scholarly journals Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey

Life ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 249
Author(s):  
Alexander G. Mathioudakis ◽  
Murad Ghrew ◽  
Andrew Ustianowski ◽  
Shazaad Ahmad ◽  
Ray Borrow ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Hospital Care ◽  
Online Survey ◽  
Viral Vector ◽  
Vaccine Dose ◽  
Vaccine Recipient ◽  
Increased Risk ◽  
Local Reactions ◽  
Randomised Controlled

An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose ≥ 7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95% confidence intervals (1.05–1.11)), fever (2.24 (1.86–2.70)), breathlessness (2.05 (1.28–3.29)), flu-like illness (1.78 (1.51–2.10)), fatigue (1.34 (1.20–1.49)) and local reactions (1.10 (1.06–1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14–2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01–1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31–0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions.

scholarly journals Self-reported real-world safety and reactogenicity of COVID-19 vaccines: An international vaccine-recipient survey

2021 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Murad Ghrew ◽  
Andrew Ustianowski ◽  
Shazaad Ahmad ◽  
Ray Borrow ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Hospital Care ◽  
Online Survey ◽  
Viral Vector ◽  
Vaccine Dose ◽  
List Type ◽  
Increased Risk ◽  
Systemic Side Effects ◽  
Local Reactions

AbstractBackgroundThe safety of COVID-19 vaccines has been demonstrated in selected populations in recent studies, but more data in specific groups is needed to inform vaccine choice and health policy.ObjectivesAn international, online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups.MethodsThis survey was launched in February 2021, for 11 days. Recipients of a first COVID-19 vaccine dose ≥7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed.ResultsSurvey was completed by 2,002 respondents, of whom 26.6% had prior COVID-19 infection (68.8% laboratory confirmed). Prior COVID-19 infection was associated with increased risk of any side effect (risk ratio 1.08, 95% confidence intervals [1.05-1.11]), fever (2.24 [1.86-2.70]), breathlessness (2.05 [1.28-3.29]), flu-like illness (1.78 [1.51-2.10]), fatigue (1.34 [1.20-1.49]) and local reactions (1.10 [1.06-1.15]). It was also associated with increased risk of severe side effects, leading to hospital care (1.56 [1.14-2.12]).While mRNA vaccines were associated with a higher incidence of any side effect (1.06 [1.01-1.11]) compared to viral vector-based vaccines, these were generally milder (p<0.001), mostly local reactions. Importantly, mRNA vaccine-recipients reported considerably lower incidence of systemic reactions (RR<0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue, and of side effects requiring hospital care (0.42 [0.31-0.58]).ConclusionFor the first time, our study links prior COVID-19 illness with increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects, but more local reactions.Key messages–People with prior COVID-19 illness appear to experience significantly increased incidence and severity of side effects after receiving the COVID-19 vaccine.–In this first head-to-head comparison of the safety and reactogenicity of different types of vaccines, it was demonstrated that mRNA vaccines cause milder, less frequent systemic side effects, compared to viral vector vaccines, but more local reactions.Tweetable SummaryA survey of >2000 COVID-19 vaccine-recipients links prior COVID-19 illness with increased incidence of vaccination side effects; mRNA vaccines cause milder, less frequent systemic side effects, but more local reactions.

scholarly journals Side Effects of mRNA-Based and Viral Vector-Based COVID-19 Vaccines among German Healthcare Workers

Biology ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 752
Author(s):  
Miloslav Klugar ◽  
Abanoub Riad ◽  
Mohamed Mekhemar ◽  
Jonas Conrad ◽  
Mayte Buchbender ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Healthcare Workers ◽  
Viral Vector ◽  
Demographic Data ◽  
Cross Sectional Survey ◽  
Post Vaccination ◽  
Increased Risk ◽  
Systemic Side Effects ◽  
Local Side

