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1.
Pharmacol Res Perspect ; 10(2): e00931, 2022 04.
Article in English | MEDLINE | ID: covidwho-1782680

ABSTRACT

The aim of this study was to estimate healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions in Finland from 2008 to 2019. Serious adverse reaction types were identified from the Finnish Pharmaceutical Insurance Pool's pharmaceutical injury claims and the Finnish Medicines Agency's Adverse Reaction Register. A decision tree model was built to predict costs and mortality associated with serious adverse drug reactions (ADR). Severe clostridioides difficile infections, severe cutaneous adverse reactions, tendon ruptures, aortic ruptures, and liver injuries were included as serious adverse drug reactions in the model. Direct healthcare costs of a serious ADR were based on the number of reimbursed fluoroquinolone prescriptions from the Social Insurance Institution of Finland's database. Sensitivity analyses were conducted to address parameter uncertainty. A total of 1 831 537 fluoroquinolone prescriptions were filled between 2008 and 2019 in Finland, with prescription numbers declining 40% in recent years. Serious ADRs associated with fluoroquinolones lead to estimated direct healthcare costs of 501 938 402 €, including 11 405 ADRs and 3,884 deaths between 2008 and 2019. The average mortality risk associated with the use of fluoroquinolones was 0.21%. Severe clostridioides difficile infections were the most frequent, fatal, and costly serious ADRs associated with the use of fluoroquinolones. Although fluoroquinolones continue to be generally well-tolerated antimicrobials, serious adverse reactions cause long-term impairment to patients and high healthcare costs. Therefore, the risks and benefits should be weighed carefully in antibiotic prescription policies, as well as with individual patients.


Subject(s)
Anti-Bacterial Agents/adverse effects , Fluoroquinolones/adverse effects , Health Care Costs/statistics & numerical data , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Anti-Bacterial Agents/economics , Databases, Factual/statistics & numerical data , Decision Trees , Drug-Related Side Effects and Adverse Reactions/economics , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/mortality , Finland , Fluoroquinolones/economics , Humans , Retrospective Studies
2.
Int J Environ Res Public Health ; 19(6)2022 03 10.
Article in English | MEDLINE | ID: covidwho-1765706

ABSTRACT

BACKGROUND: Monitoring of adverse drug reactions (ADRs) to antimicrobials is important, as they can cause life-threatening illness, permanent disabilities, and death. We assessed country-wide ADR reporting on antimicrobials and their outcomes. METHODS: A cross-sectional study was conducted using individual case safety reports (ICSRs) entered into the national pharmacovigilance database (VigiFlow) during 2017-2021. RESULTS: Of 566 ICSRs, inconsistent reporting was seen, with the highest reporting in 2017 and 2019 (mass drug campaigns for deworming), zero reporting in 2018 (reasons unknown), and only a handful in 2020 and 2021 (since COVID-19). Of 566 ICSRs, 90% were for antiparasitics (actively reported during mass campaigns), while the rest (passive reporting from health facilities) included 8% antibiotics, 7% antivirals, and 0.2% antifungals. In total, 90% of the reports took >30 days to be entered (median = 165; range 2-420 days), while 44% had <75% of all variables filled in (desired target = 100%). There were 10 serious ADRs, 18 drug withdrawals, and 60% of ADRs affected the gastrointestinal system. The patient outcomes (N-566) were: recovered (59.5%), recovering (35.5%), not recovered (1.4%), death (0.2%), and unknown (3.4%). There was no final ascertainment of 'recovering' outcomes. CONCLUSIONS: ADR reporting is inconsistent, with delays and incomplete data. This is a wake-up call for introducing active reporting and setting performance targets.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adverse Drug Reaction Reporting Systems , COVID-19/drug therapy , COVID-19/epidemiology , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Sierra Leone
3.
MMWR Morb Mortal Wkly Rep ; 71(3): 90-95, 2022 Jan 21.
Article in English | MEDLINE | ID: covidwho-1636128

ABSTRACT

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.


