COVID-19 Vaccine: Safety review of the first 22 million vaccinators in U.S.

COVID-19 Vaccine: Safety review of the first 22 million vaccinators in U.S. .  94% of severe allergic reactions to Pfizer vaccine are women, and 100% to Moderna vaccine! Safety review of the first batch of 22 million vaccinators in the U.S.

The Centers for Disease Control (CDC) recently released a safety summary report for the first people in the United States to receive the COVID-19 vaccine.

According to the analysis of early safety data in the first month of COVID-19 vaccination, the safety data after the large-scale vaccination is consistent with the results obtained during the clinical study. All people with allergic reactions have been successfully treated, and among the first 22 million vaccinated people, no other serious problems have occurred.

1. Where do these safety data come from?

The CDC, FDA and other agencies use the following powerful systems and data sources to continuously monitor safety after people are vaccinated.

• V-safe-a new post-immunization health check tool for smartphones
• National Medical Safety Network (NHSN)
• Insurance company monitoring and claims data system
• Vaccine Adverse Reaction Reporting System (VAERS)
• Vaccine Safety Data Link (VSD)
• Clinical Immunization Safety Assessment (CISA)
• FDA and the Center for Medicare and Medicaid Services
• Biologics effectiveness and safety system (BEST)
• FDA Vigilance Action (Electronic Health Record, Management and Claims Data System)
• Monitoring system of the Department of Defense and the Department of Veterans Affairs
• Aboriginal Health Services Department Monitoring System

2. What are the reactions after vaccination?

As of January 24, a total of 21,843,033 people in the United States have received at least one shot of the vaccine, of which 2,080,216 (including 15,131 pregnant women) have submitted safety feedback through the mobile phone V-safe system.

Among these volunteer reporters, a total of 70% reported pain, 33% fatigue, 30% headache, 23% muscle pain, and about 11% chills, fever, swelling or joint pain. The reactions of Pfizer vaccine and Moderna vaccine are basically the same; the second shot has stronger side effects than the first shot.

More than 9,000 people have reported side effects through VAERS (as an early warning system for vaccine safety in the United States) after vaccination. No safety warning signs have been found so far.

The VSD safety reporting system can view the medical records of 21 million people in health care organizations, and more than 162,000 people in the system have received at least one vaccine injection. In this group, no increase in the risk of any of the 20 common diseases was seen.

In the vaccinated group, 4 people reported Bell’s palsy (facial paralysis, which can be seen in a small number of patients in every vaccine trial), and 348 cases in the unvaccinated group. The incidence is almost the same.

3. About severe allergic reactions anaphylaxis

50 cases of Pfizer vaccine occurred; the incidence was 5 parts per million (50/9,943,247)

• 94% (47/50) are women
• 90% (45/50) occurred within 30 minutes after injection
• 80% (40/50) have a history of allergies

21 cases of the Moderna vaccine occurred; the incidence was 2.8 parts per million (21/7,581,429)

• 100% (21/21) are female
• 90% (19/21) occurred within 30 minutes after injection
• 86% (18/21) have a history of allergies

4. Analysis of death cases

So far, 196 death reports have been received. The CDC team analyzed all death reports in a timely manner, and found that these deaths were not related to vaccination.

One way to determine whether the COVID-19 vaccine has caused death is to look at the estimated number of deaths in the population over a period of time and compare it with the number of deaths that occurred after vaccination.

Regarding the death cases of the elderly in long-term care centers:

• 1.3 million elderly people in long-term care centers received injections
• The estimated number of natural deaths among these elderly people during the injection is 11,440
• The actual number of death reports received by the VAERS system is 129

Barbara Baden-Hail of Brown University School of Public Health conducted research on residents of Genesis Healthcare, the largest nursing home in the United States.

The agency’s 7006 residents (61.4% of residents) in 118 facilities in 24 states received the first batch of vaccines from December 18 to 31. After excluding those infected with COVID-19, the researchers found that vaccinated residents had fewer deaths than unvaccinated residents. The survey results show that short-term mortality has nothing to do with COVID-19 vaccination among residents of nursing facilities.

The CDC found that among young, healthier people, there is no causal relationship between vaccination and death. Among the 13.7 million people under the age of 65, 168 people will suddenly suffer a fatal heart attack every 35 days. In contrast, among vaccinated persons, 18 such deaths were reported to VAERS.

CDC’s conclusion

• The U.S. has received 23.5 million doses of COVID-19 vaccine
• During this time, the US government implemented the most comprehensive vaccine safety monitoring program in history
• Overall, the safety of the COVID-19 vaccine is reassuring and consistent with the results observed in clinical trials
• Allergic reactions have been observed after the mRNA COVID-19 vaccine, although rarely
• Elderly deaths in long-term care centers have nothing to do with vaccination
• The security monitoring system will continuously collect data

references:
CDC: COVID-19 vaccine safety update
CDC: Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021
WebMD: CDC Panel: No COVID-19 Vaccine Safety Surprises
USA Today: The first 22M Americans have been vaccinated for COVID-19, and initial safety data shows everything is going well, CDC says
CDC: COVID Data Tracker

(source:internet, reference only)

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