Practice of Vaccination

2021 ◽  
Author(s):  
Khrystyna Hrynkevych
Keyword(s):  
Public Health ◽  
Informed Consent ◽  
Side Effects ◽  
Adverse Events ◽  
Injection Site ◽  
Package Insert ◽  
Specific Product ◽  
Life Threatening ◽  
Effective Public Health ◽  
And Storage

Vaccines are extremely effective public health tools which can dramatically improve the health of populations and individuals. Physicians who administer vaccines should familiarize themselves with the indications and contraindications of the specific product they use as well as its licensed and recommended dosing and schedules. Informed consent must be obtained according to local rules and regulations. Manufacturer requirements for shipping, handling, and storage should be followed to assure that the vaccine remains effective and safe for use. Different vaccines are administered by different routes – whether ID, SC, IM, or orally. The appropriate route should always be used as per the package insert. Vaccines do have side effects; most common are fever and reactions (pain, swelling, tenderness) at the injection site. These are usually mild, transient, and easily treated symptomatically. Providers should counsel vaccine recipients to anticipate such events. Care should be taken not to inappropriately attribute adverse events following immunization (AEFIs) to the respective vaccine as AEFIs can occur by chance (without immunization) as well. Anaphylaxis can be caused by all vaccines, but it is very rare. However, since it can be rapidly life-threatening, vaccinators must be prepared to treat this emergency.

scholarly journals Vaccination against COVID-19 in Ukraine. Safety of Vaccines

2021 ◽  
Vol 6 (6) ◽  
pp. 200-206
Author(s):  
N. O. Iakovenko ◽  
◽  
M. V. Ogloblina ◽  
O. K. Nuzhna
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Injection Site ◽  
World Literature ◽  
World Health Organisation ◽  
The State ◽  
World Health ◽  
Ministry Of Health ◽  
Life Threatening ◽  
Expert Center

COVID-19 is a life-threatening disease that can be asymptomatic in the form of a common ARVI, or in extremely severe forms, with serious long-term consequences. Vaccination against COVID-19 is critically important to restrain the pandemic. The purpose of the study was to analyze and systematize the data of pharmacological supervision of the use of vaccines against COVID-19. For this, methods of analysis, systematization and generalization of information were used using the databases of the State Expert Center of the Ministry of Health of Ukraine, Food and Drug Administration, World Health Organisation in the period from February 24, 2021 to October 31, 2021. Currently, such vaccines are registered and approved for use in Ukraine as AstraZeneca (Covishield, SKBio), Comirnaty / Pfizer-BioNTech, Moderna, CoronaVac / Sinovac Biotech. According to official data, the effectiveness of all these vaccines is quite high. They are especially effective in preventing severe course of disease, hospitalization, and death. Sometimes the vaccination process can be with the development of a number of side effects. Responsibility for the risks associated with the production and use of vaccines dictates the need for constant monitoring of these side effects. That is why we analyzed the data of the State Expert Center of the Ministry of Health of Ukraine about adverse events after immunization from COVID-19 in Ukraine. Thus, the analysis of adverse events reported showed that they took place in 0.018% cases of the total number of vaccine doses that were administered. In the context, for each vaccine separately, the number of adverse events reported were: Covishield – 1128 cases (0.23%), CoronaVac – 419 (0.008%), Comirnaty – 854 (0.02%), AstraZeneca – 540 (0.02%), Moderna – 393 (0.02%), respectively. It should be noted that most of the reported cases of adverse events reported in Ukraine during vaccination against COVID-19 are mild predictable reactions (88.72 – 93.38%). This result allows us to speak of a fairly high predictability of the adverse events reported after COVID-19 vaccination. This is confirmed by the data of world literature. After analyzing the presented data of the State Expert Center of the Ministry of Health of Ukraine, we found that the most of adverse events reported after COVID-19 vaccination are so-called general disorders and disorders at the injection site (fever, fatigue, chills, redness, pain and swelling at the injection site). Neurological disorders ranked second in terms of the number of adverse events reported, and musculoskeletal disorders ranked third. Adverse events reported manifestations from other organs and systems had isolated cases. After using all of the above vaccines, the percentage of adverse events reported was significantly higher in women than in men, which coincides with the data of the world literature. Conclusion. Thus, the analysis of the safety of vaccines against COVID-19, registered and authorized for use in Ukraine, shows that the risks of adverse events reported after COVID-19 vaccination are rare; the most of them are mild and predictable. At the same time, these manifestations of adverse events reported cannot be compared with the health and life risks associated with the COVID-19 disease itself. Ensuring continuous monitoring of the safety of vaccine use and identifying potential side effects will further reduce and manage the risks associated with vaccine use

