COVID-19 Vaccination Effects on Tinnitus and Hyperacusis: Longitudinal Case study.

The case study explores COVID-19 vaccination connection to tinnitus and hyperacusis, considering its onset and exacerbation post vaccination. The subject is a 47-year-old woman with a history of bilateral tinnitus, and her hearing history was tracked from 2014 to 2023. An intense episode of tinnitus occurred in 2021, distinct from previous experiences post COVID-19 vaccination, second dose. Symptoms manifested as sudden onset of hyperacusis, pronounced "roar" type tinnitus, and a sudden decline in hearing. Audiometric results showed reduce thresholds in low frequencies and lower speech scores in the left ear. This escalation significantly affects speech understanding in group conditions and noisy environments. There was a gradual improvement in tinnitus and hyperacusis severity, but the subject has a greater problem with speech understanding. The subject's journey involved visits to specialists, multiple testing including neuroimaging, naturopath consultations, and anxiety medication. It emphasizes the importance of healthcare practitioners recognizing and documenting these issues and need for timely multidisciplinary intervention and support. Further research is necessary to better understand the relationship between COVID-19, vaccination, and auditory symptoms.

Abnormal uterine bleeding diagnoses and care following COVID-19 vaccination.

BACKGROUND: There is evidence suggesting that COVID-19 vaccination may be associated with small, transitory effects on uterine bleeding, possibly including menstrual timing, flow, and duration, in some individuals. However, changes in health care seeking, diagnosis, and workup for abnormal uterine bleeding in the COVID-19 vaccine era are less clear. OBJECTIVE: This study aimed to assess the impact of COVID-19 vaccination on incident abnormal uterine bleeding diagnosis and diagnostic evaluation in a large integrated health system. STUDY DESIGN: Using segmented regression, we assessed whether the availability of COVID-19 vaccines was associated with changes in monthly, population-based rates of incident abnormal uterine bleeding diagnoses relative to the prepandemic period in health system members aged 16 to 44 years who were not menopausal. We also compared clinical and demographic characteristics of patients diagnosed with incident abnormal uterine bleeding between December 2020 and October 13, 2021 by vaccination status (never vaccinated, vaccinated in the 60 days before diagnosis, vaccinated >60 days before diagnosis). Furthermore, we conducted detailed chart review of patients diagnosed with abnormal uterine bleeding within 1 to 60 days of COVID-19 vaccination in the same time period. RESULTS: In monthly populations ranging from 79,000 to 85,000 female health system members, incidence of abnormal uterine bleeding diagnosis per 100,000 person-days ranged from 8.97 to 19.19. There was no significant change in the level or trend in the incidence of abnormal uterine bleeding diagnoses between the prepandemic (January 2019-January 2020) and post-COVID-19 vaccine (December 2020-December 2021) periods. A comparison of clinical characteristics of 2717 abnormal uterine bleeding cases by vaccination status suggested that abnormal bleeding among recently vaccinated patients was similar or less severe than abnormal bleeding among patients who had never been vaccinated or those vaccinated >60 days before. There were also significant differences in age and race of patients with incident abnormal uterine bleeding diagnoses by vaccination status (Ps<.02). Never-vaccinated patients were the youngest and those vaccinated >60 days before were the oldest. The proportion of patients who were Black/African American was highest among never-vaccinated patients, and the proportion of Asian patients was higher among vaccinated patients. Chart review of 114 confirmed postvaccination abnormal uterine bleeding cases diagnosed from December 2020 through October 13, 2021 found that the most common symptoms reported were changes in timing, duration, and volume of bleeding. Approximately one-third of cases received no diagnostic workup; 57% had no etiology for the bleeding documented in the electronic health record. In 12% of cases, the patient mentioned or asked about a possible link between their bleeding and their recent COVID-19 vaccine. CONCLUSION: The availability of COVID-19 vaccination was not associated with a change in incidence of medically attended abnormal uterine bleeding in our population of over 79,000 female patients of reproductive age. In addition, among 2717 patients with abnormal uterine bleeding diagnoses in the period following COVID-19 vaccine availability, receipt of the vaccine was not associated with greater bleeding severity.

