Self-reported Adverse Effects Research Articles

Safety in the application of high-velocity low-amplitude technique in upper cervical in elderly: Preliminary study

Background: The literature is still controversial regarding the safety of applying high-velocity, low-amplitude (HVLA) techniques to the upper cervical spine, as well as the effects on heart rate variability (HRV) in the elderly. To date, there are no studies reporting the safety of applying these techniques to elderly. Objective: To verify the safety and immediate effects on HRV after applying an HVLA technique to elderly, for the purpose of conducting a future clinical trial. Materials and Methods: This is a preliminary, randomized, crossover study. Six physically active elderly individuals without cardiovascular disease were recruited. The subjects underwent two interventions, with a seven-day interval between them: intervention one consisted of an HVLA technique to the upper cervical spine, while intervention two was a simulated (sham) technique. Data on self-reported symptoms after applying the techniques were collected, in addition to HRV, to assess autonomic function. Results: There were no records of immediate adverse effects after applying the intervention techniques. However, a significant increase in the root means square difference between adjacent normal RR intervals over a time interval (RMSSD) and in the instantaneous beat-to-beat heart rate recording (SD1) was observed in the HVLA group when compared to the sham group. Conclusion: The application of the HVLA technique in the upper cervical spine did not produce self-reported adverse effects in elderly. The HVLA technique increased the activity of the parasympathetic nervous system, producing adjustments in HRV, thus indicating that there may be a significant parasympathetic stimulation in elderly.

Distressed personality is associated with late adverse effects in long-term survivors of Hodgkin lymphoma.

There are few studies of personality traits in long-term Hodgkin lymphoma survivors (HLSs) treated according to contemporary stage-and risk-adapted approaches. The Distressed Personality (DP) Scale covers negative affectivity and social inhibition. We examined differences in self-reported late adverse effects (LAEs) between HLSs with and without DP and other explanatory variables. This cross-sectional questionnaire-based study included a population-based cohort of HLSs treated from 1997 to 2006, aged 8-49 years at diagnosis, and alive in 2016. Among 518 eligible HLSs, 303 responded (58%), and 294 completed the DP scale. DP was defined by scores above cut-off on both the negative affectivity and social inhibition subscales. LAEs studied were major depression, posttraumatic stress disorder, sleep problems, obesity, neuropathy, fatigue, memory problems, and general health. DP and 10 other explanatory variables were tested against LAEs as dependent variables in multivariable regression analyses. The mean age at survey was 45.9 years (standard deviation [SD] 4.6), mean follow-up time 16.7 years (SD 3.0), and 48% were females. Eighty-two HLSs had DP (28%, 95% confidence interval 23% - 33%). All LAEs except obesity were significantly more common/had higher mean score in HLSs with DP. In multivariable analyses, presence of DP was significantly associated with all LAEs except obesity. The presence of DP is common among HLSs. The presence of DP was associated with most self-report LAEs examined. Including assessment of personality traits in the survivorship care plans of HLSs should be considered. Prospective studies assessing the influence of pretreatment DP on LAEs are warranted.

The effect of a single session of psychological first aid in the emergency department on PTSD and depressive symptoms three months post-intervention: results of a randomised controlled trial

ABSTRACT Background: Despite its popularity, evidence of the effectiveness of Psychological First Aid (PFA) is scarce. Objective: To assess whether PFA, compared to psychoeducation (PsyEd), an attention placebo control, reduces PTSD and depressive symptoms three months post-intervention. Methods: In two emergency departments, 166 recent-trauma adult survivors were randomised to a single session of PFA (n = 78) (active listening, breathing retraining, categorisation of needs, assisted referral to social networks, and PsyEd) or stand-alone PsyEd (n = 88). PTSD and depressive symptoms were assessed at baseline (T0), one (T1), and three months post-intervention (T2) with the PTSD Checklist (PCL-C at T0 and PCL-S at T1/T2) and the Beck Depression Inventory-II (BDI-II). Self-reported side effects, post-trauma increased alcohol/substance consumption and interpersonal conflicts, and use of psychotropics, psychotherapy, sick leave, and complementary/alternative medicine were also explored. Results: 86 participants (51.81% of those randomised) dropped out at T2. A significant proportion of participants in the PsyEd group also received PFA components (i.e. contamination). From T0 to T2, we did not find a significant advantage of PFA in reducing PTSD (p = .148) or depressive symptoms (p = .201). However, we found a significant dose–response effect between the number of delivered components, session duration, and PTSD symptom reduction. No significant difference in self-reported adverse effects was found. At T2, a smaller proportion of participants assigned to PFA reported increased consumption of alcohol/substances (OR = 0.09, p = .003), interpersonal conflicts (OR = 0.27, p = .014), and having used psychotropics (OR = 0.23, p = .013) or sick leave (OR = 0.11, p = .047). Conclusions: Three months post-intervention, we did not find evidence that PFA outperforms PsyEd in reducing PTSD or depressive symptoms. Contamination may have affected our results. PFA, nonetheless, appears to be promising in modifying some post-trauma behaviours. Further research is needed.