Background: the increasing number of COVID-19 vaccines available to the public may trigger hesitancy or selectivity towards vaccination. This study aimed to evaluate the post-vaccination side effects of the different vaccines approved in Germany; Methods: a cross-sectional survey-based study was carried out using an online questionnaire validated and tested for a priori reliability. The questionnaire inquired about demographic data, medical and COVID-19-related anamneses, and local, systemic, oral, and skin-related side effects following COVID-19 vaccination; Results: out of the 599 participating healthcare workers, 72.3% were females, and 79.1% received mRNA-based vaccines, while 20.9% received a viral vector-based vaccine. 88.1% of the participants reported at least one side effect. Injection site pain (75.6%) was the most common local side effect, and headache/fatigue (53.6%), muscle pain (33.2%), malaise (25%), chills (23%), and joint pain (21.2%) were the most common systemic side effects. The vast majority (84.9%) of side effects resolved within 1–3 days post-vaccination; Conclusions: the mRNA-based vaccines were associated with a higher prevalence of local side effects (78.3% vs. 70.4%; Sig. = 0.064), while the viral vector-based vaccine was associated with a higher prevalence of systemic side effects (87.2% vs. 61%; Sig. < 0.001). Females and the younger age group were associated with an increased risk of side effects either after mRNA-based or viral vector-based vaccines. The gender- and age-based differences warrant further rigorous investigation and standardized methodology.

Domperidone Versus Metoclopramide: Self-Reported Side Effects in a Large Sample of Breastfeeding Mothers Who Used These Medications to Increase Milk Production

2018 ◽  
Vol 9 (1) ◽  
pp. 10-17 ◽  
Author(s):  
Thomas W. Hale ◽  
Kathleen Kendall-Tackett ◽  
Zhen Cong
Keyword(s):  
Side Effects ◽  
Milk Production ◽  
Cardiac Arrhythmias ◽  
Online Survey ◽  
Relative Safety ◽  
Increased Risk ◽  
Rare Side Effect ◽  
Increase Milk Production ◽  
The Central Nervous System ◽  
Cns Side Effects

Introduction: Metoclopramide and domperidone are medications that block dopamine receptors on the lactotrophs, allowing prolactin levels to rise. Both medications are prescribed to boost milk production in mothers with low milk production due to hypoprolactinemia. The Food and Drug Administration has not approved the use of domperidone in the U.S. because of concerns about increased risk of cardiac arrhythmias. Metoclopramide is often recommended instead. Unfortunately, metoclopramide affects the central nervous system (CNS) and increases the risk of both depression and tardive dyskinesia (TD).Method: The present study is an online survey of self-reported side effects of 1,990 mothers, representing 25 countries, who took metoclopramide, domperidone, or both medications to enhance milk production. Data were collected in 2010.Results: The results indicated that side effects, in general, affected only a small percentage of women who took either medication. Women were 3.6 times more likely to report no side effects when taking domperidone vs. metoclopramide. There were no significant differences in cardiac arrhythmias for women who took metoclopramide versus domperidone. Racing heart was more common with metoclopramide. Less than 1% reported these symptoms in both groups. However, CNS effects were significantly more common in women who took metoclopramide. Risk of depression increased by seven times, and symptoms of TD (tremors, involuntary grimaces, and jerking) increased by 4 to 19 times when women took metoclopramide.Discussion: The results of the present study are preliminary, but suggest that cardiac arrhythmias are a rare side effect with both medications. The CNS side effects with metoclopramide are more concerning, particularly depression and TD. It is hoped that the recommendations regarding the relative safety of these medications will be re-examined in light of these findings.

scholarly journals Use of information sources regarding medicine side effects among the general population: a cross-sectional survey

2019 ◽  
Vol 20 ◽  
Author(s):  
Bernadine O’Donovan ◽  
Ruth M. Rodgers ◽  
Anthony R. Cox ◽  
Janet Krska
Keyword(s):  
Side Effects ◽  
Information Seeking ◽  
Side Effect ◽  
Information Sources ◽  
Negative Impact ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Information Leaflets ◽  
Increased Risk ◽  
Use Of Information Sources

Abstract Aim: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. Background: Side effects from medicines can have considerable negative impact on peoples’ daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. Methods: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). Findings: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.

