- Updated Sept. 12, 2021 with study finding teenage boys face much higher heart risk from vaccine than Covid
- Updated Sept.10,2021 with Israel study on majority of hospitalized being vaccinated
- Updated Sept. 9, 2021 with CDC study about increased myocarditis/heart inflammation risk, lymphadenopathy, appendicitis, and herpes zoster infection
- Updated Sept. 4, 2021 with acute CNS demyelination after Pfizer and Moderna vaccines
- Updated Aug. 30, 2021 with Functional Neurological Disorder
- Updated Aug. 24, 2021 with waning immunity
- Updated Aug. 17, 2021 with Bell’s Palsy analysis, Hong Kong
- Updated Aug. 16, 2021 with Antibody Dependent Enhancement (ADE) study
- Updated Aug. 5, 2021 with heart disorders more common than CDC reported from database
- Updated July 22, 2021 with EU warning about Guillain-Barre autoimmune paralysis after Johnson and Johnson vaccination.
- Updated July 12, 2021 with new FDA warning of Guillain-Barre autoimmune paralysis cases after vaccination.
- Updated July 12, 2021 with reports of Graves disease autoimmune disorder after vaccination.
- Updated July 1, 2021 with reports of Guillain-Barre paralysis cases after vaccination.
- Updated June 30, 2021 with news of first case of blood clot disorder in double-dose RNA vaccine.
If you find yourself confused about the mixed guidance when it comes to Covid-19 vaccines and safety concerns, you’re not alone.
While the Centers for Disease Control (CDC) is marketing widespread use of the emergency-use vaccines in the U.S. for both old and young alike, many other countries are limiting Covid-19 vaccine use. Health officials around the world are giving varying advice on safety issues as Covid-19 vaccines are given to more people, and more information can be collected.
Read CDC’s information here.
Below are summaries of some of the concerns that have emerged or been raised by medical officials.
Click here to jump to: Summary by safety concern
Click here to jump to: Summary by vaccine
Click here to jump to: Summary by country
Click here to jump to: Additional reading and studies
Summary by safety concern
General
In the UK, some scientists analyzed adverse event reports and called upon the Medicines and Healthcare Products Regulatory Agency to stop the Covid-19 vaccines as “not safe for human use” due to reports of issues with bleeding/clotting, pain, immune system, neurological, loss of sight/hearing/smell/speech, and questions about impact in pregnant women.
A petition of scientists led by Linda Wastila, Professor, Pharmaceutical Health Services Research University of Maryland School of Pharmacy is calling for Covid-19 vaccines to be disapproved.
Fifty-seven authors from 17 countries have signed an endorsement urging that Covid-19 vaccinations be stopped unless new safety mechanisms are immediately implemented.
The authors include Dr. Peter McCullough, cardiologist and former Vice Chief of Medicine at Baylor University Medical Center in Dallas, Texas, who has called for a halt to vaccinating 30-year olds due to “no clinical benefit” and safety concerns. [McCullough is currently Senior Professor of Internal Medicine at the Texas A&M University Health Sciences Center.]
Lymphadenopathy
Updated Sept. 9, 2021: The Pfizer COVID-19 mRNA vaccine was found to be associated with an increased risk of lymphadenopathy, swelling or inflammation of lymph nodes according to a real-world case-control study from Israel.
Appendicitis
Updated Sept. 9, 2021: The Pfizer COVID-19 mRNA vaccine was found to be associated with increased risk of appendicitis, according to a real-world case-control study from Israel.
Herpes Zoster Infection
Updated Sept. 9, 2021: The Pfizer COVID-19 mRNA vaccine was found to be associated with an increased risk of herpes zoster infection, according to a real-world case-control study from Israel.
Acute CNS Demyelination and Multiple Sclerosis
A new study in Journal of Neurology examines possible links between Pfizer and Moderna vaccines, and acute Central Nervous System (CNS) demyelination, including Multiple Sclerosis (MS).
Demyelinating diseases damage the protective covering surrounding nerve fibers in the brain, optic nerves and spinal cord, causing neurological problems. In the study, four patients had the Pfizer vaccine and three had the Moderna vaccine. Within 21 days of the first or second dose, the patients developed active CNS demyelination of the optic nerve, brain, and/or spinal cord leading to “visual loss, dysmetria, gait instability, paresthesias, sphincter disturbance, and limb weakness.”
Age ranged from 24 to 64 years old. Four patients were ultimately diagnoses with exacerbation of their stable MS.
Two were diagnosed with new cases of MS.
One was diagnosed with neuromyelitis optica.
Functional Neurological Disorder (FND)
Researchers in the United Kingdom are studying two additional cases of Functional Neurological Disorder (FND) in women in their 30s after receiving Covid-19 vaccines.
FND is a neurological disorder involving malfunctioning of the nervous system and how the brain and body transmit signals. Symptoms can include limb weakness, paralysis, tremor, spasms, problems walking, speech problems, tingling, vision loss, seizures, fatigue, anxiety, chronic pain, memory symptoms, and blackouts.
An analysis of Covid-19 vaccine adverse events showed hundreds of thousands of reports of such symptoms.
In January, videos showing vaccine patients suffering such symptoms were treated by media outlets such as Wired as if they were fake news and “dangerous” misinformation.
In fact, the videos garnered the attention of scientists who investigated and concluded they were early warnings of what happens to some who get Covid-19 vaccines.
The newest cases are outlined in the journal NeuroPsychiatry and include:
- A 38-year old woman who got her first dose of Pfizer’s vaccine and quickly developed weakness around her ear, mouth, left arm and leg. She went to the ER the next day and was diagnosed with Bell’s palsy or a transient ischemic attack. Problems continued months later, including memory issues, and she was diagnosed with FND.
- A 36-year-old woman who got her second dose of Moderna and quickly noticed weakness in right hand and right leg limping. A day later she reported severe leg heaviness, fatigue, movement difficulties. After physical therapy her right-side weakness improved but she awoke weeks later with left-side weakness, tightness and heaviness in neck, difficulties with daily living, rapid muscle fatigue, dragging right foot, and tremor. She was diagnosed with FND.
Antibody Dependent Enhancement (ADE)
Updated (read more here). According to studies:
- Antibody Dependent Enhancement (ADE) can make vaccinated people more susceptible to serious infection from the virus
- “ADE may be a concern” for those who have been vaccinated for Covid-19
- With ADE, after people get vaccinated for an initial virus, infection by a subsequent variant or strain of the virus can result in “increased viral replication and more severe disease, leading to major safety risks”
- ADE can also “occur when neutralizing antibodies (which bind the virus and stop it from causing infection) are present at low enough levels that they don’t protect against infection. Instead, they can form immune complexes with viral particles, which in turn leads to worse illness”
- This concern was initially described by some scientists who were subsequently banned from media platforms that incorrectly claimed the scientists were disseminating disinformation
Guillain-Barre syndrome autoimmune paralysis
Update July 22, 2021: The European Union added Guillain-Barré syndrome, an autoimmune paralysis disorder, as a possible side effect from Johnson and Johnson’s Covid-19 vaccine.
Update July 12, 2021: The FDA added warnings about Guillain-Barre autoimmune paralysis, in which the immune system attacks the body’s nerves, after Johnson and Johnson vaccine. According to reports, the cases have primarily been reported about two weeks after vaccination, mostly in men, and “any aged 50 and older.”
