COVID-19 vaccines safety: Spontaneous notification data

Introduction (contexte de la recherche): Although the SARS-CoV-2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. Objectif: We aimed to assess the safety of COVID-19 vaccines among a Tunisian Pharmacovigilance database. Methodes: An exhaustive observational study including all adverse events following COVID-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital. Resultats: A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>= 65-years-old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events [anaphylaxis (seven cases), thrombotic reactions (seven cases), and thrombocytopenia (one case)]. The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s): Our study implies that the COVID-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of COVID-19 vaccines.Copyright © 2023

Covid-19 vaccines safety: Spontaneous notification data

Background: Although the SARS-CoV- 2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. We aimed to assess the safety of Covid-19 vaccines among a Tunisian Pharmacovigilance database. Method(s): An exhaustive observational study including all adverse events following Covid-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital from April to December 2021. Result(s): A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>=65 years old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events (anaphylaxis (seven cases), (thrombotic reactions (seven cases), and thrombocytopenia (one case)). The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s): Our study implies that the Covid-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of Covid-19 vaccines.

Immunological examination of patients with rheumatological involvement after Covid-19 infection

Background: The emergence of autoinflammatory/autoimmune disorders in COVID-19 patients has necessitated the development of new strategies for the management of these phenomena. Several viruses have been shown to cause autoimmunity by boosting the production of autoreactive lymphocytes, resulting in a lack of tolerance in the host's immune response. The SARS-CoV- 2 virus and/or its proteins can cause autoimmunity by molecular mimicry, superantigen activity, and disruption of type I IFN production. Method(s): The data of three patients who applied to the outpatient clinics of pediatric immunology and rheumatology at Uludag University Hospital between March 2020 and December 2021 and were followed up with autoimmune/autoinflammatory disease following CCovid-19- 19 infection were analyzed retrospectively. Result(s): All patients were female and aged between 2-17 years. They had SARS-COV- 2 infection which was mild a few months ago. Before the Covid-19 infection, all of the patients were in good health. The patients had no history of frequent infections or familial predisposition to rheumatic diseases. Following the Covid-19- infection, all of our patients showed fever, rash, joint discomfort, and muscle soreness. Despite the fact that myalgia affects the whole body, arthralgia was present on the wrists and knees of patients. CRP, sedimentation rate, and acute phase reactants increased in all of them. According to the American College of Rheumatology's diagnostic criteria, our first patient was diagnosed with systemic lupus erythematosus (SLE) and was treated with hydroxychloroquine, intravenous immunoglobulin treatment and anakinra. Two of three were diagnosed with systemic juvenile idiopathic arthritis (sJIA) according to the League of Associations for Rheumatology (ILAR) criteria. Only one patient had low IgG and IgA levels (Table 1). Two patients showed a decrease in CD19+ naive cells percent and numbers. Conclusion(s): Following SARS-CoV- 2 infection, autoimmune and autoinflammatory disorders such as rheumatoid arthritis, psoriatic arthritis, type 1 diabetes and Still disease have been documented in adult cases. There are limited pediatric cases on this issue. It has been suggested that the persistence of the latent immune response after COVID-19 infection happens by sensitizing the immune system to viral particles long after they have been eliminated from organisms. Is the autoimmune process the effect of a viral infection or mis-targeted immune system? These questions need deep research and discussion.

Three rare presentations of high-altitude pulmonary edema at a high-altitude clinic in the Everest region (4371 m): A case series.

Diagnosis of HAPE can be challenging when the presentation deviates from usual natural history. Point of care ultrasonography serves as a great diagnostic tool in such settings. An umbrella treatment could be beneficial during such scenarios.