Subject(s)
/adverse effects , Advisory Committees , COVID-19 Vaccines/therapeutic use , Thrombocytopenia/chemically induced , Vaccination/standards , Adult , Adverse Drug Reaction Reporting Systems , Aged , COVID-19/prevention & control , Centers for Disease Control and Prevention, U.S. , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Middle Aged , Risk Assessment , SARS-CoV-2/immunology , United States/epidemiology
4.
Int J Immunopathol Pharmacol ; 35: 20587384211065628, 2021.
Article in English | MEDLINE | ID: covidwho-1574616

ABSTRACT

OBJECTIVES: Vaccination rollout against COVID-19 has started in developed countries in early December 2020. Mass immunization for poor or low-income countries is quite challenging before 2023. Being a lower-middle-income country, Bangladesh has begun a nationwide COVID-19 vaccination drive in early February 2021. Here, we aimed to assess the opinions, experiences, and adverse events of the COVID-19 vaccination in Bangladesh. METHODS: We conducted this online cross-sectional study from 10 February 2021, to 10 March 2021, in Bangladesh. A self-reported semi-structured survey questionnaire was used using Google forms. We recorded demographics, disease history, medication records, opinions and experiences of vaccination, and associated adverse events symptoms. RESULTS: We observed leading comorbid diseases were hypertension (25.9%), diabetes (21.1%), heart diseases (9.3%), and asthma (8.7%). The most frequently reported adverse events were injection site pain (34.3%), fever (32.6%), headache (20.2%), fatigue (16.6%), and cold feeling (15.4%). The chances of having adverse events were significantly higher in males than females (p = 0.039). However, 36.4% of respondents reported no adverse events. Adverse events usually appeared after 12 h and went way within 48 h of vaccination. Besides, 85.5% were happy with the overall vaccination management, while 88.0% of the respondents recommended the COVID-19 vaccine for others for early immunization. CONCLUSION: According to the present findings, reported adverse events after the doses of Covishield in Bangladesh were non-serious and temporary. In Bangladesh, the early vaccination against COVID-19 was possible due to its prudent vaccine deal, previous mass vaccination experience, and vaccine diplomacy.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Mass Vaccination , Adult , Bangladesh/epidemiology , COVID-19/epidemiology , COVID-19/immunology , COVID-19 Vaccines/adverse effects , Comorbidity , Cross-Sectional Studies , Developing Countries , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Mass Vaccination/adverse effects , Middle Aged , Patient Satisfaction , Program Evaluation , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Young Adult
5.
Drug Saf ; 44(12): 1375-1390, 2021 12.
Article in English | MEDLINE | ID: covidwho-1544606

ABSTRACT

INTRODUCTION: Seasonal influenza infects millions annually in Europe. Annual influenza vaccination is the most effective measure to reduce the risk of infection and its complications, especially among young children and older adults. OBJECTIVE: We assessed adverse event (AE) frequency after receiving GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4). METHODS: A passive enhanced safety surveillance study was conducted in Belgium, Germany, and Spain. Adults who had received GSK's IIV4 or the parent(s)/guardian(s)/legally acceptable representative(s) of children given the vaccine were invited to complete an adverse drug reaction (ADR) card to document AEs experienced within 7 days post vaccination. RESULTS: A total of 1082 participants (51.6% females) received GSK's IIV4, including 115 children < 9 years of age who received two doses. The ADR card return rate was 97.0% (n = 1049) after dose 1 and 100% (n = 115) after dose 2. All participants in Belgium and Germany were adults. In Spain, 71.2% were children. After dose 1, 39.2% reported one or more AE. The most frequent AEs category was "general disorders and administration site conditions" (GDASC). AEs were most frequently reported in adults aged 18-65 years (47.2%), followed by children aged 6 months-17 years (38.1%), and adults aged > 65 years (31.6%). After dose 2, 7.8% reported one or more AE, and GDASC was again the most frequent AE category. There were no serious AEs related to GSK's IIV4 within 7 days post vaccination. CONCLUSION: No serious AEs related to GSK's IIV4 within 7 days post vaccination were reported. This study supports the favourable risk-benefit safety profile of GSK's IIV4.


