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Can COVID-19 vaccines cause injuries and death?
According to the U.S. Department of Health and Human Services, adverse events are classified into five grades. The guidelines are as follows:
- Grade 1 - Considered mild or asymptomatic and no intervention is required
- Grade 2 - A moderate event but minimal, local or noninvasive interventions are needed indicated. In some situations, certain activities of daily living are limited (shopping, meal preparations, using the telephone).
- Grade 3 - Considered a severe or medically significant adverse event but not one that is considered immediately life-threatening. In certain cases, hospitalization, including long-term hospitalization is needed. Grade 3 reactions are disabling and limit a person’s ability to perform activities of daily living (feeding self, bathing, self-care).
- Grade 4 - A life-threatening event where urgent intervention is required
- Grade 5 - Death related to an adverse event
Under EUA authority, the FDA Commissioner may permit “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN (CBRN = chemical, biological, radiological, nuclear) threat agents when there are no adequate, approved, and available alternatives.”
Currently, all COVID-19 vaccines in use in the United States have an EUA status. To learn more about EUA products and vaccines and consumer rights, visit NVIC’s FAQ on Emergency Use Vaccines (EUA) & Vaccine Injury Compensation.
Pfizer - BioNTech Vaccine Trial Data
More than 50 percent of adult participants involved in the Phase 1/2 human trials of Pfizer and BioNTech’s experimental messenger RNA (ribonucleic acid) COVID-19 vaccine reported adverse reactions. This trial, which was conducted in May and June 2020, involved 45 healthy adults between the ages of 18 and 55 years. Limitations of this data were noted as not accurately reflecting populations at highest risk for COVID-19.
In the trials, 12 adults received a 10-microgram dose of the BNT162b1 vaccine, 12 adults were injected with a 30-µg dose, 12 received a 100-µg dose, while nine adults were given a placebo of a sterile saline solution (0.9 percent sodium chloride injection, in a 0.5-mL dose). Within seven days of vaccination, seven (58.3 percent) of the participants in the 10-µg group reported adverse reactions (pain) near the injection site and 24–or 100 percent–in the 30-µg and 100-µg groups and two (22.2 percent) in the placebo group reported reactions. Severe pain was reported by one participant who received 100-µg dose.
Three weeks after the initial vaccination with the Pfizer-BioNTech experimental vaccine, all clinical trial participants were given a second dose of the vaccine at the same dosage. Of the participants in the 10-µg group, 8.3 percent developed fevers. Of those in the 30-µg group, 75 percent developed fevers. More than 50 percent of the adults, who were given either a 10-µg or 30-µg dose, experienced an adverse reaction such as sleep disturbances and fever. Two participants suffered severe reactions. A Grade 3 fever of over 101.3°F two days after vaccination was experienced by one adult in the 30-µg group and sleep disturbance one day after vaccination was experienced by one adult in the 100-µg group.
Pfizer reported early U.S. Phase 3 clinical trials results in mid-September. Company executives presented safety data for 5,664 individuals between 18 and 64 years of age, and 1,816 persons between 65 and 85 years who received one dose. In the younger age category, 16 percent reported chills, 35 percent complained of headache and 38 percent reported fatigue following vaccination. Eleven percent or less suffered diarrhea, joint pain, or chills. Side effects were reportedly lower among persons aged 65 to 85 years.
After the second vaccine dose, 36 percent of trial participants between the ages of 18 and 64 reported fatigue, while 28 percent reported a headache and 18 percent reported muscle pain. Most adverse effects following the second dose were reported as mild to moderate; however, some participants did experience severe or life-threatening adverse reactions. Severe side effects occurred more frequently after the second dose.
On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s messenger RNA (mRNA) COVID-19 vaccine for use in persons 16 years of age and older.
According to the Fact Sheet for Healthcare Providers Administering the Pfizer-BioNTech COVID-19 vaccine:
“In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).”
Additional adverse events reported in clinical trials included 12 cases of appendicitis (eight in the vaccine group vs. four in the placebo group), 70 cases of lymphadenopathy (64 in the vaccine group vs. 6 in the placebo group), and four cases of Bell’s Palsy, all in the vaccine group.
Six deaths occurred during the clinical trials, two in the vaccine arm and four in the placebo arm. Of the two deaths in the vaccine arm, one person was reported as having a cardiac arrest 62 days post Dose 2 and the other was reported as atherosclerotic disease and died three days after Dose 1.
Immediately following the FDA issuance of an EUA for Pfizer-BioNTech’s COVID-19 vaccines, reports of anaphylaxis began to appear in the media.
Between December 14 and 23, 2020, 21 cases of anaphylaxis were reported to the Vaccine Adverse Events Reporting System (VAERS), with 71 percent occurring within 15 minutes of vaccine administration. Of these cases, 17 reports were in persons with a past history of allergic reaction, including seven who had previously reported a history of anaphylaxis. A total of 4,393 adverse events were reported to VAERS, including 175 significant events that were identified for additional review as possible cases of severe allergic reactions. Eighty-six of these cases were considered by health officials to be non-anaphylaxis allergic reactions, and 61 were reported as nonallergic adverse events. Public health officials reported that anaphylaxis following Pfizer-BioNTech’s COVID-19 vaccine occurred at a rate of 11.1 cases per million doses administered.