Proton Pump Inhibitors in 2021: Pros, Cons, and Everything in Between

2021 ◽  
pp. 263451612110217
Author(s):  
Joshua A. Sloan ◽  
Philip O. Katz
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Adverse Events ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Drug Class ◽  
Life Threatening

The medical and lay literature has exploded with reports of adverse events associated with proton pump inhibitors over the last 10 to 15 years. The dissemination of these reports to patients and clinicians have created substantial concerns regarding what has been an exceptionally valuable drug class, dramatically improving patient quality of life, and in many cases preventing life threatening side effects of other medication. Patients are more frequently seeking to avoid these medications, and practitioners are reducing or discontinuing them to the patient’s detriment due to a misunderstanding of the data. This review will discuss the data regarding the most commonly publicized adverse events and attempt to put them in perspective.

scholarly journals Ovarian Torsion Presentation, Treatment and Iatrogenic Surgical Management

2021 ◽  
pp. 70-76
Author(s):  
Sheema Sabahath ◽  
Hussain Salah AL Sinan ◽  
Asalah Tariq Alsaigh ◽  
Rawan AlSalamah AlFadhli ◽  
Tahani Salman Al Mansour ◽  
...  
Keyword(s):  
Blood Flow ◽  
Abdominal Pain ◽  
Side Effects ◽  
Adverse Events ◽  
Surgical Intervention ◽  
Clinical Manifestations ◽  
Ovarian Torsion ◽  
Adult Females ◽  
Uterine Ligaments ◽  
Life Threatening

Ovarian torsion is among the gynecological life-threatening conditions that may require urgent surgical intervention among the appearance of clinical manifestations. The most common clinical manifestations include severe abdominal pain, nausea extending to vomiting. The ovarian torsion is not limited to children only. However, it can also occur in adult females, either pregnant or non-pregnant. The etiology of the disease tends to be related to the weakness of the uterine ligaments or malpositioning of it due to known and unknown causes. Despite that, the surgical intervention is needed to release the torsion. Sometimes, it can lead to adverse events or side effects such as decreased blood flow to the surrounding structures. Which by role may lead to unpleasant complications and clinical manifestations of hemorrhage and shock. In this article, we reviewed the topic of ovarian torsion from different aspects, including the definition, causes, clinical evaluation, and clinical management and its common complications.

scholarly journals Pattern of adverse events following immunization among recipients of first dose of ChAdOx1-S [recombinant] Covid-19 vaccine in a resource-limited country

2021 ◽  
Vol 12 (1) ◽  
pp. 006-012
Author(s):  
Azubuike Benjamin Nwako ◽  
Okechukwu Francis Nwako ◽  
Charles Emeka Nwolisa ◽  
Magaret-Lorritta Chidimma Nwako ◽  
Charles Nwaora Nwako
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Injection Site ◽  
Health Workers ◽  
Health Information System ◽  
Secondary Data ◽  
Allergic Reactions ◽  
District Health ◽  
Cross Sectional ◽  
Resource Limited

Background/Aim: Vaccines are said to be associated with side effects. The aim of the study was to show the pattern and distribution of adverse events following immunization observed with ChAdOx1-S [recombinant] Covid-19 vaccine after the first dose. Methodology: The study design was cross-sectional descriptive study over four weeks. We included records of 6589 high risk recipients of the vaccine and 33 of them who reported adverse events following immunization. The study used secondary data from the covid-19 vaccination register and District Health Information system II. Result: Out of 6589 individuals vaccinated with the first dose of ChAdOx1-S [recombinant] Covid-19 vaccine, 69.66% were female, 69.49% were fifty-five years or less, 86.04% were health workers and 27.26% had comorbidity. Only 0.5% of those vaccinated reported adverse events following immunization out of which 0.41% was systemic, 0.06% local and 0.03% allergic reactions. The commonest systemic side effects were headache and dizziness while local adverse events had pain at injection site as the commonest side effect. Multiple swelling in the buttock and swelling of the face and lip were the only two cases of allergic reactions reported. Eighty-eight percent of those who reported side effects did so on the day of vaccination. Conclusion The study reported less adverse events with the first dose of ChAdOx1-S [recombinant] Covid-19 vaccine than in other studies which included headache, dizziness and pain at the injection site. Most were reported in the first day of vaccination. There is need for encouraging vaccine recipients to report any adverse events following immunization.

scholarly journals Suspected Cardiovascular Side Effects of two Covid-19 Vaccines

2021 ◽  
Author(s):  
Karla Johanna Lehmann
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
European Medicines Agency ◽  
Vein Thrombosis ◽  
Cardiovascular Side Effects ◽  
Life Threatening ◽  
The Individual ◽  
A Current ◽  
Circulatory Disturbances ◽  
Cardiovascular Reactions

