set of nine principles that can be useful in establishing epidemiologic evidence of a causal relationship.[68] Dr. Peter McCullough,[69] cardiologist and epidemiologist explains how causation can be shown in this situation.
The Israeli government researchers found a causal link in many adverse events. They found patients who experienced adverse events shortly after vaccination. The symptoms subsequently disappeared but returned after receiving a booster. This, according to the researchers, was sufficient proof of causation. [70]
Although autopsies were not conducted on all the thousands of suspected vaccine deaths, there were a number of studies that investigated and concluded a causal relationship between the COVID vaccination and death; the mechanism often being blood clots or other cardiovascular issues. [71][72][73][74][75][76]
Safety compared to other routine vaccines:
One meta-analysis compared various adverse events after COVID and after non- COVID vaccinations. There were 2,263.4 cases of arrhythmia per million doses after COVID shots vs. 9.9 cases per million doses after non-COVID shots. There were 4,367.5 cases of tachyarrhythmia per million doses after COVID shots vs. 25.8 per million following non-COVID shots.[77]
Vaccine injury risk vs COVID risk:
It is worthwhile noting that if these suspected vaccine deaths were catalogued using the same criteria used to catalogue COVID deaths, they would all be considered vaccine deaths since the vaccine is a suspected contributing cause of death. However, this point speaks more to the absurdity of defining a COVID death, than it does in showing vaccine injury. Once COVID deaths are defined the same way that other causes of death are defined, a fair comparison can be made.
Previous unsafe vaccines:
Other vaccines with much safer profiles have been pulled from the market in the past. For example, the Rotavirus vaccine was suspended[78] by U.S. authorities in the late 1990s after 100 babies became ill, and one died out of approximately one million doses. The vaccine was pulled from the market even though officials stated that “no firm link had been drawn between the vaccine and the children's illnesses.”[79] The 1976 swine flu vaccine was pulled from the market[80] after 500 people contracted Guillain-Barre syndrome and were associated with 25 deaths out of 43 million doses (1 in 17 million).
There was no conclusive proof that these relatively few deaths were a result of the vaccine, yet the government halted the entire vaccination campaign. As of February 2023, there are over 34,000 deaths in question, yet the government still maintains the COVID vaccines are safe.
Lists of COVID vaccine safety studies:
1000 Peer-Reviewed Studies Questioning COVID-19 Vaccine Safety (Jan 2022):
750+ Studies About the Dangers of the COVID-19 Injections (April 2022)
https://doctors4covidethics.org/750-studies-about-the-dangers-of-the-covid-19-injections/
1250+ COVID Vaccine Publications and Case Reports (July 2022)
https://react19.org/1250-covid-vaccine-reports/
Science, Facts & Data About COVID-19 and Vaccines
https://www.scribd.com/document/586415641/Science-Facts-Data-about-COVID-19-and-vaccines#
“It was very unfortunate, that from the beginning, what was presented to us by public health officials was a picture of great certainty…but the reality was that there were extremely important unknowns. We entered a situation where essentially the stakes became too high to later present that uncertainty to people…I think that’s what set us off on the wrong foot. Public officials should have been a lot more forthright about the gaps in our knowledge.”[81]
-Dr. Peter Doshi, a senior editor at the British Medical Journal (BMJ) and associate professor at the University of Maryland School of Pharmacy
Email questions or comments to frontlinepedia@aflds.org
Footnotes:
[1] https://www.vaxtestimonies.org/en/
[2] https://covidvaccinereactions.com/wp-content/uploads/2021/04/OCR_Frontline-Workers-Testimonies_News-Reports_VAERS-data_12APR2021-2-optimized.pdf
[3]https://www.sfchronicle.com/health/article/The-coronavirus-vaccine-comes-with-more-side-15795971.php
[4] https://www.dw.com/en/fact-check-no-links-found-between-vaccination-and-deaths/a-56458746
[5] https://uncoverdc.com/2021/05/31/vaccine-expert-warns-we-made-a-big-mistake/
[6] https://downloads.regulations.gov/FDA-2021-P-0460-0001/attachment_1.pdf
[7] https://trialsitenews.com/wp-content/uploads/2021/06/Yellow-Card-Letter.pdf
[8] https://sputniknews.com/europe/202105061082813839-do-not-vaccinate-young-and-healthy-swedish-doctors-pen-open-letter-against-blanket-inoculation/
[9] https://americasfrontlinedoctors.org/2legal/tro/
[10] https://www.pecc.org.il/docs/call%20to%20suspend%20vaccination%20eng.pdf
[11] https://medicalcrisisdeclaration.com/
[12] https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions
[13] https://www.scientificamerican.com/article/nih-very-concerned-about-serious-side-effect-in-coronavirus-vaccine-trial/
[14] “The spike protein used in the COVID-19 vaccine posed a health risk”
[15] https://www.lifesitenews.com/news/french-infectious-disease-expert-shocked-by-the-number-of-adverse-reactions-to-covid-19-vaccine
[16] “The higher the vaccination rate, the higher the excess mortality.”