On December 30, 2020, four Kentucky seniors died on the same day that they received the Pfizer-BioNTech COVID-19 vaccine. Of the four seniors who passed away, three had previously tested positive for SARS-CoV-2. A CDC spokesman, however, reported that experts have indicated that the cluster of deaths was not concerning.
Health officials in Norway also reported in mid-January 2021 that they were investigating the deaths of 23 elderly individuals following vaccination with the Pfizer-BioNTech COVID-19 vaccine. The Norwegian Medicines Agency (NOMA) concluded that in 13 of the 23 deaths, common mRNA vaccine adverse reactions, such as diarrhea, fever, and nausea may have contributed to the deaths in the frail patients. Deaths following the Pfizer-BioNTech COVID-19 vaccine have also been reported in Israel, Germany, Portugal and Switzerland.
In a presentation on COVID-19 vaccine safety made during the January 27, 2021 CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, public health officials reported that through January 18, 2021, 50 cases of anaphylaxis following Pfizer-BioNTech COVID-19 vaccine had been confirmed using the Brighton Collaboration case definition criteria (Levels 1, 2, and 3 were considered cases). The median onset of symptoms occurred at 10 minutes (range from < 1 minute to 20 hours). Of these cases, 80 percent had reported a previous allergy history, and 24 percent had a previously documented history of anaphylaxis. Most cases of anaphylaxis occurred following the first vaccine dose.
According to data collected through the federal Vaccine Adverse Events Reporting System (VAERS) through January 18, 2021, the most commonly reported adverse events included headache, fatigue, dizziness, nausea, chills, fever, pain, injection site pain, extremity pain, and shortness of breath.
The Pfizer-BioNTech COVID-19 vaccines has been associated with shingles (herpes zoster – HZ) in persons with autoimmune inflammatory rheumatic diseases (AIIRD). A study published in the journal of Rheumatology in April 2021, found that:
“The prevalence of HZ was 1.2% (n = 6) in patients with AIIRD compared with none in controls. Six female patients aged 49 ± 11 years with stable AIIRD: rheumatoid arthritis (n = 4), Sjogren’s syndrome (n = 1), and undifferentiated connective disease (n = 1), developed the first in a lifetime event of HZ within a short time after the first vaccine dose in 5 cases and after the second vaccine dose in one case. In the majority of cases, HZ infection was mild, except a case of HZ ophthalmicus, without corneal involvement, in RA patient treated with tofacitinib. There were no cases of disseminated HZ disease or postherpetic neuralgia. All but one patient received antiviral treatment with a resolution of HZ-related symptoms up to 6 weeks. Five patients completed the second vaccine dose without other adverse effects.”
Based on these findings, the study authors concluded that more research was needed to “clarify the association between the BNT162b2 mRNA vaccination and reactivation of zoster” in persons with AIIRD.
Graves’ Disease, an autoimmune disorder affecting the thyroid, has also occurred after vaccination. A published study in May 2021 reported on two female health care workers who developed symptoms of Graves’ Disease three days post-vaccination with the Pfizer-BioNTech vaccine. Study authors noted that:
“Vaccines have been shown to trigger an immune response that leads to a broad spectrum of autoimmune diseases, including autoimmune thyroid disease. Our patients met the diagnostic criteria for ASIA; they were exposed to an adjuvant (vaccine), and they developed clinical manifestations of thyroid hyperfunction within a few days, with the appearance of antithyroid antibodies, despite being healthy before vaccination.”
Based on their findings, the authors concluded that Graves’ Disease can occur following COVID-19 vaccination.
On May 10, 2021, the FDA expanded the EUA granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in the U.S. to include administration to children as young as 12 years old and the CDC’s ACIP voted to approve its use in this population on May 12, 2021.
The approval for use in adolescents 12 to 15 years was based on a small clinical trial involving 2,260 teens, of which 1,131 received the vaccine and 1,129 received a saline placebo. According to the FDA’s Fact Sheet for Healthcare Providers Administering Vaccine:
"In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)."
During the clinical trial, nearly 11 percent of 12- to 15-year-olds experienced a severe or Grade 3 vaccine reaction, with one study participant experiencing a Grade 4 reaction of a fever of 40.4°C. Five adolescents who received the Pfizer vaccine experienced a serious adverse event (SAE) during the trial, however, none of these events were considered by clinical trial investigators to be related to vaccination.
According to data released October 8, 2021 by the CDC, reports received by VAERS for the Pfizer-BioNTech experimental COVID-19 vaccine totaled over 426,948 vaccine adverse events with 81,226 categorized as serious. Noted within these reports were 11,350 deaths; 17,699 permanent disabilities; 54,335 hospitalizations; 52,908 emergency room visits, and 12,143 life threatening events. Also noted in these reports were that 478 deaths reported were categorized as senior living administration, with 91 percent of overall reported deaths occurring in persons 65 years of age and older.
Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to VAERS, many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence to suggest that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.
Moderna COVID-19 Vaccine Trial Data
On May 18, 2020, Moderna, Inc. of Cambridge, Massachusetts announced that it had obtained “positive interim clinical data” from a Phase 1 human clinical trial of its experimental mRNA-1273 COVID-19 vaccine. However, four out of 45 healthy clinical trial participants experienced Grade 3 vaccine reactions.