Numerous case reports of Guillain-Barre syndrome paralysis after Covid-19 vaccine have prompted scientists to warn that “all physicians” should be “vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine… our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.” In the U.K., scientists flagged “bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine.” A case has also been reported in a patient who got the Pfizer vaccine. In India, there are reports of seven severe cases of Guillain-Barré syndrome 10 to 14 days after the first dose of AstraZeneca’s vaccine. Six were women, all had facial paralysis, “all progressed to quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement.”
Guillain-Barre syndrome has been reported after other vaccinations. The cause is believed to be damage to the immune system. The disorder can be extremely serious and can lead to total paralysis with dependence on artificial respiration. Even those who recover may have serious muscle wasting and may have to slowly teach the body to relearn most every normal task, such as walking. One in 20 cases is fatal.
Bell’s Palsy
Updated Aug. 17: An analysis in Hong Kong shows risk of Bell’s palsy is higher with CoronaVac (Sinovac Biotech) shot, a vaccine formulation not currently used in U.S. Bell’s palsy is facial paralysis, muscle twitching, or weakness. It may include change in taste, and pain around the ear, increased sensitivity to sound known as hyperacusis. An adverse event analysis of U.S. reports shows 4,154 Bell’s Palsy after Covid-19 vaccination.
Heart Issues
Updated Sept. 9, 2021: The Pfizer COVID-19 mRNA vaccine was found to be associated with a threefold increased risk of myocarditis, according to a real-world case-control study from Israel. “Vaccination had a strong association with an increased risk of myocarditis as well as increased risks of lymphadenopathy [swelling or inflammation of lymph nodes], appendicitis, and herpes zoster infection.”
The Food and Drug Administration has added a new warning to Pfizer and Moderna Covid-19 vaccines about risk of heart inflammation.
As of June of 2021, CDC said that more than 1,200 cases of heart inflammation (myocarditis or pericarditis) in young people had been reported after Pfizer and Moderna Covid-19 vaccination.
- More than half were after the second dose.
- Most of the injuries are in males under age 30.
Updated Aug. 4: A new, independent study of medical records found the incidences of myocarditis and pericarditis are more than five times more common than CDC reported.
The Israeli Ministry of Health announced it’s monitoring for heart inflammation after Pfizer’s vaccine due to reports of problems.
Myocarditis and Other Cardiovascular Complications of the mRNA-Based COVID-19 Vaccines [Pfizer-BioNTech, Moderna] in a number of patients are described in a scientific article:
- Two patients with clinically suspected myocarditis
- One patient with stress cardiomyopathy
- Two patients with pericarditis
According to the research:
- The two patients with clinically suspected myocarditis were otherwise healthy young men who presented with acute substernal chest pressure and/or dyspnea after receiving the second dose of the vaccine and were found to have diffuse ST elevations on electrocardiogram (ECG), elevated cardiac biomarkers and inflammatory markers, and mildly reduced left ventricular (LV) function on echocardiography. Both patients met the modified Lake Louise Criteria for acute myocarditis by cardiac magnetic resonance imaging.
- A case of stress cardiomyopathy occurred in a 60-year-old woman with known coronary artery disease (CAD) and previously normal LV function, who presented with new exertional symptoms, ECG changes, and apical akinesis following the second dose of the vaccine.
- The two patients with pericarditis who presented with chest pain, elevated inflammatory markers, and pericardial effusions after receiving the vaccine.
Updated Sept.9, 2021: An August 10 study in JAMA Cardiology confirms the previously identified Pfizer vaccine’s myocarditis (heart inflammation) risk in young boys.
Read the study here.
Updated Sept. 12, 2021: A study of Pfizer and Moderna vaccines finds teenage boys are six times more likely to suffer heart issues from Covid-19 vaccination than from Covid. (However, in both instances, the risk is considered slight.)
Blood Clots and Blood Disorders
In late June, the first case of a blood clot disorder called “thrombosis with thrombocytopenia” after an RNA double-dose vaccine was been reported in the Annals of Internal Medicine. The case was that of a 65-year-old man who developed symptoms ten days after his second dose of the Moderna vaccine. Because the blood clot disorder was not previously warned about in the Moderna and Pfizer vaccines, doctors treated the patient with heparin, the very drug that’s not supposed to be used in post-vaccine patients suffering from the disorder because it could actually worsen the condition.
The Johnson and Johnson Covid-19 vaccine was temporarily removed from the market in the U.S. on April 16, 2021 while health officials studied reports of blood clot injuries. Among them was an 18-year old teen named Emma Burkey, who got sick about a week after the Johnson and Johnson Covid-19 vaccine and ended up having three brain surgeries related to blood clots and seizures.
Read: BBC radio news anchor dies of blood clots after Covid vaccine
The Johnson and Johnson vaccine was allowed back on the market April 27, 2021 with new warnings about the disorder.
Swedish health officials determined that people under age 65 should not get the Johnson and Johnson vaccine due to reports of blood clots.
An editorial published in the Journal of the American Medical Association recommended women under age 50 avoid the Johnson and Johnson Covid-19 vaccine due to concerns about blood clots. The recommendation discussed 12 case reports of a blood disorder known as cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the Johnson and Johnson vaccine.
The AstraZeneca Covid-19 vaccine (not currently approved in the U.S.) has been linked to a dangerous disorder involving blood clots with low blood platelets. On April 7, 2021, the European Medicines Agency says it made the association after it analyzed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of March 22, 2021; 18 of which were fatal.
An otherwise healthy South Florida doctor, Gregory Michael, died of a brain hemorrhage 16 days after he got Pfizer’s Covid-19 vaccine. Authorities concluded he died of a blood disorder called “immune thrombocytopenia” (ITP) that can prevent blood from clotting and cause internal bleeding. His wife said a blood test showed the level of his platelets to be at “zero.” She said before the shot, Dr. Michael had “absolutely no medical issues” and no underlying conditions. However, authorities later categorized his death as “natural.”
In Spain, the AstraZeneca shot has been restricted in people under age 60 due to reports of blood clots in younger people.
Bulgaria, Iceland and Norway have halted AstraZeneca shots.
Austria, Italy and Romania banned certain “lots” or batches of the AstraZeneca shots.
Denmark stopped using the AstraZeneca Covid-19 vaccine altogether as well as the Johnson and Johnson vaccine after investigations into blood clots, saying “the benefits of using the COVID-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect in those who receive the vaccine.”
The Italian government recently restricted AstraZeneca Covid-19 vaccine to adults over age 60 after a teenager who got the shot died from a rare form of blood clotting. Eighteen-year-old Camilla Canepa died after getting vaccinated May 25, 2021.
Several other European countries have also stopped giving the AstraZeneca Covid-19 vaccine to people below a certain age, usually ranging from 50 to 65.
Updated Sept. 9, 2021: An August 10 study in JAMA Cardiology urged caution in giving Covid-19 vaccine to certain high risk patients due to the vaccine link to a serious blood disorder: thrombocytopenia with thrombosis. “One of the devastating manifestations of this syndrome, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), is cerebral venous sinus thrombosis (CVST),” say the study authors. The link involves the AstraZeneca/Oxford and Johnson & Johnson vaccines, according to the study. The AstraZeneca vaccine is not administered in the U.S. currently.
Read the study here.
Graves disease autoimmune disorder
Studies in Mexico and Turkey link the autoimmune thyroid disorder Graves disease to Covid-19 vaccination in numerous female health care workers, including two who were breastfeeding. Pfizer-BioNTech was the vaccine given in Mexico. A Chinese vaccine was given in Turkey. Read more at the link below.
https://sharylattkisson.com/2021/07/two-studies-covid-19-vaccines-trigger-graves-disease-in-some-female-health-care-workers/
Frail, elderly
Health officials in Norway sounded the alarm after 23 patients died shortly after getting the Pfizer Covid-19 vaccine. They advise doctors to use caution in administering the shot to “very frail elderly patients.”