Postmenopausal bleeding after COVID-19 vaccination.

BACKGROUND: There is a growing literature base regarding menstrual changes following COVID-19 vaccination among premenopausal people. However, relatively little is known about uterine bleeding in postmenopausal people following COVID-19 vaccination. OBJECTIVE: This study aimed to examine trends in incident postmenopausal bleeding diagnoses over time before and after COVID-19 vaccine introduction, and to describe cases of new-onset postmenopausal bleeding after COVID-19 vaccination. STUDY DESIGN: For postmenopausal bleeding incidence calculations, monthly population-level cohorts consisted of female Kaiser Permanente Northwest members aged ≥45 years. Those diagnosed with incident postmenopausal bleeding in the electronic medical record were included in monthly numerators. Members with preexisting postmenopausal bleeding or abnormal uterine bleeding, or who were at increased risk of bleeding due to other health conditions, were excluded from monthly calculations. We used segmented regression analysis to estimate changes in the incidence of postmenopausal bleeding diagnoses from 2018 through 2021 in Kaiser Permanente Northwest members meeting the inclusion criteria, stratified by COVID-19 vaccination status in 2021. In addition, we identified all members with ≥1 COVID-19 vaccination between December 14, 2020 and August 14, 2021, who had an incident postmenopausal bleeding diagnosis within 60 days of vaccination. COVID-19 vaccination, diagnostic procedures, and presumed bleeding etiology were assessed through chart review and described. A temporal scan statistic was run on all cases without clear bleeding etiology. RESULTS: In a population of 75,530 to 82,693 individuals per month, there was no statistically significant difference in the rate of incident postmenopausal bleeding diagnoses before and after COVID-19 vaccine introduction (P=.59). A total of 104 individuals had incident postmenopausal bleeding diagnosed within 60 days following COVID-19 vaccination; 76% of cases (79/104) were confirmed as postvaccination postmenopausal bleeding after chart review. Median time from vaccination to bleeding onset was 21 days (range: 2-54 days). Among the 56 postmenopausal bleeding cases with a provider-attributed etiology, the common causes of bleeding were uterine or cervical lesions (50% [28/56]), hormone replacement therapy (13% [7/56]), and proliferative endometrium (13% [7/56]). Among the 23 cases without a clear etiology, there was no statistically significant clustering of postmenopausal bleeding onset following vaccination. CONCLUSION: Within this integrated health system, introduction of COVID-19 vaccines was not associated with an increase in incident postmenopausal bleeding diagnoses. Diagnosis of postmenopausal bleeding in the 60 days following receipt of a COVID-19 vaccination was rare.

Case of Exacerbation of Psoriasis Following COVID-19 Vaccination During Treatment with Brodalumab, Which Resulted in Secondary Failure.

A 43-year-old Japanese man who had suffered psoriasis vulgaris for eight years visited our hospital. His comorbidities were dyslipidemia, hyperuricemia, and obesity. He received phototherapy for six months, which did not result in improvement. Following treatment with brodalumab, his skin symptoms improved. However, seven months after brodalumab treatment, he received two doses of the mRNA-1273 COVID-19 vaccine, with a one-month interval between doses. One month following the second vaccination, his skin symptoms were exacerbated. He received additional NB-UVB therapy, but his skin symptoms did not improve. Nine months after the addition of NB-UVB therapy, treatment was switched to bimekizumab, and his skin became almost clear. Psoriasis is often associated with comorbidities like metabolic syndrome. Currently, additional COVID-19 vaccination is recommended for high-risk cases such as those with metabolic syndrome. Therefore, it is essential to remain vigilant regarding the potential exacerbation of psoriasis following COVID-19 vaccination even during treatment with highly effective biologic therapy.

Acupuncture as a therapeutic intervention for post-COVID-19 vaccination urticaria: a systematic review and meta-analysis protocol.

