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1.
Drug Saf ; 45(5): 535-548, 2022 05.
Article in English | MEDLINE | ID: covidwho-1872799

ABSTRACT

INTRODUCTION: Adverse drug reaction reports are usually manually assessed by pharmacovigilance experts to detect safety signals associated with drugs. With the recent extension of reporting to patients and the emergence of mass media-related sanitary crises, adverse drug reaction reports currently frequently overwhelm pharmacovigilance networks. Artificial intelligence could help support the work of pharmacovigilance experts during such crises, by automatically coding reports, allowing them to prioritise or accelerate their manual assessment. After a previous study showing first results, we developed and compared state-of-the-art machine learning models using a larger nationwide dataset, aiming to automatically pre-code patients' adverse drug reaction reports. OBJECTIVES: We aimed to determine the best artificial intelligence model identifying adverse drug reactions and assessing seriousness in patients reports from the French national pharmacovigilance web portal. METHODS: Reports coded by 27 Pharmacovigilance Centres between March 2017 and December 2020 were selected (n = 11,633). For each report, the Portable Document Format form containing free-text information filled by the patient, and the corresponding encodings of adverse event symptoms (in Medical Dictionary for Regulatory Activities Preferred Terms) and seriousness were obtained. This encoding by experts was used as the reference to train and evaluate models, which contained input data processing and machine-learning natural language processing to learn and predict encodings. We developed and compared different approaches for data processing and classifiers. Performance was evaluated using receiver operating characteristic area under the curve (AUC), F-measure, sensitivity, specificity and positive predictive value. We used data from 26 Pharmacovigilance Centres for training and internal validation. External validation was performed using data from the remaining Pharmacovigilance Centres during the same period. RESULTS: Internal validation: for adverse drug reaction identification, Term Frequency-Inverse Document Frequency (TF-IDF) + Light Gradient Boosted Machine (LGBM) achieved an AUC of 0.97 and an F-measure of 0.80. The Cross-lingual Language Model (XLM) [transformer] obtained an AUC of 0.97 and an F-measure of 0.78. For seriousness assessment, FastText + LGBM achieved an AUC of 0.85 and an F-measure of 0.63. CamemBERT (transformer) + Light Gradient Boosted Machine obtained an AUC of 0.84 and an F-measure of 0.63. External validation for both adverse drug reaction identification and seriousness assessment tasks yielded consistent and robust results. CONCLUSIONS: Our artificial intelligence models showed promising performance to automatically code patient adverse drug reaction reports, with very similar results across approaches. Our system has been deployed by national health authorities in France since January 2021 to facilitate pharmacovigilance of COVID-19 vaccines. Further studies will be needed to validate the performance of the tool in real-life settings.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adverse Drug Reaction Reporting Systems , Artificial Intelligence , COVID-19 Vaccines , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Pharmacovigilance
2.
Retina ; 41(12): 2462-2471, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1607338

ABSTRACT

PURPOSE: To describe uveitis cases after the BNT162b2 mRNA SARS-CoV-2 vaccination. METHODS: This is a multicenter, retrospective study. Vaccine-related uveitis diagnosis was supported by the classification of the World Health Organization Adverse Drug Terminology and the Naranjo criteria. RESULTS: Twenty-one patients (23 eyes) with a mean age of 51.3 years (23-78 years) were included. Eight of the 21 patients had a known history of uveitis. The median time from previous to current attack was 1 year (0.5-15 years). There were 21 anterior uveitis cases, two with bilateral inflammation. Eight cases occurred after the first vaccination and 13 after the second vaccination. All but three presented as mild to moderate disease. Two patients developed multiple evanescent white dot syndrome after the second vaccination. The mean time from vaccination to uveitis onset was 7.5 ± 7.3 days (1-30 days). At final follow-up, complete resolution was achieved in all but two eyes, which showed significant improvement. One case of severe anterior uveitis developed vitritis and macular edema after the second vaccination, which completely resolved after an intravitreal dexamethasone injection. CONCLUSION: Uveitis may develop after the administration of the BNT162b2 mRNA vaccine. The most common complication was mild to moderate anterior uveitis, while multiple evanescent white dot syndrome can also occur less frequently.