After investigating 13 of the deaths, the Norwegian authorities concluded that common side effects from so-called “RNA” vaccines may be too much for a frail elderly person to handle, and may contribute to their death.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly,” said Steinar Madsen, medical director of the Norwegian Medicines Agency.
CDC said it is monitoring the impact of the vaccines on already-frail patients such as the chronically ill in nursing homes.
Several clusters of elderly patients in U.S. nursing homes died after Pfizer or Moderna Covid-19 vaccine. In one group, a number of the patients who died tested positive for Covid-19 after vaccination.
Pregnant women
Several Brazilian states suspended use of AstraZeneca’s Covid-19 vaccine for pregnant women in May 2021 after a pregnant woman died after getting vaccinated. The decisions follow the recommendation of the country’s National Health Surveillance Agency, which recommended “immediate suspension” of the AstraZeneca Covid-19 vaccine for pregnant women after results of vaccine adverse events monitoring in the country.
CDC says that with limited data on impact of Covid-19 vaccine in pregnant women and on their unborn children, the decision on whether to vaccinate while pregnant is an individual decision to be made between a woman and her physician.
Previously-infected
CDC falsely claimed that studies showed Covid-19 vaccines are effective for those who already had Covid-19. In fact, studies showed the opposite.
Manufacturing problems
On June 11, the European Union’s drug regulator announced it will not use batches of the Johnson & Johnson COVID-19 vaccine that were made at a Baltimore, Maryland-based plant around the time that cross-contamination manufacturing problems were reported at the facility.
Anonymous sources claimed that up to 60 million doses of the Johnson and Johnson vaccine had to be thrown out. But the FDA issued a news release saying that two batches from the Baltimore plant were safe to use. The FDA said “several other batches are not suitable for use, but additional batches are still under review.”
Waning immunity, Breakthrough Infections
Israel announced that about half of the adults infected with Covid-19 during its outbreak in the June 2021 time period were fully vaccinated. The fully-vaccinated individuals had gotten Pfizer’s shots.
According to Epoch Times, in June 2021 nearly 4,000 fully vaccinated people in Massachusetts tested positive for Covid-19. On April 30, “the CDC reported that some 10,626 breakthrough cases were reported in 46 states and territories.” Breakthrough cases are where fully vaccinated people still end up infected with Covid-19.
Scientists hoped that Covid-19 vaccines would be effective in variants of Covid-19, which are mutations that occur naturally with viruses and were always expected with Covid-19. However, the vaccine effectiveness against variants may be limited. CDC and vaccine makers are studying the medical landscape to find out more.
Other states, such as Maine, are noting Covid-19 deaths occurring in fully vaccinated people.
Update Aug. 24, 2021: With evidence of seriously-waning immunity at the five- to six-month mark, CDC is now recommending a third “booster” shot. In highly-vaccinated Israel, recognition that vaccination likely does not confer protection beyond a few months, the country has reimagined its vaccine passports. They will only apply to people who have had three shots, and only be good for a six month period of time.
Update Sept. 10, 2021: An analysis of data in Israel, which has one of the world’s highest Covid-19 vaccination levels, showed almost 60% of those hospitalized for Covid were fully vaccinated. “This is a very clear warning sign for the rest of the world,” said Ran Balicer, CIO at Clalit Health Services, Israel’s largest health maintenance organization. “If it can happen here, it can probably happen anywhere.” The Pfizer vaccine is given in Israel.
Summary by vaccine
Pfizer and Moderna
Acute CNS Demyelination and Multiple Sclerosis
A new study in Journal of Neurology examines possible links between Pfizer and Moderna vaccines, and acute Central Nervous System (CNS) demyelination, including Multiple Sclerosis (MS).
Demyelinating diseases damage the protective covering surrounding nerve fibers in the brain, optic nerves and spinal cord, causing neurological problems. In the study, four patients had the Pfizer vaccine and three had the Moderna vaccine. Within 21 days of the first or second dose, the patients developed active CNS demyelination of the optic nerve, brain, and/or spinal cord leading to “visual loss, dysmetria, gait instability, paresthesias, sphincter disturbance, and limb weakness.”
Age ranged from 24 to 64 years old. Four patients were ultimately diagnoses with exacerbation of their stable MS.
Two were diagnosed with new cases of MS.
One was diagnosed with neuromyelitis optica.
Waning Immunity, Breakthrough Infections
Update Aug. 24, 2021: With evidence of seriously-waning immunity at the five- to six-month mark, CDC is now recommending a third “booster” shot. In highly-vaccinated Israel, recognition that vaccination likely does not confer protection beyond a few months, the country has reimagined its vaccine passports. They will only apply to people who have had three shots, and only be good for a six month period of time.
Update Sept. 10, 2021: An analysis of data in Israel, which has one of the world’s highest Covid-19 vaccination levels, showed almost 60% of those hospitalized for Covid were fully vaccinated. “This is a very clear warning sign for the rest of the world,” said Ran Balicer, CIO at Clalit Health Services, Israel’s largest health maintenance organization. “If it can happen here, it can probably happen anywhere.” The Pfizer vaccine is given in Israel.
Functional Neurological Disorder (FND)
Updated Aug. 30, 2021: Researchers in the United Kingdom are studying two additional cases of Functional Neurological Disorder (FND) in women in their 30s after receiving Covid-19 vaccines.
FND is a neurological disorder involving malfunctioning of the nervous system and how the brain and body transmit signals. Symptoms can include limb weakness, paralysis, tremor, spasms, problems walking, speech problems, tingling, vision loss, seizures, fatigue, anxiety, chronic pain, memory symptoms, and blackouts.
An analysis of Covid-19 vaccine adverse events showed hundreds of thousands of reports of such symptoms.
In January, videos showing vaccine patients suffering such symptoms were treated by media outlets such as Wired as if they were fake news and “dangerous” misinformation.
In fact, the videos garnered the attention of scientists who investigated and concluded they were early warnings of what happens to some who get Covid-19 vaccines.
The newest cases are outlined in the journal Neurology and include:
- A 38-year old woman who got her first dose of Pfizer’s vaccine and quickly developed weakness around her ear, mouth, left arm and leg. She went to the ER the next day and was diagnosed with Bell’s palsy or a transient ischemic attack. Problems continued months later, including memory issues, and she was diagnosed with FND.
- A 36-year-old woman who got her second dose of Moderna and quickly noticed weakness in right hand and right leg limping. A day later she reported severe leg heaviness, fatigue, movement difficulties. After physical therapy her right-side weakness improved but she awoke weeks later with left-side weakness, tightness and heaviness in neck, difficulties with daily living, rapid muscle fatigue, dragging right foot, and tremor. She was diagnosed with FND.
