Tag: vaccine injury

The coronavirus vaccine comes with more side effects than a flu shot. Experts urge people to get it anyway

The first coronavirus vaccine authorized in the United States may cause more side effects than the flu vaccine, but the most common reactions — soreness at the injection site, fatigue and headache — are mild or moderate in most people and fade after a few days, according to analyses of clinical trial data.

Infectious disease experts say most people can safely get the vaccine, but they should be prepared for some of these potential side effects.

“Any robust vaccine may generate some discomfort but it is worth the mild side effects — these side effects are not extraordinary — to be immune against this circulating new pandemic,” said Dr. Monica Gandhi, an infectious disease physician at UCSF.

The FDA granted emergency use authorization late Friday to the first vaccine in the U.S., developed by Pfizer and German firm BioNTech, which has been shown to be 95% effective at preventing COVID-19 illness.

Health care workers and residents of long-term care centers will be first in line to receive the vaccine in California, followed by essential workers. Mass vaccinations of the general public are expected in spring or summer 2021.

The Pfizer vaccine’s most common side effects were fatigue, headache, muscle pain and chills, according to an FDA analysis of Pfizer’s clinical trial data. Less common were joint pain, fever, diarrhea and vomiting. The vast majority of those symptoms were mild or moderate.

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Allergy risk on Pfizer jab: Day before FDA meet to give green light to vaccine UK regulators warn people with ‘significant’ food and medicine allergies NOT to take it after two health workers suffer ‘anaphylactic reaction’

There are fears over how safe Pfizer’s COVID vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock hours later, prompting British authorities to tell anyone with a ‘severe’ allergy to food or medicine not to get it. 

The FDA is due to meet tomorrow to discuss green-lighting the vaccine in America after being lambasted for taking a week longer than the Brits to get it off the ground. 

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4 volunteers develop FACIAL PARALYSIS after taking Pfizer Covid-19 jab, prompting FDA to recommend ‘surveillance for cases’

Four trial participants who received the Pfizer Covid-19 vaccine experienced facial paralysis, according to the Food and Drug Administration. The FDA said the issue should be monitored as the jab becomes more widely available.

The potentially concerning cases were revealed after the US drug regulator published an analysis of the Pfizer-BioNTech vaccine ahead of a meeting to consider emergency use authorization for the jab in the United States. 

According to the documents, Bell’s palsy, a form of temporary facial paralysis, was reported by four participants during phase 3 trials. The individuals had been administered the jab, and no members of the placebo group experienced similar adverse effects. 

The condition resembles a stroke, with most sufferers watching helplessly as one side of their face droops and their muscles go limp. In some rare situations, both sides of the face may become paralyzed. It is unclear what causes Bell’s palsy, although the temporary paralysis usually goes away on its own. 

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CBER Plans for Monitoring COVID-19Vaccine Safety and Effectiveness

FDA Safety Surveillance of COVID-19 Vaccines :
DRAFT Working list of possible adverse event outcomes
Subject to change
 Guillain-Barré syndrome
 Acute disseminated encephalomyelitis
 Transverse myelitis
 Encephalitis/myelitis/encephalomyelitis/
meningoencephalitis/meningitis/
encepholapathy
 Convulsions/seizures
 Stroke
 Narcolepsy and cataplexy
 Anaphylaxis
 Acute myocardial infarction
 Myocarditis/pericarditis
 Autoimmune disease
 Deaths
 Pregnancy and birth outcomes
 Other acute demyelinating diseases
 Non-anaphylactic allergic reactions
 Thrombocytopenia
 Disseminated intravascular coagulation
 Venous thromboembolism
 Arthritis and arthralgia/joint pain
 Kawasaki disease
 Multisystem Inflammatory Syndrome
in Children
 Vaccine enhanced disease

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The ‘Vaccine Court’ Is Hazardous To Your Health

The National Childhood Vaccine Injury Compensation Act was passed in 1986, under the shadow of multi-million dollar jury verdicts against the makers of the Diphtheria Pertussis and Tetanus (DPT) vaccine. Congress announced that vaccine injuries and deaths are real and provided that vaccine-injured children and their families would be financially compensated. Part of the larger Vaccine Act, the Vaccine Injury Compensation Program (VICP) was modeled after workers’ compensation programs. It was to be a “no-fault” program.

Very well. As one of the earliest “vaccine attorneys”—a very limited practice niche—I know first-hand it didn’t work that way. I practiced in the National Childhood Vaccine Injury Compensation Program for more than 25 years after its inception in 1988, and have been personally involved in over 100 vaccine-injury cases. I represented an entire fragile population in omnibus proceedings. I was able to obtain reversal in the Federal Circuit Court of Appeals of the denial of compensation to a vaccine-injured child in a case that the government appealed to the United States Supreme Court as Shalala v. Whitecotton. It was the only Vaccine Act case to be argued before the United States Supreme Court until Sebelius v. Cloer in 2013, where I was co-counsel for the vaccine-injured petitioner, and guided the attorneys-fees litigation that the Supreme Court upheld on review against the government’s objection. I have seen the injured and their families cruelly oppressed.

From the passing of the legislation in 1986, the process has been rigged, one major step at a time, in favor of the vaccine-industrial complex. Policy makers nationwide are yearning, with financial support and lobbying from the pharmaceutical industry, for mandatory vaccination. Before further compulsory vaccinationlegislation passes—on a state or federal level—the failure of the VICP must be acknowledged and properly addressed. The VICP creates a classic moral hazard, granting immunity from suit to the vaccine industry while providing insurance against any loss. The vaccine-industrial complex has become a thriving giant; according to a 2013 report presented by the Pharmaceutical Research and Manufacturers of America, nearly300 vaccines were reported to be in development. Its lobbying money drives agency denial of the reality of vaccine injury, which in turn permeates policy decisions in a sinister fashion.

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South Korea sticks to flu vaccine plan despite safety fears after 25 die

South Korean officials refused on Thursday to suspend a seasonal influenza inoculation effort, despite growing calls for a halt, including an appeal from a key group of doctors, after the deaths of at least 25 of those vaccinated.

Health authorities said they found no direct links between the deaths and the vaccines.

At least 22 of the dead, including a 17-year-old boy, were part of a campaign to inoculate 19 million teenagers and senior citizens for free, the Korea Disease Control and Prevention Agency (KDCA) said.

“The number of deaths has increased, but our team sees low possibility that the deaths resulted from the shots,” the agency’s director, Jeong Eun-kyeong, told parliament.

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AstraZeneca COVID-19 vaccine trial Brazil volunteer dies, trial to continue

Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca AZN.L and Oxford University had died but added that the trial would continue.

Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment “there have been no concerns about safety of the clinical trial.” Brazilian newspaper O Globo reported that the volunteer had been given a placebo and not the trial vaccine, citing unnamed sources.

Anvisa provided no further details, citing medical confidentiality of those involved in trials.

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