Seasonal influenza infects millions annually in Europe, especially young children and older adults. Annual influenza vaccination is the most effective measure to reduce the risk of infection and its complications. As the wild influenza virus strains change every year, the composition of the influenza vaccine changes as well. Since the vaccine is produced in the same way over the years, extensive safety studies are no longer required by regulatory authorities. Instead, monitoring of any unwanted medical incidents (adverse events) after vaccination is required. For the 2019/2020 season, we monitored the adverse events reported by a representative sample of people in Belgium, Germany, and Spain within 7 days after receiving GSK's seasonal influenza vaccine.Of the 1082 people who received the first dose of the vaccine, 39% reported at least one adverse event, such as pain and swelling at the injection site, tiredness, fever, headache, or dizziness. A total of 115 children under 9 years of age received two doses 4 weeks apart. After their second dose, few of these children (8%) reported adverse events. The most frequent adverse events were fever, swelling and pain at the injection site, runny nose, or irritability. No serious adverse events were reported after either the first or second dose.No serious adverse events related to GSK's seasonal influenza vaccine within the 7 days after vaccination were reported. This study supports the favourable risk­benefit safety profile of GSK's seasonal influenza vaccine.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Influenza Vaccines , Influenza, Human , Aged , Belgium/epidemiology , Child , Child, Preschool , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Germany/epidemiology , Humans , Influenza Vaccines/adverse effects , Influenza, Human/prevention & control , Male , Seasons , Spain/epidemiology , Vaccines, Inactivated/adverse effects
6.
Pharmacol Rep ; 74(1): 229-240, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1536392

ABSTRACT

BACKGROUND AND OBJECTIVES: Corticosteroids are commonly used in the treatment of hospitalized patients with COVID-19. The goals of the present study were to compare the efficacy and safety of different doses of dexamethasone in the treatment of patients with a diagnosis of moderate to severe COVID-19. METHODS: Hospitalized patients with a diagnosis of moderate to severe COVID-19 were assigned to intravenous low-dose (8 mg once daily), intermediate-dose (8 mg twice daily) or high-dose (8 mg thrice daily) dexamethasone for up to 10 days or until hospital discharge. Clinical response, 60-day survival and adverse effects were the main outcomes of the study. RESULTS: In the competing risk survival analysis, patients in the low-dose group had a higher clinical response than the high-dose group when considering death as a competing risk (HR = 2.03, 95% CI: 1.23-3.33, p = 0.03). Also, the survival was significantly longer in the low-dose group than the high-dose group (HR = 0.36, 95% CI = 0.15-0.83, p = 0.02). Leukocytosis and hyperglycemia were the most common side effects of dexamethasone. Although the incidence was not significantly different between the groups, some adverse effects were numerically higher in the intermediate-dose and high-dose groups than in the low-dose group. CONCLUSIONS: Higher doses of dexamethasone not only failed to improve efficacy but also resulted in an increase in the number of adverse events and worsen survival in hospitalized patients with moderate to severe COVID-19 compared to the low-dose dexamethasone. (IRCT20100228003449N31).


Subject(s)
Anti-Inflammatory Agents/administration & dosage , Anti-Inflammatory Agents/therapeutic use , COVID-19/drug therapy , Dexamethasone/administration & dosage , Dexamethasone/therapeutic use , Adult , Aged , Anti-Inflammatory Agents/adverse effects , Dexamethasone/adverse effects , Dose-Response Relationship, Drug , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Hyperglycemia/chemically induced , Incidence , Leukocytosis/chemically induced , Male , Middle Aged , Survival Analysis , Treatment Outcome
7.
PLoS One ; 16(11): e0260656, 2021.
Article in English | MEDLINE | ID: covidwho-1533423

ABSTRACT

Therapeutic drug monitoring (TDM) is essential for voriconazole to ensure optimal drug exposure, mainly in critically ill patients for whom voriconazole demonstrated a large variability. The study aimed at describing factors associated with trough voriconazole concentrations in critically ill patients and evaluating the impact of voriconazole concentrations on adverse effects. A 2-year retrospective multicenter cohort study (NCT04502771) was conducted in six intensive care units. Adult patients who had at least one voriconazole TDM were included. Univariable and multivariable linear regression analyses were performed to identify predictors of voriconazole concentrations, and univariable logistic regression analysis, to study the relationship between voriconazole concentrations and adverse effects. During the 2-year study period, 70 patients were included. Optimal trough voriconazole concentrations were reported in 37 patients (52.8%), subtherapeutic in 20 (28.6%), and supratherapeutic in 13 (18.6%). Adverse effects were reported in six (8.6%) patients. SOFA score was identified as a factor associated with an increase in voriconazole concentration (p = 0.025), mainly in the group of patients who had SOFA score ≥ 10. Moreover, an increase in voriconazole concentration was shown to be a risk factor for occurrence of adverse effects (p = 0.011). In that respect, critically ill patients who received voriconazole treatment must benefit from a TDM, particularly if they have a SOFA score ≥ 10. Indeed, identifying patients who are overdosed will help to prevent voriconazole related adverse effects. This result is of utmost importance given the recognized COVID-19-associated pulmonary aspergillosis in ICU patients for whom voriconazole is among the recommended first-line treatment.


