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1.
J Int Med Res ; 49(11): 3000605211056783, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1533180

ABSTRACT

The ongoing global administration of vaccines for coronavirus disease 2019 (COVID-19) means that increasing numbers of patients are likely to present with post-vaccination complications. We describe the first reported case of neuralgic amyotrophy (NA) involving the lumbosacral plexus occurring after AstraZeneca COVID-19 vaccination. The patient presented with acute-onset leg paralysis following administration of the vaccine. Based on the clinical, electrodiagnostic, and radiologic findings, the patient was diagnosed with post-vaccination NA. We speculate that the COVID-19 vaccine elicited an immune-mediated inflammatory response to the injected antigen due to inflammatory immunity in a patient with predisposed susceptibility to NA.


Subject(s)
Brachial Plexus Neuritis , COVID-19 , Brachial Plexus Neuritis/chemically induced , Brachial Plexus Neuritis/diagnosis , COVID-19 Vaccines , Humans , Leg , Lumbosacral Plexus , Paraplegia , SARS-CoV-2 , Vaccination/adverse effects
2.
J Korean Med Sci ; 36(45): e318, 2021 Nov 22.
Article in English | MEDLINE | ID: covidwho-1528810

ABSTRACT

BACKGROUND: Older adults are given high priority for coronavirus disease 2019 (COVID-19) vaccination; however, little is known about the safety of vaccines. This study was conducted to examine the safety of the COVID-19 vaccine for people who were ≥ 75 years of age, specifically those who first took two doses of the vaccine at the COVID-19 central vaccination center in South Korea. METHODS: Safety monitoring after the BNT162b2 vaccine was conducted in three ways for older adults who received the first dose of the vaccine at our center between April 5 and April 23, 2021. For immediate adverse reactions, every person who was vaccinated was observed for 15-30 minutes after injection at the center. For active surveillance, a telephone interview was conducted for stratified randomly sampled people after 7 days of each vaccination to enquire regarding types of adverse reactions they experienced, and its severity and duration. For passive surveillance, reported adverse event data were collected from the COVID-19 vaccine adverse event following immunization (AEFI) surveillance system-run by the Korea Disease Control and Prevention Agency (KDCA). The data were then reviewed. RESULTS: In total, 2,123 older adults received at least one vaccine dose during the study period. The frequency of acute adverse reactions that developed during the observed 15-30 minutes after injection was 8.5 cases per 1,000 doses. None of the reactions was assessed as acute allergic reactions to the vaccine and no cases required special treatment or drug administration. Overall, 638 people were followed up at least once by telephone interview 7 days post vaccination. The overall response rate was 82.3%. The rates of local reactions were 50.3% after the first dose and 45.2% after the second dose, and the rates of systemic reactions were 15.2% and 26.0%, respectively. During the study period, 23 medically attended adverse events (5.4 cases per 1,000 administered doses) were reported to the KDCA AEFI surveillance system. The most common symptoms of medically attended cases were nonspecific general weakness (26%) and dizziness (26%), followed by muscle pain (22%), headache (13%), fever (13%), and skin rash or urticaria (13%). Among them, there were five serious adverse events reported, which required hospitalization, including one death. However, most of them were not related to the vaccines. CONCLUSION: BNT162b2 vaccination was tolerable among adults who were ≥ 75 years of age.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , SARS-CoV-2/immunology , Vaccination/adverse effects , Aged , Aged, 80 and over , Female , Humans , Male
3.
J Korean Med Sci ; 36(45): e312, 2021 Nov 22.
Article in English | MEDLINE | ID: covidwho-1528809

