Vaccine-related Adverse Events Research Articles

Influenza Vaccination in Perioperative Settings: A Teachable Moment.

Influenza Vaccination in Perioperative Settings: A Teachable Moment.

Antibody response to three SARS-CoV-2 mRNA vaccines in adolescent solid organ transplant recipients

Antibody response to three SARS-CoV-2 mRNA vaccines in adolescent solid organ transplant recipients

Awake Breast Conservative Surgery: A Strategy to Shorten Surgical Waiting Lists During and Post COVID-19 Emergency.

SARS-CoV-2 with a dramatical worldwide spread, impacted greatly daily life and healthcare. In order to avoid delay in cancer treatment, many strategies and measures were implemented. The Awake breast surgery was a strategy implemented in our Unit during the pandemic, aimed to reduce operatory room occupancy and increase the number of procedures performed during the daily surgical session. The aim of the study was to evaluate how the use of this strategy has changed before and after the advent of the COVID-19 pandemic, and its relative benefits. This was a retrospective study analysing all patients subjected to breast conservative surgery for oncological disease from July 2018 to December 2021. Out of 498 patients enrolled in the study, 253 (50.8%) cases were treated before the pandemic and were designated as "pre-COVID-19" group. The remaining 245 (49.1%) cases were considered the "COVID-19" group. Cases of awake surgery in COVID-19 group were 141 (54.7%) vs. 84 (33.2%), p<0.001. Length of hospitalization and surgical time were comparable between the groups: relative p=0.188 and 0.264, respectively. Differently, operation room occupation was significantly shorter in the COVID-19 group, p<0.001; and number of outpatient surgical procedures was higher, p=0.0304. Multivariate analysis identified the period of surgery (OR=1.47) as a statistically significant factor, p=0.011, predictive of prolonged operatory room occupancy. Awake surgery was one of the strategies which made more operating rooms available and allowed avoiding further delays.

Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial

ABSTRACT To evaluate the safety of the 15-valent pneumococcal conjugate vaccine (PCV15 (by LvZhu & Co. Ltd)) in healthy infants aged 2 months (minimum to 6 weeks) and 3 months old. This phase I clinical trial enrolled 80 subjects in Laishui County, Hebei Province, China. The total population was divided into 4 age groups on average: 20 adults (≥18 years) and 20 children (1–5 years) all received one vaccine dose; 20 infants (3 months) received the vaccine according to a 3-dose schedule at 0, 1, and 2 months. Twenty infants (2 months, minimum of 6 weeks old) received the vaccine according to a 3-dose schedule of 0, 2, and 4 months. The adverse events (AEs) until 30 days after each dose and serious adverse events (SAEs) until 6 months after the whole dose were reported. The solicited and unsolicited AE frequencies and laboratory indices were similar among the treatment groups. No vaccine-related SAEs were reported. Most vaccine-related adverse events consisting of systemic and local reactions were fever and pain. One hypersensitivity manifested as systemic urticaria that occurred on the third day after the second dose in the 2-month group. The 15-valent pneumococcal conjugate vaccine was generally well tolerated in infants.

A Survey Exploring Reasons behind Immunization Refusal among the Parents and Caregivers of Children under Two Years Living in Urban Slums of Karachi, Pakistan.

This study assesses the experiences of parents/caregivers regarding the refusal to childhood immunization. A cross-sectional study was conducted among the parents/caregivers of children under two years old from January 2019 to June 2019 who were residents of either Pathan Colony or Orangi Town, Karachi. In this study, the data collectors targeted parents/caregivers of 440 households who showed a refusal mark “R” in the Expanded Program of Immunization (EPI) H-chalking system. These households were approached using a 30 × 7 multistage-stratified-cluster random sampling technique and were interviewed using a structured questionnaire. The study sample produced two different types of refusals: true refusal (absence) and potential refusal (presence), based on the absence and presence of a vaccination card at the time of the survey. Multivariate logistic regression was used to analyze the data using Jamovi (V-1.6.13). A total of 230 households consented to participate in this study, of which 141 (61.3%) represented true refusals, while 89 (38.7%) represented potential refusals. More than half of the participants from both groups complained about fever and pain at the injection site following immunization. The use of alternative medicines and a history of adverse events following immunization (AEFI) were associated with increasing the odds of immunization refusals by four-to-five fold. However, advanced paternal age, a long distance to the clinic, a lack of trust in government, and the influence of community/religious leaders were associated with lower immunization refusal odds. Thus, an unawareness about self-limiting vaccine-related adverse events, the use of alternative medicines, and an increased concern about the safety and efficacy of vaccines were found to be barriers to immunization, which can be improved by increasing public awareness through media campaigns and policy reform.