Subject(s)
/adverse effects , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/etiology , SARS-CoV-2 , Uveitis, Anterior/chemically induced , Vaccination/adverse effects , Adult , Aged , Drug-Related Side Effects and Adverse Reactions/diagnosis , Female , Humans , Male , Middle Aged , Retrospective Studies , Uveitis, Anterior/diagnosis , Young Adult
3.
JAMA Netw Open ; 4(9): e2125524, 2021 09 01.
Article in English | MEDLINE | ID: covidwho-1414844

ABSTRACT

Importance: As of May 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths. Anaphylactic reactions associated with the Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines have been reported. Objective: To characterize the immunologic mechanisms underlying allergic reactions to these vaccines. Design, Setting, and Participants: This case series included 22 patients with suspected allergic reactions to mRNA COVID-19 vaccines between December 18, 2020, and January 27, 2021, at a large regional health care network. Participants were individuals who received at least 1 of the following International Statistical Classification of Diseases and Related Health Problems, Tenth Revision anaphylaxis codes: T78.2XXA, T80.52XA, T78.2XXD, or E949.9, with documentation of COVID-19 vaccination. Suspected allergy cases were identified and invited for follow-up allergy testing. Exposures: FDA-authorized mRNA COVID-19 vaccines. Main Outcomes and Measures: Allergic reactions were graded using standard definitions, including Brighton criteria. Skin prick testing was conducted to polyethylene glycol (PEG) and polysorbate 80 (P80). Histamine (1 mg/mL) and filtered saline (negative control) were used for internal validation. Basophil activation testing after stimulation for 30 minutes at 37 °C was also conducted. Concentrations of immunoglobulin (Ig) G and IgE antibodies to PEG were obtained to determine possible mechanisms. Results: Of 22 patients (20 [91%] women; mean [SD] age, 40.9 [10.3] years; 15 [68%] with clinical allergy history), 17 (77%) met Brighton anaphylaxis criteria. All reactions fully resolved. Of patients who underwent skin prick tests, 0 of 11 tested positive to PEG, 0 of 11 tested positive to P80, and 1 of 10 (10%) tested positive to the same brand of mRNA vaccine used to vaccinate that individual. Among these same participants, 10 of 11 (91%) had positive basophil activation test results to PEG and 11 of 11 (100%) had positive basophil activation test results to their administered mRNA vaccine. No PEG IgE was detected; instead, PEG IgG was found in tested individuals who had an allergy to the vaccine. Conclusions and Relevance: Based on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy. Immunological testing suggests non-IgE-mediated immune responses to PEG may be responsible in most individuals.


Subject(s)
COVID-19 Vaccines/adverse effects , Hypersensitivity/diagnosis , Adolescent , Adult , Aged , COVID-19 Vaccines/therapeutic use , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Hypersensitivity/epidemiology , Male , Middle Aged , Risk Factors , United States/epidemiology , United States Food and Drug Administration/organization & administration , United States Food and Drug Administration/statistics & numerical data , Vaccination/adverse effects
5.
Expert Opin Drug Saf ; 20(12): 1559-1564, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1334105

ABSTRACT

Background: Remdesivir has been used for treating patients with moderate to severe coronavirus disease 2019 (COVID-19) although there is conflicting evidence regarding its usefulness. Data regarding its safety largely come from the clinical trials conducted to support its emergency use authorization (EUA). This study aimed to identify the adverse events of remdesivir with disproportionately high reporting using real-world data.Research design and methods: The adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) by health-care professionals for drugs that have received EUA or approved for the treatment of COVID-19 in the US were studied. Adisproportionality analysis was performed to determine adverse events more frequently reported with remdesivir compared with other COVID-19 drugs in the database.Results: Elevated liver enzymes, acute kidney injury, raised blood creatinine levels, bradycardia, cardiac arrest, and death had disproportionately higher reporting with remdesivir as asuspect drug compared with other drugs. There is no significant difference in the reporting of these events based on patient sex or age.Conclusions: Our study confirms the drug label information regarding liver enzyme elevation. The renal and cardiac safety signals identified necessitate reevaluation for potential drug-labeling changes.