Antibody Dependent Enhancement (ADE)
Updated (read more here). According to studies:
- Antibody Dependent Enhancement (ADE) can make vaccinated people more susceptible to serious infection from the virus
- “ADE may be a concern” for those who have been vaccinated for Covid-19
- With ADE, after people get vaccinated for an initial virus, infection by a subsequent variant or strain of the virus can result in “increased viral replication and more severe disease, leading to major safety risks”
- ADE can also “occur when neutralizing antibodies (which bind the virus and stop it from causing infection) are present at low enough levels that they don’t protect against infection. Instead, they can form immune complexes with viral particles, which in turn leads to worse illness”
- This concern was initially described by some scientists who were subsequently banned from media platforms that incorrectly claimed the scientists were disseminating disinformation
Guillain-Barre autoimmune paralysis
Numerous case reports of Guillain-Barre syndrome paralysis after Covid-19 vaccine have prompted scientists to warn that “all physicians” should be “vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine… our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.” In the U.K., scientists flagged “bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine.” A case has also been reported in a patient who got the Pfizer vaccine. In India, there are reports of seven severe cases of Guillain-Barré syndrome 10 to 14 days after the first dose of AstraZeneca’s vaccine. Six were women, all had facial paralysis, “all progressed to quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement.”
Guillain-Barre syndrome has been reported after other vaccinations. The cause is believed to be damage to the immune system. The disorder can be extremely serious and can lead to total paralysis with dependence on artificial respiration. Even those who recover may have serious muscle wasting and may have to slowly teach the body to relearn most every normal task, such as walking. One in 20 cases is fatal.
Blood Clots
In late June, the first case of a blood clot disorder called “thrombosis with thrombocytopenia” after an RNA double-dose vaccine was been reported in the Annals of Internal Medicine. The case was that of a 65-year-old man who developed symptoms ten days after his second dose of the Moderna vaccine. Because the blood clot disorder was not previously warned about in the Moderna and Pfizer vaccines, doctors treated the patient with heparin, the very drug that’s not supposed to be used in post-vaccine patients suffering from the disorder because it could actually worsen the condition.
Heart inflammation
Updated Sept. 9, 2021: The Pfizer COVID-19 mRNA vaccine was found to be associated with a threefold increased risk of myocarditis, according to a real-world case-control study from Israel. “Vaccination had a strong association with an increased risk of myocarditis as well as increased risks of lymphadenopathy [swelling or inflammation of lymph nodes], appendicitis, and herpes zoster infection.”
The Food and Drug Administration has added a new warning to Pfizer and Moderna Covid-19 vaccines about risk of heart inflammation.
As of June of 2021, CDC said that more than 1,200 cases of heart inflammation (myocarditis of pericarditis) in young people had been reported after Pfizer and Moderna Covid-19 vaccination.
- More than half were after the second dose.
- Most of the injuries are in males under age 30.
Updated Aug. 4: A new, independent study of medical records found the incidences of myocarditis and pericarditis are more than five times more common than CDC reported.
The Israeli Ministry of Health announced it’s monitoring for heart inflammation after Pfizer’s vaccine due to reports of problems.
Myocarditis and Other Cardiovascular Complications of the mRNA-Based COVID-19 Vaccines [Pfizer-BioNTech, Moderna] in a number of patients are described in a scientific article:
- Two patients with clinically suspected myocarditis
- One patient with stress cardiomyopathy
- Two patients with pericarditis
According to the research:
- The two patients with clinically suspected myocarditis were otherwise healthy young men who presented with acute substernal chest pressure and/or dyspnea after receiving the second dose of the vaccine and were found to have diffuse ST elevations on electrocardiogram (ECG), elevated cardiac biomarkers and inflammatory markers, and mildly reduced left ventricular (LV) function on echocardiography. Both patients met the modified Lake Louise Criteria for acute myocarditis by cardiac magnetic resonance imaging.
- A case of stress cardiomyopathy occurred in a 60-year-old woman with known coronary artery disease (CAD) and previously normal LV function, who presented with new exertional symptoms, ECG changes, and apical akinesis following the second dose of the vaccine.
- The two patients with pericarditis who presented with chest pain, elevated inflammatory markers, and pericardial effusions after receiving the vaccine.
An otherwise healthy South Florida doctor, Gregory Michael, died of a brain hemorrhage 16 days after he got Pfizer’s Covid-19 vaccine. Authorities concluded he died of a blood disorder called “immune thrombocytopenia” (ITP) that can prevent blood from clotting and cause internal bleeding. His wife said a blood test showed the level of his platelets to be at “zero.” She said before the shot, Dr. Michael had “absolutely no medical issues” and no underlying conditions. However, authorities later categorized his death as “natural.”
Updated Sept. 12, 2021: A study of Pfizer and Moderna vaccines finds teenage boys are six times more likely to suffer heart issues from Covid-19 vaccination than from Covid. (However, in both instances, the risk is considered slight.)
Frail, elderly
Health officials in Norway sounded the alarm after 23 patients died shortly after receiving the Pfizer Covid-19 vaccine. They advise doctors to use caution in administering the shot to “very frail elderly patients.”
After investigating 13 of the deaths, the Norwegian authorities concluded that common side effects from so-called “RNA” vaccines may be too much for a frail elderly person to handle, and may contribute to their death.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly,” said Steinar Madsen, medical director of the Norwegian Medicines Agency.
CDC said it is monitoring the impact of the vaccines on already-frail patients such as the chronically ill in nursing homes.
Several clusters of elderly patients in U.S. nursing homes died after Pfizer or Moderna Covid-19 vaccine. In one group, a number of the patients who died tested positive for Covid-19 after vaccination.
Israel announced that about half of the adults infected with Covid-19 during its outbreak in the June 2021 time period were fully vaccinated. The fully-vaccinated individuals had gotten Pfizer’s shots.
Graves Disease
Studies in Mexico and Turkey link the autoimmune thyroid disorder Graves disease to Covid-19 vaccination in numerous female health care workers, including two who were breastfeeding. Pfizer-BioNTech was the vaccine given in Mexico. A Chinese vaccine was given in Turkey. Read more at the link here.
Johnson and Johnson
Update Sept. 9, 2021: An August 10 study in JAMA Cardiology urged caution in giving Johnson and Johnson Covid-19 vaccine to certain high risk patients due to the vaccine link to a serious blood disorder: thrombocytopenia with thrombosis. “One of the devastating manifestations of this syndrome, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), is cerebral venous sinus thrombosis (CVST),” say the study authors.
Read the study here.
Update July 22, 2021: The European Union added Guillain-Barré syndrome, an autoimmune paralysis disorder, as a possible side effect from Johnson and Johnson’s Covid-19 vaccine.
Update July 12, 2021: The FDA added warnings about Guillain-Barre autoimmune paralysis, in which the immune system attacks the body’s nerves, after Johnson and Johnson vaccine. According to reports, the cases have primarily been reported about two weeks after vaccination, mostly in men, and “any aged 50 and older.”
The Johnson and Johnson Covid-19 vaccine was temporarily removed from the market in the U.S. on April 16, 2021 while health officials studied reports of blood clot injuries.
Updated Aug. 4: A new, independent study of medical records found the incidences of myocarditis and pericarditis are more than five times more common than CDC reported.
The Johnson and Johnson vaccine was allowed back on the market April 27, 2021 with new warnings about the disorder.
Swedish health officials determined that people under age 65 should not get the Johnson and Johnson vaccine due to reports of blood clots.
An editorial in the Journal of the American Medical Association recommended women under age 50 avoid the Johnson and Johnson Covid-19 vaccine due to concerns about blood clots: a blood disorder known as cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the Johnson and Johnson vaccine.
On June 11, the European Union’s drug regulator announced it will not use batches of the Johnson & Johnson COVID-19 vaccine that were made at a Baltimore, Maryland-based plant around the time that cross-contamination manufacturing problems were reported at the facility.
Anonymous sources claimed that up to 60 million doses of the Johnson and Johnson vaccine had to be thrown out. But the FDA issued a news release saying that two batches from the Baltimore plant were safe to use. The FDA said “several other batches are not suitable for use, but additional batches are still under review.”
