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1.
Stud Health Technol Inform ; 290: 704-708, 2022 Jun 06.
Article in English | MEDLINE | ID: covidwho-1879419

ABSTRACT

This study aims to find out the variation of Twitter users' sentiment before and after the COVID-19 vaccine rollout. We analyzed all COVID-19 related tweets posted on Twitter within two timeframes: September 2020 (T1) and March 2021 (T2). A total of 3 million tweets from over 132 thousand users were analyzed. We then categorized the users into two groups whose overall sentiment shifted positively or negatively from T1 to T2. Our analysis showed that 27% of users' sentiment shifted from T1 to T2 positively and the users were more confident about vaccine safety and efficacy. Users reported positive sentiments about travelling and the easing of lockdown measures. Also, 20.4% of the users' sentiment shifted negatively from T1 to T2. This group of Twitter users were more concerned about the adverse side effects of the vaccine, the pace of vaccine development as well as the emerging novel coronavirus variants. Interestingly, over half of the users' overall sentiment remained the same in both periods of T1 and T2, indicating indifference about vaccine rollout. We believe that our analysis will support the exploration of public reaction to COVID-19 vaccine rollout and assess policy makers' decision to combat the pandemic.


Subject(s)
COVID-19 Vaccines , COVID-19 , Drug-Related Side Effects and Adverse Reactions , Social Media , Attitude , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Communicable Disease Control , Humans , Vaccines
2.
Stud Health Technol Inform ; 290: 330-334, 2022 Jun 06.
Article in English | MEDLINE | ID: covidwho-1879406

ABSTRACT

COVID-19 patients with multiple comorbid illnesses are more likely to be using polypharmacy to treat their COVID-19 disease and comorbid conditions. Previous literature identified several DDIs in COVID-19 patients; however, various DDIs are unrecognized. This study aims to discover novel DDIs by conducting comprehensive research on the FDA Adverse Event Reporting System (FAERS) data from January 2020 to March 2021. We applied seven algorithms to discover DDIs. In addition, the Liverpool database containing DDI confirmed by clinical trials was used as a gold standard to determine novel DDIs in COVID-19 patients. The seven models detected 2,516 drug-drug pairs having adverse events (AEs), 49 out of which were confirmed by the Liverpool database. The remaining 2,467 drug pairs tested to be significant by the seven models can be candidate DDIs for clinical trial hypotheses. Thus, the FAERS database, along with informatics approaches, provides a novel way to select candidate drug-drug pairs to be examined in COVID-19 patients.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , COVID-19/drug therapy , Databases, Factual , Drug Interactions , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Polypharmacy
3.
Virol J ; 19(1): 100, 2022 Jun 05.
Article in English | MEDLINE | ID: covidwho-1879245

ABSTRACT

Recently, The Lancet published a study on the effectiveness of COVID-19 vaccines and the waning of immunity with time. The study showed that immune function among vaccinated individuals 8 months after the administration of two doses of COVID-19 vaccine was lower than that among the unvaccinated individuals. According to European Medicines Agency recommendations, frequent COVID-19 booster shots could adversely affect the immune response and may not be feasible. The decrease in immunity can be caused by several factors such as N1-methylpseudouridine, the spike protein, lipid nanoparticles, antibody-dependent enhancement, and the original antigenic stimulus. These clinical alterations may explain the association reported between COVID-19 vaccination and shingles. As a safety measure, further booster vaccinations should be discontinued. In addition, the date of vaccination should be recorded in the medical record of patients. Several practical measures to prevent a decrease in immunity have been reported. These include limiting the use of non-steroidal anti-inflammatory drugs, including acetaminophen to maintain deep body temperature, appropriate use of antibiotics, smoking cessation, stress control, and limiting the use of lipid emulsions, including propofol, which may cause perioperative immunosuppression. In conclusion, COVID-19 vaccination is a major risk factor for infections in critically ill patients.


