Abstract
BACKGROUND Serious and severe harms of the COVID-19 vaccines have been downplayed or deliberately excluded by the study sponsors in high impact medical journals.
METHODS Systematic review of papers with data on serious adverse events (SAEs) associated with a COVID-19 vaccine.
RESULTS We included 18 systematic reviews, 14 randomised trials, and 34 other studies with a control group. Most studies were of poor quality. A systematic review of regulatory data on the two pivotal trials of the mRNA vaccines found significantly more SAEs of special interest with the vaccines compared to placebo, and the excess risk was considerably larger than the benefit, the risk of hospitalisation. The adenovirus vector vaccines increased the risk of venous thrombosis and thrombocytopenia, and the mRNA-based vaccines increased the risk of myocarditis, with a mortality of about 1-2 per 200 cases. We found evidence of serious neurological harms, including Bell’s palsy, Guillain-Barré syndrome, myasthenic disorder and stroke, which are likely due to an autoimmune reaction. Severe harms, i.e. those that prevent daily activities, were underreported in the randomised trials. These harms were very common in studies of booster doses after a full vaccination and in a study of vaccination of previously infected people.
CONCLUSIONS Further randomised trials are needed. Authorities have recommended populationwide COVID-19 vaccination and booster doses. They do not consider that the balance between benefits and harms becomes negative in low-risk groups such as children and people who have already recovered from COVID-19 infection.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
Institute for Scientific Freedom and a private funder requesting anonymity, a retired filmmaker with no conflicts of interests in relation to our review.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Data Availability
All data are publicly available
FAQs
To date, the systems in place to monitor the safety of these vaccines have found two serious types of adverse events following COVID-19 vaccination. The two serious adverse events following COVID-19 vaccination currently used in the United States are anaphylaxis and myocarditis or pericarditis.
What are the side effects of the COVID vaccine systematic review? ›
Injection site discomfort and fatigue were the most common side effect observed in mRNA, non-replicating viral vector, inactivated, and protein subunit-based vaccines.
What are the clinical outcomes of a COVID-19 vaccine implementation over efficacy? ›
Our results demonstrate that the benefits of any COVID-19 vaccine — whether highly, moderately, or modestly efficacious by any trial-defined outcome — will depend at least as much on how swiftly and broadly it is implemented and the epidemiological environment into which it is introduced as it will on the vaccine's ...
What are the side effects of the Covid vaccine 24 hours? ›
Some common side effects include arm pain at the injection site, fatigue, headache or other body aches, or fever for a few days.
What are the negatives of getting the vaccine? ›
Vaccines do have some risk for adverse reaction, the most common being redness and soreness at the injection site or fever and allergic reactions.
How long does the COVID vaccine last in the body? ›
The Moderna, Pfizer-BioNTech, and Novavax vaccines protect against many known variants of COVID-19. The Moderna and Pfizer-BioNTech vaccines offer immunity against COVID-19 for up to six months.
What are the impacts of COVID-19 vaccines? ›
In some people, COVID-19 vaccines can lead to heart complications called myocarditis and pericarditis. Myocarditis is the swelling, also called inflammation, of the heart muscle. Pericarditis is the swelling, also called inflammation, of the lining outside the heart.
Did the COVID vaccine lose effectiveness? ›
COVID-19 vaccine efficacy or effectiveness against severe disease remained high, although it did decrease somewhat by 6 months after full vaccination. By contrast, vaccine efficacy or effectiveness against infection and symptomatic disease decreased approximately 20–30 percentage points by 6 months.
Does the COVID vaccine reduce severity? ›
Full COVID-19 vaccination greatly reduced the risk of hospitalisation and severe outcomes in COVID-19 cases with the Omicron variant, and a booster dose improved this effect in people aged over 65 years.
What are the unusual side effects of the COVID-19 vaccine? ›
The largest vaccine safety study to date has identified two new, but very rare, side effects associated with covid-19 vaccines—transverse myelitis and acute disseminated encephalomyelitis. The Global Vaccine Data Network cohort study included 99 million vaccinated people from 10 sites across eight countries.
Note: The Johnson & Johnson (Janssen) COVID-19 vaccine expired as of May 6, 2023, and is no longer available in the U.S. Those who did get the J&J shot are considered up-to-date when they get one updated (2023–2024 formula) COVID vaccine.
What are the emotional side effects of the Pfizer COVID vaccine? ›
52.2% of the participants had received the COVID-19 vaccine. 26.5% of the participants reported anxiety and 20.3% reported depression (Table 1).
Is the latest COVID vaccine safe? ›
How safe is the updated COVID vaccine? COVID vaccines are safe and effective, according to the CDC. The safety of COVID vaccines has been rigorously monitored and evaluated since their emergency use authorization (EUA) in December 2020.
What are the serious complications of COVID-19? ›
Complications of severe COVID-19 illness can include:
- Acute respiratory distress syndrome, when the body's organs do not get enough oxygen.
- Shock caused by the infection or heart problems.
- Overreaction of the immune system, called the inflammatory response.
- Blood clots.
- Kidney injury.
Common side effects include tiredness, headaches, pain where the shot was given, and chills. Less common but other known side effects are fever, diarrhea, joint aches, vomiting and swollen lymph nodes in the underarm on the same side as the shot.
Which has worse side effects, Pfizer or Moderna? ›
This finding is consistent with prior evidence that adverse effects are more frequent in patients who receive the Moderna vaccine than in those receiving the Pfizer vaccine.
