Comics, 4-5-21: Vaccine Side Effects

COVID-19 Vaccine Side Effect Tracker – MedShadow
Last update: March 18, 2021
 
To help you sort through the news on the COVID-19 vaccine’s progress, MedShadow has created the MedShadow Vaccine Tracker, the only tracker focused on the side effects and adverse events associated with proposed COVID-19 vaccinations.
 
Rather than injecting patients with a weakened virus or proteins from the pathogen that our immune systems can recognize, which is what’s typically done when we get a flu vaccine, the new vaccines from Moderna and Pfizer — the two that made it to the market first in the U.S. — contain mRNA (messenger RNA), which is a genetic template that instructs our cells to build the viral proteins that our immune systems can then recognize.

Its main perk is that allowing our bodies to produce the proteins (rather than growing them in a lab like traditional vaccines) slashes production time. For nearly 20 years, researchers have been interested in using mRNA in vaccines; and some were even tested in early clinical trials for rabies, influenza and Zika. However, the vaccines for COVID-19 will be the first mRNA vaccines ever authorized by the FDA.
 
Some risks and side effects do occur:
 
Moderna started Phase III clinical trials for its vaccine candidate in July. In earlier trials, nearly half of patients experienced common adverse effects like injection site pain, rash, headaches, muscle soreness, nausea and fevers after the second injection. These effects generally subsided within two days. CNBC spoke to a few individuals, some participating in Moderna’s trial and some in Pfizer’s trial who said much the same thing: the side effects were intense and included a high fever, body aches, bad headaches and exhaustion, but were worth it for protection from Covid-19.
 
The CDC reports that 11% of patients experienced swollen lymph nodes after the first shot. That raised to 16% after the second shot. A few patients with facial fillers experienced swelling after receiving the vaccine. They were treated with antihistamines and steroids.
 
January 18: In California, officials halted the use of one particular batch of Moderna vaccines (lot 41L20A) after a cluster of patients at one particular site experienced allergic reactions that required medical attention.
 
February 1: patients who received the vaccine after having been previously infected with COVID-19 showed greater immune response to the first shot and more intense side effects that are associated with strong immune responses like fever and muscle aches. The study included patients who received either the Moderna or Pfizer vaccine. Some scientists believe these patients may only need a single shot to provide sufficient immunity, but more research is needed.
 
February 12: Out of the first 7.5 million doses administered from Dec 14- Jan 18, cases of anaphylaxis were reported to VAERS after the Moderna vaccine. No patients have died from anaphylaxis. Patients are now being monitored for 15-30 minutes after receiving the vaccine to watch for signs of anaphylaxis. The CDC suggests that anyone who has an immediate allergic reaction to a single dose of an mRNA vaccine (Moderna or Pfizer) should not get the second dose. If your reaction was not immediate, you may be referred to an allergy specialist. The vaccines do not contain polysorbate, but do have a related ingredient, polyethylene glycol (PEG). If you have an allergy to either of these chemicals, you should not get the vaccines.
 
Many patients are reporting injection site reactions that show up shortly after the injection or up to a week later. These reactions — which are characterized by swelling, redness, itching, rashes, heat and pain — are expected to last a day to a week. Physicians emphasize that while these effects can be scary, they are not dangerous and should not prevent someone from getting the second shot. So far, doctors do not report seeing these reactions after the second shot, however so few have been given so far that scientists are not sure how common it will be on round two.
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March 3: Allergy researchers at Mass General Hospital created a registry for healthcare professionals to report  immediate and delayed reactions to COVID-19 vaccinations. On March 3, the researchers published a letter in the New England Journal of Medicine describing a series of 12 delayed injection site reactions including swelling and rashes. The researchers wrote that one patient received antibiotics although they were not necessary. Several others were treated with steroids or anti inflammatories. The letter included some photos and said that the reactions cleared up within a median of six days. Patients were encouraged to receive their second dose. Half of them did not experience the reaction the second time. A quarter did, but to a lesser degree.
 
March 8: Researchers from Mass General Brigham published a Research Letter in JAMA analyzing allergic reactions in employees who received their shots there. Out of 52,805 participants, 2.1% experienced some kind of allergic reaction, including hives, itching, rash, swelling or respiratory symptoms within the first three days after vaccination. Allergies were slightly more common with the Moderna vaccine than the Pfizer vaccine (2.2% compared to 1.95%). Sixteen experienced anaphylaxis.
 
Moderna has announced that it will begin testing its vaccine in children and adolescents, who they believe may have stronger immune responses, leading to more intense side effects.
 
Pfizer began Phase III clinical trial for its vaccine candidate in July. In earlier trials, some patients experienced common adverse effects like injection site pain, rash, headaches, muscle soreness, nausea and fevers. These effects generally subsided within two days. CNBC spoke to a few individuals, some participating in Pfizer’s trial and others in Moderna’s trial who said much the same thing: the side effects were intense and included a high fever body aches, bad headaches and exhaustion in addition to the more common side effects, but were worth it for protection from Covid-19.
 