Each of the 45 participants was given two doses of the Moderna vaccine about a month apart at dosage levels that were either 25, 100 or 250 micrograms (µg). The mRNA-1273 vaccine reportedly produced a “Grade 3 adverse event” in one participant who received doses of between 25 µg and 100 µg. That individual experienced Grade 3 erythema (a rash) around the injection site. A Grade 3 rash can include blistering, open ulcers, wet peeling (moist desquamation) or a serious rash over large areas of the body.
Three participants in the clinical trial who received a vaccine dose of 250 µg experienced “Grade 3 systemic symptoms” following administration of the second dose. Moderna described these as the “most notable” of the adverse events and said that they had been “transient and self-resolving.”
On July 27, 2020, the National Institutes of Health (NIH) announced that Phase 3 trials of Moderna’s mRNA-1273 had begun. According to the press release issued by NIH:
“Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.”
In September 2020, three participants involved in the Phase 3 trial reported suffering reactions such as high fever, headaches, body aches and exhaustion. One of these participants, 44-year-old Luke Hutchison of Utah, suffered a bad headache, chills, a fever (over 100°F), and shortness of breath after getting the second vaccine dose. Hutchison described his symptoms as “full-on COVID-like symptoms.” He cautioned that people receiving the vaccine should be made aware that serious adverse reactions can occur, especially after the second dose. Another of the trial participants, a woman in her 50s from North Carolina, suffered a migraine that “left her exhausted and struggling to focus.”
On November 16, 2020, Moderna reported that adverse reactions were generally mild or moderate, and included headache, fatigue, and injection site pain
The FDA issued an EUA for Moderna’s COVID-19 vaccine on December 18, 2020. In its press release, the FDA reported that during clinical trials, common reactions following Moderna vaccination included injection site pain, headache, fatigue, joint and muscle pain, fever, nausea, vomiting, and swelling of the lymph nodes in the arm where the vaccine was given. Vaccine adverse events typically persisted for several days and were more common following the second dose of the two-dose series.
Serious adverse events occurring at higher rates in the vaccine group included myocardial infarction, kidney stones, gall bladder inflammation and Bell’s Palsy. Seven serious adverse events occurred in the vaccine group following vaccination, with four considered by clinical trial investigators to be related to the vaccine. These included intractable nausea and vomiting, rheumatoid arthritis, and two incidents of facial swelling that occurred in persons who had previously received cosmetic injections of dermal fillers.
Thirteen deaths were reported during the clinical trials, with six occurring in the vaccine group and seven in the placebo group. In the vaccine group, two individuals over the age of 75 years with a history of heart disease died of heart related complications, two individuals were found deceased at home and the exact cause was not determined (a 56-year-old with a history of hypertension and chronic back pain being treated with opioid medication died 37 days after dose 1 and a 70-year-old with a history of cardiac disease was found dead 57 days after dose 2). One vaccine recipient died of suicide 21 days after dose 1, and a 72-year-old vaccine recipient with a history of Crohn’s disease and short bowel syndrome who was hospitalized for acute kidney failure and thrombocytopenia developed complications resulting in multiorgan failure and death 40 days after dose 2.
According to data collected through the Vaccine Adverse Events Reporting System (VAERS) through January 18, 2021, the most commonly reported adverse events included headache, fever, chills, pain, dizziness, fatigue, nausea, injection site pain, extremity pain, and shortness of breath.
In a presentation on COVID-19 vaccine safety made during the January 27, 2021 CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, public health officials reported that through January 18, 2021, 21 cases of anaphylaxis following Moderna’s COVID-19 vaccine had been confirmed using the Brighton Collaboration case definition criteria (Levels 1, 2, and 3 were considered cases). The median onset of symptoms occurred at 10 minutes (range from < 1 minute to 45 minutes). Of these cases, 86 percent had reported a previous allergy history, and 24 percent had a previously documented history of anaphylaxis. Most cases of anaphylaxis occurred following the first vaccine dose and all cases of anaphylaxis occurred in females.
A cluster of deaths occurring within a week of Moderna COVID-19 vaccination at a nursing home in Arkansas was reported to VAERS in early January 2021. All four seniors who passed away following vaccination were found to be positive for SARS-CoV-2. The deaths, however, were reported as being related to COVID-19, and not the vaccine.
Also in January, baseball Hall of Famer Hank Aaron was administered the Moderna vaccine in an event that appeared to encourage others, especially African-Americans, to receive the vaccine. Seventeen days later, on January 22, 2021, Aaron died. Health officials have denied that the COVID-19 vaccine played a role in his death, and report that it was purely coincidental.
According to the federal vaccine adverse event reporting system (VAERS), as of CDC’s October 8, 2021 release of data there were a total of 309,258 reports submitted to VAERS associated with the experimental Moderna COVID-19 vaccine. Noted within these reports were 27,959 serious events including 4,144 deaths; 5,498 permanent disabilities; 19,514 hospitalizations; 7,911 emergency room visits; and 4,585 life threatening events. Of the deaths reported to VAERS, 463 were noted as senior living administration settings, with over 91 percent of overall reported deaths occurring in persons 65 years of age and older.
