Vaccines have caused severe side effects emerging months or years post-injection
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Peer-reviewed literature documents that vaccines can cause rare, severe side effects, but notes that these adverse events typically emerge shortly after administration (within hours to several weeks) rather than months or years post-injection.
<h4>Introduction</h4>The common reported adverse effects of COVID-19 vaccination consist of the injection site's local reaction followed by several non-specific flu-like symptoms. However, rare cases of vaccine-induced immune thrombotic thrombocytopenia (VITT) and cerebral venous sinus thrombosis (CVST) after viral vector vaccines (ChAdOx1 nCoV-19 vaccine, Ad26.COV2 vaccine) have been reported. Herein we systemically reviewed the reported cases of CVST and VITT following the COVID-19 vaccination.<h4>Methods</h4>This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched PubMed until May 19, 2021, and the following Keywords were used: COVID Vaccine & Neurology, AstraZeneca COVID vaccine, ChAdOx1 nCoV-19 COVID vaccine, AZD1222 COVID vaccine, Janssen COVID vaccine, Johnson & Johnson COVID vaccine, Ad26.COV2 COVID vaccine. The authors evaluated the abstracts and titles of each article for screening and inclusion. English reports about post-vaccine CVST and VITT in humans were collected.<h4>Results</h4>Until May 19, we found 877 articles with the searched terms. We found 12 articles, which overall present clinical features of 36 patients with CVST and VITT after the ChAdOx1 nCoV-19 vaccine. Moreover, two articles were noted, which present 13 patients with CVST and VITT after Ad26.COV2 vaccine. The majority of the patients were females. Symptom onset occurred within one week after the first dose of vaccination (Range 4-19 days). Headache was the most common presenting symptom. Intracerebral hemorrhage (ICH) and/or Subarachnoid hemorrhage (SAH) were reported in 49% of the patients. The platelet count of the patients was between 5 and 127 cells×10<sup>9</sup>/l, PF4 IgG Assay and d-Dimer were positive in the majority of the reported cases. Among 49 patients with CVST, at least 19 patients died (39%) due to complications of CVST and VITT.<h4>Conclusion</h4>Health care providers shoul
The common adverse effects post COVID-19 vaccination consist of the injection site's local reaction followed by non-specific systemic symptoms such as headache, fatigue, myalgia, and fever. These symptoms may occur soon after vaccination and resolve in a short period [ 6 ]. However, some rare cases of vaccine-induced immune thrombotic thrombocytopenia (VITT) have been reported, mainly with viral vector vaccines [ 6 ]. Among these reports, there are patients with VITT and cerebral venous sinus thrombosis (CVST), a severe and rare neurological condition [ 8 , 9 ]. In this study, we systematically reviewed the CVST cases reported post-COVID-19 vaccination so far.
Common side effects including injection-site reaction and pain, headache, malaise, and nausea, all generally resolving within a few days [ 6 ]. However, there are few reports of VITT after vaccination [ 9 ]. According to the “European Medicine Agency's Pharmacovigilance Risk Assessment Committee,” from the 34 million people that received the AstraZeneca COVID-19 vaccine in the European Economic Area and the United Kingdom as of April 4, 2021, 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported. Most of these cases occurring within the first two weeks of vaccination and in women <60 years [ 6 ].
It has been modified to contain the gene for making the spike protein of the SARS-CoV-2 that causes COVID-19 [ 24 ]. The vaccine's efficacy is about 66.1%against symptomatic moderate and severe SARS-CoV-2 infection and about 85.4% against hospitalization or death [ 25 ]. Common side effects after vaccination include injection site reactions, fever, chills, and malaise, but there are rare reports of venous thrombosis after vaccination [ 26 ]. Table 2 summarizes the articles which report CVST and associated venous infarct and hemorrhagic stroke and VITT after Johnson & Johnson COVID-19 vaccine. In this group, we found 2 articles that present 13 patients. All of these patients were females.