Subject(s)
Acute Kidney Injury , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Bradycardia , COVID-19 , Drug-Related Side Effects and Adverse Reactions , Liver Function Tests , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Adenosine Monophosphate/administration & dosage , Adenosine Monophosphate/adverse effects , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Alanine/administration & dosage , Alanine/adverse effects , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Bradycardia/chemically induced , Bradycardia/diagnosis , COVID-19/complications , COVID-19/drug therapy , COVID-19/epidemiology , Drug Approval/methods , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Liver Function Tests/methods , Liver Function Tests/statistics & numerical data , Male , Middle Aged , SARS-CoV-2 , United States/epidemiology , United States Food and Drug Administration/statistics & numerical data
6.
BMJ ; 374: n1647, 2021 07 21.
Article in English | MEDLINE | ID: covidwho-1320441

ABSTRACT

OBJECTIVE: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations. DESIGN: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. SETTING: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. PARTICIPANTS: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years. INTERVENTION: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. MAIN OUTCOME MEASURES: The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ). RESULTS: For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group. CONCLUSIONS: Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic. TRIAL REGISTRATION: Clinicaltrials.gov NCT02356081.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Cell Phone , Drug-Related Side Effects and Adverse Reactions/diagnosis , Quality of Life , Telemedicine/methods , Adult , Aged , Austria , Breast Neoplasms/psychology , Breast Neoplasms/therapy , Chemotherapy, Adjuvant/adverse effects , Colorectal Neoplasms/psychology , Colorectal Neoplasms/therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/psychology , Female , Greece , Hodgkin Disease/psychology , Hodgkin Disease/therapy , Humans , Ireland , Lymphoma, Non-Hodgkin/psychology , Lymphoma, Non-Hodgkin/therapy , Male , Middle Aged , Norway , Telemedicine/instrumentation , Treatment Outcome , United Kingdom
7.
J Immunother Cancer ; 9(7)2021 07.
Article in English | MEDLINE | ID: covidwho-1318086

ABSTRACT

Expanding the US Food and Drug Administration-approved indications for immune checkpoint inhibitors in patients with cancer has resulted in therapeutic success and immune-related adverse events (irAEs). Neurologic irAEs (irAE-Ns) have an incidence of 1%-12% and a high fatality rate relative to other irAEs. Lack of standardized disease definitions and accurate phenotyping leads to syndrome misclassification and impedes development of evidence-based treatments and translational research. The objective of this study was to develop consensus guidance for an approach to irAE-Ns including disease definitions and severity grading. A working group of four neurologists drafted irAE-N consensus guidance and definitions, which were reviewed by the multidisciplinary Neuro irAE Disease Definition Panel including oncologists and irAE experts. A modified Delphi consensus process was used, with two rounds of anonymous ratings by panelists and two meetings to discuss areas of controversy. Panelists rated content for usability, appropriateness and accuracy on 9-point scales in electronic surveys and provided free text comments. Aggregated survey responses were incorporated into revised definitions. Consensus was based on numeric ratings using the RAND/University of California Los Angeles (UCLA) Appropriateness Method with prespecified definitions. 27 panelists from 15 academic medical centers voted on a total of 53 rating scales (6 general guidance, 24 central and 18 peripheral nervous system disease definition components, 3 severity criteria and 2 clinical trial adjudication statements); of these, 77% (41/53) received first round consensus. After revisions, all items received second round consensus. Consensus definitions were achieved for seven core disorders: irMeningitis, irEncephalitis, irDemyelinating disease, irVasculitis, irNeuropathy, irNeuromuscular junction disorders and irMyopathy. For each disorder, six descriptors of diagnostic components are used: disease subtype, diagnostic certainty, severity, autoantibody association, exacerbation of pre-existing disease or de novo presentation, and presence or absence of concurrent irAE(s). These disease definitions standardize irAE-N classification. Diagnostic certainty is not always directly linked to certainty to treat as an irAE-N (ie, one might treat events in the probable or possible category). Given consensus on accuracy and usability from a representative panel group, we anticipate that the definitions will be used broadly across clinical and research settings.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/diagnosis , Immune Checkpoint Inhibitors/adverse effects , Immunotherapy/adverse effects , Nervous System Diseases/diagnosis , Practice Guidelines as Topic , Consensus , Humans , Nervous System Diseases/chemically induced , Nervous System Diseases/immunology , Neurologists/statistics & numerical data , Oncologists/statistics & numerical data , Patient Care Team/organization & administration , Patient Care Team/statistics & numerical data
8.
Eur Rev Med Pharmacol Sci ; 25(12): 4418-4421, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1296353