Subject(s)
COVID-19 Vaccines , COVID-19 , Drug-Related Side Effects and Adverse Reactions , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions/prevention & control , Humans , Liposomes , Nanoparticles , SARS-CoV-2 , Vaccination/adverse effects
5.
Oncologist ; 27(2): e203-e205, 2022 03 04.
Article in English | MEDLINE | ID: covidwho-1873980

ABSTRACT

BACKGROUND: Few data are available on the safety of COVID-19 vaccines in cancer patients undergoing active cancer-directed treatment. PATIENTS AND METHODS: This case series analyzes outcomes in terms of adverse events in 5297 patients undergoing anti-cancer treatment who were vaccinated with anti-SARS-CoV-2 Pfizer-BioNTech vaccine at a single cancer center from March 6, 2021 to May 9, 2021. Adverse events were retrieved from the national Italian pharmacovigilance platform (http://www.vigicovid.it). RESULTS: Of the 5297 patients treated for either solid tumors (87%) or onco-hematologic malignancies (13%) who were vaccinated, 8 adverse drug reactions (ADRs) were reported. One was a severe ADR and 7 were non-severe ADRs. Non-severe ADRs resolved within 48 hours. CONCLUSION: BNT162b2 Pfizer-BioNTech vaccine was safely administered in the largest cohort of cancer patients reported to date.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Hematologic Neoplasms , Vaccines , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Vaccines/adverse effects
6.
Drug Saf ; 45(5): 429-438, 2022 05.
Article in English | MEDLINE | ID: covidwho-1872800

ABSTRACT

There is great interest in the application of 'artificial intelligence' (AI) to pharmacovigilance (PV). Although US FDA is broadly exploring the use of AI for PV, we focus on the application of AI to the processing and evaluation of Individual Case Safety Reports (ICSRs) submitted to the FDA Adverse Event Reporting System (FAERS). We describe a general framework for considering the readiness of AI for PV, followed by some examples of the application of AI to ICSR processing and evaluation in industry and FDA. We conclude that AI can usefully be applied to some aspects of ICSR processing and evaluation, but the performance of current AI algorithms requires a 'human-in-the-loop' to ensure good quality. We identify outstanding scientific and policy issues to be addressed before the full potential of AI can be exploited for ICSR processing and evaluation, including approaches to quality assurance of 'human-in-the-loop' AI systems, large-scale, publicly available training datasets, a well-defined and computable 'cognitive framework', a formal sociotechnical framework for applying AI to PV, and development of best practices for applying AI to PV. Practical experience with stepwise implementation of AI for ICSR processing and evaluation will likely provide important lessons that will inform the necessary policy and regulatory framework to facilitate widespread adoption and provide a foundation for further development of AI approaches to other aspects of PV.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Pharmacovigilance , Adverse Drug Reaction Reporting Systems , Algorithms , Artificial Intelligence , Drug-Related Side Effects and Adverse Reactions/prevention & control , Humans
7.
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
8.
BMC Health Serv Res ; 22(1): 725, 2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-1869085

ABSTRACT

AIMS: The COVID-19 pandemic has challenged health systems and their capacity to deliver essential health services while responding to COVID-19. This study examines the pandemic's impact on health service usage among patients with type 2 diabetes in the North Karelia region, in Finland. METHODS: This retrospective cohort study used electronic health records of 11,458 type 2 diabetes patients, comprising all primary and specialised care contacts in 2019 and 2020. We analysed diabetes and dental healthcare contacts to primary care nurses, doctors and dentists and all emergency visits in specialised care. We compared healthcare usage in three different periods in 2020 (pre-lockdown [1 January-15 March], lockdown [16 March-31 May], post-lockdown [1 June-31 December]) with the equivalent period in 2019. RESULTS: During the lockdown period, the number of diabetes-related contacts decreased significantly but quickly increased again to nearly the same level as in 2019. Overall, healthcare usage was lower in the pandemic year, with proportionally 9% fewer contacts per person (mean 2.08 vs 2.29) and a proportionally 9% lower proportion of patients making any contact (59.9% vs 65.8%). The proportion of remote consultations was similar in both years in the pre-lockdown period (56.3-59.5%) but then increased to 88.0% during the 2020 lockdown. Patterns were similar when analysed by age group and gender. Emergency visits went down significantly at the beginning of the lockdown period, but a "rebound effect" was observed, so after the lockdown, the number of emergency visits in 2020 exceeded the numbers of the previous year. CONCLUSION: Despite the COVID-19 pandemic, diabetes care was continuous, and even elderly patients aged ≥70 years accessed the health services. The delivery of many essential services was facilitated by processes that strongly relied on telemedicine already before the pandemic.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 2 , Drug-Related Side Effects and Adverse Reactions , Aged , COVID-19/epidemiology , Communicable Disease Control , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/therapy , Finland/epidemiology , Health Services , Humans , Pandemics , Retrospective Studies
10.
Stud Health Technol Inform ; 294: 721-722, 2022 May 25.
Article in English | MEDLINE | ID: covidwho-1865440