Some patients described the side effects as being similar to a bad hangover. A nurse who participated in the clinical trial reported feeling minimal effects after the first dose, but a fever that reached more than 104 degrees Fahrenheit after the second injection, along with chills, headache, and intense injection site pain. According to researchers, her experience of having all symptoms together was rare, though many patients had one or two of these side effects. “Clinicians will need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could look a lot like COVID-19,” the nurse wrote on Dec 7.
 
The FDA report published in December said the most common reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Swollen lymph nodes occurred in 0.3% of patients. The FDA reported that four patients who received the vaccine experienced Bell’s Palsy.
 
January 12: A doctor in Florida died 16 days after receiving the vaccine from a rare blood disorder, acute immune thrombocytopenia. Both Pfizer and the CDC are investigating, though the company has released a statement that so far, they haven’t seen any signs in the clinical trials or data collected from early vaccinations that the death could be related to the vaccine. The blood disorder immune thrombocytopenia, has also been seen as a rare complication of COVID-19 itself, in both symptomatic and asymptomatic patients.
 
January 19: Twenty-three elderly patients in Norway died after receiving Pfizer’s vaccine. Officials are investigating whether or not the deaths are vaccine-related. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, suggests that while the deaths may be coincidental given the fragile population, it’s possible that side effects of the vaccines, like fevers, may have strained the frail patients’ bodies and contributed to their deaths. Norway has vaccinated about 45,000 people so far, most of whom live in nursing homes.
 
February 1: A study posted on Feb 1 showed that patients who received the vaccine after having been previously infected with COVID-19 showed greater immune response to the first shot and more intense side effects that are associated with strong immune responses like fever and muscle aches. The study included patients who received either the Moderna or Pfizer vaccine. Some scientists believe these patients may only need a single shot to provide sufficient immunity, but more research is needed.
 
February 12: Out of the first 9.9 million doses administered from Dec 14- Jan 18, 47 cases of anaphylaxis were reported to VAERS after the Pfizer vaccine. Patients are now being monitored for 15-30 minutes after receiving the vaccine to watch for signs of anaphylaxis. The CDC suggests that anyone who has an immediate allergic reaction to a single dose of an mRNA vaccine (Moderna or Pfizer) should not get the second dose. If your reaction was not immediate, you may be referred to an allergy specialist. The vaccines do not contain polysorbate, but do have a related ingredient, polyethylene glycol (PEG). If you have an allergy to either of these chemicals, you should not get the vaccines.

March 8: Researchers from Mass General Brigham published a Research Letter in JAMA analyzing allergic reactions in employees who received their shots there. Out of 52,805 participants, 2.1% experienced some kind of allergic reaction, including hives, itching, rash, swelling or respiratory symptoms within the first three days after vaccination. Allergies were slightly more common with the Moderna vaccine than the Pfizer vaccine (2.2% compared to 1.95%). Sixteen experienced anaphylaxis.
 
CanSinBio, China granted the CanSinBio vaccine emergency approval prior to beginning a Phase III trial in August. In the Phase II trial, nearly three-quarters of patients reported at least one common mild adverse events including injection site pain, rash, headaches, muscle soreness, and fevers. Five people also reported vomiting.Gamaleya Research Institute, Russia launched Phase III trials in August. But before they got started, President Putin announced that the vaccine was approved early, however, the Phase III trials are expected to continue. In the earlier trials, almost all of the patients experienced low-grade fevers. A small number of patients reported heart palpitations. Otherwise, reported side effects were similar to other vaccines and included injection site pain, rash, headaches, and muscle soreness.
 
On Feb 1, the group reported efficacy data along with some data on side effects in The Lancet. The most common adverse events were flu-like illness (15.2% of those vaccinated) and local reactions (5.4% of those vaccinated). The report also states that there were six grade 3 adverse events which were not associated with the vaccination: acute sinusitis, an exacerbation of urolithiasis along with renal colic and deep vein thrombosis (both associated with pre-existing comorbidities) and extremity abscess (due to physical injury and subsequent infection of the wound surface of the soft tissues of the finger).
 
Johnson & Johnson started a Phase III trial for its vaccine candidate in September 2020, but paused it on October 12 due to an unexplained illness and remains on hold. The company announced it would restart the trial on October 26. Pauses are common during clinical trials to evaluate specific adverse events, but the company has not shared details about the illness experienced by one of the trial volunteers. In earlier trials, about 70% of patients experienced at least one mild adverse effect similar to those seen with other vaccines, including injection site pain, rash, headaches, muscle soreness, and fevers.
 
On Feb 24, Johnson & Johnson shared data from its Phase III trials. The data suggested that while the vaccine is slightly less protective overall (but more protective against the 501Y.V2 variant that emerged from South Africa,) than the Moderna and Pfizer vaccines, it produced fewer side effects. The report says the most common reactions were injection site reactions (50.2%), fatigue (38.2%), headache (38.9%), muscle pain (33.2%), nausea (14.2%) and fever (9.0%).  Reactions were more common in patients under 60 than over 60. Injection site pain lasted a median of 2 days, but up to 7 days in 2.3% of patients.
 