Assessing the effectiveness of virtual reality to promote empathy for patients through a mixed-methods study

ObjectiveTo describe the implementation and outcomes of EmpathyVR, an immersive experience using virtual reality (VR) to promote empathy for patients with physical limitations due to chronic diseases. MethodsFirst-year student pharmacists participated in a learning experience that incorporated VR and stiff gloves to simulate physical limitations associated with color-blindness and arthritis, respectively. Students completed pre- and post-intervention surveys that included the Kiersma-Chen Empathy Scale and measures of immersion, user enjoyment, perceived usefulness for learning, and adverse effects of the experience. A focus group was also conducted with 6 students to obtain additional feedback on the learning experience. ResultsOf the 132 students who were enrolled in the program, 131 completed the assigned tasks; 117 of these agreed to participate in the study, and their data were included in the analyses. There was a significant improvement in empathy scores in the cognitive domain from pre- to post-intervention. Post-intervention survey results also demonstrated a high degree of immersion in the experience, high levels of self-reported enjoyment, and high levels of perceived usefulness of the activity to support learning. There was a low to moderate incidence of minor self-reported adverse effects from the activity. Focus group feedback was also positive. One student stated, “… it really allowed you to think and put yourself in their shoes.” ConclusionImplementation of a VR-based learning activity into the first semester of the PharmD curriculum was successful and resulted in improved student empathy scores and a positive learning experience.

COVID-19 Booster Vaccination Adverse Effects and Willingness to Receive a Yearly Booster Dose among Members of Health Sciences Faculties: A Descriptive Cross-Sectional Study

ABSTRACT Background: New severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and waning vaccine efficacy led to the administration of booster doses. Healthcare workers (HCWs) are vulnerable to contract the infection, and vaccination hesitancy in this group may have an impact on vaccine uptake among the general public. Aims: This study aimed to (1) assess the prevalence of self-reported adverse effects (AEs) after the first booster dose vaccine, (2) evaluate the AEs between the homologous and heterologous booster vaccines, and (3) evaluate the willingness to receive a hypothetical yearly booster dose. Materials and Methods: An online, cross-sectional, self-administered, structured questionnaire was distributed to members of the health sciences faculties (HSFs), XXXX University, Malaysia. Convenience sampling was adopted, and descriptive statistics was used to interpret the results. Results: About 67.1% of participants experienced systemic or local AEs. The common AEs were pain at the site of injection (60.2%), fatigue (45.7%), headache (31.6%), and fever (24.7%). About 64% of our participants believed that the booster dose provided extra immunity against the coronavirus disease 2019 (COVID-19) infection and 57.7% of participants expressed concern over the “mix–match” of vaccination. About 78% of the participants were keen to receive the hypothetical yearly booster dose. The severity of AEs between the booster dose and the primary dose was statistically insignificant (P < 0.159). Conclusion: Booster vaccination AEs were similar to the primary dose. However, a higher severity of AEs occurring in heterologous vaccine receivers was noted in our study.

Self-reported side effects of COVID-19 vaccines among the public.