Side Effects of the mRNA COVID-19 Vaccines in Women Treated for Breast Cancer

Background: The introduction of the novel COVID-19 vaccination raised concerns regarding side effects from patients who had undergone breast cancer treatment. Lymph node swelling after the mRNA vaccines (Moderna, Pfizer) is a distressing side effect for women treated for breast cancer as it may indicate cancer progression or recurrence. Patients at risk of breast cancer-related lymphedema (BCRL) are fearful that lymph node swelling from the vaccine could incite or worsen BCRL. Data investigating associated side effects in this population is essential for patient education and future self-advocacy. Purpose(s): The purpose of this study was to elicit side effects associated with the COVID vaccine in women treated for breast cancer. Method(s): 4,945 surveys were sent to women over the age of 18 who had received breast cancer treatment and had been prospectively screened for BCRL with perometry. 621 participants who received an mRNA vaccine and responded to the survey were included in analysis, 469 of whom completed booster dose surveys. Participants were asked about type and duration of side effects after each vaccine dose. Solicited side effects included injection site soreness, swelling, or redness;swelling, numbness, or heaviness of the arm;generalized muscle soreness (GMS);fatigue;headache;joint pain;chills;nausea;vomiting;fever;Bell's palsy;axillary or supraclavicular lymph node swelling;other;or none of the above. We computed frequencies and the median duration of side effects for each dose. To investigate predictors of side effects, we fit multivariable logistic regression models separately for each side effect, with random effects for participants to account for clustered responses. We considered significant predictors those with p < 0.05. Result(s): Of the 621 participants, the median follow-up time between breast surgery and date of first vaccine dose was 69 months. The distribution of the top 5 side effects is presented in Table 1. Of note, the majority of participants who reported lymph node swelling (9.8% dose 1, 12.9% dose 2, 11.3% dose 3) reported it in the axilla ipsilateral to the vaccine (54.1% D1, 61.3% D2, 71.7% D3). Lymph node swelling was also reported in the axilla contralateral to the vaccine (45.9% D1, 45% D2, 24.5% D3), supraclavicular region ipsilateral (29.5% D1, 26.3% D2, 32.1% D3) and contralateral (18% D1, 18.8% D2, 9.4% D3) to the vaccine. Older patients reported each side effect significantly less frequently. Those who had received neoadjuvant chemotherapy reported significantly more GMS and headache than those who did not. Those who had received regional lymph node radiation were less likely to report GMS, as were patients who had sentinel lymph node biopsies (vs. no lymph node surgery). The median duration of side effects for all three doses was 48 hours or less, with the plurality (41.0% D1, 38.7% D2, 44.1% D3) of participants reporting side effects lasting 24 hours or less. While all side effects apart from injection site soreness were significantly more common in the second than the first doses, the duration of side effects only increased for 28.1% of participants. Conclusion(s): Over 86% of women treated for breast cancer may experience at least one side effect after any dose of the COVID-19 vaccine. This data, collected specifically for patients with breast cancer, will help enhance guidelines for structured and universal education regarding additional doses of the vaccine in the future. This will allow patients to better understand COVID vaccine side effect profiles after breast cancer treatment and self-advocate prior to future doses. (Table Presented).

Inflammatory Response Inhibition and Improvement of COVID-19 Symptoms in COVID-19 Patients by Combination of Antiviral Regimen and Tanreqing Injection

The present study explored the inflammatory response and clinical efficacy of Tanreqing injection in combination with antiviral therapy in patients with coronavirus disease (COVID-19). The results demonstrated that the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) in the treatment group were significantly lower than those in the control group (p < 0.05). Clinical efficacy assessment revealed a significant improvement in the time necessary for image absorption improvement in the treatment group (p < 0.05), while the time taken for fever and muscle soreness symptoms to resolve significantly reduced (p < 0.05). Furthermore, the time taken to obtain a negative COVID-19 test result was significantly shortened (p < 0.05). Tanreqing injection combined with antiviral treatment improved clinical symptoms of COVID-19 faster than when the anti-viral treatments were used alone and this may be related to the reduction in inflammatory response. Copyright © 2022, Colegio de Farmaceuticos de la Provincia de Buenos Aires. All rights reserved.