ABSTRACT

In this article, we present a methodology and a tool for extracting and analyzing information, reported by a social media monitor, of people who have taken drugs to treat Covid-19 and the adverse effects encountered.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Social Media , Data Science , Humans , Pharmacovigilance
11.
BMC Infect Dis ; 22(1): 476, 2022 May 18.
Article in English | MEDLINE | ID: covidwho-1854775

ABSTRACT

BACKGROUND: Vaccination is a key intervention to prevent COVID-19. Many vaccines are administered globally, yet there is not much evidence regarding their safety and adverse effects. Iran also faces this challenge, especially as data regarding the Sputnik V vaccine is sparse. Therefore, the aim of this study is to determine the adverse effects of the most commonly used vaccines in Iran. METHODS: Using a retrospective cohort study design, 6600 subjects aged 18 years or older who had received two doses of any of the three COVID-19 vaccines (Sinopharm, AstraZeneca, and Sputnik V) were selected using a random sampling method between March and August 2021. Subjects were asked about any adverse effects of the vaccines by trained interviewers via telephone interview. Vaccine-related adverse effects in individuals during the first 72 h and subsequently following both doses of the vaccines were determined. The demographic variables, type of administered vaccine, adverse effects, and history of the previous infection with COVID-19 were collected. Descriptive statistics (mean, standard deviation) and analytical statistics (Chi-squared and Wilcoxon tests) were performed at a 95% significance level using STATA software version 15 (STATA Corp, College Station, TX, USA). RESULTS: From 6600 participants, 4775 responded (response rate = 72.3%). Of the participants, 1460 (30.6%) received the AstraZeneca vaccine, 1564 (32.8%) received the Sinopharm vaccine and 1751 (36.7%) received the Sputnik V vaccine. 2653 participants (55.56%) reported adverse effects after the first dose and 1704 (35.7%) after the second dose. Sputnik V caused the most adverse effects with 1449 (82.7%) vaccine recipients reporting symptoms after the first or second dose, compared with 1030 (70.5%) for AstraZeneca and only 585 (37.4%) for the Sinopharm vaccine. The most common adverse effects after the first dose were fatigue (28.37%), chill/fever (26.86%), and skeletal pain (22.38%). These three adverse effects were the same for the second dose, although their prevalence was lower. CONCLUSIONS: In this study, we demonstrate that the Sputnik V vaccine has the highest rate of adverse effects, followed by the AstraZeneca and Sinopharm vaccines. COVID-19 vaccines used in Iran are safe and there were no reports of serious adverse effects.


Subject(s)
COVID-19 Vaccines , COVID-19 , Drug-Related Side Effects and Adverse Reactions , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/therapeutic use , /therapeutic use , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Iran/epidemiology , Retrospective Studies , SARS-CoV-2 , Vaccination/adverse effects , Vaccines/adverse effects , Vaccines/therapeutic use , Vaccines, Inactivated/adverse effects , Vaccines, Inactivated/therapeutic use , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/therapeutic use
12.
Asian Pac J Cancer Prev ; 23(4): 1263-1270, 2022 Apr 01.
Article in English | MEDLINE | ID: covidwho-1836500