ABSTRACT

As the number of people vaccinated increases, people who complain of adverse reactions continue to occur. We experienced a case characterized by low blood pressure, persistent fever, edema due to increased systemic vascular permeability, and systemic inflammation confirmed by image and laboratory examinations after ChAdOx1 coronavirus disease 2019 (COVID-19) vaccination. The diagnostic criteria for multisystem inflammatory syndrome (MIS) in adults are known as fever of 3 days or more in adults, 2 or more mucocutaneous/gastrointestinal/neurologic symptoms, elevation of inflammatory markers, and clinical/imaging diagnosis of heart failure. A 67-year-old man who was medicated for hypertension and diabetes was admitted complaining of fever, maculopapular rash, diarrhea, headache, chills, and dizziness 6 days after the first vaccination of ChAdOx1 nCoV-19 in Korea. The COVID-19 test was negative but with low blood pressure, leukocytosis, skin rash, pulmonary edema, and increased inflammation markers. His lab findings and clinical course were consistent with those of MIS after COVID-19 vaccination. He was medicated with methylprednisolone 1 mg/kg and diuretics and recovered rapidly. He was discharged after 2 weeks and confirmed cure at outpatient clinic. We report an MIS case after COVID-19 vaccination in Korea.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , SARS-CoV-2/immunology , Systemic Inflammatory Response Syndrome/etiology , Vaccination/adverse effects , Aged , COVID-19/etiology , Humans , Male
4.
Am J Case Rep ; 22: e934066, 2021 Nov 19.
Article in English | MEDLINE | ID: covidwho-1527016

ABSTRACT

BACKGROUND Since Emergency Use Authorization of COVID-19 vaccines in December 2020, more is becoming known about their adverse effects. Growing numbers of myopericarditis cases after COVID-19 vaccination are being reported, mostly in younger adults. While most of these patients have recovered rapidly and without complications, it is still unclear whether patients who are older and have greater cardiac dysfunction secondary to myopericarditis will also experience the same recovery. CASE REPORT We report the case of a middle-aged man with myopericarditis and significant left ventricular dysfunction after the second dose of the Pfizer/BioNTech BNT162b2 COVID-19 vaccine. He presented several days after vaccination, and with non-steroidal anti-inflammatory treatment, he quickly recovered ventricular function, and symptoms resolved within 1 week after vaccination. CONCLUSIONS Vaccines are a key tool in combating the COVID-19 pandemic, yet many people are hesitant to seek vaccination, perhaps for fear of adverse events. Our report of a middle-aged patient with significant left ventricular dysfunction, who still experienced rapid recovery, should reassure the public about the safety of vaccines. Such rare adverse effects should not deter people from receiving COVID-19 vaccination.


Subject(s)
COVID-19 , Ventricular Dysfunction, Left , Adult , COVID-19 Vaccines , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2 , Vaccination/adverse effects , Ventricular Dysfunction, Left/etiology
5.
8.
J Korean Med Sci ; 36(43): e306, 2021 Nov 08.
Article in English | MEDLINE | ID: covidwho-1506220

ABSTRACT

Immune thrombocytopenia (ITP) is an autoimmune condition characterized by platelet destruction through antibody-mediated mechanism. ITP is one of the manifestations of a coronavirus disease, as well as an adverse event occurring after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Several cases of ITP have been described after vaccination with two mRNA-based vaccines-BTN162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna)-against SARS-CoV-2. Herein, we report a case of ITP occurring after vaccination with ChAdOx1 adenovirus vector nCoV-19 (AstraZeneca) vaccine in Korea. A 66-year-old woman presented with multiple ecchymoses on both upper and lower extremities and gingival bleeding, appearing 3 days after receiving the first dose of ChAdOx1 nCoV-19. Her laboratory results showed isolated severe thrombocytopenia without evidence of combined coagulopathy. She was diagnosed with ITP and successfully treated with high-dose dexamethasone and intravenous immunoglobulin. Clinical suspicion to identify vaccine-related ITP is important to promptly initiate appropriate treatment.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Ecchymosis/etiology , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Vaccination/adverse effects , Aged , COVID-19/epidemiology , COVID-19 Vaccines/adverse effects , Dexamethasone/therapeutic use , Female , Humans , Immunoglobulins, Intravenous/therapeutic use , Periodontal Index , Purpura, Thrombocytopenic, Idiopathic/drug therapy , SARS-CoV-2
9.
Panminerva Med ; 63(3): 324-331, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1504553

