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Can COVID-19 vaccines cause injuries and death?


vaccine injury 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

COVID-19 Vaccines in the U.S.

As of February 27, 2021, the U.S. Food and Drug Administration had authorized three COVID-19 vaccines under Emergency Use Authorization (EUA). 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.”1 To learn more about EUA products and vaccines and consumer rights, visit NVIC’s FAQ on Emergency Use Vaccines (EUA) & Vaccine Injury Compensation.

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Pfizer - BioNTech mRNA COVID-19 Vaccine

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-19.2

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.3 4

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.5 6

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.7

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.8

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.9

According to the Fact Sheet for Healthcare Providers Administering the Pfizer-BioNTech:10

“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 1.11

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Pfizer - BioNTech Vaccine and Anaphylaxis

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 nonanaphylaxis 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.12

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.13

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.14 Deaths following the Pfizer-BioNTech COVID-19 vaccine have also been reported in Israel,15 Germany,16 Portugal17 and Switzerland.18

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.19

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.20 

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Pfizer - BioNTech COVID-19 Vaccine and Shingles

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:21

“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.

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Pfizer - BioNTech COVID-19 Vaccine and Graves’ Disease

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:22

“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 old23 and the CDC’s ACIP voted to approve its use in this population on May 12, 2021.24

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.25 According to the FDA’s Fact Sheet for Healthcare Providers Administering Vaccine:26

"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."27

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Pfizer - BioNTech COVID-19 Vaccine and VAERS Reports

According to data released July 16, 2021 by the CDC, reports received by VAERS for the Pfizer-BioNTech experimental COVID-19 vaccine totaled over 252,561 vaccine adverse events with over 36,000 categorized as serious. Noted within these reports were 7,770 deaths; 7,942 permanent disabilities; 22,452 hospitalizations; 33,587 emergency room visits, and 6,237 life threatening events. Also noted in these reports were that 425 deaths reported were categorized as senior living administration, with 41 percent of overall reported deaths occurring in persons 65 years of age and older and 51 percent of deaths noted as unknown age.  

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.28 29 30 31

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Moderna mRNA COVID-19 Vaccine

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.32

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.33

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.” 34

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:35

“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.36 Another of the trial participants, a woman in her 50s from North Carolina, suffered a migraine that “left her exhausted and struggling to focus.”37

On November 16, 2020, Moderna reported that adverse reactions were generally mild or moderate, and included headache, fatigue, and injection site pain38

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.39

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.40

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. 41

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.42 

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Moderna COVID-19 Vaccine and Anaphylaxis

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.43

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Moderna COVID-19 Vaccine and Deaths Post Vaccination

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. 44 

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.45

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Moderna COVID-19 Vaccine and VAERS Reports

According to the federal vaccine adverse event reporting system (VAERS), as of CDC’s July 16, 2021 release of data there were a total of 193,724 reports submitted to VAERS  associated with the experimental Moderna COVID-19 vaccine. Noted within these reports were 15,797 serious events including 3,013 deaths; 2,643 permanent disabilities; 10,896 hospitalizations; 5,966 emergency room visits; and 3,067 life threatening events. Of the deaths reported to VAERS, 428 were noted as senior living administration settings, with nearly 74 percent of overall reported deaths occurring in persons 65 years of age and older.

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Adverse Events Following mRNA COVID-19 Vaccine Administration

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.46

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.47

COVID-19 mRNA Vaccines and Blood Clots

Thrombocytopenia, a serious blood disorder that causes low platelets which will prevent the blood from clotting, has been reported following mRNA vaccination.48 In some cases, death has resulted from the bleeding disorder.49 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.50 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.51

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.52

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COVID-19 mRNA Vaccines and Heart Inflammation

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. 53

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.54

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.55

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.56

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.57 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.58

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. 59  

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.60

The FDA reported that the Moderna and Pfizer Fact Sheets would be updated to include a warning of the risk of myocarditis/pericarditis.61

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Impact of COVID-19 mRNA Vaccination of Placebo Group to Long-Term Clinical Trial Data

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. If 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 have both suggested that the COVID-19 vaccine clinical trial participants who received a placebo should be vaccinated.62

Pfizer-BioNTech officials have already stated that they will begin offering the vaccine to placebo recipients by March 1, 2021, which is several months earlier than what they had originally planned for.63 By mid- January 2021, Moderna had already begun offering the vaccine to some placebo group participants.64

Janssen/Johnson & Johnson COVID-19 Vaccine

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.65 66

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. 67 68

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

“[T]here 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.”69 

The most common adverse events experienced by trial participants were headaches, muscle pain, fatigue and pain the injection site. 70 71

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.72 However, on October 12, 2020, all clinical trials stopped after a participant developed an “unexplained illness.” 73 Sources familiar with the event reported that a male in his 20’s had a stroke after receiving the experimental vaccine.74 Clinical trials in the U.S  resumed in late October 2020.75

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.76

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.77

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: 78

“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.”

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Janssen/Johnson & Johnson COVID-19 Vaccine and Blood Clots

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 49.79 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 2 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.80 81

The FDA updated the Janssen/Johnson & Johnson’s COVID-19 Fact Sheet on April 23, 2021 and acknowledged that:82

“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.” 

As of May 7, 2021, there have been 28 cases of TTS and 3 deaths confirmed by the CDC to be related to the Johnson & Johnson/Jannsen 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.83

On July 13, 2021, the FDA announced revisions to the Fact Sheet for Healthcare Providers Administering the Johnson & Johnson/Jannsen 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/Jannsen COVID-19 vaccine and GBS, and reported that “the known and potential benefits clearly outweigh the known and potential risks.”84

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Janssen/Johnson & Johnson COVID-19 Vaccine and VAERS Reports

As of the CDC July 16, 2021 data release, vaccine adverse events submitted to VAERS associated with the Johnson & Johnson/Jannsen COVID-19 vaccine totaled 44,237, with 3,472 noted as serious. Included in these reports were 596 deaths; 612 permanent disabilities; 6,068 emergency room visits, and 2,567 hospitalizations.

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.

« Return to Vaccines & Diseases Table of Contents

Updated July 27, 2021

References

1 U.S. Food and Drug Administration. Emergency Use Authorization. July 13, 2021.

2 Herper M. Covid-19 vaccine from Pfizer and BioNTech shows positive resultsSTAT News July 1, 2020.

3 Herper M. Covid-19 vaccine from Pfizer and BioNTech shows positive resultsSTAT News July 1, 2020.

4 Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim ReportNature August 2020; pp. 589-593.

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23 U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. May 10, 2021.

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27 Wallace M. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Pfizer-BioNTech COVID-19 Vaccine. U.S. Centers for Disease Control and Prevention May 12, 2021.

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31 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS). Dec 1, 2007-Sep. 30, 2010

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