Safety of ChAdOx1 nCoV-19 vaccination in patients with end-stage renal disease on hemodialysis.

COVID-19 vaccination is essential. However, no study has reported adverse events (AEs) after ChAdOx1 nCoV-19 vaccination in patients with end-stage renal disease (ESRD) on hemodialysis (HD). This study investigated the AEs within 30-days after the first dose of ChAdOx1 nCoV19 (Oxford-AstraZeneca) in ESRD patients on HD. A total of 270 ESRD patients on HD were enrolled in this study. To determine the significance of vascular access thrombosis (VAT) post vaccination, we performed a self-controlled case study (SCCS) analysis. Of these patients, 38.5% had local AEs; local pain (29.6%), tenderness (28.9%), and induration (15.6%) were the most common. Further, 62.2% had systemic AEs; fatigue (41.1%), feverishness (20%), and lethargy (19.9%) were the most common. In addition, post-vaccination thirst affected 18.9% of the participants with female predominance. Younger age, female sex, and diabetes mellitus were risk factors for AEs. Five patients had severe AEs, including fever (n = 1), herpes zoster (HZ) reactivation (n = 1), and acute VAT (n = 3). However, the SCCS analysis revealed no association between vaccination and VAT; the incidence rate ratio (IRR)-person ratio was 0.56 (95% CI 0.13-2.33) and 0.78 (95% CI 0.20-2.93) [IRR-event ratio 0.78 (95% CI 0.15-4.10) and 1.00 (95% CI 0.20-4.93)] in the 0-3 months and 3-6 months period prior to vaccination, respectively. Though some ESRD patients on HD had local and systemic AEs after first-dose vaccination, the clinical significance of these symptoms was minor. Our study confirmed the safety profile of ChAdOx1 nCoV-19 in HD patients and presented a new viewpoint on vaccine-related AEs. The SCCS analysis did not find an elevated risk of VAT at 1 month following vaccination. Apart from VAT, other vaccine-related AEs, irrespective of local or systemic symptoms, had minor clinical significance on safety issues. Nonetheless, further coordinated, multi-center, or registry-based studies are needed to establish the causality.

Safety of an inactivated 2019-nCoV vaccine (Vero) in adults aged 60 years and older

Objective: To analyze the safety of an inactivated 2019-nCoV vaccine (Vero cell) in adults aged 60 years and older. Methods: A randomized, double-blind, placebo-controlled clinical study was conducted in May 2020 The eligible residents aged 60 and above were recruited in Renqiu city, Hebei Province. A total of 422 subjects (phase Ⅰ/Ⅱ:72/350) were enrolled. Two doses of the trial vaccine or placebo were randomly administered according to a 0 and 28-day immunization schedule. Subjects were randomly divided into two groups in Phase Ⅰ. Within each group, participants received vaccine or placebo in a ratio of 2∶1. Subjects were randomly divided into four groups in phase Ⅱ to receive low-dose, medium-dose, high-dose vaccine and placebo, respectively, in a ratio of 2∶2∶2∶1. A combination of regular follow-up and active reporting was used to observe adverse reactions within 28 days after vaccination, and compare the incidence rate of adverse reactions in the trial and control groups. Results: 422 subjects were (66.45±4.70) years old, and 48.82% were male (206/422). There were 100, 124, 124 and 74 patients enrolled into the low-dose, medium-dose, high-dose vaccine groups and the placebo group, respectively. One person without the vaccination was removed, and 421 participants who received at least one dose of vaccine were included in the safety analysis. Within 28 days after the first or second dose, a total of 20.67% (87/421) subjects had adverse reactions (both solicitation and non-solicitation). About 76 patients suffered grade 1 adverse reactions [18.05% (76/421)] and 22 patients suffered grade 2 adverse reactions [5.23% (22/421)]. No grade 3 or above adverse reactions occurred. A total of 19.71% (83/421) subjects had solicited adverse reactions. The most common grade 1 adverse reaction was injection site pain, followed by fever and fatigue. The most common grade 2 adverse reactions were fever and fatigue, followed by muscle pain and injection site redness. A total of 2.61% (11/421) subjects had unsolicited adverse reactions. A total of 1.66% (7/421) subjects had serious adverse events after vaccination, and no serious vaccine-related adverse events were reported. Conclusions: The inactivated SARS-CoV-2 vaccine is safe for people aged 60 years and above.