The safety, side effects and efficacy profile of COVID-19 vaccines remain subjects of ongoing concern among the public in Malaysia. The aim of this study was to determine the types of adverse effects following immunisation with COVID-19 vaccines and the differences based on various types of COVID-19 vaccines to raise public awareness and reduce vaccine hesitancy among the public. A total of 901 Malaysian adults (≥18 years) who received various COVID-19 vaccines were selected to participate in our cross-sectional study through an online survey between December 2021 and January 2022. A total of 814 (90.3%) of the participants reported ≥1 side effect following COVID-19 immunisation. Of these, the predominant symptoms were swelling at the injection site (n = 752, 83.5%), headache (n = 638, 70.8%), pain or soreness at the injection site (n = 628, 69.7%), fatigue or tiredness (n = 544, 60.4%), muscle weakness (n = 529, 58.7%) and diarrhea (n = 451, 50.1%). Recipients of the Pfizer-BioNTech (Comirnaty ®) vaccine reported the highest number of adverse effects (n = 355, 43.6%), followed by mixed COVID-19 vaccines (n = 254, 31.2%), the Oxford-AstraZeneca (ChAdOx1-®[recombinant]) vaccine (n = 113, 13.9%) and the Sinovac (CoronaVac®) vaccine (n = 90, 11.1%). The study showed that individuals who reported significantly more side effects were of elderly age, female gender and high educational level [P value < 0.05]. Mixed COVID-19 vaccine recipients also reported significantly more local and systemic symptoms after the first dose and third dose when compared with other single vaccine recipients. This study demonstrated the types of self-reported adverse effects following immunisation with single and mixed COVID-19 vaccines. These findings may provide the side effects of different COVID-19 vaccines with the hope of educating the public on the safety profiles of these vaccines and reducing vaccine hesitancy among the public.

Short-term COVID-19 vaccine adverse effects among adults in Ekiti State, Nigeria

Background The safety of the COVID-19 vaccines has been a topic of concern globally. This issue of safety is associated with vaccine hesitancy due to concerns about the adverse effects of the vaccines. Consequently, this study determined the short-term safety profile of the Oxford/AstraZeneca COVID-19 vaccine in Ekiti State, Nigeria. Methods Descriptive cross-sectional study conducted between May and July 2021 among individuals who had received the first dose of the first batch of the Oxford/AstraZeneca COVID-19 vaccine at Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, Nigeria. A Google form was used to collect data on the adverse effects of the vaccine. Results Out of over 1,000 individuals who were approached, 758 respondents completed the study. A large percentage (57.4%) of those who received the vaccines were healthcare workers. Adverse effects were reported in 70.8% of the participants with most manifesting on the first day of the vaccination. The predominant adverse effects were injection site soreness (28.5%), followed by fatigue (18.7%) and muscle pain (8.6%). There was no report of severe adverse effects such as anaphylactic reactions, thrombosis, myocarditis, transient myelitis, or Guillen-Barre syndrome. Conclusion This study found that self-reported adverse effects of the Oxford/AstraZeneca COVID-19 vaccine were mild and short in duration. This outcome has promising implications for improving COVID-19 vaccine uptake in the immediate environment and Nigeria.

Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty®).

In healthcare workers (HCWs) and in the general population, fear of adverse effects is among the main reasons behind COVID-19 vaccine hesitancy. We present data on self-reported adverse effects from a large cohort of HCWs who underwent primary (N = 470) and booster (N = 990) mRNA vaccination against SARS-CoV-2. We described general patterns in, and predictors of self-reported adverse effect profiles. Adverse effects following immunisation (AEFI) were reported more often after the second dose of primary immunisation than after the first dose, but there was no further increase in adverse effects following the booster round. Self-reported severity of systemic adverse effects was less following booster immunisation. Prior infection with SARS-CoV-2 was found to be a significant predictor of AEFI following primary immunisation, but was no longer a predictor after booster vaccination. Compared to other studies reporting specifically on adverse effects of SARS-CoV-2 vaccination in healthcare workers, we have a relatively large cohort size, and are the first to compare adverse effects between different rounds of vaccination. Compared to studies in the general population, we have a considerably homogenous population. Insights in AEFI following primary and booster vaccinations may help in addressing vaccine hesitancy, both in HCWs and in the general population.