On October 8, 2021, Iceland halted the use of the Moderna COVID-19 mRNA vaccine following increasing rates of heart inflammation. According to Iceland’s Directorate of Health:
“In recent days, there has been data from the Nordic countries on the increased incidence of myocarditis and pericarditis after vaccination with Moderna vaccine in addition to vaccination with Pfizer/ BioNTeck (Comirnaty)…As there is a sufficient supply of Pfizer vaccine in Iceland for both the pre-vaccine activation vaccines and the primary vaccinations of those who have not yet been vaccinated, the epidemiologist has decided not to use the Moderna vaccine in Iceland, while providing further information on the safety of the Moderna vaccine.”
As of October 6, 2021, Sweden and Denmark restricted the use of the Moderna vaccine to persons born prior to 1991 due to heart inflammation in younger populations, especially following the second dose. Finland stopped use of the vaccine in men under age 30 on October 7, 2021 due to the risk of heart inflammation in this population.
Health officials have cautioned that symptoms of adverse reactions following COVID-19 vaccination may overlap with those of COVID-19 illness and be difficult to distinguish. However, symptoms of loss of taste or smell, shortness of breath, cough, rhinorrhea or sore throat are not considered common vaccine reactions, and persons experiencing these symptoms post-vaccination may be positive for SARS-CoV-2 or another infection.
Persons who have pre-existing immunity to SARS-CoV-2 may be at increased risk of severe reactogenicity following mRNA COVID-19 vaccination. In a study pending peer review conducted by the Icahn School of Medicine at Mount Sinai, researchers reported that persons with pre-existing immunity to SARS-CoV-2 who received mRNA COVID-19 vaccines had significantly higher rates of systemic reactions when compared to those who were not immune at the time of vaccination. Systemic reactions included fatigue, headache, chills, fever, joint or muscle pains.
Thrombocytopenia, a serious blood disorder that causes low platelets which will prevent the blood from clotting, has been reported following mRNA vaccination. In some cases, death has resulted from the bleeding disorder. In one case, a 56-year-old obstetrician who developed the condition within three days of receiving the Pfizer-BioNTech COVID-19 vaccine died of a stroke 16 days post-vaccination. Thrombocytopenia with thrombosis syndrome (TTS), a serious and potentially fatal blood clotting disorder linked to the Janssen/Johnson & Johnson and AstraZeneca COVID-19 vaccines, has also been reported following mRNA vaccination. In late June 2021, the Annals of Internal Medicine published a case report on a fatal case of TTS following the completion of the Moderna two doses vaccine series.
On May 7, 2021, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reported that they were monitoring a potential risk of blood clots with low platelets in persons who have received the Pfizer-BioNTech and Moderna COVID-19 vaccines. The committee acknowledged that cases of this serious side effect had been reported following mRNA vaccination but the numbers were considered extremely low.
Additionally, PRAC reported that cases of pericarditis (inflammation of the membrane surrounding the heart) and myocarditis (inflammation of the heart muscle) following mRNA vaccination, primarily in persons who have received the Pfizer-BioNTech vaccine had been reported.
In late April 2021, the Israeli Health Ministry reported that it was investigating a link between the Pfizer COVID-19 vaccine and myocarditis after reporting that 62 cases had been reported following vaccination. Of these cases, 56 had occurred following the second shot, and most had involved persons 30 years of age and younger. A Pfizer spokesperson, however, has stated that a causal link has not been established and that they have not observed a higher rate of myocarditis post-vaccination then what would be expected in the overall population.
On May 17, 2021, the Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical (VaST) Work Group met and reviewed information on myocarditis following mRNA vaccines. VaST reported that most of the cases had occurred in teens and young adults, and more cases had occurred in males. Additionally, there were more cases reported after the second vaccine dose, and most occurred on average within four days of vaccination. Members of VaST reported that few cases had been reported but that information on myocarditis following COVID-19 vaccination should be given to vaccine providers.
Reports of myocarditis and pericarditis following mRNA vaccines continued to increase and on June 11, 2021, the CDC scheduled an emergency ACIP meeting for June 18, 2021 to discuss the higher than expected number of cases. A total of 301 cases following Moderna vaccination and 488 cases following Pfizer vaccination had been reported at the time the meeting was scheduled.
The meeting, however, was postponed due to the newly created Juneteenth National Independence Day holiday, with the CDC announcing that it would discuss concerns the following week at the regularly scheduled June ACIP meeting. By the June 23, 2021 meeting, CDC officials reported that through June 11, 2021, 1,226 cases of myocarditis/pericarditis had been reported to VAERS, with 791 occurring after Pfizer vaccination and 435 after Moderna vaccination. Most cases were reported in males, and most occurred following the second dose.
In the data presented during the June 23, 2021, the CDC reported that in females between the age of 12 and 17 years, after the second dose, the case rate of myocarditis/ pericarditis was 9.1 per million doses administered. In males 12 to 17 years of age, however, the rate after the second vaccine dose was 66.7 per million doses. Cases among females 18 to 24 years old after the second dose were reported at 5.5 per million, while after the second dose, males of the same age range were affected at a rate of 56.3 per million doses. Most cases of myocarditis/pericarditis resulted in hospitalization, and while most were reported as being resolved, the long-term health outcomes were reported to be unknown.