Denmark banned the Johnson and Johnson vaccine altogether saying “the benefits of using the COVID-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect in those who receive the vaccine”.
AstraZeneca (not given in the U.S.)
Update: Sept. 9, 2021: An August 10 study in JAMA Cardiology urged caution in giving AstraZeneca Covid-19 vaccine to certain high risk patients due to the vaccine link to a serious blood disorder: thrombocytopenia with thrombosis. “One of the devastating manifestations of this syndrome, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), is cerebral venous sinus thrombosis (CVST),” say the study authors.
Read the study here.
The AstraZeneca Covid-19 vaccine has been linked to a dangerous disorder involving blood clots with low blood platelets.
On April 7, 2021: The European Medicines Agency says it made the association after it analyzed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of March 22, 2021, 18 of which were fatal.
In Spain, the AstraZeneca shot has been restricted in people under age 60 due to reports of blood clots in younger people.
Bulgaria, Iceland and Norway have halted AstraZeneca shots.
Austria, Italy and Romania banned certain “lots” or batches of the AstraZeneca shots.
Denmark stopped using the AstraZeneca Covid-19 vaccine altogether after investigations into blood clots.
The Italian government recently restricted AstraZeneca Covid-19 vaccine to adults over age 60 after a teenager who got the shot died from a rare form of blood clotting. Eighteen-year-old Camilla Canepa died after getting vaccinated May 25, 2021.
Several other European countries have also stopped giving the AstraZeneca COVID-19 vaccine to people below a certain age, usually ranging from 50 to 65.
Several Brazilian states suspended use of AstraZeneca’s Covid-19 vaccine for pregnant women in May 2021 after a pregnant woman died after getting vaccinated. The decisions follow the recommendation of the country’s National Health Surveillance Agency, which recommended “immediate suspension” of the AstraZeneca Covid-19 vaccine for pregnant women after results of vaccine adverse events monitoring in the country.
Numerous case reports of Guillain-Barre syndrome paralysis after Covid-19 vaccine have prompted scientists to warn that “all physicians” should be “vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine… our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.” In the U.K., scientists flagged “bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine.” A case has also been reported in a patient who got the Pfizer vaccine. In India, there are reports of seven severe cases of Guillain-Barré syndrome 10 to 14 days after the first dose of AstraZeneca’s vaccine. Six were women, all had facial paralysis, “all progressed to quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement.”
Guillain-Barre syndrome has been reported after other vaccinations. The cause is believed to be damage to the immune system. The disorder can be extremely serious and can lead to total paralysis with dependence on artificial respiration. Even those who recover may have serious muscle wasting and may have to slowly teach the body to relearn most every normal task, such as walking. One in 20 cases is fatal.
Summary by country
Austria: Banned certain “lots” or batches of AstraZeneca shots.
Brazil: Several Brazilian states suspended use of AstraZeneca’s Covid-19 vaccine for pregnant women in May 2021 after a pregnant woman died after getting vaccinated. The decisions follow the recommendation of the country’s National Health Surveillance Agency, which recommended “immediate suspension” of the AstraZeneca Covid-19 vaccine for pregnant women after results of vaccine adverse events monitoring in the country.
Bulgaria: Halted AstraZeneca shots.
Denmark: stopped using the AstraZeneca Covid-19 vaccine and the Johnson and Johnson vaccine altogether after investigations into blood clots.
European Union: July 22, 2021: The European Union added Guillain-Barré syndrome, an autoimmune paralysis disorder, as a possible side effect from Johnson and Johnson’s Covid-19 vaccine.
The AstraZeneca Covid-19 vaccine (not currently approved in the U.S.) has been linked to a dangerous disorder involving blood clots with low blood platelets. On April 7, 2021, the European Medicines Agency says it made the association after it analyzed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of March 22, 2021, 18 of which were fatal.
On June 11, the European Union’s drug regulator announced it will not use batches of the Johnson & Johnson COVID-19 vaccine that were made at a Baltimore, Maryland-based plant around the time that cross-contamination manufacturing problems were reported at the facility.
Several European countries have stopped giving the AstraZeneca COVID-19 vaccine to people below a certain age, usually ranging from 50 to 65.
Numerous case reports of Guillain-Barre syndrome paralysis after Covid-19 vaccine have prompted scientists to warn that “all physicians” should be “vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine… our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.” In the U.K., scientists flagged “bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine.” A case has also been reported in a patient who got the Pfizer vaccine. In India, there are reports of seven severe cases of Guillain-Barré syndrome 10 to 14 days after the first dose of AstraZeneca’s vaccine. Six were women, all had facial paralysis, “all progressed to quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement.”
Guillain-Barre syndrome has been reported after other vaccinations. The cause is believed to be damage to the immune system. The disorder can be extremely serious and can lead to total paralysis with dependence on artificial respiration. Even those who recover may have serious muscle wasting and may have to slowly teach the body to relearn most every normal task, such as walking. One in 20 cases is fatal.
Hong-Kong: Updated Aug. 17: An analysis in Hong Kong shows risk of Bell’s palsy is higher with CoronaVac (Sinovac Biotech) shot, a vaccine formulation not currently used in U.S. Bell’s palsy is facial paralysis, muscle twitching, or weakness. It may include change in taste, and pain around the ear, increased sensitivity to sound known as hyperacusis. An adverse event analysis of U.S. reports shows 4,154 Bell’s Palsy after Covid-19 vaccination.
Iceland: Has halted AstraZeneca shots.
India: Numerous case reports of Guillain-Barre syndrome paralysis after Covid-19 vaccine have prompted scientists to warn that “all physicians” should be “vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine… our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.” In the U.K., scientists flagged “bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine.” A case has also been reported in a patient who got the Pfizer vaccine. In India, there are reports of seven severe cases of Guillain-Barré syndrome 10 to 14 days after the first dose of AstraZeneca’s vaccine. Six were women, all had facial paralysis, “all progressed to quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement.”
Guillain-Barre syndrome has been reported after other vaccinations. The cause is believed to be damage to the immune system. The disorder can be extremely serious and can lead to total paralysis with dependence on artificial respiration. Even those who recover may have serious muscle wasting and may have to slowly teach the body to relearn most every normal task, such as walking. One in 20 cases is fatal.
Israel: The Israeli Ministry of Health announced it’s monitoring for heart inflammation after Pfizer’s vaccine due to reports of problems.
Announced that about half of the adults infected with Covid-19 during its outbreak in the June 2021 time period were fully vaccinated. The fully-vaccinated individuals had gotten Pfizer’s shots.
Update Aug. 24, 2021: In highly-vaccinated Israel, recognition that vaccination likely does not confer protection beyond a few months, the country has reimagined its vaccine passports. They will only apply to people who have had three shots, and only be good for a six month period of time.
Updated Sept. 9 2021: The Pfizer COVID-19 mRNA vaccine was found to be associated with a threefold increased risk of myocarditis, according to a real-world case-control study from Israel. “Vaccination had a strong association with an increased risk of myocarditis as well as increased risks of lymphadenopathy [swelling or inflammation of lymph nodes], appendicitis, and herpes zoster infection.”
Italy: Restricted AstraZeneca Covid-19 vaccine to adults over age 60 after a teenager who got the shot died from a rare form of blood clotting. Eighteen-year-old Camilla Canepa died after getting vaccinated May 25, 2021.
Banned certain “lots” or batches of the AstraZeneca shots.