Patient-reported outcomes on treatment-related side effects in renal cell carcinoma.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 654-654
Author(s):  
Dena Battle ◽  
Wendy Kimryn Rathmell ◽  
Eric Jonasch ◽  
Pavlos Msaouel ◽  
Adam P. Stern ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Native American ◽  
Side Effects ◽  
Cell Carcinoma ◽  
Dose Reduction ◽  
Side Effect ◽  
Renal Cell ◽  
Online Survey ◽  
Medical Oncologist ◽  
Patient Reported

654 Background: Effective management of treatment related toxicities is crucial to maximizing patient outcomes and enhancing quality of life in renal cell carcinoma. Little is known about patient perception and reporting of side effects in a real world setting outside clinical trials. We sought to gather independent data from online patient communities to estimate gaps in communication and reporting. Methods: KCCure conducted an anonymous online survey from 07/19 to 09/19 using questions related to side-effect experience and management. Results: 1,136 patients (median age 57 years [range 28-86], 54% male) participated, 411 patients on systemic therapy were asked about side-effects. 47% of patients reported bothersome side effects impacting their daily lives. The most poorly managed side-effect was fatigue (25%), followed by taste alteration (15%) and loss of appetite (15%). Only 50% of patients are confident their medical oncologist will offer help for side effects, and 20% are worried that reporting side effects may result in dose reduction or treatment discontinuation. 6% of patients don’t talk about their side effects. Patients who identified as non-white (Hispanic, African American, Asian/Pacific Islander and Native American) were three times less likely to talk about side effects. 51% indicated the best advice on managing treatment related side effects was provided by their medical oncologist; 40% seek advice from online patient communities and 35% from advocacy organizations. Only 8% used manufacturer support websites. 13% had never had any concomitant medication prescribed to manage side effects. Major unreported side effects are sexual dysfunction, cognitive impairment and vision disturbances. Conclusions: The majority of patients experience treatment related side-effects on a regular basis, but underreporting may be significant due to a variety of factors, including fear of dose-reduction or discontinuation. Sexual side-effects are underreported. Future studies need to explore differences in reporting for minority populations as well as side effect experiences according to the class of agent prescribed, and the setting in which treatment occurs.

scholarly journals A Scoping Review of Respirator Literature and a Survey among Dental Professionals

2020 ◽  
Vol 17 (16) ◽  
pp. 5968 ◽  
Author(s):  
Marco Farronato ◽  
Elisa Boccalari ◽  
Ettore Del Rosso ◽  
Valentina Lanteri ◽  
Riaan Mulder ◽  
...  
Keyword(s):  
Side Effects ◽  
Online Survey ◽  
Cochrane Central Register ◽  
Search Terms ◽  
Global Pandemic ◽  
Literature Searches ◽  
Central Register ◽  
Increased Risk ◽  
Close Proximity ◽  
Dental Professionals

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus was discovered in China in late 2019 and subsequently triggered a global pandemic. Dentists, like many other health professionals, are at an increased risk of contracting the virus as they work in close proximity to patients, especially when performing aerosol-generating procedures. Thus, in order for dentists to protect themselves and their patients, it is recommended that practitioners wear filtering facepiece 2 (FFP2) respirators. The prolonged use of these FFP2 respirators has been linked to several side effects. The aim of this paper is to assess the perceived experience associated with N95/FFP2 respirators based on the available literature and data collected through an online survey completed by Italian dental professionals. Articles were included up to May 2020 and literature searches were conducted through The National Library of Medicine, Cochrane Central Register of Controlled Trials, and Embase databases. The search terms included COVID-19, respirators, masks, and discomfort. An online survey was administered to 256 Italian dentists. The results from this survey were in agreement with the available literature. The findings concurred that the prolonged use of respirators was associated with headaches (47.5%), severe exertion and discomfort (50.8%), moderate concentration problems (54.3%), moderate breathing difficulties (63.5%), and consequently, an impaired work ability (85.5%). These findings were not influenced by the number of hours spent wearing the respirator. Despite several side effects, FFP2 respirators are fundamental in protecting dentists and their importance was acknowledged.

scholarly journals Side Effects and Efficacy of COVID-19 Vaccines among the Egyptian Population

Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 109
Author(s):  
Marwa O. Elgendy ◽  
Ahmed O. El-Gendy ◽  
Sarah Mahmoud ◽  
Tarek Yehia Mohammed ◽  
Mohamed E. A. Abdelrahim ◽  
...  
Keyword(s):  
Immune Response ◽  
Side Effects ◽  
Side Effect ◽  
Muscle Pain ◽  
Online Survey ◽  
The Body ◽  
Vaccine Acceptance ◽  
Safety And Efficacy ◽  
Egyptian Population ◽  
Side Effect Severity

Background: Knowledge about a vaccine’s side effects and efficacy is important to improving public vaccine acceptance. This study aimed to detect the safety and efficacy of vaccines among the Egyptian population. Methodology and Results: Data was collected using an online survey from participants who took two doses of the BBIBP-CorV, ChAdOx1, or BNT162 vaccines. Pain at the vaccine injection site, muscle pain, fatigue, dizziness, fever, and headache were the most common side effects after the first and second doses. The number pf side effects was higher in ChAdOx1 than in BNT162 and BBIBP-CorV. Most of the side effects started on the first day after vaccination and persisted for 1–2 days. Vaccinated people with past coronavirus infections before vaccination developed better antibodies than those who were only vaccinated. The side-effect severity was greater after the first dose of BBIBP-CorV and ChAdOx1 than after the second dose, but in contrast, the side-effect severity was greater after the second dose of BNT162 vaccine than after the first dose. ChAdOx1 was more effective than BBIBP-CorV, and one dose of ChAdOx1 produced an immune response similar to that of two doses of BBIBP-CorV. Conclusions: Coronavirus vaccines were well-tolerated, safe, and produced an immune response against the virus in most cases. Most postvaccine side effects were mild to moderate, which indicated the building of immunity by the body for protection.

scholarly journals SUN-610 Acquired Generalized Lipodystrophy: A Rare Side Effect of PD1-Inhibitor Therapy

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Amy Shah ◽  
Juan Pablo Perdomo Rodriguez
Keyword(s):  
Insulin Resistance ◽  
Weight Loss ◽  
Side Effects ◽  
Side Effect ◽  
Inhibitor Therapy ◽  
Rapid Weight Loss ◽  
Metabolic Complications ◽  
Daily Insulin ◽  
Increased Risk ◽  
Rare Side Effect

Abstract Background:Program cell death-1 (PD1) inhibitors, such as nivolumab and pembrolizumab, have shown efficacy as adjuvant treatment for cancers, including melanoma, and their frequency of use is increasing. A potential, but rare, side effect of PD1-inhibitors is acquired generalized lipodystrophy (AGL), an immune-related adverse event characterized by loss of subcutaneous adipose tissue (SAT) and insulin resistance-associated complications. AGL can result in irreversible endocrinopathies, including diabetes. Clinical Case: A 60-year-old overweight female (BMI 29.2), with no related metabolic complications or medical history of autoimmune disorders, was treated with nivolumab (240mg IV q2 weeks) for 1 year for metastatic melanoma on her right arm (staged T4bN2a) that underwent wide local resection. She completed therapy with no complications or lab abnormalities.One-month post-treatment, she noticed rapid weight loss and facial atrophy. Within 3 months, she had a 58% weight loss withsignificant loss of SAT; insulin resistance and diabetes(impaired fasting glucose 201; A1c 9.2%);hepatic steatosis diagnosed by liver biopsy; hypertriglyceridemia (5,309 mg/dL,); and undetectable leptin levels. She also developed prominent forearm muscles and leg veins. GAD antibody was negative. The loss of SAT and rapid weight loss, physical exam findings, onset of diabetes, steatosis and hypertriglyceridemia—all closely following therapy with nivolumab—led to a diagnosis of nivolumab-associated AGL. In addition to treatment for hypertriglyceridemia, the patient was placed on multiple oral and parenteral antihyperglycemic medications, including metformin, SGLT2i, GLP-1, and DPP4, but all were discontinued due to side effects. Ultimately, her A1c increased to 12.4% and she was placed on basal/bolus therapy. Discussion: AGL is associated with an increased risk of lymphoma. Metreleptin, a recombinant analogue of human leptin, is approved for treatment of metabolic complications of AGL. Some instances of lymphoma in AGL have occurred while the patient was receiving metreleptin, but data is inconclusive as to whether development of lymphoma is a side effect of metreleptin.(Brown RJ, Chan JL, Jaffe ES, et al, 2016) We believe treatment with metreleptin would have benefited our patient, but she declined due to potential side effects, including lymphoma. Nine months after nivolomuab therapy, her melanoma is in remission but she still has lipodystrophic characteristics with insulin resistant diabetes. She is being treated with pioglitazone and multiple daily insulin injections but has not achieved euglycemia despite a total daily insulin dose of 2 u/kg. Of note, injecting insulin and use of a continuous glucose monitor have been a challenge given the lack of SAT. Although AGL resulting from PD1-inhibitor therapy is rare, it is a condition for which this patient will need life-long treatment.