COVID-19 Vaccine Hesitancy and Self-reported Adverse Effects: A Narrative Review

This study reviewed articles investigating the types and severity of adverse effects (AE) of COVID-19 vaccines and the reasons for vaccine hesitancy (VH). Google Scholar, the U.S. National Library of Medicine (PubMed), Science Direct, and Scopus were searched for relevant articles published between 2020 and 2022. Pfizer-BioNTech (92.1%) and Moderna (94.2%) vaccines reported the highest incidence of AEs compared to viral vector and inactivated vaccines. Local AEs were more prevalent in Pfizer-BioNTech, Moderna, Sputnik V, Sinopharm, and Covaxin vaccines, while systemic AEs were more prevalent in Johnson &amp;Johnson, AstraZeneca, and Coronavac. The primary reasons for VH were fear of the AEs (up to 96.8%), disbelief in the efficacy (up to 93.2%), and preference to “wait and see” ( up to 83.2%). VH has been a significant challenge in the global fight against COVID-19. It is crucial to address these concerns and provide accurate information to increase vaccine uptake and ultimately curb the spread of COVID-19.

Adverse effects, perceptions and attitudes related to BNT162b2, mRNA-1273 or JNJ-78436735 SARS-CoV-2 vaccines: Population-based cohort

Long-term control of SARS-CoV-2 requires effective vaccination strategies. This has been challenged by public mistrust and the spread of misinformation regarding vaccine safety. Better understanding and communication of the longer-term and comparative experiences of individuals in the general population following vaccination are required. In this population-based longitudinal study, we included 575 adults, randomly selected from all individuals presenting to a Swiss reference vaccination center, for receipt of BNT162b2, mRNA1273, or JNJ-78436735. We assessed the prevalence, onset, duration, and severity of self-reported adverse effects over 12 weeks following vaccination. We additionally evaluated participants’ perceptions of vaccines, trust in public health authorities and pharmaceutical companies, and compliance with public health measures. Most participants reported at least one adverse effect within 12 weeks following vaccination. Adverse effects were mostly mild or moderate, resolved within three days, and rarely resulted in anaphylaxis or hospitalizations. Female sex, younger age, higher education, and receipt of mRNA-1273 were associated with reporting adverse effects. Compared to JNJ-78436735 recipients, a higher proportion of mRNA vaccine recipients agreed that vaccination is important, and trusted public health authorities. Our findings provide real-world estimates of the prevalence of adverse effects following SARS-CoV-2 vaccination and highlight the importance of transparent communication to ensure the success of current or future vaccination campaigns.

The Adverse Effects After COVID-19 Vaccination and Its Determinants among Adults in Kuala Terengganu

Background: Although Centre for Disease Control and Prevention (CDC) recommends people aged 12 and older obtain one dose of age-appropriate bivalent mRNA booster after completing the primary series, only 68.8% of the Malaysian adult population received their booster injection. The rate was even lower in Terengganu (43.5%). One of the main reasons for unwillingness to receive booster injections was due to the vaccination side effects as reported in a local study.&#x0D; Aim/objectives: This study aimed to determine the prevalence of adverse effects (AEs) after COVID-19 vaccination and its determinants among our local population.&#x0D; Methods: This cross-sectional study examined the prevalence of self-reported AEs after COVID-19 vaccination (BNT162b2 mRNA vaccine) and its determinants within 7 days following the second dose of vaccination among 379 adults in September 2021 at a public vaccination centre in Kuala Terengganu, Terengganu, Malaysia. The questionnaire consists of socio-demographic information, comorbidities, allergy history, history of COVID-19 infection, AEs post-vaccination, and duration of recovery. Descriptive statistics and logistic regression analyses were conducted using IBM SPSS ver. 26.0. &#x0D; Results: Most participants were 18 to 39 years old (n=307; 81%) and male (n=224; 59.1%). 43 (11.3%) participants had at least one comorbidity, and 28 (7.4%) participants had a history of COVID-19 infection prior to vaccination. 213 (56.2%) participants had mild adverse effects, and 16 (4.2%) reported severe adverse effects. Local pain (n=139; 36.7%), fever (n=91; 24%), and headache (n=61; 16.1%) were the commonest reported AEs. The mean duration of recovery was 1.21 days (SD=1.41). The commonest severe AEs reported was dyspnoea (n=4; 1.1%). From logistic regression, femaleshad 2.06 times the odds of having side effects compared to males (adjusted OR=2.06; 95% CI (1.32,3.22), p = 0.001). Those who never had COVID-19 infection were more likely to have side effects, as compared to those with COVID-19 infection (adjusted OR=3.50; 95% CI (1.52,8.84), p = 0.005).&#x0D; Conclusion: Our study provides the real-life safety of the COVID-19 vaccination (BNT162b2 mRNA vaccine) in our community, even among those with previous COVID-19 infection. &#x0D; Keywords: SARS-CoV-2; vaccines; vaccination; immunity; adverse effects&#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D;

