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npj Vaccines ◽  
2022 ◽  
Vol 7 (1) ◽  
Author(s):  
Paola Villanueva ◽  
Ushma Wadia ◽  
Nigel Crawford ◽  
Nicole L. Messina ◽  
Tobias R. Kollmann ◽  
...  

AbstractThe reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk factors for the development of BCG injection site abscess and regional lymphadenopathy. Injection site abscess occurred in 3% of 1387 BCG-vaccinated participants; the majority (34/41, 83%) resolved without treatment. The rate was higher in BCG-revaccinated participants (OR 3.6, 95% CI 1.7–7.5), in whom abscess onset was also earlier (median 16 vs. 27 days, p = 0.008). No participant with an abscess had a positive interferon-gamma release assay. Regional lymphadenopathy occurred in 48/1387 (3%) of BCG-vaccinated participants, with a higher rate in revaccinated participants (OR 2.1, 95% CI 1.1–3.9). BCG-associated lymphadenopathy, but not injection site abscess, was influenced by age and sex. A previous positive tuberculin skin test was not associated with local reactions. The increased risk of injection site abscess or lymphadenopathy following BCG revaccination is relevant to BCG vaccination policy in an era when BCG is increasingly being considered for novel applications.


2022 ◽  
Vol 0 (0) ◽  
Author(s):  
Sylvia Marshall ◽  
Sara Winter ◽  
John D. Capobianco

Abstract Pfizer-BioNTech BNT162b2 is one of the three U.S. Food and Drug Administration (FDA)-approved vaccines for the prevention of COVID-19. Its most common side effect, injection site pain, occurs because of locally recruited inflammatory mediators and is mitigated by the lymphatic system. Side effects may discourage individuals from receiving vaccines; therefore, reducing the duration of injection site pain can promote vaccination compliance. Osteopathic manipulative treatments (OMT) can directly affect the physiology underlying muscle soreness; however, there is currently no literature that supports the use of OMT in this scenario. In this case report, an otherwise healthy male presented with acute left deltoid soreness after receiving the Pfizer COVID-19 vaccine. The pain began 5 h prior to the visit. Three hours after being treated with lymphatic OMT, the severity of the pain was significantly reduced and was alleviated 8h after onset in comparison to the median duration of 24–48 h. He received his second dose 3 weeks later. This case report can provide future studies with the groundwork for further investigating the role of OMT in treating postvaccination muscle soreness, which can improve patient satisfaction and potentially promote vaccination compliance.


2022 ◽  
Vol 11 (1) ◽  
pp. 238
Author(s):  
Ji Yeon Park ◽  
Ji Young Lee ◽  
Seong Yoon Yi

Purpose: This study aimed to assess the incidence of axillary lymphadenopathy on ultrasound after COVID-19 vaccination and to investigate the factors affecting lymphadenopathy. Methods: We evaluated patients who had received a COVID-19 vaccination within 12 weeks before an ultrasound examination between August and October 2021. The incidence of vaccine-related ipsilateral axillary lymphadenopathy was evaluated using ultrasound. Age, sex, presence of axillary symptoms, injection site, vaccine type, interval from vaccination, and dose were compared between the groups with and without axillary lymphadenopathy. Results: We included 413 patients, 202 (49%) of whom showed axillary lymphadenopathy on ultrasound after COVID-19 vaccination. Age, interval from vaccine, vaccine brand, vaccine type, dose, and symptom were significantly different between the lymphadenopathy and non-lymphadenopathy groups (p < 0.001), while the injection site and sex were not. Receiving an mRNA vaccine was the most important factor for axillary lymphadenopathy (p < 0.001), followed by intervals of 1–14 (p < 0.001) and 15–28 days (p < 0.001), younger age (p = 0.006), and first dose (p = 0.045). Conclusion: COVID-19 vaccine-related axillary lymphadenopathy on ultrasound is common. mRNA type, an interval of 4 weeks, younger age, and first dose were the important factors. Breast clinicians should be well aware of these side effects when performing imaging examinations and provide accurate information to patients.