ABSTRACT

OBJECTIVE: Side effects of vaccines are common, but people react differently to different vaccines. Manufacturers provide lists of the side effects of their products. Adverse reactions are proof of the effectiveness of vaccines and that the immune system is responding. In this study, we compare the side effects of the AstraZeneca and Pfizer vaccines. Our survey results show that the side effects of the first dose of the AstraZeneca vaccine are more common than after the first and second doses of the Pfizer vaccine. Most respondents in our survey reported at least one side-effect after the AstraZeneca and Pfizer vaccine, but these reactions were less common after the Pfizer preparation. PATIENTS AND METHODS: A survey was distributed via the internet. It was conducted among people vaccinated with Pfizer or AstraZeneca. The respondents were asked about the side effects after the first and second doses of the vaccines, such as injection site pain, arm pain, muscle pain, headache, fever, chills, and fatigue. RESULTS: The questionnaire was completed by 705 people. 196 of them had been vaccinated with Pfizer and 509 with AstraZeneca. Among those vaccinated with the first dose of the AstraZeneca vaccine, 96.5% reported at least one post-vaccination reaction. 17.1% of respondents reported all the side effects listed in the survey. Among those vaccinated with the first Pfizer dose, vaccine reactions were reported by 93.9% of respondents; 2% of respondents experienced all the side effects mentioned in the survey. The second dose of the Pfizer vaccine caused post-vaccinal reactions in most of the subjects: 54.8% of respondents had more adverse reactions, and 15.8% had fewer adverse reactions than after the first dose of this vaccine; 29.4% experienced the same side effects after the first and second doses of the Pfizer vaccine. CONCLUSIONS: Side effects as a result of vaccination are not rare and are proof that the immune system is responding. However, severe adverse reactions to vaccines can be dangerous, and they engender fear. Concerns about the side effects and complications of COVID-19 vaccines may eclipse opinions regarding their benefits. This study shows that the first dose of the AstraZeneca vaccine causes side effects more often than either dose of the Pfizer vaccine.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/epidemiology , Surveys and Questionnaires , Vaccination/adverse effects , Adult , Aged , Aged, 80 and over , COVID-19 Vaccines/administration & dosage , Drug-Related Side Effects and Adverse Reactions/diagnosis , Female , Humans , Male , Middle Aged , Poland/epidemiology , Young Adult
9.
S Afr Fam Pract (2004) ; 63(1): e1-e3, 2021 06 28.
Article in English | MEDLINE | ID: covidwho-1296012

ABSTRACT

The use of hand sanitisers is common practice to prevent the spread of coronavirus disease 2019 (COVID-19). However, the safety thereof requires consideration as this may be hazardous in children. Recent studies have shown that the misuse and increased unsupervised availability of alcohol-based hand sanitisers may result in adverse events in children such as skin irritation, dryness, cracking and peeling. Unintentional or intentional ingestion of hand sanitisers in children under the age of 12 years may occur because of the colour, smell and flavour added to it. Consumption of alcohol in children may result in hypoglycaemia, apnoea and acidosis. This allows the invasion of other bacterial and viral infections. Children may also rub their eyes with sanitised hands and cause ocular injury. Therefore, the use of hand sanitisers in general needs to be revised in both children and adults. Other interventions on lowering the risk of adverse events because of misuse of hand sanitiser should be practised more often. These include promoting washing of hands over sanitisers where possible, training children on how to use hand sanitisers and creating awareness of the dangers if ingested or in contact with the eyes.