Subject(s)
Antifungal Agents/administration & dosage , Critical Illness/therapy , Drug Monitoring/methods , Drug-Related Side Effects and Adverse Reactions/epidemiology , Intensive Care Units/statistics & numerical data , Voriconazole/administration & dosage , Antifungal Agents/adverse effects , Female , France/epidemiology , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Voriconazole/adverse effects
8.
BMC Pharmacol Toxicol ; 22(1): 58, 2021 10 12.
Article in English | MEDLINE | ID: covidwho-1468104

ABSTRACT

INTRODUCTION: Coronavirus Disease (COVID-19) caused by Novel Coronavirus named as Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) was declared Pandemic by The World Health Organization (WHO) and a Public Health Emergency of International Concern (PHEIC) on January 30, 2020. Many COVID-19 vaccines have been developed, including CoronaVac vaccines by Sinovac. Health care workers, along with medical clerkship students are the priority to receive the vaccine. However, the Adverse Events Following Immunization (AEFI) of the CoronaVac remains unclear. This study aims to describe and analyze the adverse events following immunization (AEFI) of COVID-19 vaccination in medical students in clerkship programs. METHOD: We conducted a cross-sectional study using a questionnaire to assess AEFI after CoronaVac vaccination among medical clerkship students. A Chi-Square test with 95 % of CI was used to determine whether gender correlated with symptoms of AEFI. RESULT: We identified 144 medical clerkship students. The most common AEFI of SARS-CoV-2 vaccinations was localized pain in the injection site during the first dose with 25 (45 %) reports and the booster dose with 34 (67 %) reports. Then followed by malaise, the first dose with 20 (36 %) reports and the booster dose with 21 (41 %) reports. Other symptoms like headache, fever, shivering, sleepiness, nausea, dysphagia, and cold were also reported. CONCLUSIONS: CoronaVac SARS-COV-2 vaccine has several mild symptoms of AEFI and not correlated with gender. Nevertheless, follow-up after vaccination is needed to prevent immunologic responses that may occur in some patients.


Subject(s)
COVID-19 Vaccines/adverse effects , Adult , Adverse Drug Reaction Reporting Systems , Apathy , Clinical Clerkship , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Immunization, Secondary/adverse effects , Indonesia , Injections/adverse effects , Male , Pain/etiology , Sex Factors , Students, Medical , Surveys and Questionnaires , Vaccination/adverse effects , Young Adult
9.
MMWR Morb Mortal Wkly Rep ; 70(39): 1379-1384, 2021 Oct 01.
Article in English | MEDLINE | ID: covidwho-1444557

ABSTRACT

On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose after completion of a primary vaccination series to eligible persons with moderate to severe immunocompromising conditions (1,2). On September 22, 2021, FDA authorized an additional dose of Pfizer-BioNTech vaccine ≥6 months after completion of the primary series among persons aged ≥65 years, at high risk for severe COVID-19, or whose occupational or institutional exposure puts them at high risk for COVID-19 (1). Results from a phase 3 clinical trial conducted by Pfizer-BioNTech that included 306 persons aged 18-55 years showed that adverse reactions after receipt of a third dose administered 5-8 months after completion of a 2-dose primary mRNA vaccination series were similar to those reported after receipt of dose 2; these adverse reactions included mild to moderate injection site and systemic reactions (3). CDC developed v-safe, a voluntary, smartphone-based safety surveillance system, to provide information on adverse reactions after COVID-19 vaccination. Coincident with authorization of an additional dose for persons with immunocompromising conditions, the v-safe platform was updated to allow registrants to enter information about additional doses of COVID-19 vaccine received. During August 12-September 19, 2021, a total of 22,191 v-safe registrants reported receipt of an additional dose of COVID-19 vaccine. Most (97.6%) reported a primary 2-dose mRNA vaccination series followed by a third dose of the same vaccine. Among those who completed a health check-in survey for all 3 doses (12,591; 58.1%), 79.4% and 74.1% reported local or systemic reactions, respectively, after dose 3, compared with 77.6% and 76.5% who reported local or systemic reactions, respectively, after dose 2. These initial findings indicate no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine; most of these adverse reactions were mild or moderate. CDC will continue to monitor vaccine safety, including the safety of additional doses of COVID-19 vaccine, and provide data to guide vaccine recommendations and protect public health.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Product Surveillance, Postmarketing , Adolescent , Adult , Adverse Drug Reaction Reporting Systems , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/prevention & control , Centers for Disease Control and Prevention, U.S. , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , United States/epidemiology , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Young Adult
10.
Ghana Med J ; 54(4 Suppl): 62-70, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-1436196