ABSTRACT

According to the instructions of Iran's National Corona Response Committee in the Iranian Ministry of Health and Medical Education, patients undergoing treatments for their cancer are prioritized in Covid-19 vaccination. The present study was therefore conducted to investigate the toxicity and acute side-effects of a Covid-19 vaccine in cancer patients presenting to Medical Oncology Clinic of Kermanshah University of Medical Science. After excluding the patients with active infection and the recently-infected ones with Covid-19, they underwent the vaccination. The patients with cell counts exceeding 3,000 received two doses of the vaccine with a 21-day interval and treatment of their underlying disease was postponed for 7 days. The side-effects were mild and tolerable and included fever (case 10), pain at the injection site (7), dizziness (7), body pain (6), abdominal pain (6), myalgia (6), headache (6), chills (3), shortness of breath (3), diarrhea (1), runny nose (1) and dryness of the throat (1). No significant toxicity was reported in the patients who were safely vaccinated under the supervision of the medical oncology clinic.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Neoplasms , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Iran/epidemiology , Neoplasms/therapy , Pain
13.
Saudi Med J ; 43(4): 386-393, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1836049

ABSTRACT

OBJECTIVES: To measure and assess the side-effects of Pfizer/BioNTech and AstraZeneca vaccines on residents of Saudi Arabia, as well as provide a database that gives insight into the relative safety of these 2 COVID-19 vaccines. METHODS: A community-based cross-sectional study was conducted to determine the side-effects of the two COVID-19 vaccines. The study was initiated on the 5th of June 2021 at Hail University, Hail, Saudi Arabia. The information was collected through an online survey designed on Google forms. The questionnaire was pre-tested for validity, with all information carefully reviewed. RESULTS: The study included 2,530 participants from different regions of Saudi Arabia, with a mean age of 26.9 ± 12.4 years old. The most common vaccine among the study group was Pfizer, which 73.8% of the population were provided; the remaining 26.2% received the AstraZeneca vaccine. Regarding the Pfizer vaccine, the common systemic side-effects followed the first dose, included headaches, followed by muscle pain, fever, and joint pain. Those who had the AstraZeneca vaccine reported a few more side-effects. For example, during the first dose fever was reported as the most common side-effect, followed by headache, muscle pain and fatigue. CONCLUSION: The present study confirmed that vaccine side-effects are more frequently reported by smokers and those who received the AstraZeneca vaccine. Further studies are needed to acquire a better understanding of the association between risk factors and the experiencing of post-vaccine side-effects.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Vaccines , Adolescent , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cross-Sectional Studies , Headache/chemically induced , Headache/epidemiology , Humans , Myalgia , SARS-CoV-2 , Saudi Arabia/epidemiology , Young Adult
14.
Sao Paulo Med J ; 140(3): 372-377, 2022.
Article in English | MEDLINE | ID: covidwho-1833818

ABSTRACT

BACKGROUND: Favipiravir is generally used in treating coronavirus disease 2019 (COVID-19) pneumonia in Turkey. OBJECTIVE: To determine the side effects of favipiravir and whether it is a good treatment option. DESIGN AND SETTING: Retrospective study conducted in Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Ankara, Turkey. METHODS: 357 patients who completed favipiravir treatment at the recommended dose were included. 37 patients with drug side effects and 320 patients without drug side effects were examined in two groups. RESULTS: Side effects were observed in 37 (10.36%) out of 357 patients using favipiravir. The most common side effect was liver dysfunction, in 26 (7.28%) of the patients. The following other side effects were also observed: diarrhea (1.4%), nausea (0.84%), abdominal pain (0.28%) and thrombocytopenia (0.28%). One patient (0.28%) presented both increased transaminases and nausea. CONCLUSION: In this study, it was determined that favipiravir may constitute an alternative for treating COVID-19 pneumonia given that its side effects are generally well tolerated and not serious.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Amides , Antiviral Agents/adverse effects , COVID-19/drug therapy , Drug-Related Side Effects and Adverse Reactions/drug therapy , Humans , Nausea/chemically induced , Nausea/drug therapy , Pyrazines , Retrospective Studies , SARS-CoV-2 , Treatment Outcome
15.
Cogn Res Princ Implic ; 7(1): 38, 2022 05 07.
Article in English | MEDLINE | ID: covidwho-1833372