'rEACTIVE' MYOSITIS FOLLOWING ANTI-SARS-2 VACCINATION in TWO PATIENTS CARRYING HLA-B∗35 HAPLOTYPE

Background: The anti-SARS2 vaccination is considered the best way to reduce the frequency and the subsequent effects of COVID19 pandemic. To this aim, the most used in western countries are mRNA vaccines BNT16162b2 (Pfzer-Bi-oNT) and mRNA-1273 (Moderna). With both these vaccines the risk/benefts balance is largely favorable and severe adverse effects are almost rare. In keeping, although transient myalgia and arthralgia are frequently seen, myositis have been until now rarely reported. Objectives: To report two cases of myositis occurring in two patients after BNT16162b2 vaccine administration evaluated at the Center for Rheumatic Diseases in Venice, Italy. Methods: In these patients clinical examination, blood and instrumental investigations for myositis and, in addition HLA typing, were performed. Patients were followed for at least six months after the onset of symptoms. Results: The frst patient, a 54-year-old male, complained of high-grade fever 4 days after the I dose of BNT16162b2 (Pfzer-BioNT) followed, by mild fatigue, muscle soreness and increasing weakness. He was sent to the emergency department of the local Hospital. The physical examination confrmed the muscle weakness. Blood investigation revealed an increase of AST: 509 U/L (NV< 37), ALT:189 U/L (NV <78), LDH 609, CPK 11394 U/L (NV<, 309), Myoglobin 3571 ng/ml (VN <96), CRP 1. 6 mg/dl. Prednisone (PN) was started (50 mg orally day) and tapered to 5 mg in two weeks. At high doses, the symptoms slightly improved, but when < 10 mg, all the symptoms reappeared. Thus, he was hospitalized again. The new examination confrmed the increase of all indices of myositis;antinuclear antibodies and myositis antibodies were absent and PN was restarted at 10 mg/day without beneft;echo-cardiography and TC scan were negative. He was then sent to our observation. We increased the dose of PN at 1 mg/PN/kg and we required HLA typing. Two weeks later symptoms disappared almost completely and then we tapered PN 5 mg/day weekly. At present the patients is completely well and muscle indices negative since two months. HLA typing revealed the presence of B∗35 and DRB1∗15. The second case was a 29-year-old female presented with a history of complaints appeared two days after the vaccination with BNT16162b2 administration (Pfzer-BioNT) characterized by three days of high-degree fever, followed by sever weakness, especially in the arms. The family doctor decide to hear our advise. At the initial presentation arm strenght was very decrease and the patient was accompanied. We required a serie of investigations which revealed: CPK 8950 U/L (NV 250), CRP 3.5 mg/dl increased;antinuclear and anti-myositis antibodies absent;cardiac (Ultrasound) and thoracic (CT) investigation and electro-myography negative. HLA typing revealed the presence of haplotypes B∗35 and DRB1∗15. PN (50 mg orally day) was started;two weeks later she improved and both muscle indices and CRP negative. Thus, we reduce the dosage at 25 mg/day with tapering 5 mg weekly. She was completely remitted at end of PN cycle. At present, three month later she is well. Conclusion: The rare occurrence of some particular side effects is not predictable. Our cases of severe myositis which in both cases completely remitted in some months are associated with haplotypes HLA-B∗35 and DRB1∗15. These are both binding sites linked to high-affinity interactions to S-protein T-cell epitope which account for high potentials to trigger immunogenic responses to the S protein of SARS-CoV-2 (1). Furthermore classically, HLA-B35 is associated with reactive arthritis and self-limiting, unclassifed rheumatism (2).

The Contributing Factors of Delayed-Onset Post-traumatic Stress Disorder Symptoms: A Nested Case-Control Study Conducted After the 2008 Wenchuan Earthquake.