COVID-19 Vaccine-Related Adverse Events in Solid Cancer Patients Treated with Immunotherapy

Little data are available regarding the effects of COVID-19 vaccine in cancer patients undergoing immunotherapy. Thereby, COVID-19 vaccine-related adverse events were monitored through a short questionnaire in solid cancer patients receiving immunotherapy. A total of 95 patients were included in this study. Two doses of vaccines were administered to cancer patients which mainly received Pembrolizumab (51.1%). Respectively 78.2% and 62.2% of patients reported no adverse events after the first and the second dose regardless of the type of vaccine used. Considering the high mortality rate due to COVID-19 among cancer patients, this study demonstrated the good tolerance of COVID-19 vaccine.

330.3: Safety and Immunogenicity Protocol of Vaccination For SARS-COV 2 in Solid Organ Transplant Patients in Argentinasociedad Argentina de Trasplante

Introduction: Coronavirus 19 disease (COVID-19) in solid organ transplant recipients (SOT) is associated with increased morbidity and mortality. The WHO recommends vaccination as a primary prevention tool. We evaluate the safety and generation of Ab Anti-Spike in SOT patients at 28 and 90 days after Covid 19 vaccination schedule. Methods: This is a Multicenter prospective study in SOT with a complete vaccination schedule who agreed to participate in the study. Demographic, vaccination schedule, adverse events and transplant variables were collected. Anti-spike antibodies were evaluated by the COVIDAR-IgG method at the Universidad de Buenos Aires School of Medicine. Results: 244 SOT patients were included from September 2021 to February 2022. Median age was 50 (IQR 41-61, women 47%).Transplant type: 62.1% kidney, 14.8% cardiac, 15.6% liver, 0.6% pancreas, kidney-pancreas 5.3% and 1.6% lung. Deceased donors 70%. The median time since transplantation to vaccination was 72.3 months (IQR 30.6 -140). Only 10.3% of patients had developed rejection one year prior to vaccination and 3.3% of patients rejected post-vaccination. 146 ptes (60.3%) had triple immunosuppressive maintenance regimen (steroids +calcineurin inhibitors (ICN) + antiproliferatives), 46ptes19.8% (received double regimen without steroids and 12 ptes 5.2% monotherapy with ICN. Vaccination scheme was: Sputnik 33%, Sputnik-AstraZeneca 5.4%, Sputnik-Moderna 19.6%, Sinopharm 6.7%, AstraZeneca 35%. The eGFR (CKD-EPI Cr) in patients who had a positive anti-Spike antibody response was higher than in those with no response: 60 ml/min/1.73 m2 (IQR 41.65 - 78.15) vs 49.4 ml/min/1.73 m2 (IQR 35.60 - 65.40) (p=0.010). Vaccine-related adverse events were observed in 22.3% of patients, 76% were mild. Patients with no response at 28 days had triple immunosuppressive regimen (p < 0.001, RR 0.419 (0.26 -0.66) and lower time post-transplant 55 vs 107 months (p < 0.001). Patients infected with Covid-19 prior to vaccine (13%), had a higher response rate: p <0.0001 RR 2.58 (1.90-3.51). Patients previously infected with Covid-19 and Anti-Spike Ab + at 28 days had a higher response at 90 days. 16% of patients were infected with COVID-19 after vaccination. Conclusion: In our SOT population, a lower generation rate of anti-spike Ab was observed, compared to the reported in the general population. Lower eGFR and the triple IS regimen were associated with a lower response rate. Covid-19 prior to vaccination was associated with a higher antibody response to the vaccine.

