Adverse events following immunisation of COVID-19 vaccine among health care workers in the first phase of vaccination.

INTRODUCTION: The new COVID-19 vaccine was met with worldwide overwhelming uncertainties pertaining to its safety profile, effectiveness, and potential adverse reactions when it was first introduced. This led to vaccine refusal and delay in vaccine uptake in many countries including Malaysia. The objective of this study was to determine the Adverse Events Following Immunization (AEFI) to the COVID-19 vaccine. MATERIALS AND METHODS: A retrospective cross-sectional study was conducted among healthcare workers who received the COVID-19 vaccine during the first phase of immunisation from eight public primary clinics in Johor Bahru district. Data were collected between May and September 2021 using a self-administered questionnaire. RESULTS: A total of 240 healthcare workers participated and all of them received the Pfizer Messenger RNA vaccine. Our study found that a large majority of vaccine recipients (87.5%, n=210) experienced AEFI to COVID-19 vaccine for either the first, second, or both doses. More than 80% of them experienced more than one type of AEFI. The most common AEFI reported during the first and second dose was localised symptom such as pain at injection site (60-68%), pain on the injected arm (52-61%), and swelling at injection site (32-33%). Common systemic symptoms were fever (22- 57%), myalgia (20-45%), and dizziness (24-26%). Although a large majority experienced AEFI, these reactions were mostly of mild to moderate severity (47.3-73.6%). The mean duration of AEFI onset was within 30 minutes to about 1 day (0.33-22.5 hours) of injection and lasted between 30 minutes and 2.5 days. There was no association between demographic characteristic of participants and severity of AEFI to COVID-19 vaccine. Mean duration of fever was significantly (p=0.005) longer after the second dose (34.2 hours) of vaccine compared to first (20.6 hours) CONCLUSION: This study shows that a large majority of COVID-19 vaccine recipients experienced AEFI; however, these reactions were mostly of mild to moderate severity and lasted between 30 minutes and 2.5 days. A large majority experienced more than one type of AEFI. The most common AEFI was localised reactions consisting of pain and swelling at the injection site and pain on the injected arm. The most common systemic reactions were fever, myalgia, and dizziness. Duration of fever was significantly longer after the second dose.

Adverse events after BNT162b2 mRNA COVID-19 vaccination in health care workers and medical students in Japan.

To control the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the promotion of vaccination is important. However, adverse reactions following vaccination remain a concern. To investigate adverse events in the vaccinated Japanese population, we conducted a survey-based study among health care workers, including medical doctors and nurses; other medical staff; and medical university faculty, staff, and students in a single medical school and affiliated hospital in Japan. In addition, we analyzed the association of different adverse events with individual factors (e.g., age, sex) by performing network analysis. While young age and female sex are often considered risk factors for more severe adverse events, the regression models showed neither age nor sex was associated with local injection-site reactions after the second dose in this study. In contrast to local reactions, systemic adverse events were associated with young age and female sex. However, myalgia was unique in that it was not associated with younger age even though the network analysis showed that myalgia was consistently related to arthralgia and belonged to the group of systemic events after both the first and second vaccine doses. Further study is needed to ensure safe and effective vaccination to aid in controlling the COVID-19 pandemic.

Efficacy and Safety of Lianhua Qingwen for Patients with COVID-19: A Systematic Review and Meta-Analysis.

BACKGROUND: Corona virus disease 2019 (COVID-19) has spread around the world since its outbreak, and there is no ascertained effective drug up to now. Lianhua Qingwen (LHQW) has been widely used in China and overseas Chinese, which had some advantages in the treatment of COVID-19. OBJECTIVE: To evaluate the efficacy and safety of LHQW for COVID-19 by conducting a systematic review with meta-analysis. METHODS: A comprehensive literature search was conducted in 12 electronic databases from their establishment to October 30, 2021. Note Express 3.2.0 was used for screening of trials, and the data was independently extracted in duplicate by 2 researchers. The risk of bias of randomized controlled trials (RCTs) and retrospective studies were assessed by using the Cochrane collaboration tool and Newcastle Ottawa Scale, respectively, followed by data analysis using RevMan 5.3. The RCTs or retrospective studies to treat COVID-19 using LHQW were included. The intervention measures in the experimental group were LHQW alone or combined with chemical drugs (LCWC), and that in the control group were chemical drugs (CDs). Outcome measures included computed tomography (CT) recovery rate, disappearance rates of primary (fever, cough, fatigue), respiratory, gastrointestinal and other symptoms, exacerbation rate and adverse reaction. Subgroup analysis was conducted according to whether LHQW was combined with CDs and the different treatment methods in the control group. RESULTS: Nine trials with 1,152 participants with COVID-19 were included. The CT recovery rates of LHQW and LCWC were 1.36 and 1.32 times of CDs, respectively (P<0.05). Compared with CDs, LCWC remarkably increased the disappearance rates of fever, cough, fatigue, expectoration, shortness of breath, and muscle soreness (P<0.05). LHQW also obviously decreased the exacerbation rate, which was 0.45 times of CDs alone (P<0.05). There was no obvious difference between LCWC and CDs in adverse reaction (P>0.05). CONCLUSIONS: LHQW was more suitable for treating COVID-19 patients with obvious expectoration, shortness of breath and muscle soreness. LHQW had advantages in treating COVID-19 with no obvious exacerbation. (PROSPERO No. CRD42021235937).

Long-term adverse events of three COVID-19 vaccines as reported by vaccinated physicians and dentists, a study from Jordan and Saudi Arabia.