INTRODUCTION: The COVID-19 pandemic persisted for over 3 years since its onset in December 2019, posing an ongoing global threat to human health. In the absence of specific antiviral medications for COVID-19, vaccination has emerged as a popular preventive measure adopted by the general public. However, an undesirable consequence of COVID-19 vaccination has been the frequent incidence of urticaria, a type of adverse skin manifestations. Despite the prevalence of this issue, there is currently a lack of clinical evidence exploring the potential utility of acupuncture as a therapeutic approach to managing urticaria arising after COVID-19 vaccination. To address this knowledge gap, this study aims to comprehensively evaluate the effectiveness and safety of acupuncture as a therapeutic intervention for treating urticaria in the general population following COVID-19 vaccination. METHODS AND ANALYSIS: The retrieval strategies employed in this study involve obtaining all relevant articles published from December 2019 to October 2023. These articles will be obtained from databases including PubMed, EMBASE, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (SinoMed), VIP database and the WanFang database. Subsequently, the collected articles will undergo a thorough screening process based on predefined inclusion and exclusion criteria. Additionally, study quality will be evaluated using the Cochrane risk bias assessment tool. To conduct the meta-analysis, we will employ the Review Manager software (RevMan V.5.3). Finally, the study findings will be evaluated for their level of evidence. ETHICS AND DISSEMINATION: As this is a secondary review of published clinical data, this study does not involve direct contact with human subjects, and therefore, ethical approval and consent are not required. The findings of the study will be disseminated through a peer-reviewed journal, ensuring that the results undergo rigorous evaluation by experts in the field. PROSPERO REGISTRATION NUMBER: CRD42022377343.

Risk Factors for Not Completing a 2-Dose Primary Series of Messenger RNA COVID-19 Vaccination in a Large Health Care System in Southern California: Retrospective Cohort Study.

BACKGROUND: COVID-19 vaccination is crucial in combating the COVID-19 pandemic. Messenger RNA COVID-19 vaccines were initially authorized as a 2-dose primary series and have been widely used in the United States; completing the 2-dose primary series offers protection against infection, severe illness, and death. Understanding the risk factors for not completing the 2-dose primary series is critical to evaluate COVID-19 vaccination programs and promote completion of the 2-dose primary series. OBJECTIVE: This study examined potential risk factors for not completing a 2-dose primary series of mRNA COVID-19 vaccination. METHODS: We conducted a retrospective cohort study among members aged ≥18 years from a large integrated health care system, Kaiser Permanente Southern California, from December 14, 2020, to June 30, 2022. Noncompletion of the 2-dose primary series was defined as not completing the second dose within 6 months after receipt of the first dose. Crude noncompletion rates were estimated overall and by demographic characteristics, health care use patterns, comorbidity, and community-level socioeconomic factors. A Poisson regression model was fit to examine associations of individual-level and community-level risk factors with noncompletion of the 2-dose primary series. RESULTS: Among 2.5 million recipients of ≥1 dose of mRNA COVID-19 vaccines, 3.3% (n=81,202) did not complete the second dose within 6 months. Members aged 25-44 years, 65-74 years, and ≥75 years were less likely to not complete the 2-dose primary series than those aged 18-24 years, while members aged 45-64 years were more likely to not complete the 2-dose primary series (adjusted risk ratio [aRR] 1.13, 95% CI 1.10-1.15). Male sex was associated with a higher risk of noncompletion (aRR 1.17, 95% CI 1.15-1.19). Hispanic and non-Hispanic Black race/ethnicity were associated with a lower risk of noncompletion (range aRR 0.78-0.91). Having Medicaid and prior influenza vaccination were associated with a higher risk of noncompletion. Having SARS-CoV-2 infection, experiencing an adverse event, or having an inpatient and emergency department visit during the minimum recommended dose intervals were associated with a higher risk of not completing the 2-dose primary series (aRR 1.98, 95% CI 1.85-2.12; 1.99, 95% CI 1.43-2.76; and 1.85, 95% CI 1.77-1.93, respectively). Those who received the first dose after June 30, 2021, were more likely to not complete the 2-dose primary series within 6 months of receipt of the first dose. CONCLUSIONS: Despite limitations such as being a single-site study and the inability to consider social factors such as employment and vaccine attitudes, our study identified several risk factors for not completing a 2-dose primary series of mRNA vaccination, including being male; having Medicaid coverage; and experiencing SARS-CoV-2 infection, adverse events, or inpatient and emergency department visits during the minimum recommended dose intervals. These findings can inform future efforts in developing effective strategies to enhance vaccination coverage and improve the completion rate of necessary doses.