ABSTRACT

BACKGROUND: New messenger RNA (mRNA) and adenovirus-based vaccines (AdV) against Coronavirus disease 2019 (COVID-19) have entered large scale clinical trials. Since healthcare professionals (HCPs) and armed forces personnel (AFP) represent a high-risk category, they act as a suitable target population to investigate vaccine-related side effects, including headache, which has emerged as a common complaint. METHODS: We investigated the side-effects of COVID-19 vaccines among HCPs and AFP through a 38 closed-question international survey. The electronic link was distributed via e-mail or via Whatsapp to more than 500 contacts. Responses to the survey questions were analyzed with bivariate tests. RESULTS: A total of 375 complete surveys have been analyzed. More than 88% received an mRNA vaccine and 11% received AdV first dose. A second dose of mRNA vaccine was administered in 76% of individuals. No severe adverse effects were reported, whereas moderate reactions and those lasting more than 1 day were more common with AdV (P=0.002 and P=0.024 respectively). Headache was commonly reported regardless of the vaccine type, but less frequently, with shorter duration and lower severity that usually experienced by participants, without significant difference irrespective of vaccine type. CONCLUSIONS: Both mRNA and AdV COVID-19 vaccines were safe and well tolerated in a real-life subset of HCPs and AFP subjects.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Headache/chemically induced , Vaccination/adverse effects , Adolescent , Adult , Aged , COVID-19/transmission , Cross-Sectional Studies , Female , Headache/diagnosis , Headache/epidemiology , Health Care Surveys , Health Personnel , Humans , Incidence , Male , Middle Aged , Occupational Health , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Young Adult
10.
Acta Biomed ; 92(S6): e2021487, 2021 10 19.
Article in English | MEDLINE | ID: covidwho-1503980

ABSTRACT

BACKGROUND AND AIM: The urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI. METHODS: Data come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA. RESULTS: Among the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)]. CONCLUSIONS: In conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 , Vaccination , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , Cross-Sectional Studies , Female , Humans , Immunization , Italy/epidemiology , Male , Vaccination/adverse effects
11.
Emerg Microbes Infect ; 10(1): 365-375, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1490458

ABSTRACT

Concerns about vaccine safety are an important reason for vaccine hesitancy, however, limited information is available on whether common adverse reactions following vaccination affect the immune response. Data from three clinical trials of recombinant vaccines were used in this post hoc analysis to assess the correlation between inflammation-related solicited adverse reactions (ISARs, including local pain, redness, swelling or induration and systematic fever) and immune responses after vaccination. In the phase III trial of the bivalent HPV-16/18 vaccine (Cecolin®), the geometric mean concentrations (GMCs) for IgG anti-HPV-16 and -18 (P<0.001) were significantly higher in participants with any ISAR following vaccination than in those without an ISAR. Local pain, induration, swelling and systemic fever were significantly correlated with higher GMCs for IgG anti-HPV-16 and/or anti-HPV-18, respectively. Furthermore, the analyses of the immunogenicity bridging study of Cecolin® and the phase III trial of a hepatitis E vaccine yielded similar results. Based on these results, we built a scoring model to quantify the inflammation reactions and found that the high score of ISAR indicates the strong vaccine-induced antibody level. In conclusion, this study suggests inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response.


Subject(s)
Hepatitis E/immunology , Human papillomavirus 16/immunology , Human papillomavirus 18/immunology , Papillomavirus Infections/immunology , Papillomavirus Vaccines/immunology , Vaccines, Synthetic/immunology , Viral Hepatitis Vaccines/immunology , Adolescent , Adult , Aged , Antibodies, Viral/immunology , Female , Hepatitis E/prevention & control , Hepatitis E/virology , Human papillomavirus 16/genetics , Human papillomavirus 18/genetics , Humans , Immunity , Immunoglobulin G/immunology , Male , Middle Aged , Papillomavirus Infections/prevention & control , Papillomavirus Infections/virology , Papillomavirus Vaccines/administration & dosage , Papillomavirus Vaccines/adverse effects , Papillomavirus Vaccines/genetics , Vaccination/adverse effects , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/genetics , Viral Hepatitis Vaccines/administration & dosage , Viral Hepatitis Vaccines/adverse effects , Viral Hepatitis Vaccines/genetics , Young Adult
12.
Eur Rev Med Pharmacol Sci ; 25(20): 6408-6410, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1503072
13.
Rinsho Ketsueki ; 62(10): 1519-1521, 2021.
Article in Japanese | MEDLINE | ID: covidwho-1502775