In contrast to the previous reports of thrombotic thrombocytopenia after vaccination, in these patients, cases of CVST have been reported post-COVID-19
3.6 Diagnosis Despite the high mortality associated with VITT and CVST post-COVID-19 vaccination, prompt recognition and early management will likely lead to better neurological outcomes. Key diagnostic criteria of VITT include the following items (must meet all four criteria): 1- The patient has received the AstraZeneca COVID (ChAdOx1) or Johnson & Johnson (Ad26.COV2) vaccines within the last 30 days (between 4 and 30 days). 2- Presence of moderate to severe thrombocytopenia. However, in some cases, this thrombocytopenia may be mild, particularly in the beginning stages of VITT.
3 3.9 Risks and benefits of vaccination There is approximately 1 to 2% risk of mortality and several potential long-term sequelae in COVID-19 patients [ 4 , 43 ]. In patients with chronic underlying diseases or patients on particular medications, this rate might be even higher [ 44 ]. Conversely, Vaccination has a significant effect on the prevention of severe SARS-Cov-2 infection and ensuing complications [ 25 ] with an extremely low rate of severe complications. As initially estimated, the incidence of VITT is perhaps 1 case per 100,000 vaccine exposures [ 40 ]. Consequently, COVID-19 vaccination should be strongly encouraged given benefits outweigh its potential risks [ 40 ].
However, monitoring of the vaccines' adverse effects is essential and should be performed by the health authorities. 4 Conclusion Health care providers should be aware of clinical presentations, pathophysiology, diagnostic criteria, and management strategies of CVST associated with VITT post-COVID-19 vaccination. Despite being very rare, this phenomenon is serious and potentially fatal. Promote diagnosis and quick initiation of the appropriate treatment may help to provide patients with a better neurological outcome [ 22 ]. Declaration of Competing Interest None.
SARS-CoV-2 and adverse reactions to SARS-CoV-2 vaccinations show a tropism for neuronal structures and tissues. This narrative review was conducted to collect and discuss published data about neurological side effects of SARS-CoV-2 vaccines in order to discover type, frequency, treatment, and outcome of these side effects. The most frequent neurological side effects of SARS-CoV-2 vaccines are headache, Guillain-Barre syndrome (GBS), venous sinus thrombosis (VST), and transverse myelitis. Other neurological side effects occur in a much lower frequency. Neurological side effects occur with any of the approved vaccines but VST particularly occurs after vaccination with vector-based vaccines. Treatment of these side effects is not at variance from similar conditions due to other causes. The worst outcome of these side effects is associated with VST, why it should not be missed and treated appropriately in due time. In conclusion, safety concerns against SARS-CoV-2 vaccines are backed by an increasing number of studies reporting neurological side effects. The most frequent of them are headache, GBS, VST, and transverse myelitis. Healthcare professionals, particularly neurologists involved in the management of patients having undergone SARS-CoV-2 vaccinations, should be aware of these side effects and should stay vigilant to recognize them early and treat them adequately.
<h4>Background</h4>Since the emergency use approval of different types of COVID-19 vaccines, several safety concerns have been raised regarding its early and delayed impact on the nervous system.<h4>Objective</h4>This study aims to systematically review the reported cases of CNS demyelination in association with COVID-19 vaccination, which has not been performed, to our knowledge.<h4>Methods</h4>A systematic review was performed by screening published articles and preprints of cases of CNS demyelination in association with COVID-19 vaccines in PubMed, SCOPUS, EMBASE, Google Scholar, Ovid and medRxiv databases, until September 30, 2021. This study followed PRISMA guidelines. Descriptive findings of reported cases were reviewed and stratified by demographic and clinical findings, diagnostic work-up, management, and overall outcome.<h4>Results</h4>A total of 32 cases were identified, with female predominance (68.8%) and median age of 44 years. Eleven cases were reported after Pfizer vaccine, 8 following AstraZeneca vaccine, 6 following Moderna, 5 following Sinovac/ Sinopharm vaccines, and one following each of Sputnik and Johnson&Johnson vaccines. The majority of cases (71.8%) occurred after the first dose of the vaccine, with neurological symptoms manifesting after a median of 9 days. The most common reported presentations were transverse myelitis (12/32) and MS-like pictures (first diagnosis or a relapse) in another 12/32 cases, followed by ADEM- like (5/32), and NMOSD- like (3/32) presentations. History of a previous immune-mediated disease was reported in 17/32 (53.1%) cases. The mRNA-based vaccines resulted in the greatest number of demyelinating syndromes (17/32), followed by viral vector vaccines (10/32), and inactivated vaccines (5/32). Most MS-like episodes (9/12) were triggered by mRNA-based vaccines, while TM occurred following both viral vector and mRNA-based vaccines. Management included high dose methylprednisolone, PLEX, IVIg, or a combination of those, with a favorable outcome in the majority of case; marked/complete improvement (25/32) or stabilized/ partial recovery in the remaining cases.<h4>Conclusion</h4>This systematic review identified few cases of CNS demyelination following all types of approved COVID-19 vaccines so far. Clinical presentation was heterogenous, mainly following the first dose, however, half of the reported cases had a history of immune-mediated disease. Favorable outcome was observed in most cases. We suggest long-term post-marketing surveillance for these cases, to assess for causality, and ensure the safety of COVID-19 vaccines.
