Table of Contents
Introduction
As the global rollout of COVID-19 vaccines continues into 2023 and 2024, concerns about potential vaccine side effects remain at the forefront of public health discussions. While these vaccines have proven effective in reducing the spread and severity of COVID-19, reports of adverse reactions have raised questions about their safety profile and the factors contributing to side effects.
This article delves into the disturbing findings surrounding COVID-19 vaccine side effects, examining the latest scientific studies and the complex interplay of factors influencing these adverse reactions. By providing an overview of the reported side effects, exploring the scientific evidence, and discussing the variables that may impact an individual’s risk of experiencing side effects, this article aims to shed light on this critical aspect of the ongoing pandemic response.
Overview of COVID-19 Vaccinations
The development of COVID-19 vaccines began years before the pandemic, with scientists studying coronaviruses to find ways to protect against them. This prior research enabled the rapid growth of vaccines when the COVID-19 pandemic emerged 4.
The FDA reviews and evaluates COVID-19 vaccines for quality, safety, and effectiveness. Vaccines that meet rigorous standards are issued Emergency Use Authorizations (EUAs) by the FDA, deeming them safe and effective for public use 5.
After FDA authorization, the Advisory Committee on Immunization Practices (ACIP) provides recommendations and guidance to the CDC Director regarding vaccine use 5. When the FDA fully approves a vaccine, it undergoes the agency’s standard approval process, which includes a comprehensive analysis of benefits and risks to ensure it meets FDA standards 5.
Development and Approval Process
The federal government has been working since the pandemic’s start to develop, manufacture, and distribute safe and effective COVID-19 vaccines 4. Researchers were able to quickly develop vaccines for the new virus by leveraging ongoing work on coronaviruses 4.
The FDA’s rigorous review process ensures that authorized and approved COVID-19 vaccines meet science-based quality, safety, and efficacy standards 5. ACIP then provides usage recommendations to the CDC Director following FDA authorization 5.
Public Health Impact
Vaccinations in the United States began on December 14, 2020. 4. To ensure equitable vaccine distribution, the federal government implemented programs to reach high-risk communities directly and quickly 4.
These programs included:
- The Federal Retail Pharmacy Program sent doses to pharmacy partners, with 40% located in high-risk zip codes 4.
- The Health Center COVID-19 Vaccine Program, which allocated doses directly to community-based health centers serving individuals and families living at or below 200% of the Federal Poverty Guidelines 4.
- The Rural Health Clinic COVID-19 Vaccine Distribution Program, which distributed doses to Rural Health Clinics in medically underserved rural communities 4.
- Tribal health programs and Urban Indian Organizations, which received vaccines through the Indian Health Service or states, with tribal consultation initiated in September 2020 to understand the needs of American Indian and Alaska Native communities 4.
The CDC’s COVID Data Tracker shows the total number of COVID-19 vaccinations administered in the United States 4.
Reported Side Effects
The COVID-19 vaccines have been extensively monitored for safety and effectiveness, with millions of doses administered worldwide. While the vaccines have proven to be safe and effective in preventing severe illness and death from COVID-19, some side effects have been reported. These side effects range from common and mild to rare and severe 10.
Common and Mild Side Effects
The most common side effects reported after receiving a COVID-19 vaccine include:
- Soreness, swelling, or redness at the injection site
- Fatigue
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy) 12
These side effects are generally mild and typically resolve within a few days. They are a sign that the body is building protection against the virus 12. It is important to note that not everyone experiences side effects, and the absence of side effects does not mean the vaccine is ineffective 12.
Severe and Rare Side Effects
In rare cases, more severe side effects have been reported following COVID-19 vaccination. These include:
- Anaphylaxis (severe allergic reaction): Anaphylaxis has occurred at a rate of approximately 5 cases per one million vaccine doses administered 14. Symptoms usually occur within a few minutes to one hour after vaccination and can include difficulty breathing, swelling of the face and throat, rapid heartbeat, and dizziness 15.
- Myocarditis and pericarditis (inflammation of the heart muscle and outer lining): These conditions have been reported primarily in adolescents and young adults, more often in males, and usually after the second dose of an mRNA vaccine (Pfizer-BioNTech or Moderna) 14. Symptoms typically develop within a few days of vaccination and include chest pain, shortness of breath, and feelings of having a fast-beating, fluttering, or pounding heart 15.
- Thrombosis with thrombocytopenia syndrome (TTS): TTS, a rare blood clotting disorder, has been observed in approximately 4 cases per one million doses of the Johnson & Johnson/Janssen COVID-19 vaccine administered 14. Symptoms usually begin within 1-2 weeks after vaccination and can include severe headache, abdominal pain, leg pain, or shortness of breath 14.
