Adverse events report of inactivated COVID-19 vaccine from 4040 healthcare workers

Author(s):  
Selma Tosun ◽  
Hülya Ozkan Ozdemir ◽  
Esin Erdogan ◽  
Seniz Akcay ◽  
Murat Aysin ◽  
...  
Drug Safety ◽  
2007 ◽  
Vol 30 (10) ◽  
pp. 919-990 ◽  
Author(s):  
J Addison ◽  
A Okraku-Yirenkyi ◽  
A NO Dodoo ◽  
A Appiah-Danquah ◽  
J Nee-Whang ◽  
...  

2021 ◽  
Author(s):  
Eugenia Isabel Gorlin ◽  
Vera Bekes ◽  
Laura M. Mazer

The challenges faced by healthcare workers (HCWs) on the frontlines of the COVID-19 pandemic have been widely analogized to the experience of military service members, both in terms of general burnout and the mental health effects of frequent trauma exposure. This analogy has the potential to yield a wealth of science-based recommendations for addressing the pandemic’s psychological impacts on frontline HCWs, and in particular the challenge of helping HCWs cope with adverse events for which they bear some actual or perceived responsibility. As we will argue, the “second victim” framework that currently guides the medical system’s approach to supporting these individuals is misleading at best and harmful at worst. This paper suggests an alternative, more agentic framework for supporting these HCWs—one that normalizes the acknowledgement, emotional processing, and active remediation of errors as part of what it means to exemplify the core values of a healer. Drawing on psychological research with military personnel and other trauma survivors, we summarize the key principles of this alternative framework, and we recommend strategies that medical facilities can adopt to help HCWs cope more resiliently with errors and adverse events during the pandemic and beyond.


2016 ◽  
Vol 146 (4) ◽  
pp. 155-159
Author(s):  
Cesar Velasco Munoz ◽  
Víctor-Guillermo Sequera ◽  
Alba Vilajeliu ◽  
Marta Aldea ◽  
Guillermo Mena ◽  
...  

2009 ◽  
Vol 30 (10) ◽  
pp. 1000-1005 ◽  
Author(s):  
Kathleen E. Corey ◽  
Julie C. Servoss ◽  
Deborah R. Casson ◽  
Arthur Y. Kim ◽  
Gregory K. Robbins ◽  
...  

Background and Objective.Hepatitis C virus (HCV) transmission occurs in 0.2%-10% of people after accidental needlestick exposures. However, postexposure prophylaxis is not currently recommended. We sought to determine the safety, tolerability, and acceptance of postexposure prophylaxis with peginterferon alfa-2b in healthcare workers (HCWs) exposed to blood from HCV-infected patients.Design.Open-label pilot trial of peginterferon alfa-2b for HCV postexposure prophylaxis.Setting.TWO academic tertiary-referral centers.Methods.HCWs exposed to blood from HCV-infected patients were informed of the availability of postexposure prophylaxis. Persons who elected postexposure prophylaxis were given weekly doses of peginterferon alfa-2b for 4 weeks.Results.Among 2,702 HCWs identified with potential exposures to bloodborne pathogens, 213 (7.9%) were exposed to an HCV antibody-positive source. Of 51 HCWs who enrolled in the study, 44 (86%) elected to undergo postexposure prophylaxis (treated group). Seven subjects elected not to undergo postexposure prophylaxis (untreated group). No cases of HCV transmission were observed in either the treated or untreated group, and no cases occurred in the remaining 162 HCWs who did not enroll in this study. No serious adverse events related to a peginterferon alfa-2b regimen were recorded, but minor adverse events were frequent.Conclusion.In this pilot study, there was a lower than expected frequency of HCV transmission after accidental occupational exposure. Although peginterferon alfa-2b was safe, because of the lack of HCV transmission in either the treated or untreated groups there is little evidence to support routine postexposure prophylaxis against HCV in HCWs.


2007 ◽  
Vol 28 (6) ◽  
pp. 695-701 ◽  
Author(s):  
A. Luque ◽  
S. Hulse ◽  
D. Wang ◽  
U. Shahzad ◽  
E. Tanzman ◽  
...  

Objective.To assess adverse events associated with antiretroviral regimens for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP), with a particular focus on the treatment combination of zidovudine, lamivudine, and tenofovir (ZDV-3TC-TDF).Methods.Retrospective chart review for individuals who received HIV PEP for occupational and nonoccupational exposure, and multivariate analyses to identify risk factors for noncompletion of PEP and adverse events associated with PEP.Setting.University of Rochester Health Service Occupational Health Program and University of Rochester AIDS Center.Participants.Healthcare workers who received HIV PEP for occupational exposure from January 1, 1999, to December 31, 2004, and individuals who received HIV PEP for nonoccupational exposure from January 1, 2002, to December 31, 2004.Results.We found increased rates of nausea among subjects who received treatment with ZDV-3TC-TDF and subjects who received treatment with zidovudine, lamivudine, and indinavir (ZDV-3TC-IDV). Analyses showed that female sex was a risk factor for nausea. Compared with subjects who received treatment with ZDV-3TC-TDF, subjects who received treatment with ZDV-3TC-IDV were less likely to not complete the HIV PEP for occupational exposure.Conclusion.Preventive treatment of adverse events may be necessary to ensure completion of HIV PEP.