SARS-CoV-2 vaccinations are not free from side effects. Usually, they are mild or moderate but occasionally severe. One of these severe side effects is Guillain-Barré syndrome (GBS). This review summarizes and discusses GBS as a side effect of SARS-CoV-2 vaccinations (SCoVaG) based on recent research reports. Altogether, nine articles reporting 18 patients with SCoVaG were identified and one more report on another patient is under review. The age for the studies ranged between 20-86y. Nine patients were male, and ten were female. In all 19 patients, SCoVaG developed after the first dose of the vaccine. The Astra Zeneca vaccine was used in fourteen patients, the Pfizer vaccine in four patients, and the Johnson & Johnson vaccine was applied in one patient. The latency between vaccination and onset of GBS ranged from 3h to 39d. The treatment of SCoVaG included IVIGs (n=13), steroids (n=3), or no therapy (n=3). Six patients required mechanical ventilation. Only a single patient recovered completely and partial recovery was achieved in nine patients. In conclusion, GBS may develop time-linked to the first dose of a SARS-CoV-2 vaccination. Though a causal relationship between SARS-CoV-2 vaccinations and SCoVaG remains speculative, more evidence is in favour than against it.
Abstract Following the COVID-19 virus epidemic, extensive, coordinated international research has led to the rapid development of effective vaccines. Although vaccines are now considered the best way to achieve collective safety and control mortality, due to the critical situation, these vaccines have been issued the emergency use licenses and some of their potential subsequence side effects have been overlooked. At the same time, there are many reports of side effects after getting a COVID-19 vaccine. According to these reports, vaccination can have an adverse event, especially on nervous system. The most important and common complications are cerebrovascular disorders including cerebral venous sinus thrombosis, transient ischemic attack, intracerebral hemorrhage, ischemic stroke, and demyelinating disorders including transverse myelitis, first manifestation of MS, and neuromyelitis optica. These effects are often acute and transient, but they can be severe and even fatal in a few cases. Herein, we have provided a comprehensive review of documents reporting neurological side effects of COVID-19 vaccines in international databases from 2020 to 2022 and discussed neurological disorders possibly caused by vaccination.
Although vaccines are now considered the best way to achieve collective safety and control
The most important and common complications are cerebrovascular disorders including cerebral venous sinus thrombosis, transient ischemic attack, intracerebral hemorrhage, ischemic stroke, and demyelinating disorders including transverse myelitis, first manifestation of MS, and neuromyelitis optica. These effects are often acute and transient, but they can be severe and even fatal in a few cases. Herein, we have provided a comprehensive review of documents reporting neurological side effects of COVID-19 vaccines in international databases from 2020 to 2022 and discussed neurological disorders possibly caused by vaccination.
However, in order to prove the effectiveness of the vaccine in terms of safety and side effects, the implementation of phase 4 of clinical studies is necessary. Because the results of the phase 4 studies are the proper criteria for how the vaccine works in the real world [ 5 ]. Vaccines have always been known to be the most effective and safest drugs; however, different side effects have been identified for them, for example, the link between influenza, hepatitis, and HPV vaccines with demyelinating syndromes has been discovered, and the injection of influenza vaccine is a reason for the incidence of narcolepsy in young people [ 6 ].