Cutaneous ulcers following hydroxyurea therapy

Phlebologie ◽  
2004 ◽  
Vol 33 (06) ◽  
pp. 202-205 ◽  
Author(s):  
K. Hartmann ◽  
S. Nagel ◽  
T. Erichsen ◽  
E. Rabe ◽  
K. H. Grips ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Antineoplastic Agent ◽  
Limited Time ◽  
Myeloproliferative Diseases ◽  
Dermatological Side Effects ◽  
Chronic Myeloproliferative Diseases ◽  
Hydroxyurea Therapy

SummaryHydroxyurea (HU) is usually a well tolerated antineoplastic agent and is commonly used in the treatment of chronic myeloproliferative diseases. Dermatological side effects are frequently seen in patients receiving longterm HU therapy. Cutaneous ulcers have been reported occasionally.We report on four patients with cutaneous ulcers whilst on long-term hydroxyurea therapy for myeloproliferative diseases. In all patients we were able to reduce the dose, or stop HU altogether and their ulcers markedly improved. Our observations suggest that cutaneous ulcers should be considered as possible side effect of long-term HU therapy and healing of the ulcers can be achieved not only by cessation of the HU treatment, but also by reducing the dose of hydroxyurea for a limited time.

EFFECTS OF “HOE HOA TAN II” REMEDY IN THE TREATMENT OF INTERNAL HAEMORROHIDS GRADE I, II AND III

2015 ◽  
pp. 80-85
Author(s):  
Van Anh Nguyen ◽  
Van Nhan Le ◽  
Nguyen Nhu Phuong Phan
Keyword(s):  
Side Effects ◽  
Key Words ◽  
Patient Group ◽  
Controlled Study ◽  
Therapeutic Effects ◽  
Radix Angelicae Sinensis ◽  
Randomised Controlled Study ◽  
Citrus Deliciosa ◽  
Randomised Controlled ◽  
Angelicae Sinensis

Objectives: To investigate and evaluate the therapeutic effects of Hoe hoa tan II in the treatment of internal haemorroids grade I, II and III. Ingredients of the remedy include: Hoe Hoa (Styphonolonium japonicum), Chi xac (Fructus citri Aurantii), Hau phac (Magnolia offinalis), Tran bi (Citrus deliciosa Tenore), Thuong thuat (Atractylodes lancea), O mai (Armeniaca vulgaris Lamk), Cam thao (Clycyrrhiza uralensis), Duong quy (Radix Angelicae Sinensis). Subjects and methods: Randomised controlled study (RCT) has been conducted on 60 patients which were divided into two groups, i.e. the first 30 patient group were treated with Hoe hoa tan II remedy 20 g, and the second 30 patient group were treated with Daflon 500 mg in the course of 14 days. Results: Study showed that Hoe hoa tan II has helped improve symptoms of internal haemorroids grade I, II and III such as bleeding, anal exudation, pain, reducing the size of the haemorroid tissues. The remedy has been shown to have the most significant effect on relieving constipation which is typical in haemorroids. The study also revealed no unwanted effects caused by this formula. Conclusion: Hoe hoa tan II can be therapeutically used to treat internal haemorroids grade I, II and III without causing any serious side effects. Key words: Hoe hoa tan II, internal haemorroids grade I, II, III.

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