Subject(s)
COVID-19 , Disease Transmission, Infectious/prevention & control , Drug-Related Side Effects and Adverse Reactions , Hand Sanitizers , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/transmission , Child , Child Health , Communicable Disease Control/methods , Drug Misuse/adverse effects , Drug Misuse/prevention & control , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Eye Diseases/chemically induced , Eye Diseases/prevention & control , Hand Disinfection/methods , Hand Sanitizers/pharmacology , Hand Sanitizers/toxicity , Humans , Risk Adjustment/methods , SARS-CoV-2/drug effects , Skin Diseases/chemically induced , Skin Diseases/prevention & control
11.
Expert Rev Vaccines ; 20(8): 1037-1042, 2021 08.
Article in English | MEDLINE | ID: covidwho-1258700

ABSTRACT

Objectives: Several cases of unusual thrombotic events with thrombocytopenia were reported in several countries, in association with AstraZeneca's COVID-19 vaccine. The European medicines agency conducted a detailed review and concluded that there was no evidence to suggest an association of thrombotic events with the use of COVID-19 vaccine AstraZeneca.Methods: King Abdulaziz Medical City is a 1500 bed tertiary care hospital in Riyadh, Saudi Arabia; this study describes spontaneously reported vaccine adverse effects received through the hospital's internal electronic safety reporting system from December 2020 to 13 April 2021.We assessed each report for causality association utilizing the world health organization's (WHO) causality assessment of an adverse event following immunization (AEFI) classification 2nd Edition 2019.Results: The majority of the reported events were mild to moderate, there were five serious events, one reported cardiac arrest, two cerebral venous sinus thrombosis, and two pulmonary embolism. Clinical and laboratory summary of the five patients are presented in detail.Conclusions: Efforts of pharmacovigilance in mediating the rare risk of thrombosis associated with COVID-19 vaccine are crucial in providing awareness on the possible risk factors and signs/symptoms that should raise red flags.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Pulmonary Embolism/chemically induced , Sinus Thrombosis, Intracranial/chemically induced , Tertiary Care Centers , Vaccination/adverse effects , Adult , COVID-19/epidemiology , COVID-19 Vaccines/administration & dosage , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Fatal Outcome , Female , Humans , Male , Middle Aged , Pulmonary Embolism/diagnosis , Saudi Arabia/epidemiology , Sinus Thrombosis, Intracranial/diagnosis , Young Adult
12.
Dermatol Clin ; 39(4): 653-673, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1252657

ABSTRACT

In 2021, we entered a new phase of the COVID-19 pandemic. As mass vaccinations are underway and more vaccines are approved, it is important to recognize cutaneous adverse events. We review the dermatologic manifestations of COVID-19 vaccines as reported in clinical trial data and summarize additional observational reports of skin reactions to COVID-19 vaccines. Early-onset local injection reactions were the most common cutaneous side effects observed in clinical trials; delayed injection reactions were the most common cutaneous side effect reported outside of clinical trials. Understanding the landscape of cutaneous manifestations to COVID-19 vaccines is key to providing appropriate vaccine guidance.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , COVID-19 Vaccines/adverse effects , Drug Eruptions/etiology , Drug-Related Side Effects and Adverse Reactions/diagnosis , Registries , Administration, Cutaneous , Drug Eruptions/epidemiology , Humans
14.
Dermatitis ; 32(3): 133-139, 2021.
Article in English | MEDLINE | ID: covidwho-1183048