https://frontline.news/post/german-study-the-higher-the-vaccination-rate-the-more-excess-mortality
[17] https://expose-news.com/2021/07/31/calls-ambulance-cardiac-arrest-unconsciousness-skyrocket/
[18] https://dailyexpose.uk/2021/11/26/heart-disorders-and-excess-deaths-among-young-adults-rising/
[19] https://frontline.news/post/new-study-shows-25percent-increase-in-cardiovascular-event-during-vaccine-rollout
[20] https://frontline.news/post/queensland-health-minister-unable-to-explain-high-increase-in-heart-attacks-chest-pains
[21] "Based on the figures from Techniker Krankenkasse, as many as one in 500 injections is expected to cause a serious side effect"
[22] https://fred.stlouisfed.org/series/LNU00074597
[23] https://goodsciencing.com/covid/athletes-suffer-cardiac-arrest-die-after-covid-shot/
[24] https://expose-news.com/2022/06/04/athlete-deaths-18x-higher-than-expected/
[25] https://www.theepochtimes.com/more-than-270-sudden-cardiac-deaths-in-us-athletes-after-vaccination-peer-reviewed-study_4960561.html
[26] https://americasfrontlinedoctors.org/2/wp-content/uploads/2021/11/vlc-record-2021-11-12-10h50m18s-Whats-Going-On_-.mp4?_=1
[27] https://amidwesterndoctor.substack.com/p/the-most-important-dataset-of-the
[28] https://galileoisback.substack.com/p/translated-israeli-moh-survey-of?utm_source=url
[29] https://jackanapes.substack.com/p/the-israeli-ministry-of-health-actually-db7
[31] https://zenodo.org/record/6629551#.YthrfHbMJD8
[32] https://icandecide.org/V-Safe-data/
[33] https://www.prnewswire.com/news-releases/cdcs-covid-19-vaccine-V-Safe-data-released-pursuant-to-court-order-
[34] https://jme.bmj.com/content/early/2022/12/05/jme-2022-108449
[35] https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-analysis.pdf?utm_medium=email&utm_source=govdelivery
[36] https://content.govdelivery.com/accounts/FLDOH/bulletins/3312697
[37] https://www.cdc.gov/mmwr/volumes/72/wr/mm7202a5.htm
[38] https://www.theepochtimes.com/29-percent-of-young-pfizer-covid-vaccine-recipients-suffered-heart-effects-study_4655100.html
https://www.mdpi.com/2414-6366/7/8/196
[39] https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94892
[40] https://pubmed.ncbi.nlm.nih.gov/35456309/
[41] https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1
[42] https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239
[43] https://brownstone.org/articles/are-the-covid-mrna-vaccines-safe/
[44] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf (page 12)
[45] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557944/
[46] https://frontline.news/post/profiles-in-courage-aseem-malhotra
[47] https://vaers.hhs.gov/about.html
[48] https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&VAX%5B%5D=COVID19&DIED=Yes
[49] https://www.openvaers.com/covid-data/mortality
[50] https://healthimpactnews.com/2021/12184-dead-1196190-injuries-european-database-of-adverse-drug-reactions-for-covid-19-vaccines/
[51] https://ukfreedomproject.org/covid-19-vaccines-yellow-card-analysis/
[53] https://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=CAT&EVENTS=ON&VAX=COVID19
[54] https://www.theepochtimes.com/mkt_breakingnews/spike-in-death-reports-following-covid-19-vaccination-an-error-cdc_3911934.html?utm_source=newsnoe&utm_medium=email&utm_campaign=breaking-2021-07-21-3&mktids=245868de338d30200637a1f4212930dd&est=[EMAIL_SECURE_LINK
[55] https://dailyexpose.co.uk/2021/07/19/vaers-whistleblower-45000-dead-from-covid-19-vaccines-within-3-days-sparks-lawsuit-against-federal-government/
[56] https://frontline.news/post/cdc-admits-failure-to-monitor-covid-vaccine-safety
[57] https://openvaers.com/faq/who-reports-to-vaers
[58] https://vaers.hhs.gov/reportevent.html
[59] https://jamanetwork.com/journals/jama/fullarticle/2777417
[60] http://www.skirsch.com/covid/anaphylaxisLetter.pdf
[61] https://link.springer.com/article/10.2165/00002018-200629050-00003
[62] https://www.fda.gov/media/144245/download (5.2.6 page 33)
[63] https://roundingtheearth.substack.com/p/how-underreported-are-post-vaccination?s=r
[64] https://www.theepochtimes.com/data-show-significant-underreporting-of-vaccine-side-effects-german-health-insurer_4297632.html
[65] https://vaersanalysis.info/2021/12/13/using-cms-whistleblower-data-to-approximate-the-under-reporting-factor-for-vaers/
https://thevaccinereaction.org/2020/01/only-one-percent-of-vaccine-reactions-reported-to-vaers/
[66] https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf (page 6 &7)
[67] "To date, Pfizer has onboarded approximately 600 additional full-time employees (FTEs). More are joining each month with an expected total of more than
1,800 additional resources by the end of June 2021." (page 6)
https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf
[68] https://en.wikipedia.org/wiki/Bradford_Hill_criteria
[69] https://www.linkedin.com/in/petermcculloughmd
[70] https://childrenshealthdefense.org/defender/israeli-health-officials-safety-problems-pfizer-covid-vaccine/
[71] https://link.springer.com/article/10.1007/s00414-021-02706-9
[72] https://pubmed.ncbi.nlm.nih.gov/35157759/
[73] https://link.springer.com/article/10.1007/s00392-022-02129-5
[74] https://doctors4covidethics.org/on-covid-vaccines-why-they-cannot-work-and-irrefutable-evidence-of-their-causative-role-in-deaths-after-vaccination/
[75] https://www.trialsitenews.com/a/autopsy-series-after-covid-19-vaccination-0d3500b8
[76] https://petermcculloughmd.substack.com/p/autopsy-series-after-covid-19-vaccination
[77] https://www.medrxiv.org/content/10.1101/2022.11.21.22282554v1.full
[78] https://www.tampabay.com/archive/1999/10/16/diarrhea-vaccine-pulled-from-market/
[79] https://www.tampabay.com/archive/1999/10/16/diarrhea-vaccine-pulled-from-market/
[80] https://edition.cnn.com/2009/HEALTH/04/30/swine.flu.1976/index.html
[81] https://maryannedemasi.substack.com/p/no-balanced-coverage-of-covid-vaccines