The CDC, however, declined to pause use or make changes to the vaccine recommendations, as they reported the benefits to vaccination outweighed the risk. Additionally, they stated that persons with a history of myocarditis and pericarditis could still receive an mRNA vaccine and persons who developed pericarditis after the first mRNA vaccine dose could receive the second dose after symptoms resolved. The CDC also advised that individuals who developed myocarditis after the first dose could consider receiving a second dose under certain circumstances. No data to support this recommendation was provided.
The FDA reported that the Moderna and Pfizer Fact Sheets would be updated to include a warning of the risk of myocarditis/pericarditis.
A study of myocarditis after mRNA vaccines on members of the military has found a higher than expected number of cases following vaccination. Additional studies have also associated mRNA vaccines with heart inflammation, with researchers reporting the need for further investigation.
A real-world study on the Pfizer-BioNTech vaccine conducted by Israeli scientists found that vaccination most likely caused myocarditis in one to five individuals per 100,000 who would not have developed the condition. Their study also found that young males were at highest risk for developing the condition.
A preprint study posted on September 8, 2021 on MedRxiv found that teenage boys are most likely to be hospitalized for heart inflammation from mRNA COVID-19 vaccines than from COVID-19 disease. This study was based on filed reports to the Vaccine Adverse Events Reporting System (VAERS) between January 1 and June 18, 2021 in teens between the ages of 12 and 17 years of age. Researchers concluded that:
“For boys with no underlying health conditions, the chance of either cardiac adverse event (CAE), or hospitalization for CAE, after their second dose of mRNA vaccination are considerably higher than their 120-day risk of COVID-19 hospitalization, even at times of peak disease prevalence. The long-term consequences of this vaccine-associated cardiac inflammation are not yet fully defined and should be studied.”
Study authors suggested that the U.S. could consider a policy change that would delay vaccination in healthy children who have a low risk of developing severe COVID-19 illness or recommend only a single vaccine dose of mRNA vaccine.
According to the CDC, as of October 6, 2021, 1,640 reports of myocarditis and pericarditis following COVID-19 mRNA vaccines had been reported to VAERS among persons 30 years of age and younger. Most cases have occurred in teenage boys.
On August 11, 2021, the European Medicines Agency (EMA) announced that it was investigating a link between two kidney disorders, glomerulonephritis and nephrotic syndrome, and mRNA COVID-19 vaccines.
Glomerulonephritis is a condition where inflammation of the glomeruli of the kidneys occur. Glomeruli filter excess waste, fluid, and electrolytes from bloodstream and move them into the urine. This condition can lead to kidney damage.
Nephrotic syndrome occurs when damage of the small blood vessels in the kidney that filter excess water and waste happens. Nephrotic syndrome generally causes swelling, frequently in the feet and ankles, and may increase a person’s risk of blood clots and infection.
Erythema multiforme, an allergic skin reaction characterized by red, raised, symmetrical areas over the entire body, has been linked to COVID-19 mRNA vaccines. On August 11, 2021, the EMA reported that it was investigating reports of this immune-mediated reaction following mRNA vaccination. This reaction can cause fever, joint pain, itching, and cold sores.
A case series published in the Journal of Neurology has linked both the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines to Central Nervous System (CNS) Demyelination, including multiple sclerosis (MS). The published case series reported on four cases of exacerbation of their stable MS, two new cases of MS following vaccination, and one case of neuromyelitis optica. Three of these events occurred following Moderna COVID-19 vaccination, while four occurred after Pfizer-BioNTech COVID-19 vaccination.
In early September 2021, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reported that it was assessing a potential link between COVID-19 vaccines and Multisystem Inflammatory Syndrome (MIS) following the report of a 17-year-old male who developed the condition following receipt of the Comirnaty (Pfizer-BioNTech) mRNA vaccine. The committee also reported that five cases of MIS had been reported in Europe following Pfizer vaccination, and one case had been reported following vaccination with both the Moderna and Johnson & Johnson/Janssen vaccines.
Long-term follow-up of clinical trial participants to monitor for conditions such as cancer and autoimmune diseases will become difficult, if not impossible, if the vaccine makers hasten to offer their vaccines to the placebo groups. Once this occurs, it will completely erase the ability of researchers to compare or evaluate potential long-term differences in health outcomes among the vaccinated and placebo groups. Pfizer and Moderna company executives both suggested that the COVID-19 vaccine clinical trial participants who received a placebo should be vaccinated.
In December 2020, Pfizer-BioNTech officials stated that they would begin offering the vaccine to placebo recipients by March 1, 2021, which was several months earlier than what they had originally planned for. By mid- January 2021, Moderna had already begun offering the vaccine to some placebo group participants.
Janssen/Johnson & Johnson COVID-19 Vaccine Trial Data
In late September 2020, Janssen/Johnson & Johnson released results of the Phase 1/2a clinical trial for its Ad26.COV2.S vaccine. This study was a double-blind, randomized, placebo-controlled trial and included 796 participants divided into two groups consisting of 402 healthy adults 18 to 55 years of age in one group and 394 healthy elderly individuals 65 years of age and older in the other.
In this trial, the first group was broken out into cohort 1a and cohort 1b. The second group was cohort 3. Trial participants were administered a single intramuscular injection of Ad26.COV2.S at dose levels of either 5×1010 or 1×1011 viral particles (vp) per dose of vaccine.