Effectiveness of aroma-Tea Tree Oil and Eucalyptus oil in alleviating COVID-19 vaccine discomfort side effects.

CONTEXT: Aromatherapy is considered a mild and non-invasive complementary treatment to relieve post-vaccination discomforts. There have been no studies that examine the use of aroma-Tea Tree oil and Eucalyptus oil to relieve the discomfort side effects related to COVID-19 vaccines. OBJECTIVE: This study examined the use of two aroma-essential oils to relieve discomfort side effects of COVID-19 vaccination. DESIGN: The study used experimental design to match two groups of participants. SETTING: The participants' home. PARTICIPANTS: Adults who had not yet been vaccinated against COVID-19 but were planning to receive it were recruited. The current study included 87 control participants matched to 83 experimental participants. INTERVENTION: The participants in the experimental group used Tea tree and Eucalyptus while the control group did not. MAIN OUTCOME MEASURES: A questionnaire was used to collect data on the topical and systematic symptoms related to COVID-19 vaccines. Both groups were asked to complete the online questionnaire and report their health status 24 h (T1) and 48 h (T2) after vaccination. RESULTS: The results revealed a statistically significant difference between the groups in swelling, injection side pain, lump, fever, and muscle ache (p = .05, 0.04, <0.00, 0.02, 0.02, respectively) for T1; but for T2, a significant difference between the two groups was found only in lump and fever (p = .05, 0.03). Aroma-Tea Tree oil and Eucalyptus oil may be recognized and accepted by more people worldwide to provide a safe and healthy option not only for post-vaccination care but also to relieve pain, fever, and skin lumps associated with other diseases or conditions.

Effectiveness of Nutritional Supplements for Attenuating the Side Effects of SARS-CoV-2 Vaccines.

Supplementation is known to enhance the immune response and reduce infection. Therefore, the association between immune nutrients and vaccine side effects needs to be investigated. Our aim was to analyze the relationship between vaccination side effects and supplement intake among the Italian population. The study included a questionnaire asking for personal data, anthropometric information, COVID-19 infection and immunity response, and COVID-19 vaccination and supplementation. The survey was conducted from 8 February to 15 June 2022. In the study, 776 respondents were included, aged between 18 and 86 (71.3% females). We observed a statistically significant correlation between supplement consumption and side effects at the end of the vaccination cycle (p = 0.000), which was also confirmed by logistic regression (p = 0.02). Significant associations were observed between supplement intake and side effects of diarrhea and nausea at the end of the vaccination cycle (p = 0.001; p = 0.04, respectively). Significant associations were observed between side effects and omega-3 and mineral supplementation at the start of the vaccination cycle (p = 0.02; p = 0.001, respectively), and between side effects and vitamin supplementation at the end of the vaccination cycle (p = 0.005). In conclusion, our study shows a positive impact of supplementation on vaccination response, increasing host immune defenses, and reducing side effects.

Effectiveness and safety of coronavirus disease 2019 vaccines.