ABSTRACT

We are entering a new stage of the severe acute respiratory syndrome coronavirus 2 pandemic with the initiation of large-scale vaccination programs globally. In these circumstances, even rare adverse effects of vaccines may be encountered more often, if millions of people are to be vaccinated in a short period. Vaccination has the potential for causing cutaneous adverse effects. Thus, it is paramount that dermatologists worldwide are acquainted with the possible skin reaction patterns to the coming vaccines. Herein, we conduct a review to discuss the most frequent cutaneous adverse effects of vaccines and their management, with a particular focus on the expected adverse reactions for the coming severe acute respiratory syndrome coronavirus 2 vaccines, such as local reactions, as well as immediate- and delayed-type hypersensitivity reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrosis, serum sickness-like reactions, and vasculitides. We also discuss the yet unanswered questions on vaccines for which we may soon be asked to provide an expert opinion.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Drug Eruptions/etiology , Drug-Related Side Effects and Adverse Reactions/diagnosis , Administration, Cutaneous , Adverse Drug Reaction Reporting Systems/standards , Humans
15.
Emerg Infect Dis ; 27(4): 1220-1222, 2021 04.
Article in English | MEDLINE | ID: covidwho-1145543

ABSTRACT

Coronavirus disease (COVID-19) symptoms can be mistaken for vaccine-related side effects during initial days after immunization. Among 4,081 vaccinated healthcare workers in Israel, 22 (0.54%) developed COVID-19 from 1-10 days (median 3.5 days) after immunization. Clinicians should not dismiss postvaccination symptoms as vaccine-related and should promptly test for COVID-19.


Subject(s)
COVID-19 Serological Testing , COVID-19 Vaccines/adverse effects , COVID-19 , Health Personnel/statistics & numerical data , Vaccination , Adult , Adverse Outcome Pathways , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Serological Testing/methods , COVID-19 Serological Testing/statistics & numerical data , COVID-19 Vaccines/administration & dosage , Diagnosis, Differential , Drug-Related Side Effects and Adverse Reactions/diagnosis , Female , Humans , Israel/epidemiology , Male , SARS-CoV-2/isolation & purification , Vaccination/adverse effects , Vaccination/methods , Vaccination/statistics & numerical data
16.
Int Forum Allergy Rhinol ; 11(7): 1041-1046, 2021 07.
Article in English | MEDLINE | ID: covidwho-1136915

ABSTRACT

The frequent association between coronavirus disease 2019 (COVID-19) and olfactory dysfunction is creating an unprecedented demand for a treatment of the olfactory loss. Systemic corticosteroids have been considered as a therapeutic option. However, based on current literature, we call for caution using these treatments in early COVID-19-related olfactory dysfunction because: (1) evidence supporting their usefulness is weak; (2) the rate of spontaneous recovery of COVID-19-related olfactory dysfunction is high; and (3) corticosteroids have well-known potential adverse effects. We encourage randomized placebo-controlled trials investigating the efficacy of systemic steroids in this indication and strongly emphasize to initially consider smell training, which is supported by a robust evidence base and has no known side effects.


Subject(s)
Adrenal Cortex Hormones/pharmacology , COVID-19 , Medication Therapy Management/statistics & numerical data , Olfaction Disorders , COVID-19/complications , COVID-19/physiopathology , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/prevention & control , Global Health , Humans , Medication Therapy Management/standards , Needs Assessment , Olfaction Disorders/drug therapy , Olfaction Disorders/epidemiology , Olfaction Disorders/etiology , Olfactory Mucosa/drug effects , Olfactory Mucosa/virology , Remission, Spontaneous , Research Design , SARS-CoV-2/pathogenicity
17.
Drug Saf ; 44(1): 95-105, 2021 01.
Article in English | MEDLINE | ID: covidwho-1092875

ABSTRACT

INTRODUCTION: Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce. OBJECTIVE: This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment. METHODS: This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA®) Preferred Terms and subsequent clinical review were used to characterize COVID-19 cases. RESULTS: Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented. CONCLUSIONS: This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.