Mexico: Studies in Mexico and Turkey link the autoimmune thyroid disorder Graves disease to Covid-19 vaccination in numerous female health care workers, including two who were breastfeeding. Pfizer-BioNTech was the vaccine given in Mexico. A Chinese vaccine was given in Turkey. Read more at the link here.
Norway: Halted AstraZeneca shots. Cautioned use of the vaccine in “very frail elderly patients” after nearly two dozen deaths.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly,” said Steinar Madsen, medical director of the Norwegian Medicines Agency.
Romania: Banned certain “lots” or batches of the AstraZeneca shots.
Spain: The AstraZeneca shot has been restricted in people under age 60 due to reports of blood clots in younger people.
Sweden: Health officials determined that people under age 65 should not get the Johnson and Johnson vaccine due to reports of blood clots.
Turkey: Studies in Mexico and Turkey link the autoimmune thyroid disorder Graves disease to Covid-19 vaccination in numerous female health care workers, including two who were breastfeeding. Pfizer-BioNTech was the vaccine given in Mexico. A Chinese vaccine was given in Turkey. Read more at the link here.
UK: Some scientists analyzed adverse event reports and called upon the Medicines and Healthcare products Regulatory Agency to stop the Covid-19 vaccines as “not safe for human use” due to reports of issues with bleeding/clotting, pain, immune system, neurological, loss of sight/hearing/smell speech, and questions about impact in pregnant women.
Updated: Researchers in the United Kingdom are studying two additional cases of Functional Neurological Disorder (FND) in women in their 30s after receiving Covid-19 vaccines.
FND is a neurological disorder involving malfunctioning of the nervous system and how the brain and body transmit signals. Symptoms can include limb weakness, paralysis, tremor, spasms, problems walking, speech problems, tingling, vision loss, seizures, fatigue, anxiety, chronic pain, memory symptoms, and blackouts.
An analysis of Covid-19 vaccine adverse events showed hundreds of thousands of reports of such symptoms.
In January, videos showing vaccine patients suffering such symptoms were treated by media outlets such as Wired as if they were fake news and “dangerous” misinformation.
In fact, the videos garnered the attention of scientists who investigated and concluded they were early warnings of what happens to some who get Covid-19 vaccines.
The newest cases are outlined in the journal Neurology and include:
- A 38-year old woman who got her first dose of Pfizer’s vaccine and quickly developed weakness around her ear, mouth, left arm and leg. She went to the ER the next day and was diagnosed with Bell’s palsy or a transient ischemic attack. Problems continued months later, including memory issues, and she was diagnosed with FND.
- A 36-year-old woman who got her second dose of Moderna and quickly noticed weakness in right hand and right leg limping. A day later she reported severe leg heaviness, fatigue, movement difficulties. After physical therapy her right-side weakness improved but she awoke weeks later with left-side weakness, tightness and heaviness in neck, difficulties with daily living, rapid muscle fatigue, dragging right foot, and tremor. She was diagnosed with FND.
issues from Covid-19 vaccination than from Covid. (However, in both instances, the risk is considered slight.)
Update Sept. 9, 2021: An August 10 study in JAMA Cardiology confirms the previously identified Pfizer vaccine’s myocarditis (heart inflammation) risk in young boys.
Read the study here.
Update Sept. 4, 2021: Acute CNS Demyelination and Multiple Sclerosis: A new study in Journal of Neurology examines possible links between Pfizer and Moderna vaccines, and acute Central Nervous System (CNS) demyelination, including Multiple Sclerosis (MS).
Demyelinating diseases damage the protective covering surrounding nerve fibers in the brain, optic nerves and spinal cord, causing neurological problems. In the study, four patients had the Pfizer vaccine and three had the Moderna vaccine. Within 21 days of the first or second dose, the patients developed active CNS demyelination of the optic nerve, brain, and/or spinal cord leading to “visual loss, dysmetria, gait instability, paresthesias, sphincter disturbance, and limb weakness.”
Age ranged from 24 to 64 years old. Four patients were ultimately diagnoses with exacerbation of their stable MS.
Two were diagnosed with new cases of MS.
One was diagnosed with neuromyelitis optica.
Update Aug. 24, 2021: With evidence of seriously-waning immunity at the five- to six-month mark, CDC is now recommending a third “booster” shot. In highly-vaccinated Israel, recognition that vaccination likely does not confer protection beyond a few months, the country has reimagined its vaccine passports. They will only apply to people who have had three shots, and only be good for a six month period of time.
Update Aug. 16, 2021: Antibody Dependent Enhancement (ADE) (read more here). According to studies:
- Antibody Dependent Enhancement (ADE) can make vaccinated people more susceptible to serious infection from the virus
- “ADE may be a concern” for those who have been vaccinated for Covid-19
- With ADE, after people get vaccinated for an initial virus, infection by a subsequent variant or strain of the virus can result in “increased viral replication and more severe disease, leading to major safety risks”
- ADE can also “occur when neutralizing antibodies (which bind the virus and stop it from causing infection) are present at low enough levels that they don’t protect against infection. Instead, they can form immune complexes with viral particles, which in turn leads to worse illness”
- This concern was initially described by some scientists who were subsequently banned from media platforms that incorrectly claimed the scientists were disseminating disinformation
Update Aug. 4, 2021: A new, independent study of medical records found the incidences of myocarditis and pericarditis are more than five times more common than CDC reported.
Update July 12, 2021: The FDA added warnings about Guillain-Barre autoimmune paralysis, in which the immune system attacks the body’s nerves, after Johnson and Johnson vaccine. According to reports, the cases have primarily been reported about two weeks after vaccination, mostly in men, and “any aged 50 and older.”
In late June, the first case of a blood clot disorder called “thrombosis with thrombocytopenia” after an RNA double-dose vaccine was been reported in the Annals of Internal Medicine. The case was that of a 65-year-old man who developed symptoms ten days after his second dose of the Moderna vaccine. Because the blood clot disorder was not previously warned about in the Moderna and Pfizer vaccines, doctors treated the patient with heparin, the very drug that’s not supposed to be used in post-vaccine patients suffering from the disorder because it could actually worsen the condition.
Dr. Peter McCullough, cardiologist and Vice Chief of Medicine at Baylor University Medical Center in Dallas, Texas, has called for a halt to vaccinating 30-year olds due to “no clinical benefit” and safety concerns.
A petition of scientists led by Linda Wastila, Professor, Pharmaceutical Health Services Research University of Maryland School of Pharmacy is calling for Covid-19 vaccines to be disapproved.
The Food and Drug Administration has added a new warning to Pfizer and Moderna Covid-19 vaccines about risk of heart inflammation.
As of June of 2021, CDC said that more than 1,200 cases of heart inflammation (myocarditis of pericarditis) in young people had been reported after Pfizer and Moderna Covid-19 vaccination.
- More than half were after the second dose.
- Most of the injuries are in males under age 30.
Myocarditis and Other Cardiovascular Complications of the mRNA-Based COVID-19 Vaccines [Pfizer-BioNTech, Moderna] in a number of patients are described in a scientific article:
- Two patients with clinically suspected myocarditis
- One patient with stress cardiomyopathy
- Two patients with pericarditis
According to the research:
- The two patients with clinically suspected myocarditis were otherwise healthy young men who presented with acute substernal chest pressure and/or dyspnea after receiving the second dose of the vaccine and were found to have diffuse ST elevations on electrocardiogram (ECG), elevated cardiac biomarkers and inflammatory markers, and mildly reduced left ventricular (LV) function on echocardiography. Both patients met the modified Lake Louise Criteria for acute myocarditis by cardiac magnetic resonance imaging.