PURPOSE OF REVIEW: To review and summarise recent evidence on the effectiveness of coronavirus disease 2019 (COVID-19) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 hospitalisation and death in adults as well as in specific population groups, namely pregnant women, and children and adolescents. We also sought to summarise evidence on vaccine safety in relation to cardiovascular and neurological complications. In order to do so, we drew primarily on evidence from two our own data platforms and supplement these with insights from related large population-based studies and systematic reviews. RECENT FINDINGS: All studies showed high vaccine effectiveness against confirmed SARS-CoV-2 infection and in particular against COVID-19 hospitalisation and death. However, vaccine effectiveness against symptomatic COVID-19 infection waned over time. These studies also found that booster vaccines would be needed to maintain high vaccine effectiveness against severe COVID-19 outcomes. Rare cardiovascular and neurological complications have been reported in association with COVID-19 vaccines. SUMMARY: The findings from this paper support current recommendations that vaccination remains the safest way for adults, pregnant women, children and adolescents to be protected against COVID-19. There is a need to continue to monitor the effectiveness and safety of COVID-19 vaccines as these continue to be deployed in the evolving pandemic.

COVID­19 vaccine hesitancy among pregnant women and their reported reasons for vaccine refusal - A prospective study in Tehran, Iran.

OBJECTIVE: Evaluation of covid­19 vaccine hesitancy among pregnant women and their reported reasons for vaccine refusal. METHODS: This prospective study was performed in Arash women's Hospital, Tehran, Iran, between December 1, 2021 and January 1, 2022. All pregnant women who were attended to prenatal care unit were considered eligible for inclusion. A validated questionnaire was used for data gathering. Written informed consent was obtained from all participants. RESULTS: Finally, 477 pregnant women were recruited and were divided into two groups according the status of vaccine acceptance (237 accepted and 240 women refused vaccination). The mean age of accepted participants was higher (31.65 ± 5.69 vs 30.39 ± 5.5; P = 0.01). There was a significant statistical difference between the groups regarding education level. Access to internet and social media were also significantly different between the two groups (94.8% in accepted vs 86.6% in refused group; P = 0.002). There was more rate of severe COVID-19 infection in friends or relatives of accepted group (50% vs 38%). we did not find any statistically significant differences in obstetric characteristics and the rate of obstetric complications between the two groups. The most common reasons reported by participants for vaccine refusal, was fear of vaccination side effects on the fetus (86.5%), and the less common reported reasons were husband's disagreement (9.7%), use of traditional medicine (5.6%), religious beliefs (3.7%), and information obtained from social media (2.8%). After advices from medical staff, most of these mothers (86.5%) still refused vaccination. CONCLUSION: Based on the results of the present study,rate of COVID-19 vaccine hesitancy was about 50% and its most common reported reason was fear of probable side effects of vaccine on the fetus.

Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.

BACKGROUND: Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety. METHODS: We conducted an observational study using data from a digital survey and EHR of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 mRNA vaccine across Kaiser Permanente Southern California during November 4, 2021-February 28, 2022. Parents/guardians who enrolled their children were sent a 14-day survey on reactions. Survey results were combined with EHR, and medical encounters were described for children whose parents or guardians indicated seeking medical care for vaccine-related symptoms. This study describes self-reported reactions (local and systemic) and additional symptoms (chest pain, tachycardia, and pre-syncope). RESULTS: The study recruited 7,077 participants aged 5-11 years who received the Pfizer-BioNTech COVID-19 mRNA vaccine. Of 6,247 participants with survey responses after dose 1, 2,176 (35 %) reported at least one systemic reaction, and 1,076 (32 %) of 3,401 respondents following dose 2 reported at least one systemic reaction. Local reactions were reported less frequently following dose 2 (1,113, 33 %) than dose 1 (3,140, 50 %). The most frequently reported reactions after dose 1 were pain at the injection site (48 %), fatigue (20 %), headache (12 %), myalgia (9 %) and fever (5 %). The most frequently reported symptoms after dose 2 were also pain at the injection site (30 %), fatigue (19 %), headache (13 %), myalgia (10 %) and fever (9 %). Post-vaccination reactions occurred most frequently-one day following vaccination. Chest pain or tachycardia were reported infrequently (1 %). EHR demonstrated that parents rarely sought care for post-vaccination symptoms, and among those seeking care, the most common symptoms documented in EHR were fever and nausea, comprising <0.5 % of children. No encounters were related to myocarditis. CONCLUSION: While post-vaccination reactions to the Pfizer-BioNTech COVID-19 mRNA vaccine were common in children aged 5-11 years, our data showed that in most cases they were transient and did not require medical care.