Prevalence of self-reported adverse effects associated with drug use among nightclub and festival attendees, 2019–2022

BackgroundResearch investigating adverse effects from drug use has focused extensively on poisonings and mortality. This study focuses on drug-related adverse effects not necessarily resulting in hospitalization or death among a population known for high prevalence of party drug use—electronic dance music (EDM) nightclub and festival attendees. MethodsAdults entering EDM venues were surveyed in 2019–2022 (n = 1952). Those reporting past-month use of a drug were asked whether they had experienced a harmful or very unpleasant effect after use. We examined 20 drugs and drug classes with a particular focus on alcohol, cannabis, cocaine, and ecstasy. Prevalence and correlates of adverse effects were estimated. ResultsAlmost half (47.6%) of adverse effects involved alcohol and 19.0% involved cannabis. 27.6% of those using alcohol reported an adverse effect, while 19.5%, 15.0%, and 14.9% of participants reported an effect from use of cocaine, ecstasy, and cannabis, respectively. Use of less prevalent drugs, such as NBOMe, methamphetamine, fentanyls, and synthetic cathinones, tended to be associated with higher prevalence of adverse effects. The most consistent risk factor was younger age, while past-month use of a greater number of drugs was often a protective factor against adverse effects. For most drugs, taking too much was the most common perceived reason for the adverse effect, and visiting a hospital after use was most prevalent among those experiencing an adverse effect from cocaine (11.0%). ConclusionsAdverse drug effects are common in this population and results can inform prevention and harm reduction in this population and the general population.

The use of Traditional Medicines for Sexual Enhancement in Northern Nigeria.

There is a paucity of information on the use of traditional medicine TM to improve sexual performance. This study aims to assess the prevalence and self-reported adverse effects associated with the use of TM as a sexual enhancer in northern Nigeria. The study was a cross-sectional design among adults aged 18 years and above, who are residing in northern Nigeria. A mixed-mode approach was utilized using face-to-face interviews and an online survey. For the online survey, a link to the questionnaire was shared on the social media platforms of the targeted participants. A total of 794 eligible participants completed the survey over the six weeks. Of this number, 508 reported ever using TM for sexual enhancement, with a prevalence of 64% (95% CI: 60.5, 67.3). About 30 (3.8%) reported daily use, 49 (4.9%) weekly, 65 (8.2%) monthly and 473 (59.6%) as when needed. Islamic medicine was the most frequently implicated TM. Most respondents obtained it TM practitioners 213 (26.8%). Participants 164 (20.7%) reported experiencing side effects, mostly headaches 59 (35.9%), and 31 (3.9%) were severe (required hospitalization). Predictors of TM use for sexual enhancement were found to be gender, marital status, number of wives, ethnicity, educational level, and lifestyle. The use of TM for sexual enhancement is common among the adult population in northern Nigeria. One out of five of the users reported an adverse event. Therefore, there is a need for improved awareness of the safe use of the TM in the community, especially among females, those with multiple wives, a low education level, and poor lifestyles.

Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study.