Drug Safety ◽  
2013 ◽  
Vol 36 (4) ◽  
pp. 259-266 ◽  
Author(s):  
Daniel N. A. Ankrah ◽  
Aukje K. Mantel-Teeuwisse ◽  
Marie L. De Bruin ◽  
Philip K. Amoo ◽  
Charles N. Ofei-Palm ◽  
...  

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1379
Author(s):  
Sung-Hee Lim ◽  
Seong-Hyeok Choi ◽  
Bora Kim ◽  
Ji-Youn Kim ◽  
Young-Sok Ji ◽  
...  

The COVID-19 pandemic is changing rapidly and requires different strategies to maintain immunization. In Korea, different COVID-19 vaccines are recommended and available for various populations, including healthcare workers (HCWs) at high risk of SARS-CoV-2 infection. We plan to evaluate the adverse events (AEs) and immunogenicity of the BNT162b2 and ChAdOx1 vaccines in HCWs at a single center. This cohort study included HCWs fully vaccinated with either BNT162b2 or ChAdOx1. Blood samples were taken eight weeks after the second vaccination with both COVID-19 vaccines and six months after the second vaccination from participants with the BNT162b2 vaccine. The primary endpoint for immunogenicity was the serum neutralizing antibody responses eight weeks after vaccination. The secondary endpoint was the incidence of various AEs within 28 days of each vaccination. Between 16 March and 23 June 2021, 115 participants were enrolled (65 in the ChAdOx1 group and 50 in the BNT162b2 group). Significantly higher surrogate virus neutralization test (sVNT) inhibition was observed in participants vaccinated with two doses of BNT162b2 (mean (SD) 91.4 (9.68)%) than in those vaccinated with ChAdOx1 (mean (SD) 73.3 (22.57)%). The effectiveness of the BNT162b2 vaccine was maintained across all age and gender categories. At six months after the second dose, serum antibody levels declined significantly in the BNT162b2 group. The main adverse events, including fever, myalgia, fatigue, and headache, were significantly higher in the ChAdOx1 group after the first dose, whereas, after the second dose, those AEs were significantly higher in the BNT162b2 group (p < 0.05). Two doses of either the ChAdOx1 or the BNT162b2 COVID-19 vaccine resulted in very high seropositivity among the HCWs at our center. The quality of the antibody response, measured by sVNT inhibition, was significantly better with the BNT162b2 vaccine than with the ChAdOx1 vaccine. There was no significant association between neutralizing antibody response and AE after each vaccination in our cohort.


2021 ◽  
Author(s):  
Nasamon Wanlapakorn ◽  
Ritthideach Yorsaeng ◽  
Harit Phowatthanasathian ◽  
Nungruthai Suntronwong ◽  
Sitthichai Kanokudom ◽  
...  

Introduction: In August 2021, Thailand imported the BNT162b2 mRNA COVID-19 vaccine. The prioritised group to receive the BNT162b2 vaccine were health professionals. The BNT162b2 vaccine scheduled for healthcare workers were two-dose regimen administered three weeks apart, the third dose booster in two-dose inactivated CoronaVac vaccine recipients or as a second dose in health professionals who had received the CoronaVac or adenoviral-vectored (ChAdOx1-S) vaccine as the first dose regardless of the interval between the first and second dose. Methods: This study aims to evaluate the immunogenicity of the heterologous prime boost CoronaVac followed by BNT162b2 in health professionals. Results: The CoronaVac/BNT162b2 vaccine recipients elicited higher neutralizing activity against the original Wuhan and all variants of concern than in the recipients of the two-dose CoronaVac. Conclusions: The heterologous CoronaVac/BNT162b2 could be used as an alternative regimen in countries experiencing the vaccine shortages and in individuals experiencing the adverse events following CoronaVac.


Author(s):  
ANDREA CHONG VALBUENA ◽  
Isabel De-Jesus-Maria ◽  
Adriana Agurto-Ramírez ◽  
Francesc Puchades Gimeno ◽  
Mercedes Melero-García

Introduction: The Spanish Society of Immunology recently warned that a history of past COVID-19 could result in a higher incidence of adverse events (AEs) related to vaccination. We set out to analyze whether there were any differences in AEs between healthcare workers vaccinated for COVID-19 (either after the first or second dose) who had had a prior diagnosis SARS-CoV-2 infection compared to those who had not had COVID-19 before vaccination. Methods: This was a retrospective cohort study in a population of healthcare workers. AEs related to the first and second doses of the Pfizer vaccine were recorded. We compared the incidence of AEs and compared individuals with 0–3 different AEs to those with 4 or more AEs. The relative risks (RR) and their 95% confidence intervals were calculated. Results: Past infection was associated with having more AEs after the first dose (p < 0.001), but not the second one (p = 0.476), as well as a higher incidence of AEs (p < 0.001). Common AEs that were statistically associated with past COVID infection included arthralgia, asthenia, fever, chills, headache, and myalgia (p ≤ 0.001). The RR for having an increased absolute number of different AEs was 1.18 (95%CI [1.05, 1.33]) after the first dose and 1.05 (95%CI [0.96, 1.14]) after the second dose. Conclusions: Our results showed that the incidence of AEs was higher in individuals with a history of prior COVID-19 infection.


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