Subject(s)
Adverse Drug Reaction Reporting Systems/trends , COVID-19/epidemiology , Drug Industry/trends , Drug-Related Side Effects and Adverse Reactions/epidemiology , Global Health/trends , Pharmacovigilance , Adverse Drug Reaction Reporting Systems/standards , Anticoagulants/adverse effects , Antimalarials/adverse effects , Antiviral Agents/adverse effects , COVID-19/drug therapy , Databases, Factual/standards , Databases, Factual/trends , Drug Industry/standards , Drug-Related Side Effects and Adverse Reactions/diagnosis , Global Health/standards , Humans , Immunosuppressive Agents/adverse effects , Retrospective Studies
19.
Emerg Infect Dis ; 27(4): 1220-1222, 2021 04.
Article in English | MEDLINE | ID: covidwho-1058388

ABSTRACT

Coronavirus disease (COVID-19) symptoms can be mistaken for vaccine-related side effects during initial days after immunization. Among 4,081 vaccinated healthcare workers in Israel, 22 (0.54%) developed COVID-19 from 1-10 days (median 3.5 days) after immunization. Clinicians should not dismiss postvaccination symptoms as vaccine-related and should promptly test for COVID-19.


Subject(s)
COVID-19 Serological Testing , COVID-19 Vaccines/adverse effects , COVID-19 , Health Personnel/statistics & numerical data , Vaccination , Adult , Adverse Outcome Pathways , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Serological Testing/methods , COVID-19 Serological Testing/statistics & numerical data , COVID-19 Vaccines/administration & dosage , Diagnosis, Differential , Drug-Related Side Effects and Adverse Reactions/diagnosis , Female , Humans , Israel/epidemiology , Male , SARS-CoV-2/isolation & purification , Vaccination/adverse effects , Vaccination/methods , Vaccination/statistics & numerical data
20.
Trials ; 21(1): 1028, 2020 Dec 22.
Article in English | MEDLINE | ID: covidwho-992539

ABSTRACT

BACKGROUND: Randomised controlled trials (RCTs) provide valuable information and inform the development of harm profiles of new treatments. Harms are typically assessed through the collection of adverse events (AEs). Despite AEs being routine outcomes collected in trials, analysis and reporting of AEs in journal articles are continually shown to be suboptimal. One key challenge is the large volume of AEs, which can make evaluation and communication problematic. Prominent practice is to report frequency tables of AEs by arm. Visual displays offer an effective solution to assess and communicate complex information; however, they are rarely used and there is a lack of practical guidance on what and how to visually display complex AE data. METHODS: In this article, we demonstrate the use of two plots identified to be beneficial for wide use in RCTs, since both can display multiple AEs and are suitable to display point estimates for binary, count, or time-to-event AE data: the volcano and dot plots. We compare and contrast the use of data visualisations against traditional frequency table reporting, using published AE information in two placebo-controlled trials, of remdesivir for COVID-19 and GDNF for Parkinson disease. We introduce statistical programmes for implementation in Stata. RESULTS/CASE STUDY: Visualisations of AEs in the COVID-19 trial communicated a risk profile for remdesivir which differed from the main message in the published authors' conclusion. In the Parkinson's disease trial of GDNF, the visualisation provided immediate communication of harm signals, which had otherwise been contained within lengthy descriptive text and tables. Asymmetry in the volcano plot helped flag extreme events that were less obvious from review of the frequency table and dot plot. The dot plot allowed a more comprehensive representation by means of a more detailed summary. CONCLUSIONS: Visualisations can better support investigators to assimilate large volumes of data and enable improved informal between-arm comparisons compared to tables. We endorse increased uptake for use in trial publications. Care in construction of visual displays needs to be taken as there can be potential to overemphasise treatment effects in some circumstances.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , COVID-19/drug therapy , Data Display , Data Visualization , Drug-Related Side Effects and Adverse Reactions/diagnosis , Glial Cell Line-Derived Neurotrophic Factor/adverse effects , Parkinson Disease/drug therapy , Research Design/standards , Adenosine Monophosphate/adverse effects , Alanine/adverse effects , Antiparkinson Agents/adverse effects , Antiviral Agents/adverse effects , Computer Graphics , Data Accuracy , Data Analysis , Drug Monitoring/methods , Humans , Randomized Controlled Trials as Topic
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