While these severe side effects are concerning, it is crucial to understand that they are extremely rare. The benefits of COVID-19 vaccination in preventing severe illness, hospitalization, and death far outweigh the risks of these rare side effects 12 14. Individuals who experience any concerning symptoms after vaccination should seek medical attention promptly.
Scientific Studies of Side Effects
Numerous scientific studies have investigated the side effects associated with COVID-19 vaccines. The Centers for Disease Control and Prevention (CDC) has identified anaphylaxis, a severe allergic reaction, as a rare side effect occurring at a rate of approximately 5 cases per one million vaccine doses administered 14. CDC scientists have conducted detailed reviews of anaphylaxis cases and made the information available to healthcare providers and the public 14.
Reports of death after COVID-19 vaccination have also been studied. Multiple factors contribute to these reports, including heightened public awareness, reporting requirements for healthcare providers, and the large number of people receiving the vaccines 14. CDC scientists and partners have performed detailed assessments of deaths after COVID-19 vaccination and found that rates of death among vaccinated individuals were lower than those of unvaccinated people, reinforcing the safety of the vaccines 14.
Key Findings from Recent Studies
Studies have also focused on specific side effects, such as Guillain-Barré syndrome (GBS) and myocarditis. Based on an analysis of data from the Vaccine Safety Datalink (VSD), the rate of GBS within the first 21 days following Johnson & Johnson/Janssen COVID-19 vaccination was found to be 21 times higher than after Pfizer-BioNTech or Moderna vaccination 14. The analysis found no increased risk of GBS after Pfizer-BioNTech or Moderna vaccination 14.
Myocarditis and pericarditis, inflammation of the heart muscle and outer lining, have been reported primarily in adolescents and young adults, more often in males, and usually after the second dose of an mRNA vaccine 14. Data from VSD and the Vaccine Adverse Event Reporting System (VAERS) indicate that rates of myocarditis after COVID-19 vaccination are highest among males in their late teens and early 20s, usually following the second dose 14.
Analysis of Study Data
Thrombosis with thrombocytopenia syndrome (TTS), a rare blood clotting disorder, has been observed in approximately 4 cases per one million doses of the Johnson & Johnson/Janssen COVID-19 vaccine administered 14. A review of reports indicates a causal relationship between the vaccine and TTS 14.
Despite these reported side effects, evidence indicates that the benefits of COVID-19 vaccination outweigh the risks 12 14. CDC and the U.S. Food and Drug Administration (FDA) continue to monitor the safety of COVID-19 vaccines and evaluate reports of adverse events 14. While severe reactions after COVID-19 vaccination are rare, millions of people in the United States have received the vaccines under the most intense safety monitoring program in U.S. history 14.
Factors Influencing Side Effects
Several factors can influence the occurrence and severity of side effects following COVID-19 vaccination. Age remains the strongest risk factor, with the risk of severe outcomes increasing markedly with increasing age. Compared to ages 18-29 years, the risk of death is 25 times higher in those ages 50-64 years, 60 times higher in those ages 65-74 years, 140 times higher in those ages 75-84 years, and 340 times higher in those ages 85+ years 4.
Demographic Factors
Studies have shown that COVID-19 does not affect all population groups equally. Three important factors are age, race, and ethnicity.
Some racial and ethnic minority groups are more likely to face multiple barriers to accessing health care, including lack of insurance, transportation, childcare, or the ability to take time off from work. Studies have identified racial and ethnic differences in at-home COVID-19 test use, vaccination coverage, and access to outpatient therapeutics 14 15 16. Compared to non-Hispanic White people, people from racial and ethnic minority groups are more likely to be infected with SARS-CoV-2, and once infected, more likely to be hospitalized, be admitted to the ICU, and die from COVID-19 at a younger ages 17.
Pre-existing Conditions
Certain underlying medical conditions are associated with an increased risk for severe COVID-19 illness in adults. Having multiple conditions also increases the risk of severe outcomes.