Vaccination against coronavirus disease 2019 (COVID-19) is the most effective way to end the pandemic. Any development of adverse events (AEs) from various vaccines should be reported. We therefore aimed to explore major and minor AEs among vaccinated individuals in Saudi Arabia. This is a nationwide report based on the Saudi Arabian Ministry of Health (MOH) registry. It included those who received COVID-19 vaccines from 17th December 2020 to 31st December 2021. The study included spontaneous self-reported adverse effects to COVID-19 vaccines where the study participants used a governmental mobile app (Sehhaty) to report their AEs following vaccination using a checklist option that included a selection of side-effects. The primary outcome was to determine AEs reported within 14 days of vaccination which included injection site itching, pain, reaction, redness, swelling, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue, seizures, anaphylaxis, shortness of breath, wheezing, swelling of lips, face, and throat, loss of consciousness, and admissions into the intensive care unit (ICU). The study included a total number of 28,031 individuals who reported 71,480 adverse events (AEs); which were further classified into minor and major adverse events including ICU admissions post vaccination. Of the reported AEs, 38,309 (53. 6%) side-effects were reported following Pfizer-BioNTech, 32,223 (45%) following Oxford-AstraZeneca, and 948 (1.3%) following Moderna. The following reported AEs were statistically significant between the different vaccine types: shortness of breath\difficulty of breathing, dizziness, fever above 39°C, headache, hoarseness, injection site reactions, itchiness, nausea, sleep disruption, fatigue, wheezing, swelling of lips/face and\or throat, and loss of consciousness (p-value < 0.05). Fever and seizure were the only statistically significant AEs amongst the number of vaccine doses received (p-value < 0.05). Ten ICU admissions were reported in the 14 days observation period post-COVID-19 vaccination with the following diagnoses: acute myocardial infarction, pneumonia, atherosclerosis, acute respiratory failure, intracranial hemorrhage, grand mal seizure, Guillain-Barré syndrome, abnormal blood gas levels, and septic shock. This study demonstrated that the most prevalent SARS-CoV-2 vaccine side-effects among adults in Saudi Arabia were mild in nature. This information will help reduce vaccine hesitancy and encourage further mass vaccination to combat the COVID-19 pandemic, especially as booster doses are now available. Further studies are warranted to obtain a better understanding of the association between risk factors and the experiencing of side-effects post vaccination.

Multimorbidity and Its Effect on Self-Reported Adverse Effects Following COVID-19 Vaccination.

Introduction The coronavirus disease 2019 (COVID-19) vaccination has been suggested for those with comorbidities, although there are concerns regarding the vaccine's safety. This study aimed to compare the severity and incidence of post-vaccination side effects in people with and without comorbidities. Another aim of this study was also to look for the effect of multimorbidity on adverse events. Methods This observational study was conducted from November 2021 to February 2022. Data were collected from all over Pakistan using a self-administered online questionnaire that inquired about the subject's demographic, clinical, and COVID-19 vaccination profiles. Data analysis was done by using SPSS software version 22.0. (Chicago, IL, IBM Corp.). Results A total of 421 participants were included in the study, and 31.4% of individuals had underlying comorbidity. The overall mean age was 33 years (range: 13-85 years). This study included recipients of all major types of COVID-19 vaccines being used in Pakistan. Only 67.4% ofthe subjects had only underlying comorbidity, and hypertension was the most common one out of all comorbidities. Participants with comorbidities were not at a greater risk to produce vaccine-related adverse events when compared to those with no comorbidities. Comorbidity was also found to be statistically non-significant to the severity of the side effects. Only one subject with comorbidity produced a side effectand required hospitalization. Multimorbidity was not associated with a greater incidence of side effects. Multimorbidity was not significantly linked with the severity of the adverse effects, except muscle pain (p<0.05) and breathlessness (p<0.05). Conclusion It can be concluded that comorbidities do not affect the COVID-19 vaccine's reactogenicity but studies on an extensive scale should be conducted regarding individuals with multiple pre-existing comorbidities.

