While some studies and case reports note rare or investigated long-term adverse events, comprehensive safety data and systematic reviews generally indicate that serious complications are extremely rare with no documented long-term complications.
There have been massive studies to develop an effective vaccine against SARS-CoV-2 which fortunately led to manage the recent pandemic, COVID-19. According to the quite rapidly developed vaccines in a fast window time, large investigations to assess the probable vaccine-related adverse events are crucially required. COVID-19 vaccines are available of different platforms and the primary clinical trials results presented acceptable safety profile of the approved vaccines. Nevertheless, the long-term assessment of the adverse events or rare conditions need to be investigated. The present systematic review, aimed at classification of probable vaccine-related unsolicited adverse events in Iranian population through the data collection of the published case report studies. The related published case reports were explored via PubMed, Web of Science and Google scholar according to the available published data up to 14^th Dec, 2022 using PRISMA guideline. Out of 437 explored studies, the relevant data were fully investigated which totally led to 40 studies, including 64 case reports with a new onset of a problem post-vaccination. The cases were then classified according to the various items, such as the type of adverse event and COVID-19 vaccines. The reported COVID-19 vaccines in the studied cases included BBIBP-CorV, ChAdOx1-S, Sputnik V and COVAXIN. The results showed that the adverse events presented in 8 different categories, including cutaneous involvements in 43.7% ( n = 28), neurologic problems ( n = 16), blood/vessel involvement ( n = 6), cardiovascular involvement ( n = 5), ocular disorders ( n = 4), liver disorder/failure ( n = 2), graft rejection ( n = 2) and one metabolic disorder. Notably, almost 60% of the cases had no comorbidities. Moreover, the obtained data revealed nearly half of the incidences occurred after the first dose of injection and the median duration of improvement after the symptom was 10 days (range: 2–120). In addition, 73% of all the cases were either significantly improved or fully recovered. Liver failure following ChAdOx1-S vaccination was the most serious vaccine adverse event which led to death in two individuals with no related medical history. Although the advantages of COVID-19 vaccination is undoubtedly significant, individuals including with a history of serious disease, comorbidities and immunodeficiency conditions should be vaccinated with the utmost caution. This study provides a comprehensive overview and clinical implications of possible vaccine-related adverse events which should be considered in further vaccination strategies. Nevertheless, there might be a bias regarding potential under-reporting and missing data of the case reports included in the present study. Although the reported data are not proven to be the direct vaccination outcomes and could be a possible immune response over stimulation, the people the population with a medium/high risk should be monitored after getting vaccinated against COVID-19 of any platforms. This could be achieved by a carefull attention to the subjects ‘ medical history and also through consulting with healthcare providers before vaccination.
ABSTRACT Background Public health concerns due to ongoing emergence of SARS-CoV-2 variants necessitates further development of improved COVID-19 vaccines. One major innovation are self-amplifying mRNA vaccines, such as ARCT-154 (Arcturus Therapeutics, Inc.), which induces superior immunogenicity compared with conventional mRNA in terms of magnitude, breadth and persistence of neutralizing antibodies. Research design and methods In a pivotal placebo-controlled trial in Vietnam combining phase 1, 2 and 3 cohorts, over 17,000 adults received at least one dose of ARCT-154. Here, we report the safety and reactogenicity observations made. Results ARCT-154 elicited more local reactions than the saline placebo, most reports of injection site pain were mild/moderate with only a few reporting severe pain. Most frequent solicited adverse events were fatigue, myalgia, headache, arthralgia and chills. Solicited local and systemic reactogenicity resolved within 7 days. Long-term follow-up has not revealed any safety concerns, with no reports of myocarditis or pericarditis. Acceptable tolerability of ARCT-154 was also observed in older participants and in those liable to severe consequences of COVID-19 due to underlying medical conditions. No serious consequences occurred in several pregnancies reported after vaccination, with normal outcomes when followed to term. Conclusions Data from this large trial suggest that ARCT-154 is safe and well tolerated.
Background and Objectives: To respond to the health emergency caused by the Covid-19pandemic, several anti-Covid-19vaccines have been marketed. The speed of their development has prompted several questions about their safety. Therefore, the objective of this study is to carry out a systematic review of the side effects of the anti-Covid 19 vaccines, as well as their associated factors. Material and Methods: The recommendations of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were used for the selection of the studies included in this review. Articles published in English and French, aiming to identify “the side effects of anti-Covid-19 vaccines in adults” were included. Results: Most of the side effects associated with anti-Covid-19 vaccines are pain at the injection site, fatigue, myalgia and headache. Some rare side effects (myocarditis, thrombocytopenia) are more prevalent with specific types of vaccine (mRNA vaccine and adenoviral vaccine). Other serious adverse events (pulmonary embolism, pericarditis) have been reported but are rare. Conclusion: Anti-Covid 19 vaccines are reasonably safe. Further multicentre studies are needed to identify rare and long-term side effects in order to prevent or better manage them.
ported cases following J&J vaccination have occurred in men 50 years old and older.
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COVID-19 vaccines — like all vaccines and other medical products — come with side effects, including serious side effects in rare cases. The vaccines were rolled out to protect people from a novel virus that has killed millions of people globally and would likely have killed millions more without the arrival of the vaccines. There is a broad consensus from experts and governmental health agencies that the benefits of COVID-19 vaccination outweigh the risks.
Researchers have scrutinized the COVID-19 vaccines’ safety and continue to do so. A study published Feb. 12 in the journal Vaccine reported on an international group of more than 99 million people who received COVID-19 vaccines, primarily finding links to known rare side effects. The study largely focused on the Pfizer/BioNTech and Moderna vaccines, which have been widely given in the U.S., as well as the AstraZeneca vaccine, which was never authorized in the U.S.
“What we take away, is that the Covid-19 vaccination campaigns have been very effective in preventing severe disease,” study co-author Anders Hviid , head of the department of epidemiology research at the Statens Serum Institut in Denmark, told us in an email. “The few serious side effects that we have observed in this and other studies have been rare.”
Many popular posts on social media have shared results from the study, some lacking the context that the identified health problems are rare , that most aren’t new and that the vaccines have proven benefits. Various posts made unfounded claims, stating or implying that people should not have received the vaccines , that the risks outweigh the benefits or that the risk of the rare side effects is greater than was reported in the study.
“Hundreds of millions of people were used as lab rats and now the truth that WE ALL ALREADY KNEW can no longer be denied,” said one popular post , referring to the va
serious side effects, such as allergic reactions, remain very rare with no long-term complications documented. The vaccine is the first COVID‑19 vaccine to
The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in humans to provide protection against COVID-19, caused by infection with
The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial guidance recommended a two-dose regimen, given 21 days apart; this interval was subsequently extended to up to 42 days in the United States, and up to four months in Canada.
Clinical trials began in April 2020; by November 2020, the vaccine had met the primary efficacy goals of the phase III clinical trial, with over 40,000 people participating. Interim analysis of study data showed a potential efficacy of 91.3% in preventing symptomatic infection within seven days of a second dose and no serious safety concerns. Most side effects are mild to moderate in severity and resolve within a few days. Common side effects include mild to moderate pain at the injection site, fatigue, and headaches. Reports of serious side effects, such as allergic reactions, remain very rare with no long-term complications documented.
The vaccine is the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency use and the first to be approved for regular use. In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis. It is authorized for use at some level in the majority of countries. On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the US by the Food and Drug Administration (FDA). The logistics of distributing and storing the vaccine present significant challenges due to the requirement for its storage at extremely low temperatures.
In August 2022, a bivalent version of the vaccine (Pfizer-BioNTech COVID-19 Vaccine,…
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