Keywords used for this search included COVID-19, SARS-CoV-2, vaccination, side effects, complications, vascular thrombosis, thrombocytopenia, myelitis, demyelination, and all kind of mRNA vaccines, Adenovirus vaccine, Pfizer, AstraZeneca, Johnson & Johnson, Moderna, Sinovac, Sinopharm, Sputnik, and Covaxin. For ease of understanding the various side effects of COVID-19 vaccination, the main categories are shown in Fig. 1 . Fig.
1 Classification of neurological complications observed after COVID-19 vaccination Neurological complications following COVID-19 vaccination According to reports published in the VAERS database, COVID-19 vaccines have several local and systemic neurological complications that occur in different people, from mild to severe, depending on age, sex, history of the disease, and pre-existing immunity [ 7 ]. Complications usually appear within one day to 1 month after injection and are usually acute, transient, and self-limiting, but in severe cases lead to hospitalization and intensive care [ 8 ].
On the other hand, severe neurological complications included Bell's palsy, Guillain–Barre syndrome (GBS), stroke, seizures, anaphylaxis, and demyelinating syndromes such as transverse myelitis and acute encephalomyelitis [ 10 ]. Among these, the most dangerous neurological complication caused by COVID-19 vaccines, especially adenovirus-based, is cerebral venous sinus thrombosis in women of childbearing age [ 8 ].
According to the WHO, in the case of side effects of inactivated virus-based vaccines, especially Sinopharm, the most common local and systemic adverse reactions are injection site reactions, fatigue, fever, headache, and allergic dermatitis, which are self-limiting, and the person does not need to be hospitalized [ 11 , 12 ]. It is noteworthy that rare and scattered reports have been published on the side effects of Sinopharm and other inactivated virus-based vaccines (Table 1 ). Vaccine reactivity has been linked to a temporary increase in inflammatory cytokines that act on blood vessels, muscles, and other tissues.
COVID-19 vaccination can sometimes have severe side effects on nervous system, including the brain, spinal cord, cranial nerves, and peripheral nerves, and has been shown to have adverse vascular, metabolic, inflammatory, and functional effects on the brain [ 1 ].
Headache The first and most common systemic side effect of COVID-19 vaccines is headache, which is mild to severe and is felt in the frontal area of the head. Post-vaccination headaches can be caused by stress, vascular spasm, and intracerebral or subarachnoid hemorrhage. Vaccines based on mRNA and adenovirus have been reported to be most likely to cause headaches [ 26 ]. Vascular complications in the brain Due to the activity of the immune system, after the injection of COVID-19 vaccines, especially adenovirus-based type, thrombocytopenia, cerebral venous sinus thrombosis, ischemic stroke and intracerebral hemorrhage, have also been reported [ 27 ].
Conclusion According to the vaccine study literature, adverse effects have always been part of the mass vaccination strategy, but ultimately the desired effects of the vaccination are more significant. Side effects of COVID-19 vaccination have been reported more frequently in people with a history of immune-related diseases or who are more sensitive to age and physiological conditions.
Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) has caused a severe global pandemic with major public health issues. Public health sectors implemented several control strategies, such as social distancing, hygienic measures, and the development of anti-viral drugs and vaccines. However, the situation is still critical due to several challenges facing the global control strategy. SARS-CoV-2 has undergone several mutations that will drive viral evolution, which might impact the virus’s transmissibility and pathogenicity and the immune escape and development of resistance to therapeutics. Moreover, although the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have approved several vaccines, however, some vaccines, especially vector-based vaccines, have rarely induced severe fatal side effects. These side effects led to widespread doubts about the safety of the coronavirus disease-19 (COVID-19) vaccines, which in turn dragged a certain proportion of the public from getting vaccinated. This review highlights some of the ongoing challenges in controlling the COVID-19 pandemic, including side effects of the developed vaccines, potential mechanisms for the development of thrombocytopenia, and the clinical impacts of the emerged SARS-CoV-2 variants on the pathogenesis of the virus and vaccine efficacy. Additionally, we discuss the comorbidity and the potential role of gastrointestinal microbiota in controlling SARS-CoV-2. Finally, we shed
is given by injection into a muscle. Severe side effects are extremely rare. About 20 to 25% of people develop pain at the site of injection while about
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It is recommended by both the World Health Org
The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that…
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