ABSTRACT

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There is limited information on the safety of drugs used for the treatment of COVID-19. OBJECTIVE: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for low- and middle-income countries. METHODS: This is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1st April 2020 to 31st July 2020 in SARS-CoV-2 positive patients in Ghana. The ICSRs were retrieved from the SafetyWatch System and descriptive statistics used to describe the ADRs by System Organ Classification and Preferred Term. RESULTS: Information was received from 40 COVID-19 Treatment Centres across the country with 9 centres submitting a total of 53 ICSRs containing 101 ADRs; approximately two ADRs per ICSR. Females accounted for 29(54.7%) of the ICSRs and males 24(45.3%). Newly reported ADRs of interest were one report each of tremor for doxycycline; scrotal pain, dyspnoea, gait disturbances and dysgeusia for chloroquine; and dry throat, hyperhidrosis, restlessness and micturition frequency increased for hydroxychloroquine. A strong spontaneous system with the availability of focal persons at the Treatment Centres played a key role in reporting ADRs during the pandemic. CONCLUSION: This is the first experience with spontaneous reporting during COVID-19 pandemic in Ghana. The profile of most of the ADRs reported appears consistent with what is expected from the summary of product characteristics. A study with a larger sample size with well-defined denominator in future studies is paramount in determining the relative risk of these medications in SARS-CoV-2 positive patients. FUNDING: None declared.


Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , COVID-19/drug therapy , Drug-Related Side Effects and Adverse Reactions/epidemiology , SARS-CoV-2 , Adult , Aged , Drug-Related Side Effects and Adverse Reactions/virology , Female , Ghana/epidemiology , Humans , Male , Middle Aged , Prospective Studies
11.
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
13.
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
14.
Clin Gastroenterol Hepatol ; 19(9): 1970-1972.e3, 2021 09.
Article in English | MEDLINE | ID: covidwho-1212376

ABSTRACT

Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19)1-4 and was first approved for COVID-19 patients.5 However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear.1-4,6 Therefore, we aimed to detect a diverse spectrum of GI-ADRs associated with remdesivir using VigiBase, the World Health Organization's international pharmacovigilance database of individual case safety reports.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adenosine Monophosphate/analogs & derivatives , Adverse Drug Reaction Reporting Systems , Alanine/analogs & derivatives , COVID-19/drug therapy , Databases, Factual , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Pharmacovigilance , SARS-CoV-2 , World Health Organization
15.
Vaccine ; 39(36): 5087-5090, 2021 08 23.
Article in English | MEDLINE | ID: covidwho-1322380

ABSTRACT

INTRODUCTION: COVID-19 vaccination seems to be the most pertinent pharmacologic public health measure to control the pandemic. Reactogenicity symptoms were frequent in vaccine recipients mostly mild to moderate and commonly reported after the second dose. However, there is a lack of data in patients with a previous diagnosis of Covid-19. METHODS: We analysed side effects of 311 patients after the first dose of Pfizer-BioNTech COVID-19 vaccine, in a french university hospital. We compared patients with COVID-19 history to naive individuals. All the data collected are based on self-reported, including COVID-19 exposure status. RESULTS: Overall, 229 (74%) patients reported at least one side effect. Among participants with history of Covid-19, 95% reported at least one adverse event versus 70% in naive patients (p < 0.01). However, symptom intensity was not different between the 2 groups. CONCLUSION: Vaccine recipients with prior COVID-19 reported more, but no more serious, side effects than naive participants.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , COVID-19 Vaccines , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Pandemics , SARS-CoV-2
16.
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
17.
PLoS Negl Trop Dis ; 15(4): e0009354, 2021 04.
Article in English | MEDLINE | ID: covidwho-1287260