Fatalities or cardiovascular side effects of vaccines were rather uncommon in the past. So far, numerous reports of side effects and deaths associated with Covid-19 vaccination have been accepted behind the background of the pandemic situation. Cardiac and heart circulatory disturbances resp. cardiovascular side effects associated with the application of Covid-19 vaccines have not been recognized up to now with the exception of thrombotic/embolic side effects and cases of myocarditis. But the mechanism of action suggests that downregulation of ACE2 by non-neutralised spike proteins may have cardiovascular effects.The objective of this analysis was to determine the total number of reported adverse events and fatalities and to record suspected cardiovascular adverse events up to the cut-off date in European countries. Therefore, a current review/analysis of spontaneously reported fatalities as well as of adverse events after application of Covid-19 vaccines has been performed. Data were retrieved from the EudraVigilance web reports of the European Medicines Agency (EMA), partly also from the safety reports of the German PEI. Covid-19 vaccine-associated suspected side effects and related deaths are alarming. Surprisingly, numerous cardiovascular reactions were reported, many of which were life-threatening. Cardiac and heart circulatory caused fatalities alone accounted for about 33% of all ComirnatyR vaccine-related deaths. The second most important side effects were vascular thrombotic/embolic side effects, often also associated with serious consequences. Based on their quality and quantity, these side effects seem to be characteristic for spike-producing vaccines and do not appear to be substance-specific. Further investigations are needed to clarify the approximately 3.5 times more frequent cases of sinus vein thrombosis and the some different frequent cases of thrombotic/embolic events after VaxzevriaR. The hypothesis could be confirmed. Because of their importance and their sometimes life-threatening consequences, cardiovascular side effects need to be better communicated.Limitations of the investigation result from the individual reporting and recording procedure, the lack of detailed individual information and the lack of an appropriate comparison population.

Cutaneous Adverse Events during Vemurafenib Therapy

2014 ◽  
Vol 18 (4) ◽  
pp. 223-228 ◽  
Author(s):  
Shivani Felicia Chandrakumar ◽  
Jensen Yeung
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Squamous Cell ◽  
Case Series ◽  
Stage Iv ◽  
Therapeutic Benefit ◽  
Braf V600e ◽  
Life Threatening ◽  
The Common ◽  
Dose Reductions

Background: Vemurafenib, an oral agent that selectively targets the BRAF V600E mutation, has recently emerged as the mainstay of treatment in patients with BRAF-positive stage IV melanoma. A spectrum of cutaneous adverse events has been associated with vemurafenib, ranging from benign rashes to malignant side effects such as keratoacanthoma and squamous cell carcinoma. Objective: In this article, we review clinical data regarding the frequency and severity of the common dermatologic side effects associated with vemurafenib; case series and noncontrolled studies evaluating the safety of vemurafenib therapy are used to further characterize these adverse events. Conclusion: Benign vemurafenib-induced side effects generally tend not to be severe or life threatening, with most patients managed by dose interruptions, dose reductions, or topical therapies. Squamous cell carcinomas and keratoacanthomas associated with vemurafenib therapy are easily treated by simple excision of the lesion without discontinuation of vemurafenib. Thus, awareness of potential adverse events coupled with routine dermatologic assessment and timely management will allow for optimal therapeutic benefit in patients receiving vemurafenib therapy.

Identification of target small molecule tyrosine kinase inhibitors that need monitoring and clinical application of protocol for early detection of cancer therapeutics-related cardiac dysfunction using signal detection: An investigation of real world data

2020 ◽  
pp. 107815522093036
Author(s):  
Takahito Mizuno ◽  
Takamasa Sakai ◽  
Kouichi Tanabe ◽  
Koji Kozaki ◽  
Takumi Umemura ◽  
...  
Keyword(s):  
Side Effects ◽  
Early Detection ◽  
Adverse Events ◽  
Tyrosine Kinase ◽  
Signal Detection ◽  
Tyrosine Kinase Inhibitors ◽  
Cardiac Dysfunction ◽  
Kinase Inhibitors ◽  
Package Insert ◽  
Cancer Therapeutics

Purpose In order to detect cancer therapeutics-related cardiac dysfunction (CTRCD) early, we identified which drugs were to be monitored using signal detection and the package insert, and created and applied a protocol to address this. Methods Adverse event data recorded in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and January 2018 were used. Among small molecule tyrosine kinase inhibitors that are not described in the serious side-effects section of the package insert despite signal detection, tyrosine kinase inhibitors with severe side-effects in the background of cases reported by JADER database were selected to be monitored in clinical practice. We applied our findings clinically by creating a protocol to detect CTRCD early. All cases at Tosei General Hospital where the target tyrosine kinase inhibitors were administered from when they were first released in November 2019 were included. We compared the results from before and after we began the protocol to clarify its effects. Results We found that CTRCD was not described in the serious side-effect section of the package inserts for Bosutinib, Alectinib, and Osimertinib even though CTRCD signals were detected for them. Therefore, it is possible that we may have previously overlooked CTRCD. When we applied our protocol using Osimertinib as the target drug, we were able to detect CTRCD early in 5/21 (24%) patients. Conclusions It was clarified that the drug identification method used in this study for early detection of adverse events leads to early detection of adverse events when applied clinically.