Safety and use of complementary and alternative medicine in Norway during the first wave of the COVID-19 pandemic using an adapted version of the I-CAM-Q; a cross-sectional survey

BackgroundThe COVID-19 pandemic lockdown has had a profound impact on physical and mental well-being throughout the world. Previous studies have revealed that complementary and alternative medicine (CAM) is frequently used for, and can be potential beneficial for strengthening physical mental resilience. The aims of this study were therefore to determine the prevalence and reasons for use of CAM during the first wave of the COVID-19 pandemic among a representative sample of the Norwegian population, and further determine self-reported effects and adverse effects of the CAM modalities used.MethodsComputer assisted telephone interviews using a COVID-adapted I-CAM-Q questionnaire were conducted with 1008 randomly selected Norwegians aged 16 and above using multistage sampling during April and May 2020 applying age and sex quotas for each area. Frequencies, Pearson’s chi-square tests, Fisher exact tests, and independent sample t-test were used to identify the users of CAM, what they used, why they used it and whether they experienced effect and/or adverse effects of the modalities used, and further to describe differences in sociodemographic factors associated with CAM use. Cronbach's alpha tests were used to test for internal consistency in the different groups of CAM. Significance level was set to p < 0.05.ResultsThe study revealed that two thirds of the respondents (67%) had used CAM within the first 3 months of the COVID-19 pandemic, in particular CAM modalities that did not involve a provider. Most used were natural remedies and dietary supplement (57%, mainly vitamins and minerals), but self-help practices like yoga and meditation were also widely used (24%). Women used CAM modalities significantly more than men (77% vs. 58%). Most of the respondents found the modalities they used beneficial, and few reported adverse effects of the treatments.ConclusionsA large proportion of the Norwegian population used CAM during the first wave of the COVID-19 pandemic with high satisfaction and few reported adverse effects. CAM was rarely used to prevent or treat COVID-19, but rather to treat a long-term health condition, and to improve well-being.

COVID-19 and Bipolar Affective Disorder: Subjective Changes in Lifestyle Variables During the First Lockdown During the COVID-19 Pandemic in Austria

The COVID-19 pandemic with its protective measures (e. g. lockdown) had far-reaching effects on everyone's well-being. The aim of this study was to examine lifestyle variables during the first Austrian lockdown in patients with bipolar disorder in comparison to a healthy control group and to assess subjective changes caused by the pandemic. At the beginning of April 2020, an online survey of n=75 participants (35 people with bipolar disorder and 40 healthy controls) with standardized questionnaires (Beck Depression Inventory-2, Food Craving Inventory, Altman Self Rating Mania Scale) as well as non-standardized COVID-19-specific questions on the subject of "Psychological stress and effects of the COVID-19 pandemic in bipolar disorder" was created and distributed via LimeSurvey. Both groups reported a negative impact on their mental health. The participants with bipolar disorder showed significantly higher values in the Beck Depression Inventory-2 score (p<0,001), in emotional distress due to social distancing (p=0,003) and significantly lower values in muscle-strengthening exercise (p=0,039) and in sport units (p=0,003) compared to the control group. In addition, patients with bipolar disorder smoked more often than individuals of the control group. People with bipolar disorder were 42,9% more likely to report they were less efficient during the pandemic, and 22,9% experienced weight gain compared to before the pandemic. The control group, on the other hand, was less efficient at 17,5% and 5,0% reported weight gain. However, a comparison with pre-pandemic data showed a decrease in food craving in both groups. This study provided first evidence of self-reported adverse effects on mental stress and lifestyle in people with bipolar disorder at the beginning of the COVID-19 pandemic. Psychiatric care and early interventions for patients with bipolar disorder would be particularly important in times of crisis in order to help maintain a healthy lifestyle and thus counteract unfavourable developments.

Self-reported Adverse Effects in Health Care Professionals Following First and Second Dose Vaccination Against SARS-CoV 2 (Covishield)

Introduction: The ChAdOx 1 n Cov-19 vaccine, called Covishield, was rolled out in Nepal targeting health care professionals. The study was conducted to assess the pattern of self-reported adverse events following immunization and to compare AEFI on the basis of previous COVID status. Methods: A cross sectional study of four months duration was conducted in Shree Birendra Hospital, a tertiary care hospital, in Kathmandu, Nepal. AEFI associated with first and second dose of Covishield were assessed for a period of seven days from the day of vaccination in health care professionals and comparison was done based on COVID status. Results: A total of 100 vaccine recipients were included in the study, out of which 83% showed AEFI. The most commonly reported AEFI after first dose were headache (56%), injection site tenderness (42%), myalgia (29%), fatigue (24%), dizziness (20%), pyrexia (19%), malaise (17%), nausea (10%), chills (8%), vomiting (2%) and arthralgia (1%) while among the AEFI after second dose were injection site tenderness (36%), headache (15%), myalgia (12%), fatigue (11%), nausea (9%), malaise (8%), pyrexia (8%), chills (5%), rashes (3%), drowsiness (3%), arthralgia (1%) and dizziness (1%). Previously infected participants were found to be prone to develop systemic adverse effects. The most of the adverse effects were subsided within four days and commonly used medication was paracetamol to relieve the symptoms. Conclusions: AEFI following the first and second dose of vaccine were mild. Systemic adverse effects were more frequent in those with the history of COVID-19 infection.