Approximately 58 percent of participants in cohorts 1a and 1b experienced a localized adverse event, while 64 percent of them also suffered systemic adverse events. Of the participants in cohort 3, 27 percent of them experienced a localized adverse event, and 36 percent suffered systemic events (e.g. fever, irritability, drowsiness, rash, etc.) Of healthy adults aged 18 to 55 years old in cohorts 1a and 1b, 19 percent came down with fevers, while four percent of the adults aged over 65 years old in cohort 3 developed fevers.
The fevers reported by participants were considered mild or moderate and resolved within one to two days after vaccination. However, five percent (20 participants) of participants in cohorts 1a and 1b suffered from Grade 3 fevers of over 101.3°F.
A news report on the Janssen/Johnson & Johnson Phase 1/2a trial reported that
“There were two severe adverse events recorded. One participant had hypotension; however, this effect is not related to vaccination as the participant had a history of hypotension. Another participant with fever was hospitalized as a suspected case of COVID-19; however, the fever resolved within 12 hours.”
The most common adverse events experienced by trial participants were headaches, muscle pain, fatigue and pain the injection site.
On September 23, 2020, Janssen/Johnson & Johnson announced the start of its Phase 3 clinical trials. The trial, a randomized, double-blind, placebo-controlled study, would enroll up to 60,000 participants in three continents. However, on October 12, 2020, all clinical trials stopped after a participant developed an “unexplained illness.” Sources familiar with the event reported that a male in his 20’s had a stroke after receiving the experimental vaccine. Clinical trials in the U.S resumed in late October 2020.
On February 27, 2021, the FDA issued an EUA for Janssen/Johnson & Johnson’s experimental vaccine for use in persons 18 years of age and older.
Common side effects reported after vaccine administration with the Janssen COVID-19 in clinical trials included injection site pain, headache, fatigue, myalgia, nausea, fever, injection site redness and swelling.
According to the Fact Sheet for Healthcare Providers issued by the FDA, serious adverse effects (SAE) were reported in 0.4 percent of vaccine recipients and 0.4 percent of placebo recipients. The Fact Sheet reports:
“Urticaria (all non-serious) was reported in five vaccinated individuals and 1 individual who received placebo in the 7 days following vaccination. In addition, an SAE of hypersensitivity, not classified as anaphylaxis, was reported in 1 vaccinated individual with urticaria beginning two days following vaccination and angioedema of the lips with no respiratory distress beginning four days following vaccination. The event was likely related to the vaccine.
An SAE of severe pain in the injected arm, not responsive to analgesics, with immediate onset at time of vaccination, and that was ongoing 74 days following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine. An SAE of severe generalized weakness, fever, and headache, with onset on the day following vaccination and resolution three days following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine. Both SAEs are likely related to the vaccine.
Numerical imbalances, with more events in vaccine than placebo recipients, were observed for the following serious and other adverse events of interest in individuals receiving the vaccine or placebo, respectively:
- Thromboembolic events: • Deep vein thrombosis: 6 events (2 serious; 5 within 28 days of vaccination) vs. 2 events (1 serious; 2 within 28 days of vaccination).
- Pulmonary embolism: 4 events (3 serious; 2 within 28 days of vaccination) vs. 1 event (serious and within 28 days of vaccination).
- Transverse sinus thrombosis: 1 event (serious and within 28 days of vaccination) vs. 0.
- Seizures: 4 events (1 serious; 4 within 28 days of vaccination) vs. 1 event (0 serious and 0 within 28 days following vaccination).
- Tinnitus: 6 events (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of vaccination) vs. 0.”
On April 13, 2021, the FDA and CDC paused use of the vaccine after serious blood clots were reported in women between the ages of 18 and 49. By April 23, 2021, 15 cases and 3 deaths had been associated with the rare blood clot disorder, now referred to by health officials as thrombosis with thrombocytopenia syndrome (TTS). All cases were reported in women, with two occurring in women over 50 years of age. The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to resume full use of the vaccine in all persons 18 years of age and older on April 23, 2021, by a vote of 10 to 4 (with one voting member abstaining due to a conflict of interest). Those who voted against the recommendation expressed concern regarding the lack of warning on the risk of TTS in women under 50 years of age.
The FDA updated the Janssen/Johnson & Johnson’s COVID-19 Fact Sheet on April 23, 2021 and acknowledged that:
“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”
By May 7, 2021, there had been 28 cases of TTS and 3 deaths confirmed by the CDC to be related to the Johnson & Johnson/Janssen COVID-19 vaccine. Additionally, TTS has been reported in men and in women between 50 and 60, in addition to women between 18 and 49 years.
As of October 6, 2021, 47 cases of TTS following the Janssen/Johnson & Johnson COVID-19 vaccine had been confirmed by the CDC and FDA.
In early September 2021, the European Medicines Agency reported that its Pharmacovigilance Risk Assessment Committee (PRAC) was investigating a link between the Johnson & Johnson/Janssen COVID-19 vaccine and venous thromboembolism (blood clots in the veins). According to PRAC, in the initial clinical trials of the vaccine, a higher rate of venous thromboembolism was noted in the vaccine group when compared to the placebo group. Additional data collected from two larger clinical trials were expected to be submitted to PRAC in advance of vaccine marketing authorization, to determine whether the condition was linked to vaccination.