2021 ◽  
Vol 6 (6) ◽  
pp. 200-206
Author(s):  
N. O. Iakovenko ◽  
◽  
M. V. Ogloblina ◽  
O. K. Nuzhna

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


Author(s):  
Aleksandr Urakov ◽  
Natalya Urakova

It is established that very few modern high-quality drugs in the dosage form "Solution for injection" have isoosmotic activity in the range of 280-300 mosmol/l of water. The main part of solutions for injection is hypotonic or hypertonic solutions, which can have osmotic activity in the range of 0 - 4000 mosmol/l of water. The reason for this was that the osmotic activity of drugs is not included in the list of controlled indicators of drugs quality, so it is not subject to control. It is shown that the osmotic activity of drug solutions increases with an increase in the total concentration of all dissolved ingredients present in the solution.  It was found that an excessively high concentration of the drug in the solution gives it an excessively large hyperosmotic activity, which can cause a local irritant and cauterizing effect at the injection sites due to dehydration of the cells. Therefore, to exclude post-injection abscesses, it is proposed to dilute the hypertonic drug with water for injection until it is given isotonic activity.


2021 ◽  
Vol 55 (4) ◽  
Author(s):  
Aleš Vehar ◽  
Katja Vehar ◽  
Rebeka Lekše ◽  
Melita Peršolja

Uvod: Aplikacija intramuskularne injekcije predstavlja najpogosteje uporabljen način aplikacije injekcij. Namen raziskave je bil preučiti najnovejše ugotovitve s področja priprave vbodnega mesta in aplikacije intramuskularne injekcije.Metode: Izveden je bil sistematični pregled znanstvene in strokovne literature v mednarodnih podatkovnih bazah CINAHL, PubMed, The Cochrane Library ter ScienceDirect. Uporabili smo naslednje ključne besede: intramuscular injection, instramuscular vaccination, injection site, skin disinfection, injection technique. Pri iskanju smo uporabili tudi Boolove operatorje AND (IN) in OR (ALI). Iskanje literature je potekalo marca in aprila 2021. Za oceno kakovosti posameznih raziskav smo uporabili orodje Critical Appraisal Skills Programme.Rezultati: Izmed 4.208 identificiranih zadetkov je bilo v končno analizo vključenih 13 člankov. Ugotovitve smo združili v štiri vsebinske kategorije: (1) izbira vbodnega mesta, (2) tehnike intramuskularne injekcije, (3) razkuževanje vbodnega mesta, (4) aspiracija.Diskusija in zaključek: Med zaključki raziskav ni enotnega mnenja glede varne in strokovne aplikacije intramuskularne injekcije. Kot kažejo raziskave, je najprimernejše mesto aplikacije ventroglutealno področje. Razkuževanje vbodnega mesta pred aplikacijo v izvenbolnišničnem okolju ni potrebno, medtem ko je aspiracija priporočljiva zgolj na dorzoglutelnem mestu. Priporoča se aplikacija s tehniko trakcija kože – pritisk – hitro sproščanje mišic, z izbiro igle ob upoštevanju debeline podkožnega maščevja, mesta za aplikacijo in gostote zdravila. Potrebna bi bila izvedba dodatnih raziskav, s katerimi bi lahko oblikovali priporočila za optimalno tehniko intramuskularne injekcije. 


Author(s):  
Gopal Lama ◽  
Runa Jha ◽  
Sagar K Rajbhandari ◽  
Jenish Neupane ◽  
Anup Bastola

Introduction: As the COVID-19 pandemic continues to unfold, rapid global efforts to develop and test vaccines against SARS-CoV-2 have started. Adverse events after immunization are a common issue seen in many vaccines. This study aims at finding the adverse events following the first dose of CovishieldTM vaccine administered to the staffs at two health institutions in Kathmandu. Methods: This was a descriptive cross sectional study conducted among the staffs at National Public Health Laboratory and Sukraraj Tropical and Infectious Disease Hospital, Kathmandu between February to April, 2021. It included 162 participants who had taken the first dose of CovishieldTM vaccine. Ethical approval was taken from Nepal Health Research Council. Statistical Package for the Social Sciences were used for analysis. Results: Various adverse events were seen in 139 (85.8%) participants which were all minor events. None of the participants developed serious adverse events. Very common adverse events experienced were Injection site pain 116 (71.6%), myalgia 76 (46.9%), chills 68 (42%), headache 65 (40.1%), fever 54 (33.3%), dizziness 43 (26.5%) and nausea 20 (12.4%). Similarly, the range of time period from onset to recovery of adverse event was different for different adverse reactions. Conclusions: The adverse events following first dose of CovishieldTM vaccine were all minor reactions with commonest being injection site pain followed by myalgia, chills, headache and fever.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 1054-1054
Author(s):  
Ann Falsey ◽  
Kristi Williams ◽  
Efi Gymnopoulou ◽  
Stephan Bart ◽  
John Ervin ◽  
...  