- A case of stress cardiomyopathy occurred in a 60-year-old woman with known coronary artery disease (CAD) and previously normal LV function, who presented with new exertional symptoms, ECG changes, and apical akinesis following the second dose of the vaccine.
- The two patients with pericarditis who presented with chest pain, elevated inflammatory markers, and pericardial effusions after receiving the vaccine.
The Johnson and Johnson Covid-19 vaccine was temporarily removed from the market in the U.S. on April 16, 2021 while health officials studied reports of blood clot injuries. Among them was an 18-year old teen named Emma Burkey, who got sick about a week after the Johnson and Johnson Covid-19 vaccine and ended up having three brain surgeries related to blood clots and seizures.
The Johnson and Johnson vaccine was allowed back on the market April 27, 2021 with new warnings about the disorder.
An editorial published in the Journal of the American Medical Association recommended women under age 50 avoid the Johnson and Johnson Covid-19 vaccine due to concerns about blood clots. The recommendation discussed 12 case reports of a blood disorder known as cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the Johnson and Johnson vaccine.
An otherwise healthy South Florida doctor, Gregory Michael, died of a brain hemorrhage 16 days after he got Pfizer’s Covid-19 vaccine. Authorities concluded he died of a blood disorder called “immune thrombocytopenia” (ITP) that can prevent blood from clotting and cause internal bleeding. His wife said a blood test showed the level of his platelets to be at “zero.” She said before the shot, Dr. Michael had “absolutely no medical issues” and no underlying conditions. However, authorities later categorized his death as “natural.”
Several clusters of elderly patients in U.S. nursing homes died after Pfizer or Moderna Covid-19 vaccine. In one group, a number of the patients who died tested positive for Covid-19 after vaccination.
CDC falsely claimed that studies showed Covid-19 vaccines are effective for those who already had Covid-19. In fact, studies showed the opposite.
Anonymous sources claimed that up to 60 million doses of the Johnson and Johnson vaccine had to be thrown out. But the FDA issued a news release saying that two batches from the Baltimore plant were safe to use. The FDA said “several other batches are not suitable for use, but additional batches are still under review.”
According to Epoch Times, in June 2021 nearly 4,000 fully vaccinated people in Massachusetts tested positive for Covid-19. On April 30, “the CDC reported that some 10,626 breakthrough cases were reported in 46 states and territories.” Breakthrough cases are where fully vaccinated people still end up infected with Covid-19.
Scientists hoped that Covid-19 vaccines would be effective in variants of Covid-19, which are mutations that occur naturally with viruses and were always expected with Covid-19. However, the vaccine effectiveness against variants may be limited. CDC and vaccine makers are studying the medical landscape to find out more.
Other states, such as Maine, are noting Covid-19 deaths occurring in fully vaccinated people.
Additional reading and studies
Additional case studies of myocarditis in people after Pfizer and Moderna Covid-19 vaccines, Aug. 18, 2021: https://www.nejm.org/doi/full/10.1056/NEJMc2109975
Zuckerman DM. Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health. Am J Public Health [Internet]. 2021 Jun;111(6):1065–9. Available from: http://dx.doi.org/10.2105/AJPH.2021.306273
Food and Drug Administration. Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry [Internet]. 2020 [cited 2020 Oct 6]. Available from: https://www.fda.gov/media/139638/download
Food and Drug Administration. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.fda.gov/media/146217/download
CDC. Risk for COVID-19 infection, hospitalization, and death by age group [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/covid- data/investigations-discovery/hospitalization-death-by-age.html
CDC. COVID-19 Pandemic Planning Scenarios [Internet]. 2021 [cited 2021 May 28]. Available from:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html
CDC. Estimated disease burden of COVID-19 [Internet]. 2021 [cited 2021 May 28]. Available from:
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html
Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science [Internet]. 2021 Feb 5;371(6529). Available from: http://dx.doi.org/10.1126/science.abf4063
Turner JS, Kim W, Kalaidina E, Goss CW, Rauseo AM, Schmitz AJ, et al. SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans. Nature [Internet]. 2021 May 24; Available from: http://dx.doi.org/10.1038/s41586-021-03647-4
Breton G, Mendoza P, Hagglof T, Oliveira TY, Schaefer-Babajew D, Gaebler C, et al. Persistent Cellular Immunity to SARS-CoV-2 Infection. bioRxiv [Internet]. 2020 Dec 9; Available from: http://dx.doi.org/10.1101/2020.12.08.416636
Hall VJ, Foulkes S, Charlett A, Atti A, Monk EJM, Simmons R, et al. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). Lancet [Internet]. 2021 Apr 17;397(10283):1459–69. Available from: http://dx.doi.org/10.1016/S0140-6736(21)00675-9
Krammer F, Srivastava K, Simon V, the PARIS team. Robust spike antibody responses and increased reactogenicity in seropositive individuals after a single dose of SARS-CoV-2 mRNA vaccine [Internet]. bioRxiv. medRxiv; 2021. Available from: http://medrxiv.org/lookup/doi/10.1101/2021.01.29.21250653
Samanovic MI, Cornelius AR, Wilson JP, Karmacharya T, Gray-Gaillard SL, Allen JR, et al. Poor antigen-specific responses to the second BNT162b2 mRNA vaccine dose in SARS-CoV-2-experienced individuals. medRxiv [Internet]. 2021 Feb 9; Available from: http://dx.doi.org/10.1101/2021.02.07.21251311
Camara C, Lozano-Ojalvo D, Lopez-Granados E, Paz-Artal E, Pion M, Correa-Rocha R, et al. Differential effects of the second SARS-CoV-2 mRNA vaccine dose on T cell immunity in naïve and COVID-19 recovered individuals [Internet]. bioRxiv. 2021 [cited 2021 May 28]. p. 2021.03.22.436441. Available from: https://www.biorxiv.org/content/10.1101/2021.03.22.436441v1
Levi R, Azzolini E, Pozzi C, Ubaldi L, Lagioia M, Mantovani A, et al. A cautionary note on recall vaccination in ex-COVID-19 subjects [Internet]. bioRxiv. medRxiv; 2021. Available from: http://medrxiv.org/lookup/doi/10.1101/2021.02.01.21250923
Ogata AF, Cheng C-A, Desjardins M, Senussi Y, Sherman AC, Powell M, et al. Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients. Clin Infect Dis [Internet]. 2021 May 20; Available from: http://dx.doi.org/10.1093/cid/ciab465
Kuba K, Imai Y, Rao S, Gao H, Guo F, Guan B, et al. A crucial role of angiotensin converting enzyme 2 (ACE2) in SARS coronavirus-induced lung injury. Nat Med [Internet]. 2005 Aug;11(8):875–9. Available from: http://dx.doi.org/10.1038/nm1267