Assessment of safety of COVID-19 vaccines is an ongoing process. This study aims to explore long-term adverse events reported by physicians and dentists who received at least two COVID-19 vaccine doses. A group of physicians and dentists were invited to complete a validated questionnaire that was composed of items on: socio-demographics, medical history, administered vaccines, and long-term adverse events (LTAE). Data of a total of 498 practitioners were included. Age ranged from 22 to 71 years (mean age= 35.75 ± 11.74) with a female majority (N = 348, 69.9%). The most frequently administered vaccines were Pfizer-BioNtech, Sinopharm and AstraZeneca vaccines. A total of 80 (16.0%) participants reported LTAEs which were mainly fatigue, menstrual disturbances, myalgia, arthralgia, dizziness, and headache (N = 32, 15, 8, 6, 4, and 4, respectively). There was no statistically significant association between LTAEs and: age, gender, or medical history (P > .05). The collective symptoms of fatigue, myalgia, arthralgia, dizziness, and headache were significantly associated with Sinopharm vaccine (P = .04). This was further confirmed by general linear multivariate model analysis. Less than 20% of COVID-19 vaccine recipients may complain of LTAEs that are mostly fatigue-related. It seems that factors such as age, gender, and medical status play a negligible role in development of these AEs. On the other hand, Sinopharm vaccine showed the highest significant association with these AEs followed by AstraZeneca vaccine.

Muscle pain and muscle weakness in COVID19 patients: Cross-talk with statins - Preliminary results.

BACKGROUND: Muscle pain and muscle weakness, common symptoms among statin-treated patients, may worsen with COVID-19 infection. AIMS: The aim of the paper was to find out if concomitant COVID-19 infections increase the frequency of specific side effects of statins such as muscle pain and muscle weakness. METHOD: A total of 66 patients diagnosed with COVID-19 without comorbidities participated in the study. The patients were divided into two groups: statin-users who had not experienced adverse effects of statins in the past (statin group (SG)) and patients who had not used any drugs in the past six months (control group (CG)). The severity of muscle pain and creatinine kinase (CK) activity was evaluated in each patient, and muscle weakness was confirmed by a dynamometer test (grip strength on both hands). RESULTS: In SG, muscle pain was more common and it was characterized by a high level of intensity. Muscle weakness occurred more frequently in the SG and it was more frequent compared to CG. The CK parameter was observed to be higher in the SG compared to the CG and was often associated with the severity of muscle pain in the range of moderate to severe. CONCLUSIONS: Our study indicates that COVID-19 is associated with the higher risk of occurrence of typical statin-related side effects, especially with more advanced age, which should be considered in future trials and treatments.

Reactogenicity and immunogenicity of heterologous prime-boost immunization with COVID-19 vaccine.

BACKGROUND: The objective of the present work was to assess the reactogenicity and immunogenicity of heterologous COVID-19 vaccination regimens in clinical trials and observational studies. METHODS: PubMed, Cochrane Library, Embase, MedRxiv, BioRxiv databases were searched in September 29, 2021. The PRISMA instruction for systemic review was followed. Two reviewers independently selected the studies, extracted the data and assessed risk of bias. The quality of studies was evaluated using the New Castle-Ottawa and Cochrane risk of instrument. The characteristics and study outcome (e.g., adverse events, immune response, and variant of concern) were extracted. RESULTS: Nineteen studies were included in the final data synthesis with 5 clinical trials and 14 observational studies. Heterologous vaccine administration showed a trend toward more frequent systemic reactions. However, the total reactogenicity was tolerable and manageable. Importantly, the heterologous prime-boost vaccination regimens provided higher immunogenic effect either vector/ mRNA-based vaccine or vector/ inactivated vaccine in both humoral and cellular immune response. Notably, the heterologous regimens induced the potential protection against the variant of concern, even to the Delta variant. CONCLUSIONS: The current findings provided evidence about the higher induction of robust immunogenicity and tolerated reactogenicity of heterologous vaccination regimens (vector-based/mRNA vaccine or vector-based/inactivated vaccine). Also, this study supports the application of heterologous regimens against COVID-19 which may provide more opportunities to speed up the global vaccination campaign and maximize the capacity to control the pandemic.

Emergency Department Utilization by In-hospital Healthcare Workers after COVID-19 Vaccination.

BACKGROUND: This is an observational study to analyze an emergency department (ED) utilization pattern of coronavirus disease 2019 (COVID-19) vaccinated in-hospital healthcare workers (HCWs). METHODS: We included 4,703 HCWs who were administered the first dose of the COVID-19 vaccine between March 4 and April 2, 2021, in a tertiary hospital in Korea where fast-track and post-vaccination cohort zone (PVCZ) were introduced in ED. We analyzed data of participants' age, sex, occupation, date and type of vaccination, and their clinical information using SPSS v25.0. RESULTS: The sample comprised HCWs, who received either the ChAdOx1 (n = 4,458) or the BNT162B2 (n = 245) vaccines; most participants were female (73.5%), and 81.1% were under 50 years old. Further, 153 (3.3%) visited the ED and reported experiencing fever (66.9%) and myalgia (56.1%). Additionally, 91 (59.5%) of them were in their 20s, and 106 (67.5%) were assigned to the PVCZ. Lastly, 107 (68.2%) of the patients received parenteral management. No patient required hospitalization. CONCLUSION: In conclusion, vaccinated HCWs who visited the ED with adverse events had a high incidence of fever and a low likelihood of developing serious illnesses. As the COVID-19 vaccination program for Korean citizens continues to expand, strategies to minimize unnecessary ED overcrowding should be put into effect.