ABSTRACT

On April 13, 2021, the CDC announced that the administration of Johnson and Johnson's COVID-19 vaccine would be paused due to a rare blood clotting side effect in ~ 0.0001% of people given the vaccine. Most people who are hesitant to get a COVID-19 vaccine list potential side effects as their main concern (PEW, 2021); thus, it is likely that this announcement increased vaccine hesitancy among the American public. Two days after the CDC's announcement, we administered a survey to a group of 2,046 Americans to assess their changes in attitudes toward COVID-19 vaccines. The aim of this study was to investigate whether viewing icon arrays of side effect risk would prevent increases in COVID-19 vaccine hesitancy due to the announcement. We found that using icon arrays to illustrate the small chance of experiencing the blood clotting side effect significantly prevented increases in aversion toward the Johnson and Johnson vaccine as well as all other COVID-19 vaccines.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , SARS-CoV-2 , Surveys and Questionnaires , United States
17.
PLoS One ; 17(5): e0266003, 2022.
Article in English | MEDLINE | ID: covidwho-1822264

ABSTRACT

Why do people prefer one particular COVID-19 vaccine over another? We conducted a pre-registered conjoint experiment (n = 5,432) in France, Germany, and Sweden in which respondents rated the favorability of and chose between pairs of hypothetical COVID-19 vaccines. Differences in effectiveness and the prevalence of side-effects had the largest effects on vaccine preferences. Factors with smaller effects include country of origin (respondents are less favorable to vaccines of Chinese and Russian origin), and vaccine technology (respondents exhibited a small preference for hypothetical mRNA vaccines). The general public also exhibits sensitivity to additional factors (e.g. how expensive the vaccines are). Our data show that vaccine attributes are more important for vaccine preferences among those with higher vaccine favorability and higher risk tolerance. In our conjoint design, vaccine attributes-including effectiveness and side-effect prevalence-appear to have more muted effects among the most vaccine hesitant respondents. The prevalence of side-effects, effectiveness, country of origin and vaccine technology (e.g., mRNA vaccines) determine vaccine acceptance, but they matter little among the vaccine hesitant. Vaccine hesitant people do not find a vaccine more attractive even if it has the most favorable attributes. While the communication of vaccine attributes is important, it is unlikely to convince those who are most vaccine hesitant to get vaccinated.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Germany , Humans , Vaccination/adverse effects , Vaccines/adverse effects
18.
J Med Case Rep ; 16(1): 182, 2022 May 07.
Article in English | MEDLINE | ID: covidwho-1822208

ABSTRACT

BACKGROUND: Many scientists across the world got involved in the race to develop successful anti-SARS-CoV-2 vaccines to overcome COVID-19 pandemic. Among the different vaccines developed against SARS-CoV-2, Covishield was the first vaccine approved for emergency use in Nepal. We report two cases of Superficial Vein Thrombosis (SVT) for the first time in the literature after vaccination with the Chimpanzee Adenovirus-vectored Vaccine (ChAdOx1 nCoV-19 vaccine). CASES PRESENTATION: Two cases, a 24-year-old young Chhetri male and a 62-year-old Chhetri female who have received Covishield (ChAdOx1 nCoV-19) vaccine, developed pain in left calf after 2 weeks and 10 weeks of vaccination, respectively. Both the case belongs to the Chhetri ethnic group of Nepal. The pain became severe on the fourth week of immunization in the first case while the pain was acute and severe on the 10th week of vaccination in the second case. The first presented to emergency room and second case was referred to the emergency room from Orthopedic Clinic. On evaluation the first patient had normal vitals with no history of fever and swelling yet displayed non-radiating mild to moderate intensity pain localized to left leg below the knee which became aggravated by movements. In the second case however pain was more intense with other characteristics as first case. Both cases had low wells score (< 4). On local examination tenderness was noted on squeezing but other systemic examination findings of the patient were within normal limits in both cases. Among the numerous vaccines used to fight the battle against COVID-19 disease, the ChAdOx1 nCoV-19 vaccine, Covishield, has been widely used in Nepal and India. Apart from other minor side effects, in few cases thromboses have been reported after vaccination of ChAdOx1 nCoV-19, Covishield, vaccine. CONCLUSION: These cases reporting Superficial Vein Thrombosis may be an additional adverse effect to the list of adverse events associated with ChAdOx1 nCoV-19, Covishield, vaccine. However, the benefits of the vaccine in breaking the chain of COVID 19 spread are certainly greater than the risk of thromboses.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Thrombosis , Vaccines , Adult , COVID-19/prevention & control , Female , Humans , Male , Middle Aged , Pain , Pandemics , SARS-CoV-2 , Vaccination , Young Adult
19.
J Med Virol ; 94(8): 3783-3790, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1819371