The associations between COVID-19 vaccination and psychological disorders among healthcare workers in China

IntroductionCOVID-19 has caused an unprecedented psychological affection that might impact the nationwide vaccination program in China. This study was to explore the association between COVID-19 vaccination and psychological disorders among healthcare workers. MethodsThe study included 1571 healthcare workers from an anonymous online survey. Participants' sociodemographic characteristics, uptake data for the COVID-19 vaccine, and scores of the Depression, Anxiety, and Stress Scale (DASS-21) were collected. Nonparametric tests were conducted to compare the mean scores of DASS-21 between different subgroups. The potential factors related to psychological disorders of healthcare workers were analyzed using logistic regression. ResultsThe vaccination rate was 69.6 %, the incidence of vaccine-related adverse events was 35.13 %, and the prevalence of depression, anxiety, and stress were 24.8 %, 32 %, and 33.4 % in this study, respectively. Compared to vaccinated participants (single-dose and double-dose vaccines), unvaccinated participants got significantly higher mean scores of DASS-21 (p < 0.05 for all). Vaccinated participants who suffered no adverse events scored significantly lower than those who suffered 1–2 or ≥3 adverse events (p < 0.05 for all). Vaccination was negatively associated with higher depression, anxiety, and stress, however, the number of vaccine-related adverse events was positively associated with them. LimitationsAs this is a cross-sectional study, we could only speculate on the causality. ConclusionsAn obvious impact of the psychological disorders on the COVID-19 vaccine coverage and related adverse events was detected in this study. Public health agencies should attach great importance to the psychological states of our citizens before getting vaccinated.

The Actual Status of Hospitals as COVID-19 Vaccination Clinics in China and Safety Monitoring of Inactivated Vaccine: A Cross-Sectional Study.

The outbreak has had a devastating impact, and efforts are underway to speed up vaccination. The study's objective was to describe the clinical characteristics of the coronavirus disease 2019 (COVID-19) vaccination clinic in the Second People's Hospital of Fujian Province, China. Meanwhile, we monitored all the vaccine recipients to evaluate adverse reactions. A cross-sectional study was done at the COVID-19 Vaccination Clinic, the Second People's Hospital of Fujian Province, China. We systematically collected Clinical data from the COVID-19 vaccination clinic between March 11 and November 11, 2021, including the type of vaccine, number of doses, gender, age, educational level, occupational category, adverse reactions, etc. Investigators will contact vaccine recipients by means of phone call or WeChat message to record the negative responses. Last, this report covers data through 8 mo, so it will be better to Evaluate the Safety of 2 inactivated COVID-19 vaccines from China (BBIBP-CorV [Beijing Institute of Biological Products, Beijing, China] and CoronaVac [Sinovac Life Sciences, Beijing, China]). The results indicated that the Second People's Hospital of Fujian Province received a total of 64,602 COVID-19 vaccines from March 11 to November 11, 2021, including 34,331 (53.14%) first doses, 29,245 (45.27%) second doses, and 1026 (1.59%) third doses. This study found the highest proportion in other personnel (38.69% at the first dose, 38.75% at the second dose, and 2.44% at the third dose), who were mainly retirees. People with higher levels of education are more likely to be vaccinated against COVID-19 during the early stages of vaccine rollout. In terms of age stratification, the highest proportion was found among people aged 18-49 (BBIBP-CorV: first dose 61%, second dose 62.6%, and third dose 76.8%; CoronaVac: first dose 66.1%, double dose 63.6%, and third dose 75.5%), followed by those over 60. The common adverse reactions were mainly local and systemic, and there were some differences between the 2 inactivated vaccines (P < 0.05). This is the first study to analyze the actual status of hospitals as COVID-19 vaccination clinics in China. The hospital has focused on vaccinating citizens and the initial rollout of vaccines to ensure any safety issues are identified. More citizens are willing to vaccinate in hospitals because of the uncertain safety of the available vaccines and adverse reactions. The good news is that vaccine-related severe adverse events have not been found in the hospital vaccination clinic. The Safety of BBIBP-CorV and CoronaVac is relatively high.

A genetically engineered Plasmodium falciparum parasite vaccine provides protection from controlled human malaria infection.