COVID-19 vaccination rate and willingness of an additional dose among inflammatory bowel disease patients receiving biologic therapy: Fearless and with desire.

Effective vaccines against the SARS-CoV-2 are already available and offer a promising action to control the COVID-19 pandemic. IBD patients on biological agents accept the vaccine as well as an additional dose if recommended. BACKGROUND: Vaccination against COVID-19 prevents its severe forms and associated mortality and offers a promising action to control this pandemic. In September 2021, an additional dose of vaccine was approved in patients with immunosuppression including IBD patients on biologic agents. We evaluated the vaccination rate and additional dose willingness in this group of at risk patients. METHODS: A single-center, cross-sectional study was performed among IBD patients on biologic agents and eligible for an additional dose of the COVID-19 vaccine. IBD clinical characteristics and type of vaccine and date of administration were checked in medical records. Acceptance was evaluated after telephone or face-to-face surveys in IBD patients. RESULTS: Out of a total of 344 patients, 269 patients (46.1% male; mean age 47±16 years; Crohn's disease 73.6%) were included. Only 15 (5.6%) patients refused the COVID-19 vaccine mainly (40%) for conviction (COVID-19 pandemic denial). 33.3% would re-consider after discussing with their doctor and/or receiving information on the adverse effects of the vaccine. Previous to the additional dose, the COVID-19 vaccination was present in 94.4% of patients (n=254). Adverse effects occurred in 53.9% of the cases, mainly pain in the arm (40%). Up to 94.1% of the patients agreed to an additional dose and 79.4% had already received the additional dose at the final time of the assessment. CONCLUSIONS: IBD patients on biological agents accept the vaccine as well as an additional dose if recommended. Physicians in charge of IBD units should provide information and confidence in the use of the vaccine in these IBD patients.

Factors associated with reluctancy to acquire COVID-19 vaccination: A cross-sectional study in Shiraz, Iran, 2022.

BACKGROUND: Vaccination is a crucial action that can end the COVID-19 pandemic and reduce its detrimental effect on public health. Despite the availability of various vaccines, this study was conducted to better understand the factors behind individuals refusing to get vaccinated. METHOD: The current cross-sectional study was conducted with individuals above 18 years of age in Shiraz, Iran, who were eligible but refused to receive the COVID-19 vaccination. Demographic features and factors related to their hesitancy and willingness to participate in the vaccination program were recorded in a questionnaire. RESULT: Out of 801 participants in the current study, 427 (53.3%) were men, with a mean age of 37.92 years (± 14.16). The findings revealed that 350 (43.7%) participants claimed the side effects of the vaccine outweigh the benefits as one reason for their reluctance toward COVID-19 vaccination, followed by the unknown efficacy of vaccines (40.4%) and a lack of trust in vaccine companies (32.8%). Ensuring the safety of the vaccine (43.7%) and verifying its effectiveness (34.5%) were the most prevalent factors behind participating in the vaccination program. Those who reported their socio-economic status as low were significantly reluctant toward vaccination because of a self-presumption of high immunity (p-value < 0.001), the unclear efficacy of vaccines (p-value < 0.001), the side effects outweighing the benefits of vaccines (p-value < 0.001), distrust of vaccine companies (p-value < 0.001), usage of mask, gloves, and sanitizers (p-value < 0.001), contradictory speech of health authorities regarding vaccines (p-value = 0.041), and the unavailability of trusted vaccines (p-value = 0.002). It should also be noted that participants reported a greater likelihood to obtain information about vaccination reluctance from family and friends (p-value <0.001) and complementary medicine professionals (p-value <0.001). CONCLUSION: Avoiding vaccination is an undeniable public and individual health concern in Iran, as demonstrated in the current study. Concern about vaccine efficacy and side effects is the most reported cause of vaccination reluctance among individuals, which could be altered by emphasizing mass education and averting an infodemic by forming dedicated multidisciplinary organizations.