ABSTRACT

We aimed to assess longitudinal changes in clinical indexes of corona disease 2019 (Covid-19) patients with mild pulmonary infection during 5 days of remdesivir therapy and determine the effect of age and gender on remdesivir adverse effects (AE). Patients' clinical data including inflammatory markers, liver and renal function tests, and heart rate (HR) were extracted from medical records. Linear mixed model (LMM) was used to analyze longitudinal changes in patients' clinical indexes. Gender and age were inserted in LMM as covariates to find their correlation with AE and clinical indexes. Of 84 patients, 35 patients met our criteria for the study. There were significant increases in mean levels of white blood cell (WBC; p = 0.005), alanine aminotransferase (ALT; p = 0.001), aspartate aminotransferase (p = 0.001), blood urea nitrogen (BUN; p = 0.001), and creatinine (p = 0.006), whereas mean levels of erythrocyte sedimentation rate (p = 0.005), C-reactive protein (p = 0.001), alkaline phosphatase (p = 0.001), and potassium (p = 0.003) decreased significantly. Estimated glomerular filtration rate (p = 0.001) and HR (p = 0.001) showed a notable decline over the course of treatment. LMM analysis showed that mean changes in WBC (ß = 0.94, p = 0.029), creatinine (ß = 0.12, p = 0.020), and HR (ß = 6.47, p = 0.008) were greater in males than in females. Also, age of patients had a significant effect on the mean changes of WBC (ß = -0.02, p = 0.023), sodium (ß = -0.06, p = 0.010), BUN (ß = 0.23, p = 0.001), and HR (ß = -0.29, p = 0.001). Despite no renal and liver dysfunction, Covid-19 patients with mild pulmonary infection may develop some remdesivir AE and attributed side effects might be affected by gender and age of patients.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adenosine Monophosphate/adverse effects , Adenosine Monophosphate/analogs & derivatives , Alanine/adverse effects , Alanine/analogs & derivatives , COVID-19/drug therapy , Creatinine , Female , Humans , Male
20.
Sci Rep ; 12(1): 6978, 2022 04 28.
Article in English | MEDLINE | ID: covidwho-1815602

ABSTRACT

Cardiovascular adverse conditions are caused by coronavirus disease 2019 (COVID-19) infections and reported as side-effects of the COVID-19 vaccines. Enriching current vaccine safety surveillance systems with additional data sources may improve the understanding of COVID-19 vaccine safety. Using a unique dataset from Israel National Emergency Medical Services (EMS) from 2019 to 2021, the study aims to evaluate the association between the volume of cardiac arrest and acute coronary syndrome EMS calls in the 16-39-year-old population with potential factors including COVID-19 infection and vaccination rates. An increase of over 25% was detected in both call types during January-May 2021, compared with the years 2019-2020. Using Negative Binomial regression models, the weekly emergency call counts were significantly associated with the rates of 1st and 2nd vaccine doses administered to this age group but were not with COVID-19 infection rates. While not establishing causal relationships, the findings raise concerns regarding vaccine-induced undetected severe cardiovascular side-effects and underscore the already established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals. Surveillance of potential vaccine side-effects and COVID-19 outcomes should incorporate EMS and other health data to identify public health trends (e.g., increased in EMS calls), and promptly investigate potential underlying causes.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Heart Arrest , Vaccines , Adolescent , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Heart Arrest/chemically induced , Heart Arrest/epidemiology , Humans , Israel/epidemiology , Vaccines/adverse effects , Young Adult
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