Astrazeneca: On September 6, the company paused the trial to investigate a patient who developed transverse myelitis – dangerous inflammation of the spinal cord. Researchers determined that the incident was unrelated to the vaccine and quickly restarted the trial in most countries, however it remained paused in the US until October 26. On October 21, scientists reported a patient in the trial had died, however, according to a local newspaper, the patient was in the control arm of the trial, meaning they’d received a placebo instead of the vaccine, so the trial is ongoing.
 
In earlier trials, many patients reported mild adverse effects similar to those associated with the other vaccines including injection site pain, rash, headaches, muscle soreness, and fevers. The team gave some of these patients preventative acetaminophen to reduce pain and fever. Nearly half of patients also experienced temporary neutropenia – a reduction in white blood cells that can make a person more susceptible to infections. The vaccine has been approved for use in the U.K., Argentina, India, E.U. and Mexico.
 
March 11: Denmark has paused the use of the AstraZeneca vaccine while it investigates whether it is responsible for blood clots — one fatal — in some patients.
 
“It is important for us that the citizens are confident in the offer we give them and trust that we can vouch for the quality of the vaccines we have in our program. Therefore, we react promptly until we have investigated whether there is a connection between the vaccine and the possible side effects ,” officials wrote in a press release.

March 15: Several other countries (Iceland, Norway, Denmark, Ireland, the Netherlands, Italy, France and Germany) have also paused use of the vaccine while unusual clotting events are investigated. Meanwhile, Thailand, which paused its use on Friday, March 12 restarted it on Sunday, March 14. On Sunday, AstraZeneca released a statement that its own review revealed “no increased risk” of clotting issues with the vaccine and that “So far across the  EU and UK, there have been 15 events of DVT [deep vein thrombosis] and 22 events of pulmonary embolism reported 

​March 18: The European Medicines Agency (EMA) issued a statement that the benefits of the AstraZeneca vaccine outweigh the risks. The vaccine is not associated with an overall risk of blood clots, though there may be a very small increased risk of certain types of clots. The statement reads, “These are rare cases – around 20 million people in the UK and EEA had received the vaccine as of March 16 and EMA had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST [clots in the vessels that drain blood from the brain.] A causal link with the vaccine is not proven, but is possible and deserves further analysis.” These cases were more common in women under the age of 55. Germany, France, Italy, Latvia, Bulgaria and Slovenia have all stated that they’d restart or continue to offer the AstraZeneca vaccine in light of the news.
 
Novavax, England began Phase III clinical trials with its vaccine candidate in the United Kingdom in September and is had planned to start a trial in the United States in October. The trial was delayed due to manufacturing problems. The U.S. trial started on December 28. During Phase I/II trials, patients reported adverse events similar to those of other vaccine candidates, including injection site pain, rash, headaches, muscle pain, fever, nausea and vomiting.
 
In July, Sinopharm, China launched Phase III trials of its two vaccine candidates in the United Arab Emirates, Peru, Morocco, and Argentina, which are now approved for limited use in healthcare workers in China and the UAE. In earlier trials of one of the vaccines, made in collaboration with Wuhan Institute of Biological Products, about 15% of the patients reported adverse events similar to those of other vaccine candidates, including injection site pain, rash, headaches, muscle pain, fever, nausea and vomiting. There is little data available about the second vaccine, made in collaboration with the Beijing Institute of Biological Products.
 
Sinovac, China opened Phase III trials of its vaccine candidate, CoronaVac, in July. It is already being used with emergency approval for high risk individuals in China. The earlier trials showed that about a third of patients experienced adverse effects similar to those in other vaccine candidates like injection site pain, fever, and fatigue, but the study included few details about more specific symptoms like nausea, headaches, and vomiting. On November 10, the trial was halted in Brazil due to a participant’s death. However, researchers say the death was not vaccine-related and the trial should continue. It has not been halted in other countries.
 
 
The Murdoch Children’s Research Institute, England is running a Phase III trial repurposing Bacillus Calmette-Guerin — a vaccine developed nearly a century ago to prevent tuberculosis infections — to prevent Covid-19. Since the vaccine has been around such a long time, there are many reports on its potential adverse effects and the vaccine itself has been altered to minimize many of them. Injection site reactions are common, and lymphadenitis, swelling of the lymph nodes, is common. 
 
Bharat Biotech announced it would begin Phase III trials in India on October 23. In early trials demonstrated side effect profiles similar to those of the other vaccines, including pain at the injection site, fatigue, headache, and fever. The country announced emergency approval, though no Phase III data was included in the announcement.
https://medshadow.org/covid19-vaccine-side-effects/
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41 percent Republicans and 11 percent Democrats refuse Covid Jab
www.bostonglobe.com 
3-16-21, Poll finds that 41 percent of Republicans and 34 percent of independents leery of COVID-19 vaccine, but only 11 percent of Democrats refuse shots.