Auricular acupressure for adverse events following immunization after COVID-19 vaccine injection: A multicentre, blinded, randomized controlled trial.

BACKGROUND: Some adverse events following immunization (AEFI) were observed in potential corelation with COVID-19 vaccination but without prevention or ongoing trial for it. We aimed to investigate efficacy of auricular acupressure (AuriAc) therapy in preventing AEFI after first dosage of the vaccine. METHODS: We performed a multicentre randomized controlled trial with three arms, including AuriAc, SAuriAc (sham auricular acupressure), and TrAsU (treatment as usual) group, carried out in four medical institutions in Chengdu, China, from March 17th to April 23rd, 2021. We enrolled participants based on eligibility criteria and randomized them into three groups: AuriAc (AEFI-specific auricular points applied, n = 52), SAuriAc (n = 51) or TrAsU (n = 44) group. Primary outcomes were percentages of any AEFI and local pain, and secondary outcomes were percentages who reported other AEFI. They were followed at 1, 3, 5, 7, and 14 days, by phone or online, with severity evaluated. RESULTS: 147 participants (73.47% females) were included with median age as 31 years (25-45, IQR). One day after the injection, participants in AuriAc group reported significant reduction on percentages of any AEFI [intention-to-treat, difference of percentage (DP) = -20.13, 95%CI: - 0.39, - 0.02, p = 0.01; per-protocol, DP = -22.21, 95%CI: - 0.40, - 0.03, P = 0.02] and local pain (per-protocol, DP = -18.40, 95%CI: -0.36, -0.01, P = 0.04), compared with TrAsU group. The effects were slight at other follow-up days and for other outcomes, and with a low percentage of mild local allergic reactions. CONCLUSIONS: We firstly explored potential of AuriAc for preventing AEFI related to COVID-19 vaccine injection, which is beneficial for the vaccine recipients, but evidence is limited. TRIAL REGISTRATION: chictr.org.cn no. ChiCTR2100043210 (http://www.chictr.org.cn/showproj.aspx?proj=121519).

Analysis of Severe Illness After Postvaccination COVID-19 Breakthrough Among Adults With and Without HIV in the US.

Importance: Understanding the severity of postvaccination SARS-CoV-2 (ie, COVID-19) breakthrough illness among people with HIV (PWH) can inform vaccine guidelines and risk-reduction recommendations. Objective: To estimate the rate and risk of severe breakthrough illness among vaccinated PWH and people without HIV (PWoH) who experience a breakthrough infection. Design, Setting, and Participants: In this cohort study, the Corona-Infectious-Virus Epidemiology Team (CIVET-II) collaboration included adults (aged ≥18 years) with HIV who were receiving care and were fully vaccinated by June 30, 2021, along with PWoH matched according to date fully vaccinated, age group, race, ethnicity, and sex from 4 US integrated health systems and academic centers. Those with postvaccination COVID-19 breakthrough before December 31, 2021, were eligible. Exposures: HIV infection. Main Outcomes and Measures: The main outcome was severe COVID-19 breakthrough illness, defined as hospitalization within 28 days after a breakthrough SARS-CoV-2 infection with a primary or secondary COVID-19 discharge diagnosis. Discrete time proportional hazards models estimated adjusted hazard ratios (aHRs) and 95% CIs of severe breakthrough illness within 28 days of breakthrough COVID-19 by HIV status adjusting for demographic variables, COVID-19 vaccine type, and clinical factors. The proportion of patients who received mechanical ventilation or died was compared by HIV status. Results: Among 3649 patients with breakthrough COVID-19 (1241 PWH and 2408 PWoH), most were aged 55 years or older (2182 patients [59.8%]) and male (3244 patients [88.9%]). The cumulative incidence of severe illness in the first 28 days was low and comparable between PWoH and PWH (7.3% vs 6.7%; risk difference, -0.67%; 95% CI, -2.58% to 1.23%). The risk of severe breakthrough illness was 59% higher in PWH with CD4 cell counts less than 350 cells/µL compared with PWoH (aHR, 1.59; 95% CI, 0.99 to 2.46; P = .049). In multivariable analyses among PWH, being female, older, having a cancer diagnosis, and lower CD4 cell count were associated with increased risk of severe breakthrough illness, whereas previous COVID-19 was associated with reduced risk. Among 249 hospitalized patients, 24 (9.6%) were mechanically ventilated and 20 (8.0%) died, with no difference by HIV status. Conclusions and Relevance: In this cohort study, the risk of severe COVID-19 breakthrough illness within 28 days of a breakthrough infection was low among vaccinated PWH and PWoH. PWH with moderate or severe immune suppression had a higher risk of severe breakthrough infection and should be included in groups prioritized for additional vaccine doses and risk-reduction strategies.