Genetically engineered live Plasmodium falciparum sporozoites constitute a potential platform for creating consistently attenuated, genetically defined, whole-parasite vaccines against malaria through targeted gene deletions. Such genetically attenuated parasites (GAPs) do not require attenuation by irradiation or concomitant drug treatment. We previously developed a P. falciparum (Pf) GAP with deletions in P52, P36, and SAP1 genes (PfGAP3KO) and demonstrated its safety and immunogenicity in humans. Here, we further assessed safety, tolerability, and immunogenicity of the PfGAP3KO vaccine and tested its efficacy against controlled human malaria infection (CHMI) in malaria-naïve subjects. The vaccine was delivered by three (n = 6) or five (n = 8) immunizations with ~200 PfGAP3KO-infected mosquito bites per immunization. PfGAP3KO was safe and well tolerated with no breakthrough P. falciparum blood stage infections. Vaccine-related adverse events were predominately localized urticaria related to the numerous mosquito bites administered per vaccination. CHMI via bites with mosquitoes carrying fully infectious Pf NF54 parasites was carried out 1 month after the last immunization. Half of the study participants who received either three or five PfGAP3KO immunizations remained P. falciparum blood stage negative, as shown by a lack of detection of Plasmodium 18S rRNA in the blood for 28 days after CHMI. Six protected study participants received a second CHMI 6 months later, and one remained completely protected. Thus, the PfGAP3KO vaccine was safe and immunogenic and was capable of inducing protection against sporozoite infection. These results warrant further evaluation of PfGAP3KO vaccine efficacy in dose-range finding trials with an injectable formulation.

Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey.

IntroductionLittle is known about the impact of mandatory vaccination on people who are reluctant to be vaccinated, despite the potential importance in terms of public health policy.ObjectiveWe aimed to explore the relationship between vaccine hesitancy and onset, severity and characteristics of self-reported adverse events.MethodsWe used a cross-sectional online survey conducted in 2021 among a representative sample of the French population aged 18 years and older (n = 1593). All reported adverse events were analyzed and categorized by trained experts in drug safety and pharmacovigilance. Multivariate binomial regressions on the onset of self-reported adverse events, vaccine hesitancy categories and predefined responders’ characteristics were performed.ResultsOverall, 590 (37.0%) participants reported at least one adverse event, with 121 (20.5%) considered it to be severe. Proportions of reported adverse events, ranging from 18% (in non-reluctant responders) to 65% (in very reluctant responders), and their severity, ranging from 5% (non-reluctant responders) to 41% (very reluctant responders), depended highly on attitudes toward vaccination. The adverse events profile remained similar between groups. In the multivariate regression model, beyond attitude toward vaccination, younger age and female gender were significantly associated with higher reporting of vaccine adverse events.ConclusionsOur results suggest that vaccine hesitancy could be a major driver of patient-reported vaccine-related adverse events and their perceived severity. In this context, vaccinators must pay special attention to reluctant patients and inform them on the possible nocebo nature of these adverse events so as to prevent them.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40264-022-01220-0.

Rare Heterogeneous Adverse Events Associated with mRNA-Based COVID-19 Vaccines: A Systematic Review.

Background: Since the successful development, approval, and administration of vaccines against SARS-CoV-2, the causative agent of COVID-19, there have been reports in the published literature, passive surveillance systems, and other pharmacovigilance platforms of a broad spectrum of adverse events following COVID-19 vaccination. A comprehensive review of the more serious adverse events associated with the Pfizer-BioNTech and Moderna mRNA vaccines is warranted, given the massive number of vaccine doses administered worldwide and the novel mechanism of action of these mRNA vaccines in the healthcare industry. Methods: A systematic review of the literature was conducted to identify relevant studies that have reported mRNA COVID-19 vaccine-related adverse events. Results: Serious and severe adverse events following mRNA COVID-19 vaccinations are rare. While a definitive causal relationship was not established in most cases, important adverse events associated with post-vaccination included rare and non-fatal myocarditis and pericarditis in younger vaccine recipients, thrombocytopenia, neurological effects such as seizures and orofacial events, skin reactions, and allergic hypersensitivities. Conclusions: As a relatively new set of vaccines already administered to billions of people, COVID-19 mRNA-based vaccines are generally safe and efficacious. Further studies on long-term adverse events and other unpredictable reactions in close proximity to mRNA vaccination are required.

South African University Staff and Students’ Perspectives, Preferences, and Drivers of Hesitancy Regarding COVID-19 Vaccines: A Multi-Methods Study