On July 13, 2021, the FDA announced revisions to the Fact Sheet for Healthcare Providers Administering the Johnson & Johnson/Janssen COVID-19 vaccine and the Fact Sheet for Recipients and Caregivers to include information regarding an increased risk of Guillain-Barré Syndrome (GBS) following vaccination. GBS, a serious neurological disorder where the body’s immune system attacks the peripheral nervous system, can cause muscle weakness, paralysis, and even death. According to the press release, the FDA reported 100 cases of GBS following vaccination, with 95 considered serious and requiring hospitalization, and one death. Government health officials noted that there was insufficient evidence to establish a causal relationship between the Johnson & Johnson/Janssen COVID-19 vaccine and GBS, and reported that “the known and potential benefits clearly outweigh the known and potential risks.”
As of October 6, 2021, 228 cases of GBS following the Janssen/Johnson & Johnson COVID-19 had been identified in the VAERS data. According to the CDC, most cases occurred within 2 weeks of vaccination and among men, primarily those aged 50 and older.
As of the October 8, 2021 data release, vaccine adverse events submitted to VAERS associated with the Johnson & Johnson/Janssen COVID-19 vaccine totaled 61,939, with 7,982 noted as serious. Included in these reports were 1,228 deaths; 1,574 permanent disabilities; 7,948 emergency room visits, and 5,659 hospitalizations.
On Mar. 10, 2020, the Secretary of Health and Human Services (HHS) invoked the 2005 Public Readiness and Emergency Preparedness (PREP) Act, after declaring that the COVID-19 pandemic was a public health emergency. As a result, manufacturers of COVID-19 vaccines that have been developed to respond to the SARS-CoV-2 pandemic are considered public health emergency “countermeasures”. The PREP Act shields manufacturers and vaccine providers from liability and vaccine injury compensation claims will be processed by the Countermeasures Injury Compensation Program (CICP).
All COVID-19 vaccines, including the licensed Pfizer mRNA COVID-19 vaccine, are considered countermeasures. Persons harmed or who die as a result of vaccination may file for benefits through the CICP within one year of injury or death of a loved one.
As of October 1, 2021, HRSA reports that 1,357 claims alleging injury or death following COVID-19 vaccines have been filed with the CICP. Additionally, 1,801 claims alleging injury or death following additional COVID-19 countermeasures (i.e. medications, treatments, testing) have also been filled. HRSA also reports that no COVID-19 CICP claims have been compensated, and 3 claims have been denied “because the standard of proof for causation was not met and/or a covered injury was not sustained. One COVID-19 claim has been determined eligible for compensation and is pending a review of eligible expenses.”
IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
Updated October 20, 2021
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34 Cáceres M. Healthy Clinical Trial Subjects Suffer Grade 3 Side Effects to Moderna’s mRNA COVID-19 Vaccine. The Vaccine Reaction May 24, 2020.
35 National Institutes of Health. Phase 3 clinical trial of investigational vaccine for COVID-19 begins. July 27, 2020.
36 TVR Staff. Moderna’s COVID-19 Vaccine Provokes ‘COVID-Like Symptoms’ in Phase 3 Trial. The Vaccine Reaction Oct. 19, 2020.
37 TVR Staff. Moderna’s COVID-19 Vaccine Provokes ‘COVID-Like Symptoms’ in Phase 3 Trial. The Vaccine Reaction Oct. 19, 2020.
38 Dall C. Early data show Moderna's COVID vaccine 94.5% effective. CIDRAP News Nov. 16, 2020.
39 U.S Food and Drug Administration. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine. Dec. 18, 2020.
40 U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document - FDA Dec. 17, 2020.
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42 Shimabukuro T. COVID-19 vaccine safety update Advisory Committee on Immunization Practices (ACIP). U.S. Centers for Disease Control and Prevention Jan. 27, 2021.
43 Shimabukuro T. COVID-19 vaccine safety update Advisory Committee on Immunization Practices (ACIP). U.S. Centers for Disease Control and Prevention Jan. 27, 2021.
44 Attkisson S. Deaths of Elderly Who Recovered From COVID-19, but Died After Vaccine, Raise Questions The Epoch Times Feb. 10, 2021.
45 Cáceres M. Hammerin’ Hank’s COVID-19 Vaccination: A “Double-Edged Sword”? The Vaccine Reaction Jan. 31, 2021.
46 Pentchoukov I. Iceland Stops Using Moderna Vaccine Over Heart Inflammation Risk. The Epoch Times Oct. 8, 2021.
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49 Krammer F, Srivastava K, et al. Robust spike antibody responses and increased reactogenicity in seropositive individuals after a single dose of SARS-CoV-2 mRNA vaccine MedRxiv Feb. 1, 2021.
50 Lee EJ, Cines DB, Gernsheimer T et al. Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. Am J Hematol May 1, 2021;96(5):534-537.
51 Stieber Z. Authorities Probe Rare Blood Disorder Among Some COVID-19 Vaccine Recipients. The Epoch Times Feb. 11, 2021.