Shoulder Injury Related to Vaccine Administration (SIRVA) in 16 Patients Following COVID-19 Vaccination Who Presented to Chiropractic, Orthopedic, and Physiotherapy Clinics in Hong Kong During 2021.

BACKGROUND Shoulder injury related to vaccine administration (SIRVA) occurs when an intramuscular deltoid injection is administered into the shoulder joint. This observational study describes clinical features in 16 patients with SIRVA following Coronavirus 2019 (COVID-19) vaccination who presented to chiropractic, orthopedic, and physiotherapy clinics in Hong Kong between January 1, 2021, and January 1, 2022. MATERIAL AND METHODS Adults age ≥18 with new-onset shoulder pain and imaging-confirmed shoulder pathology were retrospectively identified from 35 clinics. Patient demographics and clinical and vaccination details were extracted from the electronic medical record. Shoulder injury was determined by correlating clinical and imaging features. RESULTS Of 730 patients with shoulder pain, 16 SIRVA cases (mean age, 49±10 years, 75% female) were identified; (12/16, 75%) of patients received the Pfizer-BioNTech vaccine while (4/16, 25%) received Sinovac-CoronaVac. The most common diagnosis was adhesive capsulitis (10/16, 63%), followed by bursitis (3/16, 19%) and supraspinatus tear (3/16, 19%). Mean symptom onset was 3.5±2.5 days post-vaccination, and always occurred after the 2nd or 3rd vaccination, involving reduced shoulder range of motion (ROM). Mean baseline pain was 8.1±1 (out of 10). All patients received conservative care (eg, exercise, manual therapies). At 3-month follow-up, mean pain reduced to 2.4±1.4; all patients had normal shoulder ROM. CONCLUSIONS In the past 2 years, millions of intramuscular COVID-19 vaccinations have been administered. It is important that clinicians are aware of SIRVA as a cause of new symptoms of shoulder injury and should ask the patient about recent vaccinations, including for COVID-19.

Associations between vaccination and quality of life among Taiwan general population: A comparison between COVID-19 vaccines and flu vaccines.

The COVID-19 pandemic has profoundly impacted lives worldwide and has led to global vaccination against COVID-19. However, there are concerns about the adverse effects of such vaccines on individuals' health. Therefore, it is important to investigate the association between vaccination and holistic health outcome (i.e., quality of life [QoL]). The present study analyzed data from the Taiwan Social Change Survey (TSCS), a survey conducted utilizing stratified random sampling. More specifically, data (N = 1425; 47.44% males; mean age = 50.58 y) on their vaccinations (including COVID-19 and flu vaccines) and QoL (using the Short-Form 12) were used. Participants were separated into two age subgroups for analyses (those aged below 50 y, and those 50 y or above). For participants aged below 50 y, those who received COVID-19 vaccine and those who received both COVID-19 and flu vaccines had significantly better physical QoL than those who did not receive any vaccination. Mental QoL was not significantly associated with vaccinations for participants aged below 50 y. Moreover, neither mental nor physical QoL was significantly associated with vaccinations for those aged 50 y or above. The present study showed that not having COVID-19 and flu vaccinations is associated with poor QoL. This finding should be disseminated to the public to help aid vaccination promotion.