COVID-19 vaccine hesitancy poses a threat to the success of vaccination programmes currently being implemented. Concerns regarding vaccine effectiveness and vaccine-related adverse events are potential barriers to vaccination; however, it remains unclear whether tailored messaging and vaccination programmes can influence uptake. Understanding the preferences of key groups, including students, could guide the implementation of youth-targeted COVID-19 vaccination programmes, ensuring optimal uptake. This study examined university staff and students’ perspectives, preferences, and drivers of hesitancy regarding COVID-19 vaccines. A multi-methods approach was used—an online convenience sample survey and discrete choice experiment (DCE)—targeting staff and students at the University of KwaZulu-Natal, South Africa. The survey and DCE were available for staff and students, and data were collected from 18 November to 24 December 2021. The survey captured demographic characteristics as well as attitudes and perspectives of COVID-19 and available vaccines using modified Likert rating questions adapted from previously used tools. The DCE was embedded within the survey tool and varied critical COVID-19 vaccine programme characteristics to calculate relative utilities (preferences) and determine trade-offs. A total of 1836 staff and students participated in the study (541 staff, 1262 students, 33 undisclosed). A total of 1145 (62%) respondents reported that they had been vaccinated against COVID-19. Vaccination against COVID-19 was less prevalent among students compared with staff (79% of staff vs. 57% of students). The vaccine’s effectiveness (22%), and its safety (21%), ranked as the two dominant reasons for not getting vaccinated. These concerns were also evident from the DCE, with staff and students being significantly influenced by vaccine effectiveness, with participants preferring highly effective vaccines (90% effective) as compared with those listed as being 70% or 50% effective (β = −3.72, 95% CI = −4.39 to −3.04); this characteristic had the strongest effect on preferences of any attribute. The frequency of vaccination doses was also found to have a significant effect on preferences with participants deriving less utility from choice alternatives requiring two initial vaccine doses compared with one dose (β = −1.00, 95% CI = −1.42 to −0.58) or annual boosters compared with none (β = −2.35, 95% CI = −2.85 to −1.86). Notably, an incentive of ZAR 350 (USD 23.28) did have a positive utility (β = 1.14, 95% CI = 0.76 to 1.53) as compared with no incentive. Given the slow take-up of vaccination among youth in South Africa, this study offers valuable insights into the factors that drive hesitancy among this population. Concerns have been raised around the safety and effectiveness of vaccines, although there remains a predilection for efficient services. Respondents were not enthusiastic about the prospect of having to take boosters, and this has played out in the roll-out data. Financial incentives may increase both the uptake of the initial dose of vaccines and see a more favourable response to subsequent boosters. Universities should consider tailored messaging regarding vaccine effectiveness and facilitate access to vaccines, to align services with the stated preferences of staff and students.

New-onset lichen planus and lichen planus flare in elderly women after COVID-19 vaccination.