Chen I-Y, Chang SC, Wu H-Y, Yu T-C, Wei W-C, Lin S, et al. Upregulation of the chemokine (C-C motif) ligand 2 via a severe acute respiratory syndrome coronavirus spike-ACE2 signaling pathway. J Virol [Internet]. 2010 Aug;84(15):7703–12. Available from: http://dx.doi.org/10.1128/JVI.02560-09
Patra T, Meyer K, Geerling L, Isbell TS, Hoft DF, Brien J, et al. SARS-CoV-2 spike protein promotes IL- 6 trans-signaling by activation of angiotensin II receptor signaling in epithelial cells. PLoS Pathog [Internet]. 2020 Dec;16(12):e1009128. Available from: http://dx.doi.org/10.1371/journal.ppat.1009128
Zhang S, Liu Y, Wang X, Yang L, Li H, Wang Y, et al. SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19. J Hematol Oncol [Internet]. 2020 Sep 4;13(1):120. Available from: http://dx.doi.org/10.1186/s13045-020-00954-7
Suresh SJ, Suzuki YJ. SARS-CoV-2 Spike Protein and Lung Vascular Cells. Journal of Respiration [Internet]. 2020 Dec 31 [cited 2021 May 25];1(1):40–8. Available from: https://www.mdpi.com/2673-527X/1/1/4
Angeli F, Spanevello A, Reboldi G, Visca D, Verdecchia P. SARS-CoV-2 vaccines: Lights and shadows. Eur J Intern Med [Internet]. 2021 Apr 30; Available from: http://dx.doi.org/10.1016/j.ejim.2021.04.019
Han M, Pandey D. ZMPSTE24 Regulates SARS-CoV-2 Spike Protein-enhanced Expression of Endothelial Plasminogen Activator Inhibitor-1. Am J Respir Cell Mol Biol [Internet]. 2021 May 18; Available from: http://dx.doi.org/10.1165/rcmb.2020-0544OC
Rhea EM, Logsdon AF, Hansen KM, Williams LM, Reed MJ, Baumann KK, et al. The S1 protein of SARS-CoV-2 crosses the blood-brain barrier in mice. Nat Neurosci [Internet]. 2021 Mar;24(3):368– 78. Available from: http://dx.doi.org/10.1038/s41593-020-00771-8
Idrees D, Kumar V. SARS-CoV-2 spike protein interactions with amyloidogenic proteins: Potential clues to neurodegeneration. Biochem Biophys Res Commun [Internet]. 2021 May 21;554:94–8. Available from: http://dx.doi.org/10.1016/j.bbrc.2021.03.100
Lei Y, Zhang J, Schiavon CR, He M, Chen L, Shen H, et al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circ Res [Internet]. 2021 Apr 30;128(9):1323–6. Available from: http://dx.doi.org/10.1161/CIRCRESAHA.121.318902
Zhang L, Richards A, Barrasa MI, Hughes SH, Young RA, Jaenisch R. Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient- derived tissues. Proc Natl Acad Sci U S A [Internet]. 2021 May 25;118(21). Available from: http://dx.doi.org/10.1073/pnas.2105968118
Suzuki YJ, Nikolaienko SI, Dibrova VA, Dibrova YV, Vasylyk VM, Novikov MY, et al. SARS-CoV-2 spike protein-mediated cell signaling in lung vascular cells. Vascul Pharmacol [Internet]. 2021 Apr;137:106823. Available from: http://dx.doi.org/10.1016/j.vph.2020.106823
Suzuki YJ, Gychka SG. SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines. Vaccines (Basel) [Internet]. 2021 Jan 11;9(1). Available from: http://dx.doi.org/10.3390/vaccines9010036
Ogata AF, Maley AM, Wu C, Gilboa T, Norman M, Lazarovits R, et al. Ultra-sensitive Serial Profiling of SARS-CoV-2 Antigens and Antibodies in Plasma to Understand Disease Progression in COVID-19 Patients with Severe Disease. Clin Chem [Internet]. 2020 Sep 8; Available from: http://dx.doi.org/10.1093/clinchem/hvaa213
Kloc M, Uosef A, Kubiak JZ, Ghobrial RM. Exaptation of Retroviral Syncytin for Development of Syncytialized Placenta, Its Limited Homology to the SARS-CoV-2 Spike Protein and Arguments against Disturbing Narrative in the Context of COVID-19 Vaccination. Biology [Internet]. 2021 Mar 19;10(3). Available from: http://dx.doi.org/10.3390/biology10030238
Khan I, Hatiboglu MA. Can COVID-19 induce glioma tumorogenesis through binding cell receptors? Med Hypotheses [Internet]. 2020 Nov;144:110009. Available from: http://dx.doi.org/10.1016/j.mehy.2020.110009
Singh N, Bharara Singh A. S2 subunit of SARS-nCoV-2 interacts with tumor suppressor protein p53 and BRCA: an in silico study. Transl Oncol [Internet]. 2020 Oct;13(10):100814. Available from: http://dx.doi.org/10.1016/j.tranon.2020.100814
Madla CM, Gavins FKH, Merchant H, Orlu M, Murdan S, Basit AW. Let’s Talk About Sex: Differences in Drug Therapy in Males and Females. Adv Drug Deliv Rev [Internet]. 2021 May 17; Available from: http://dx.doi.org/10.1016/j.addr.2021.05.014
European Medicines Agency. Assessment Report. Comirnaty (COVID-19 mRNA vaccine (nucleoside- modified)), EMA/707383/2020 Corr.1 [Internet]. 2021 Feb [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public- assessment-report_en.pdf#page=45
European Medicines Agency. Assessment Report. COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)), EMA/15689/2021 Corr.1 [Internet]. 2021 Mar [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine- moderna-epar-public-assessment-report_en.pdf#page=47
European Medicines Agency. Assessment Report. COVID-19 Vaccine Janssen, EMA/158424/2021 [Internet]. 2021 Mar [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar- public-assessment-report_en.pdf#page=50
Pfizer. SARS-CoV- 2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Yakubutsu dōtai shiken no gaiyō bun [summary of pharmacokinetic studies] [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf#pa ge=16
CDC. Selected adverse events reported after COVID-19 vaccination [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse- events.html
Doshi P. FDA response to BMJ on reports of death after covid-19 vaccination [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.bmj.com/content/372/bmj.n149/rr-25
Wyller TB, Kittang BR, Ranhoff AH, Harg P, Myrstad M. Nursing home deaths after COVID-19 vaccination. Tidsskr Nor Laegeforen [Internet]. 2021 May 20;141. Available from: http://dx.doi.org/10.4045/tidsskr.21.0383
Torjesen I. Covid-19: Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds. BMJ [Internet]. 2021 May 27 [cited 2021 May 28];373. Available from: https://www.bmj.com/content/373/bmj.n1372
Food and Drug Administration. Coronavirus (COVID-19) update: FDA Issues Policies to guide medical product developers addressing virus variants [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19- update-fda-issues-policies-guide-medical-product-developers-addressing-virus
Owens C. Vaccine boosters could be necessary as soon as September [Internet]. Axios. 2021 [cited 2021 May 28]. Available from: https://www.axios.com/coronavirus-vaccines-boosters-pfizer- moderna-e8d6bed6-8238-4e52-9959-ca4c6a6e0d5a.html
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med [Internet]. 2020 Dec 31;383(27):2603–15. Available from: http://dx.doi.org/10.1056/NEJMoa2034577
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA- 1273 SARS-CoV-2 Vaccine. N Engl J Med [Internet]. 2021 Feb 4;384(5):403–16. Available from: http://dx.doi.org/10.1056/NEJMoa2035389
Thacker PD. Covid-19: How independent were the US and British vaccine advisory committees? BMJ [Internet]. 2021 May 26;373:n1283. Available from: http://dx.doi.org/10.1136/bmj.n1283
Moderna. SARS-CoV- 2 mRNA Vaccine (Moderna) 2.6.4 Yakubutsu dōtai shiken no gaiyō bun [summary of pharmacokinetic studies] [Internet]. 2021 [cited 2021 May 29]. Available from: https://www.pmda.go.jp/drugs/2021/P20210519003/400256000_30300AMX00266_I100_1.pdf#pa ge=7
