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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.

Pfizer - BioNTech mRNA COVID-19 Vaccine

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

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 

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.

By April 23, 2021, reports received by VAERS for the Pfizer-BioNTech experimental COVID-19 vaccine totaled more than 45,000 vaccine adverse events with over 5,653 categorized as serious. Noted within these reports were 1,611 deaths, 738 permanent disabilities, 3,601 hospitalizations, 2,289 emergency room visits, and 898 life threatening events.22 Also noted in these reports were that 359 deaths reported were categorized as senior living administration,23 with almost 71 percent of reported deaths occurring in persons 65 years of age and older.24  

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.25 26 27 28

Moderna mRNA COVID-19 Vaccine

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.29

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.30

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.” 31

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:32

“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.33 Another of the trial participants, a woman in her 50s from North Carolina, suffered a migraine that “left her exhausted and struggling to focus.”34

On November 16, 2020, Moderna reported that adverse reactions were generally mild or moderate, and included headache, fatigue, and injection site pain35

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.36

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.37

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. 38

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.39 

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.in V40

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. 41 

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.42

According to the federal vaccine adverse event reporting system (VAERS), as of April 23, 2021 there were a total of 48,192 reports submitted to VAERS  associated with the experimental Moderna COVID-19 vaccine. Noted within these reports were 5,684 serious events, including 1,701 deaths, 668 permanent disabilities, 2,881 hospitalizations, 2,107 emergency room visits, and 998 life threatening events.43 Of the deaths reported to VAERS, 352 were noted as senior living administration settings,44  with 78 percent of overall reported deaths occurring in persons 65 years of age and older.45

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

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.48 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.49

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.50

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.51 By mid- January 2021, Moderna had already begun offering the vaccine to some placebo group participants.52

Janssen/Johnson & Johnson COVID-19 Vaccine

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.53

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.54

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: 55

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 49.56 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.57 58

The FDA updated the Janssen/Johnson & Johnson’s COVID-19 Fact Sheet on April 23, 2021 and acknowledged that:59

“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.”

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.60 61

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. 62 63

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.”64

The most common adverse events experienced by trial participants were headaches, muscle pain, fatigue and pain the injection site. 65 66

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.67 However, on October 12, 2020, all clinical trials stopped after a participant developed an “unexplained illness.” 68 Sources familiar with the event reported that a male in his 20’s had a stroke after receiving the experimental vaccine.69 Clinical trials in the U.S  resumed in late October 2020.70

As of April 23, 2021 vaccine adverse events submitted to VAERS totaled 25,084, with 1,229 noted as serious. Included in these reports were 214 deaths, 186 permanent disabilities, 578 emergency room visits, and 936 hospitalizations.71

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 April 28, 2021

References

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