Dear Editor, Owing to the widespread use of COVID-19 vaccines, the number of cutaneous vaccine-related adverse events has recently increased.1 We present two cases of lichen planus in elderly women following COVID-19 mRNA vaccination. The first patient presented with new-onset LP, whereas the second patient experienced an extensive LP flare after a 10-year remission. The first patient was an 82-year-old woman who developed an extensive pruritic rash 14 days after receiving a second dose of the Pfizer-BioNTech COVID-19 vaccine. Other possible triggers such as recent infections, medication changes, or stressful events preceding the eruption were ruled out. The patient had no significant medical history, other than well-controlled arterial hypertension. On physical examination, she had polygonal, purpuric, scaly papules in the axillary region, flexural wrists and forearms, ankles, buttocks, lower back, and abdomen (Figure 1). Mucosal lesions were not observed. Dermoscopy revealed mild desquamation and Wickham's striae. Skin biopsy demonstrated irregular epidermal hyperplasia with hypergranulosis and hyperkeratosis, vacuolar degeneration of the basal layer, and dense lymphocytic infiltrate in the superficial dermis (Figure 1). Considering the clinical presentation, histopathological analysis, and absence of an alternative trigger, we diagnosed LP triggered by the mRNA COVID-19 vaccine. Thus, we began treatment with prednisolone 20 mg daily, tapering the dose over 6 weeks, which resulted in gradual improvement of skin lesions. The second patient was a 68-year-old woman with a 2-week history of an intensely pruritic eruption that occurred 14 days after receiving a second dose of the Moderna COVID-19 (mRNA-1273) vaccine. Her medical history included arterial hypertension, hyperlipidemia, obesity, HLA-B27 spondyloarthritis, and LP, which was histologically confirmed 10 years ago and successfully treated with systemic and topical corticosteroids. During the examination, erythematous to violaceous squamous papules were discovered on the trunk, buttocks, and extremities, as well as around the ankles, flexural wrists, forearms, and axillary folds, with palmar involvement as well (Figure 2). Mucosal or nail lesions were absent. Dermoscopy revealed slight scaling and Wickham's striae, and a skin biopsy confirmed lichen planus. Therefore, we introduced 30 mg prednisolone, and tapered the dose to discontinuation over 6 weeks, which lead to the resolution of skin lesions. LP is a chronic inflammatory T-cell-mediated skin disease caused by various infections, drugs, and, in rare cases, vaccines.1-6 The most common vaccines causing LP are hepatitis B and influenza vaccines. Recently, the new-onset or reactivation of LP has been associated with COVID-19 infection and vaccination. Although most reported cases of LP following COVID vaccination were localized, we observed two cases of widespread LP.2-5 The majority of vaccine-related reactions occur in middle-aged women, implying an increased risk of such reactions in women, even in elderly ones, as observed in our cases.1, 6 Both our patients developed LP 14 days after receiving the second dose of mRNA COVID-19 vaccine, which is consistent with vaccine-related LP time onset.6 The immunopathogenesis of vaccine-induced LP likely involves Th1 cell activation with upregulation of proinflammatory cytokines IL-2, TNF-alpha, and IFN-y, which leads to apoptosis of basal keratinocytes, a hallmark of LP. However, the precise mechanism underlying LP (re)activation following vaccination remains unknown. Similarly, immune dysregulation after COVID-19 vaccination may result in the (re)activation of other immune-mediated skin diseases such as psoriasis, vitiligo, acne vulgaris, pemphigus vulgaris, and certain connective tissue diseases.2, 5 Likewise, COVID-19 pandemic has underlined the importance of dermatologists and rheumatologists in providing guidance regarding immunosuppressive and biological therapy considering their extensive experience with such treatments, as well as recognizing the immune-mediated aspects of COVID-19 infection and vaccination.7 Furthermore, as a result of a better understanding of COVID-19 disease mechanisms, novel therapeutic strategies utilizing adipose-derived mesenchymal stem cells (AD-MSCs) are being developed, and given their immuno-modulatory properties, could be employed to combat the disease.8 Finally, dermatologists should be aware of new-onset or flare-ups of LP in older women caused by COVID-19 vaccination as well as the possible (re)activation of other immune-mediated skin diseases. N.H. wrote the original manuscript. T.Z., S.P., and I.B. performed literature research and contributed to the analysis of the data. M.K. and L.P.M. performed supervision, and writing—review and editing. The authors declare no conflicts of interest. Authors declare human ethics approval was not needed for this study. The data that support the findings of this study are available from the corresponding author upon reasonable request. Written informed consent was obtained from the patients for the publication of this case report and accompanying images.

Vaccine-Related adverse events following AZD1222 (ChAdOx1-nCoV-19) Covid-19 vaccine in solid malignancy patients receiving cancer treatment, as compared to age-matched healthy controls

ABSTRACT The study aimed to evaluate vaccine-related adverse events (VRAEs) following ChAdOx1-nCoV-19 vaccine in solid cancer patients receiving treatment compared to healthy controls. 399 cancer patients and 90 healthy volunteers were enrolled. In the overall population, the incidence of VRAEs was significantly lower in cancer patients than in healthy volunteers (57% vs 80%, P < .001). Because the mean age of the cancer patients was higher than the healthy volunteers (59 vs 48 years, P < .001), we analyzed age-matched comparison and found that there was no significant difference of VRAEs between two groups (74% vs 79%, P .32). Most VRAEs were of mild severity in both groups. The most common local VRAE was pain at the injection site in both groups, and the most common systemic VRAE was fatigue in the cancer cohort, while myalgia was the most common VRAE among the healthy controls. In the cancer cohort, fever was the only VRAE that led to interruption of the cancer treatment (in two cases). Among the cancer treatment types, patients undergoing chemotherapy-containing regimens had a lower likelihood of experiencing VRAEs. In summary, the overall incidence of VRAEs following ChAdOx1-nCoV-19 vaccine in actively treated cancer patients was comparable to healthy controls after adjusting for age. The VRAEs that occurred rarely interfered with the cancer treatment. These findings substantiate that vaccination with AZD1222 is safe in cancer patients undergoing treatment.

A Comparative Analysis of a Self-Reported Adverse Events Analysis after Receiving One of the Available SARS-CoV-2 Vaccine Schemes in Ecuador.