Abstract Respiratory syncytial virus (RSV) may cause severe lower respiratory tract disease in older adults and there is currently no approved vaccine. We assessed the safety and reactogenicity of an Ad26.RSV.preF-based vaccine in a randomized, double-blind, placebo-controlled Phase 2b proof-of-concept trial in adults aged ≥65 years (CYPRESS; NCT03982199). Prior to the RSV season, participants were randomized 1:1 to receive an Ad26.RSV.preF-based vaccine or placebo. Solicited adverse events (AEs; fatigue, headache, nausea, myalgia, fever, injection site reactions) and unsolicited AEs were assessed from time of vaccination to Day 8 and Day 29, respectively, in a safety subset of 695 participants (vaccine, n=348; placebo, n=347). All participants were followed for serious AEs (SAEs) until the end of the RSV season or 6 months after vaccination, whichever occurred later. A total of 5728 participants were randomized and received vaccine or placebo (n=2891 in each group). In the safety subset, the frequency of solicited AEs and Grade ≥3 solicited AEs was 51.4% and 3.2% in the vaccine group and 20.2% and 0.6% in the placebo group, respectively. The most frequent solicited AEs in the vaccine group were fatigue, myalgia, headache, and injection site pain/tenderness. The rates of unsolicited AEs and Grade ≥3 unsolicited AEs were similar between the vaccine (16.7% and 1.7%) and placebo (14.4% and 1.4%) groups. In the overall study population, the rate of SAEs was similar between groups (vaccine, 4.6%; placebo, 4.7%); none were considered related to the vaccine. The Ad26.RSV.preF-based vaccine was safe and well tolerated in adults aged ≥65 years.


2021 ◽  
Vol 2 (12) ◽  
pp. 1315-1321
Author(s):  
Misheck Chileshe ◽  
Geoffrey Mupeta ◽  
Maisa Kasanga ◽  
Ruth Lindizyani Mfune ◽  
Steward Mudenda ◽  
...  

Introduction: COVID-19 continues to be a public health concern despite several practical interventions to curb its spread. Now, widespread vaccination appears to be the most important strategy in winning the fight against this deadly pandemic by promoting herd immunity. However, a lack of independent and local studies on vaccines’ safety may adversely impact the vaccine uptake and eventually the overarching goal of reducing disease transmission. Objective: To determine the prevalence of adverse events post COVID-19 vaccination amongst the adult Zambia population. Methods: This was a descriptive cross-sectional study conducted among recipients of COVID-19 vaccines in Zambia. The study was conducted between July and August 2021. 584 adult individuals who had access to the questionnaire were enrolled. Relationships between patients' demographics and Adverse Events (AEs) were assessed using the chi-square (χ2) test given the categorical nature of the data. Results: Pain at the injection site (79.8%), headache (57.4%), fatigue (55.5%), chills (52.6%), fever (42.3%), and joint pains (37.5%) were the most commonly reported adverse events. When stratified by gender, pain at the injection site (p = 0.01), limitation of arm movement (p < 0.001), chills (p = 0.017), headache (p = 0.044), fatigue (p = 0.004), nausea or vomiting (p < 0.001) were statistically significant, with females mostly affected. There was a statistically significant difference in the case of limitation of arm movement (20.7% vs. 9.9%, p = 0.031), chills (54.8% vs. 36.6%, p = 0.004), headache (59.6% vs. 40.8%, p = 0.003) and fatigue (57.5% vs. 40.8%, p = 0.008) between those 49 years and below compared to those above 50 years. Conclusion: Our study provides evidence of adverse events being experienced by the recipient of COVID-19 vaccines and that these have been mainly mild. Healthcare authorities need to educate the public about the possible adverse events associated with COVID-19 vaccines and how to report these events should they experience some. This will improve pharmacovigilance of adverse events associated with COVID-19 vaccines.


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