Background: Delayed-onset post-traumatic stress disorder after catastrophes is a major public health issue. However, good designs for identifying post-traumatic stress disorder (PTSD) among earthquake survivors are rare. This is the first nested case-control study to explore the possible factors associated with delayed-onset PTSD symptoms. Methods: A nested case-control study was conducted. The baseline (2011) and follow-up (2018) surveys were utilized to collect data. A total of 361 survivors of the Wenchuan earthquake were investigated and 340 survivors underwent follow-up. The survivors, from the hardest-hit areas, who met the criteria for PTSD were included in the case group, and PTSD-free survivors from the same area, matched for age, were included in the control group, with a ratio of one to four. Conditional logistic regression was used to evaluate the variables' odds ratio (OR). Results: The overall prevalence of delayed-onset PTSD symptoms in survivors of the Wenchuan earthquake was 9.7% (33/340). The unemployed earthquake survivors had a higher risk of developing delayed-onset PTSD symptoms (OR = 4.731, 95% CI = 1.408-15.901), while higher perceived social support was a protective factor against delayed-onset PTSD symptoms (OR = 0.172, 95% CI = 0.052-0.568). Conclusion: Delayed-onset PTSD symptoms, after a disaster, should not be ignored. Active social support and the provision of stable jobs can contribute to the earthquake survivors' mental health.

Delayed-Onset PTSD and Coping Strategies of Chinese College Students During the COVID-19 Pandemic.

Coronavirus disease 2019 (COVID-19) has become a pandemic, and many Chinese college students both in China and abroad were house-quarantined. This study aimed to investigate the prevalence and symptoms of delayed-onset post-traumatic stress disorder (PTSD) and coping strategies among Chinese overseas and domestic college students during this pandemic. A questionnaire was opportunistically distributed to Chinese college students studying both domestically and abroad six months after the COVID-19 outbreak. The questionnaire consisted of IES-R, SCSQ, and SSRS. The average score of delayed-onset PTSD in our population was 21.411 (full mark, 88 points), which reflected a total high level of delayed-onset PTSD symptoms. Statistical differences were shown between students who have been back to universities during the pandemic or not in the hyperarousal dimension (p = 0.016). Three coping strategies were recognized to influence the respondent's delayed-onset PTSD symptoms, and there was a significant correlation between social support and the coping strategies students chose. A moderate to high level of delayed-onset PTSD was observed among both Chinese overseas and domestic college students 6 months after the COVID-19 outbreak. The useful coping strategies and powerful social supports are significantly important to help them stay mentally healthy and alleviate delayed-onset PTSD during the COVID-19 pandemic.

Coronavirus disease (COVID-19) associated delayed-onset fulminant myocarditis in patient with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

A healthy 35-year-old man was admitted to a rural hospital with coronavirus disease (COVID-19). During 14 days of hospitalization, he had no symptoms and was not given supplemental oxygen. About 3 weeks after discharge, he was re-admitted to the same hospital with new-onset continuous fever and general weakness. At the time of his second admission, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) RT-PCR was performed on a retro-nasal swab and the result was negative. Four days after admission, the patient was transferred to our intensive care unit (ICU) following deterioration of his respiratory and haemodynamic conditions, where he received mechanical ventilation, intra-aortic balloon pumping, and veno-arterial extracorporeal membrane oxygenation. A nasopharyngeal swab was obtained again at ICU admission, but RT-PCR was negative for SARS-CoV-2. All antibody titres measured against other viruses were low. Blood cultures were negative, and no bacteria were observed in sputum samples. However, SARS-CoV-2 RNA was detected by RT-PCR from sections obtained by myocardial biopsy. The patient's final diagnosis was delayed-onset SARS-CoV-2-induced fulminant myocarditis (FM). We strongly suggested that one of the proposed mechanisms of COVID-19-related myocardial injury will be the direct invasion of SARS-CoV-2 into cardiomyocytes even if delayed-onset. And this is the first case of delayed-onset FM in which diagnosis of active myocarditis was proven by pathological examination following endomyocardial biopsy and SARS-CoV-2 was detected in the myocardium by RT-PCR.