The COVID-19 pandemic has put a lot of pressure on health systems worldwide. Mass vaccination against SARS-CoV-2 has reduced morbidity and mortality worldwide. Despite their safety profiles, vaccines, as with any other medical product, can cause adverse events. Yet, in countries with poor epidemiological surveillance and monitoring systems, reporting vaccine-related adverse events is a challenge. The objective of this study was to describe self-reported vaccine adverse events after receiving one of the available COVID-19 vaccine schemes in Ecuador. A cross-sectional analysis based on an online, self-reported, 32-item questionnaire was conducted in Ecuador from 1 April to 15 July 2021. Participants were invited by social media, radio, and TV to voluntarily participate in our study. A total of 6654 participants were included in this study. Furthermore, 38.2% of the participants reported having at least one comorbidity. Patients received AstraZeneca, Pfizer, and Sinovac vaccines, and these were distributed 38.4%, 31.1%, and 30.5%, respectively. Overall, pain or swelling at the injection site 17.2% (n = 4500) and headache 13.3% (n = 3502) were the most reported adverse events. Women addressed events supposedly attributable to vaccination or immunization [ESAVIs] (66.7%), more often than men (33.2%). After receiving the first dose of any available COVID-19 vaccine, a total of 19,501 self-reported ESAVIs were informed (87.0% were mild, 11.5% moderate, and 1.5% severe). In terms of the vaccine type and brand, the most reactogenic vaccine was AstraZeneca with 57.8%, followed by Pfizer (24.9%) and Sinovac (17.3%). After the second dose, 6776 self-reported ESAVIs were reported (87.1% mild, 10.9% moderate, and 2.1% severe). AstraZeneca vaccine users reported a higher proportion of ESAVIs (72.2%) in comparison to Pfizer/BioNTech (15.9%) and Sinovac Vaccine (11.9%). Swelling at the injection site, headache, muscle pain, and fatigue were the most common ESAVIs for the first as well as second doses. In conclusion, most ESAVIs were mild. AstraZeneca users were more likely to report adverse events. Participants without a history of COVID-19 infection, as well as those who received the first dose, were more prone to report ESAVIs.

Impact of BNT162b2 mRNA Vaccination on the Development of Short and Long-Term Vaccine-Related Adverse Events in Inflammatory Bowel Disease: A Multi-Center Prospective Study.

IntroductionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has been effective in protecting against severe COVID-19 infections and related mortality. It is recommended for all individuals including patients with inflammatory bowel disease (IBD). However, safety data are lacking in this group of patients. Therefore, we aim to evaluate the short- and long-term vaccine related adverse events (AEs) in patients with IBD.MethodsThis is a prospective, observational cohort study investigating short- and long-term AEs related to the BNT162b2 vaccine in patients with IBD (study group) after the first and second dose compared to healthy participants (control group). Patients were recruited at the time of attendance to the clinic or infusion rooms. Short term (<3 weeks) localized and systemic AEs were assessed via questionnaire. Follow-up phone-based survey was made to collect data on long term (up to 24 weeks) AEs.ResultsA total of 408 patients answered the questionnaires, 204 patients in each group, the study and control group. No serious adverse events were reported in either the study or the control group after the first or the second dose. Participants in the control group reported more frequent pain at the injection site than those in the study group after the first dose [58 (57%) vs. 38 (37%) respectively, P = 0.005]. After the second dose, tiredness was reported more frequently in the control group [49 (48%)] compared to the study group [25 (24%) (P < 0.001)]. At 20–24 weeks post vaccination, 386 out of 408 (94.6%) patients were willing to participate in the follow-up phone based questionnaire [196 (96.1%) in the study group vs. 190 (93.1%) in the control group]. In both groups, none of the patients reported local, systemic, or severe adverse events (0 out of 386) at week 20–24 post second dose.ConclusionThe BNT162b2 vaccine is safe in patients with IBD. No severe or long-term adverse events were reported in our study. The frequency of local and systemic adverse events after the second dose was generally higher among healthy participants compared to patients with IBD. Further studies including a larger cohort with a longer follow-up duration are needed to assess for possible rare adverse events.

Using the ‘8Rs’ checklist to support safe vaccination practice

Safe vaccination practice is essential to reduce the risk of vaccine-related adverse events, ensure vaccines are administered safely and maintain a high level of confidence in vaccination programmes among the general public and healthcare practitioners. This article focuses on safe vaccination practice in relation to the routine vaccination programme, as well as considering vaccination against coronavirus disease 2019 (COVID-19). It provides examples of vaccine-related adverse events and explains how using the ‘8Rs’ checklist can promote patient safety and reduce the risk of such events.