ABSTRACT

Because the coronavirus disease 2019 (COVID-19) pandemic is still rampant, vaccination is being promoted worldwide. However, the safety of various COVID-19 vaccines remains poorly understood. We herein report the case of a 37-year-old woman who experienced thrombocytopenia following BNT162b2 mRNA COVID-19 vaccination. The patient presented with purpura on the extremities 10 days after the first vaccination. She had marked thrombocytopenia and no thrombosis. Thrombocytopenia resolved spontaneously. Given the possibility of occurrence of post-vaccination thrombocytopenia, vaccinated persons should be instructed to consult a medical institution if they experience bleeding symptoms.


Subject(s)
COVID-19 , Purpura, Thrombocytopenic , Adult , COVID-19 Vaccines , Female , Humans , RNA, Messenger , SARS-CoV-2 , Vaccination/adverse effects
14.
Med Sci Monit ; 28: e935299, 2021 Nov 01.
Article in English | MEDLINE | ID: covidwho-1497922

ABSTRACT

Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , COVID-19 Vaccines/adverse effects , COVID-19/drug therapy , SARS-CoV-2/drug effects , Vaccination/adverse effects , COVID-19/immunology , COVID-19/virology , Humans , International Agencies
15.
Pan Afr Med J ; 40: 67, 2021.
Article in English | MEDLINE | ID: covidwho-1497893

ABSTRACT

Adverse consequences of the coronavirus disease 2019 (COVID-19) vaccination which have been reported in scientific papers are varied. One possible but rare consequence is myocarditis, which may have a diversity of clinical manifestations. We report a case of a 70-year-old man who presented to the hospital for some syncope, 3 days after his first COVID-19 AstraZeneca Vaccination. Initial electrocardiogram (ECG) showed a long QT interval (QTc = 600 milliseconds). Laboratory tests revealed elevated troponin and lack of evidence of viral infection. Further investigations revealed the vaccine-induced myocarditis and arrhythmias linked to it. Within one week of magnesium treatment, the QT interval was completely corrected, and the patient discharged with no typical syncope attacks. This case like the previous reported one confirms that myocarditis is a complication of COVID-19 vaccine, but implies its clinical manifestations may be varied and even may happen after the single dose of vaccination.


Subject(s)
COVID-19 Vaccines/adverse effects , Long QT Syndrome/etiology , Syncope/etiology , Aged , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , Electrocardiography , Humans , Long QT Syndrome/diagnosis , Long QT Syndrome/drug therapy , Magnesium/administration & dosage , Male , Myocarditis/diagnosis , Myocarditis/etiology , Syncope/diagnosis , Vaccination/adverse effects , Vaccination/methods
17.
Zhejiang Da Xue Xue Bao Yi Xue Ban ; 50(4): 524-528, 2021 Aug 25.
Article in English | MEDLINE | ID: covidwho-1497385

ABSTRACT

COVID-19 vaccine, as one of the critical measures to control the pandemic, has been administered in nearly all countries. However, the new-onset and relapsing glomerular diseases associated with COVID-19 vaccination have become a new concern. Both mRNA vaccine and inactivated vaccine may cause new-onset and relapsing glomerular diseases; these diseases would occur after the first dose vaccination or the second dose. New-onset glomerular disease is mainly minimal change glomerulopathy, which is mostly sensitive to steroid, while relapsing cases have good prognosis, and some cases can be spontaneously remitted. The pathogenesis of these vaccine-associated diseases is possibly due to the humoral and cellular immune responses. In this article, we provide a general review of the new-onset and relapsing glomerular diseases related to COVID-19 vaccination, and make suggestions for patients with kidney diseases to receive COVID-19 vaccination.