Conditions associated with higher risk include:
- Asthma (CDC Systematic Review) [K]
- Cancer, particularly hematologic malignancies (CDC Systematic Review, Meta-Analysis/Systematic Review, Cohort Study, Case Series, Case-Control Study) [O] 1819 20 21 22 23 24 25 26 27 28 29
- Chronic kidney disease, especially people receiving dialysis (Meta-Analysis, Cohort Studies, Case Series)
- Chronic lung diseases like COPD, interstitial lung disease, pulmonary embolism, and pulmonary hypertension (CDC Systematic Review)
- Chronic liver diseases including cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis (CDC Systematic Review)
- Diabetes mellitus type 1 and type 2 (Meta-Analysis, Case Series, Cohort Study, Systematic Review)
- Disabilities, including Down syndrome (CDC Systematic Review)
- Heart conditions such as heart failure, coronary artery disease, or cardiomyopathies (Meta-Analysis, Cohort Study)
- HIV (Meta-Analysis/Systematic Review, Cohort Study, Case Series)
- Obesity with BMI >30 kg/m2 or >95th percentile in children (Meta-Analysis, Systematic Review, Cohort)
- Pregnancy and recent pregnancy (Meta-Analysis/Systematic Review, Case-Control, Case Series, Cohort Study)
- Smoking, current and former (Meta-Analysis)
- Solid organ or blood stem cell transplantation (Meta-Analysis, Case Series, Cohort)
- Use of corticosteroids or other immunosuppressive medications (Meta-Analysis/Systematic Review, Cohort Study, Cross-Sectional, Case Series)
The CDC strongly encourages healthcare professionals, patients and their advocates, and health system administrators to regularly consult the Infectious Diseases Society of America (IDSA) COVID-19 Treatment Guidelines for the latest information on factors influencing COVID-19 vaccine side effects.
Conclusion
As the scientific community continues to study the side effects of COVID-19 vaccines, it is crucial to consider the complex interplay of factors that may influence an individual’s risk of experiencing adverse reactions. While the reported side effects range from mild to severe, the overwhelming evidence suggests that the benefits of vaccination far outweigh the risks. The ongoing monitoring and evaluation of vaccine safety by health authorities remain essential to ensure public confidence and the continued success of vaccination programs.
Moving forward, individuals must stay informed about the latest findings and consult with healthcare professionals to make informed decisions about their health. By understanding the factors that may influence side effects and the rare nature of severe reactions, we can work together to promote widespread vaccination and bring an end to the COVID-19 pandemic.
FAQs
What are the most severe risks associated with the COVID-19 vaccine? The most significant and rare risks identified from the COVID-19 vaccines are transverse myelitis and acute disseminated encephalomyelitis. These findings come from the largest vaccine safety study so far, which included 99 million people vaccinated across eight countries.
What side effects might occur with the 2023 COVID-19 vaccine? The 2023 COVID-19 vaccine can cause several side effects, similar to previous vaccines. These include soreness at the injection site, fatigue, headaches, body aches, and fever.
What are the common side effects of the latest COVID-19 booster shot? The most frequent side effects of the latest COVID-19 booster include tiredness, headaches, pain at the injection site, and chills. Other less common side effects are fever, diarrhea, joint aches, vomiting, and swollen lymph nodes in the underarm area on the same side as the injection.
What serious adverse events can occur due to COVID-19 vaccination? The serious adverse events that have been noted with COVID-19 vaccinations in the United States include anaphylaxis and myocarditis or pericarditis. Anaphylaxis is a severe allergic reaction that is extremely rare but can occur with any vaccine.
References
[1] – https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
[2] – https://www.mskcc.org/coronavirus/covid-19-vaccine
[3] – https://www.theguardian.com/australia-news/2024/feb/23/two-very-rare-covid-vaccine-side-effects-detected-in-global-study-of-99-million
[4] – https://www.hhs.gov/coronavirus/covid-19-vaccines/index.html
[5] – https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
[6] – https://www.cdc.gov/mmwr/volumes/72/wr/mm7242e1.htm
[7] – https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a5.htm
[8] – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10602621/
[9] – https://www.mskcc.org/coronavirus/covid-19-vaccine
[10] – https://www.nhs.uk/conditions/covid-19/covid-19-vaccination/about-covid-19-vaccination/
[11] – https://www.cdc.gov/vaccines/hcp/vis/vis-statements/COVID-19.html
[12] – https://www.verywellhealth.com/covid-19-vaccine-side-effects-in-2023-8364141
[13] – https://www.mskcc.org/coronavirus/covid-19-vaccine
[14] – https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
[15] – https://www.comirnaty.com/eua-six-months-to-eleven-years
[16] – https://www.mskcc.org/coronavirus/covid-19-vaccine
[17] – https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
[18] – https://www.nytimes.com/2024/05/03/health/covid-vaccines-side-effects.html
[19] – https://www.mskcc.org/coronavirus/covid-19-vaccine
[20] – https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
[21] – https://www.nature.com/articles/s41598-024-54886-0
[22] – https://www.nature.com/articles/s41598-024-54886-0
[23] – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10259333/
[24] – https://www.ajpmonline.org/article/S0749-3797(24)00044-8/fulltext
[25] – https://www.mskcc.org/coronavirus/covid-19-vaccine
[26] – https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html
[27] – https://pubmed.ncbi.nlm.nih.gov/38284355/
[28] – https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
[29] – https://www.nytimes.com/2024/05/03/health/covid-vaccines-side-effects.html
[30] – https://www.theguardian.com/australia-news/2024/feb/23/two-very-rare-covid-vaccine-side-effects-detected-in-global-study-of-99-million