ABSTRACT

BACKGROUND: Ivermectin is known to cause severe encephalopathies in subjects infected with loiasis, an endemic parasite in Sub-Saharan Africa (SSA). In addition, case reports have described ivermectin-related serious adverse drug reactions (sADRs) such as toxidermias, hepatic and renal disorders. The aim of this study was to identify suspected sADRs reported after ivermectin administration in VigiBase, the World Health Organization's global individual case safety reports database and analyze their frequency relative to the frequency of these events after other antinematodal drugs reported in SSA and other areas of the world (ROW). METHODS: All antinematodal-related sADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate nervous, cutaneous, psychiatric, respiratory, renal, hepatic and cardiac suspected sADRs reported after ivermectin and benzimidazole drug administration across the world, in SSA and RoW. PRINCIPAL FINDINGS: 2041 post-ivermectin or post-benzimidazole suspected sADRs were identified including 667 after ivermectin exposure (208 in SSA and 459 in the RoW). We found an increased reporting for toxidermias, encephalopathies, confusional disorders after ivermectin compared to benzimidazole drug administration. Encephalopathies were not only reported from SSA but also from the RoW (adjusted reporting odds ratios [aROR] 6.30, 95% confidence interval: 2.68-14.8), highlighting the fact these types of sADR occur outside loiasis endemic regions. CONCLUSION: We described for the first time suspected sADRs associated with ivermectin exposure according to geographical origin. While our results do not put in question ivermectin's excellent safety profile, they show that as for all drugs, appropriate pharmacovigilance for adverse reactions is indicated.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Ivermectin/adverse effects , Adolescent , Adult , Africa South of the Sahara/epidemiology , Aged , Databases, Factual , Female , Humans , Logistic Models , Male , Middle Aged , Pharmacovigilance , Young Adult
18.
Diabetes Metab Syndr ; 15(4): 102172, 2021.
Article in English | MEDLINE | ID: covidwho-1263249

ABSTRACT

BACKGROUND AND AIMS: Ever since the vaccination drive for COVID-19 has started in India, the citizens have been sharing their views on social media about it. The present study examines the attitude of Indian citizens towards the side effects of the COVID-19 vaccine. METHODS: Social media posts were used for this research. Using Python, we have collected social media posts of Indians focusing on side effects of COVID -19 vaccines. In study one, sentimental analysis was done to find overall attitude of Indian citizens towards the side effects of COVID-19 vaccine and in study two, topic modeling done to analyze the major side effects voiced out by the citizens after taking COVID-19 vaccine. RESULTS: The studies conducted have revealed that nearly 78.5% of tweets posted by Indian citizens about the side effects of the COVID-19 vaccine were either in neutral or positive sentiments. Our topic modeling studies have found that fear of efficiency in the workplace and the fear of death as the prime two issues that contributes Indian citizens to have negative sentiment about the side effects of the COVID-19 vaccine. CONCLUSION: While it is important for the Indian government to actively encourage its citizens to have vaccine, it is also important to help the citizens understand the important of the vaccination program. The best way to educate citizens regarding the positive aspect of the vaccination program is by addressing the fears, Indian citizens have voiced in their social media post about the COVID-19 vaccines.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Drug-Related Side Effects and Adverse Reactions/psychology , Machine Learning , SARS-CoV-2/immunology , Social Media/statistics & numerical data , Vaccination/psychology , COVID-19/epidemiology , COVID-19/psychology , COVID-19/virology , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , India/epidemiology
19.
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
20.
Int J Clin Pharm ; 43(4): 1133-1138, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1252181

ABSTRACT

The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.


Subject(s)
Adverse Drug Reaction Reporting Systems , Antiviral Agents/adverse effects , COVID-19/drug therapy , Pharmacovigilance , Adverse Drug Reaction Reporting Systems/organization & administration , Antiviral Agents/therapeutic use , COVID-19/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Humans , Patient Safety , SARS-CoV-2/drug effects
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