Subject(s)
COVID-19 , Kidney Diseases , COVID-19 Vaccines , Humans , SARS-CoV-2 , Vaccination/adverse effects
18.
G Ital Cardiol (Rome) ; 22(11): 891-893, 2021 Nov.
Article in Italian | MEDLINE | ID: covidwho-1496711

ABSTRACT

We report the case of a 20-year-old healthy male who developed acute myopericarditis 2 days after receiving the second dose of the mRNA Pfizer-BioNTech COVID-19 vaccine. The course of the disease was mild and the patient was discharged after a few days of hospitalization.Recently, several case reports involving myopericarditis in patients who received an mRNA vaccine against SARS-CoV-2 have been published and the U.S. Centers for Disease Control and Prevention and the European Medicines Agency pharmacovigilance risk assessment committee are currently investigating an overall increased number of cases. They are also assessing whether there is a higher incidence than expected in vaccinated young adults and teenagers, especially males. Although a clear causal link has not been proven at this time, physicians should be aware of such potential adverse event, taking into account the increasing number of young people that will receive mRNA vaccination over the next few months.


Subject(s)
COVID-19 , Myocarditis , Adolescent , Adult , COVID-19 Vaccines , Humans , Male , Myocarditis/chemically induced , Myocarditis/diagnosis , SARS-CoV-2 , Vaccination/adverse effects , Young Adult
19.
BMC Infect Dis ; 21(1): 958, 2021 Sep 16.
Article in English | MEDLINE | ID: covidwho-1496148

ABSTRACT

BACKGROUND: Cases of immune complex vasculitis have been reported following COVID-19 infections; so far none in association with novel mRNA-based COVID-19 vaccination. This case report describes a cutaneous immune complex vasculitis after vaccination with BNT162b2. CASE PRESENTATION: A 76-year old male with liver cirrhosis developed an immune complex vasculitis 12 days after the second injection of BNT162b2. On physical examination, the patient presented with pruritic purpuric macules on hands and feet, flexor and extensor parts of both legs and thighs and lower abdomen, and bloody diarrhoea. Laboratory testing showed elevated inflammatory markers. After short treatment with oral steroids all clinical manifestations and laboratory findings resolved. CONCLUSIONS: An increasing number of clinical manifestations have been attributed to COVID-19 infection and vaccination. This is the first written report of immune complex vasculitis after vaccination with BNT162b2. We present our case report and a discussion in the light of type three hypersensitivity reaction.


Subject(s)
COVID-19 , Vasculitis , Aged , Antigen-Antibody Complex , COVID-19 Vaccines , Humans , Male , SARS-CoV-2 , Vaccination/adverse effects , Vasculitis/diagnosis , Vasculitis/etiology
20.
BMJ Case Rep ; 14(10)2021 Oct 27.
Article in English | MEDLINE | ID: covidwho-1495133

ABSTRACT

Cerebral venous sinus thrombosis (CVST) following novel coronavirus-2019 (nCoV-19) vaccination is a rare adverse effect. We report the first case of CVST associated with ChAdOx1 vaccination, with positive anti-platelet factor 4 (PF4) antibodies, from India. A 44-year-old woman developed a thunderclap headache 4 days after the first dose of the adenoviral vector vaccine ChAdOx1 (Covishield). Physical examination was unremarkable barring mild neck stiffness with no focal neurological deficits. MRI identified right transverse sinus thrombosis. Laboratory tests revealed raised D-dimer and thrombocytopenia; anti-PF4 antibodies were subsequently identified, consistent with thrombosis with thrombocytopenia syndrome (TTS). She was treated with non-heparin anticoagulation and intravenous immunoglobulin and made an uneventful recovery. Early recognition of adenoviral vector vaccine-related TTS, which resembles heparin-induced thrombocytopenia syndrome, is important as heparin and heparin analogues are best avoided in the treatment.


Subject(s)
COVID-19 Vaccines/adverse effects , Sinus Thrombosis, Intracranial , Thrombocytopenia , Thrombosis , Adult , COVID-19 , Female , Humans , Sinus Thrombosis, Intracranial/chemically induced , Thrombocytopenia/chemically induced , Thrombosis/chemically induced , Vaccination/adverse effects
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