Interferon beta-1b injection site reactions and necroses

1998 ◽  
Vol 4 (2) ◽  
pp. 70-73 ◽  
Author(s):  
Ann Reed Gaines ◽  
Frederick Varricchio
Keyword(s):  
Adverse Events ◽  
Injection Site ◽  
Relative Frequency ◽  
Interferon Beta ◽  
Clinical Presentation ◽  
Package Insert ◽  
Study Group ◽  
Injection Site Reactions ◽  
Clinically Significant ◽  
Multiple Sclerosis Study Group

We conducted a comprehensive review of selected adverse event reports that were submitted to the Food and Drug Administration (FDA) for interferon beta-1b during the first 30 months following licensure. The adverse events reviewed were injection site reactions, injection site necroses, and non-injection site necroses. These adverse events were selected because of the relative frequency of injection site reactions and because of the severity and sequelae of certain injection site and non-injection site necroses. Our review enabled us to characterize the clinical presentation and the treatment received, which were not described in the package insert or by the IFNB (interferon beta-1b) Multiple Sclerosis Study Group publication. The time of onset of the adverse events ranged from 1-29 months after initiation of interferon beta-1b treatment, with a mean of 1 month. In general, the more clinically significant adverse events (i.e., injection site necrosis and non-injection site necrosis) developed more slowly than the injection site reactions. Greater than 85% of the adverse events presented with one or two signs/symptoms, although the number of signs/symptoms ranged from 1-8. No predominance of treatments for the adverse events was observed. The most striking finding was that the overall sex ratio, which could be due to reporting artifacts, was 8.1: 1 female: male.

scholarly journals Safety and side effect profile of Pfizer-BioNTech COVID-19 vaccination among healthcare workers: A tertiary hospital experience in Singapore

2021 ◽  
Vol 50 (9) ◽  
pp. 703-711
Author(s):  
See Ming Lim ◽  
Hwang Ching Chan ◽  
Amelia Santosa ◽  
Swee Chye Quek ◽  
Eugene Hern Choon Liu ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Adverse Events ◽  
Injection Site ◽  
Side Effect ◽  
Healthcare Workers ◽  
Tertiary Hospital ◽  
University Hospital ◽  
Health Clinic ◽  
Common Symptom

ABSTRACT Introduction: Vaccination remains a key strategy to living endemically with COVID-19. The Pfizer-BioNTech COVID-19 vaccine was first granted interim authorisation for use in Singapore in December 2020. With overseas studies published about the safety and side effect profiles of mRNA COVID-19 vaccines focusing mainly on non-Asian populations, we described the side effects of Pfizer-BioNTech COVID-19 vaccination experienced by the healthcare workers (HCWs) in a tertiary hospital in Singapore. Methods: Data were obtained from the Occupational Health Clinic (OHC) at the National University Hospital in Singapore, which monitored staff for any adverse effects within 30 minutes postvaccination on-site and any adverse effects after that. A cross-sectional study among the vaccinated HCWs was conducted using an online survey, which established basic demographics, histories of allergies or atopic disorders, and adverse events encountered after dose 1 and dose 2 of vaccination. Results: No anaphylaxis was reported. Most common symptom was giddiness (32.7%) experienced by HCWs within 30 minutes. Adverse events attended post-vaccination by OHC were generally mild and self-limiting. From the survey, odds of experiencing an adverse event after dose 2 was significantly higher than after the first dose, especially for fever/chills (odds ratio [OR] 22.5). Fever/chills, injection site reactions, headache, aches and pains, and feeling unwell were significantly more common in HCWs below 60 years compared to those ≥60 years. An allergy to food (adjusted OR 2.7) and a history of eczema/sensitive skin (adjusted OR 2.6) were associated with a skin reaction not at injection site. Conclusion: The side effects experienced after Pfizer-BioNTech COVID-19 vaccines are generally self-limiting and mild, with no anaphylaxis reported. Keywords: COVID-19, infectious diseases, occupational medicine, side effects, vaccination

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