Study on adverse effects of COVISHIELD vaccine among hospital employees of Nepal Medical College and Teaching Hospital

Nepal government provided COVISHIELD vaccine first to the hospital employees and other front liners in January 2021. The objective of our study was to observe the adverse effects of the COVISHIELD among hospital employees of Nepal Medical College and Teaching Hospital (NMCTH). This was a descriptive cross-sectional study conducted from March to August 2021. The study was commenced after obtaining ethical clearance from the Institutional Review Committee of NMCTH. Self-reported socio-demographic details and symptomatic adverse effects reported after the first and second dose of COVISHIELD were noted. The data were entered in SPSS 16 and analysed. Out of 436 participants, 360 (82.6%) and 243 (55.7%) had reported adverse effects after the first and second dose of the COVISHIELD respectively. The adverse effects reported following COVISHIELD were common and predictable.

The SHIELD Study: A preliminary analysis of nasal and oral antisepsis to prevent COVID-19

Background: Povidone-iodine and chlorhexidine gluconate are commonly used antiseptics that have broad antiviral properties, including against SARS-CoV-2. Nasal and oral antisepsis is a possible option to reduce viral transmission; however, effectiveness data are limited. The acceptability of this method for adjunct infection control is also unknown. We are conducting a clinical randomized controlled trial (NCT04478019) to evaluate the effectiveness and feasibility of nasal and oral antisepsis to prevent COVID-19. Methods: Healthcare and other essential workers with in-person job duties were recruited into a 10-week clinical trial. Participation did not require in-person activities: all communication was web- or telephone-based, supplies were shipped directly to the participant, and participants self-collected specimens. Participants completed a 3-week intervention and 3-week control phases and were randomized to the timing of these phases (Fig. 1). During the 3-week intervention phase, participants applied povidone-iodine nasal swabs 2 times per day and chlorhexidine gluconate oral rinse 4 times per day following the manufacturers’ instructions for use. Participants continued all usual infection control measures (eg, face masks, eye protection, gowns, hand hygiene) as required by their workplace. To measure effectiveness against viral transmission, participants collected midturbinate nasal swabs 3 times per week to measure SARS-CoV-2 viral load. Participants also self-reported COVID-19 tests they received and why (eg, symptoms or exposure). To assess acceptability, participants completed pre- and post-surveys about their perceived and actual experience with the interventions. Participants also self-reported adverse effects due to the intervention. Results: As of December 3, 2021, 221 participants (148 healthcare workers and 73 non–healthcare essential workers) had enrolled. Moreover, 20 adverse effects have been reported, including skin irritation, epistaxis, and mouth discoloration; 9 participants withdrew due to side effects. Laboratory analyses are ongoing to measure effectiveness in reducing SARS-CoV-2 viral load. We performed an interim analysis of intervention acceptability. Survey responses were given on a Likert scale of 1 (not at all) to 5 (extremely). Although 36% of respondents (n = 74) reported on the postsurvey that the intervention was less acceptable than they had expected on the presurvey, the overall acceptability measure was still relatively high (3.76) (Fig. 2). In addition, 76% of respondents reported that they would use the intervention in the future (n = 56). Conclusions: Participant recruitment is ongoing, and data continue to be collected to analyze effectiveness and feasibility. Preliminary data suggest that participants find the nasal and oral antisepsis intervention to be an acceptable option to complement standard infection control methods to prevent COVID-19.Funding: Professional Disposables International, Healthcare Division (PDIHC)Disclosures: None