52 Fisher BL. Miami Obstetrician Develops Bleeding Disorder, Dies After Getting COVID-19 Vaccine. The Vaccine Reaction Jan. 11, 2021.
53 Hughes S. Thrombosis With Thrombocytopenia After mRNA COVID-19 Vaccine. Medscape June 28, 2021.
54 European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021. May. 7, 2021.
55 European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021. May. 7, 2021.
56 TVR Staff. Israel Studying Possible Link Between Heart Inflammation and Pfizer/BioNTech COVID-19 Shot. The Vaccine Reaction May 17, 2021.
57 U.S. Centers for Disease Control and Prevention. COVID-19 VaST Work Group Technical Report – May 17, 2021. In: Advisory Committee on Immunization Practices (ACIP). May 20, 2021.
58 Fonrouge G. ‘We clearly have an imbalance’: CDC holding emergency meeting over COVID vax concern. New York Post June 11, 2021.
59 Woolfolk J. CDC delays meeting on kids’ COVID vaccine heart risk - New federal Juneteenth holiday prompts rescheduling. The Mercury News June 18, 2021.
62 Wallace M, Oliver S. COVID-19 mRNA vaccines in adolescents and young adults: Benefit-risk discussion. U.S. Centers for Disease Control and Prevention June 23, 2021.
63 Soucheray S. Experts: mRNA COVID-19 vaccines likely tied to heart inflammation. CIDRAP News June 23, 2021.
64 Montgomery J, Ryan M, Engler R. et al. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. Jun 29, 2021; Epub ahead of print. PMID: 34185045.
65 Kim HW, Jenista ER, Wendell DC. et al. Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination. JAMA Cardiol. 2021 Jun 29, 2021; Epub ahead of print. PMID: 34185046.
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67 Hoeg TB, Krug A, Stevenson J. et al. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. medRxiv Sept. 8, 2021.
68 Hoeg TB, Krug A, Stevenson J. et al. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. medRxiv Sept. 8, 2021.
69 U.S. Centers for Disease Control and Prevention. Selected Adverse Events Reported after COVID-19 Vaccination. In COVID-19. Oct. 13, 2021.
70 TVR Staff. Do mRNA COVID Biologics Cause Skin Allergy and Kidney Disorders? The Vaccine Reaction Aug. 15, 2021.
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72 TVR Staff. Do mRNA COVID Biologics Cause Skin Allergy and Kidney Disorders? The Vaccine Reaction Aug. 15, 2021.
73 TVR Staff. Do mRNA COVID Biologics Cause Skin Allergy and Kidney Disorders? The Vaccine Reaction Aug. 15, 2021.
74 Khayat-Khoei M, Bhattacharyya S, Katz J. et al. COVID-19 mRNA vaccination leading to CNS inflammation: a case series. J Neurol. Sept. 4, 2021. Epub ahead of print. PMID: 34480607.
75 European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021. Sept. 3, 2021.
76 Cáceres B. Moderna, Pfizer Test mRNA Experimental Biologics on Children. The Vaccine Reaction Feb. 7, 2021.
77 Herper M. Pfizer and BioNTech speed up timeline for offering Covid-19 vaccine to placebo volunteers. Stat News Jan. 1, 2021.
78 Peres J. Vaccine trial participants who received placebo now hop the line for the real thing from Pfizer, Moderna. Chicago Tribune Jan. 14, 2021.
79 Dutta SS. J&J’s COVID-19 vaccine shows potent immune response in phase 2 human trial. News-Medical.Net Sept. 28, 2020.
80 Sadoff J., et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. medRxiv Sept. 23, 2020.
81 Dutta SS. J&J’s COVID-19 vaccine shows potent immune response in phase 2 human trial. News-Medical.Net Sept. 28, 2020.
82 Sadoff J., et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv Sept. 23, 2020.
83 Sadoff J., et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv Sept. 23, 2020.
84 Dutta SS. J&J’s COVID-19 vaccine shows potent immune response in phase 2 human trial. News-Medical.Net Sept. 28, 2020.
85 Sadoff J., et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv Sept. 23, 2020.
86 Johnson & Johnson. Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate. Sept. 23, 2020.
87 Wamsley L., Harris R., Romo V. Johnson & Johnson, Eli Lilly Pause COVID-19 Drug Trials. National Public Radio Oct. 13, 2020.
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90 U.S. Food and Drug Administration. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. Feb. 27, 2021.
91 U.S Food and Drug Administration. Janssen COVID-19 Vaccine - Fact Sheet for Healthcare Providers Administering Vaccine. Aug. 27, 2021.
92 U.S Food and Drug Administration. Janssen COVID-19 Vaccine - Fact Sheet for Healthcare Providers Administering Vaccine Aug. 27, 2021.
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94 Soucheray S. ACIP opts to lift pause on Johnson & Johnson vaccine. CIDRAP News Apr. 23, 2021.
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99 European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021. Sept. 3, 2021.
100 Phillips J. Reports of Rare Body Inflammation After COVID-19 Vaccinations Being Investigated by EU Watchdog. The Epoch Times Sept. 3, 2021.
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103 Congressional Research Service. The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. Sept. 23, 2021.
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107 Health Resources & Services Administration (HRSA). Countermeasures Injury Compensation Program (CICP) Data. Sept. 1, 2021.