A Cross-Sectional Study of Untoward Reactions Following Homologous and Heterologous COVID-19 Booster Immunizations in Recipients Seventeen Years of Age and Older.

A booster dose after primary COVID-19 vaccination series was considered crucial after the emergence of the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants. Active surveillance was used to investigate reporting of adverse events post-booster dose of either of the licensed mRNA Comirnaty (Pfizer/BioNTech) or Spikevax (Moderna) vaccines in adult (17 years and older) recipients in central Italy. Eligible participants were enrolled and interviewed via phone using a structured questionnaire. Primary outcomes related to the occurrence of adverse events post-booster were stratified by vaccine, and frequency of local/systemic, mild/moderate/severe events. Of a total of 622 participants interviewed, 554 (89.1%) reported at least one adverse event (88.2% and 92.9% after the Comirnaty or Spikevax vaccine, respectively): 63.4% were female, and 78.5% aged 17 to 64 years, regardless of vaccine. 87.7% and 68.2% of all recipients described at least one local or systemic reaction, respectively: 97.3, 38.6 and 4.7% reported mild, moderate, or severe events, respectively. The most frequent adverse reactions were pain, redness, or swelling at the injection site and fatigue, while malaise and fever significantly occurred after the Comirnaty, and vomiting after the Spikevax booster. Compared to the primary vaccination, lymphadenopathy was more common after the booster (p < 0.001), especially after Comirnaty vaccine. The study findings revealed no serious or unexpected adverse events, and are in agreement with data available on booster dose for both mRNA vaccines. The transient, mild to moderate, and common to very common side reactions reported should be used to reassure potential recipients of the lack of safety concerns.

Active Surveillance of Adverse Events in Healthcare Workers Recipients After Vaccination with COVID-19 BNT162b2 Vaccine (Pfizer-BioNTech, Comirnaty): A Cross-Sectional Study.

In this cross-sectional study, adverse events after the first and second dose of BNT162b2 mRNA (Pfizer-BioNTech, Comirnaty) vaccine against coronavirus disease 2019 were investigated among employees of clinics in central Italy. A 42-items questionnaire was administrated to vaccine recipients. Adverse events were classified based on severity and occurrence as reported in the literature. A descriptive/univariate analysis using Chi-square or Fisher's Exact tests was performed. Odds ratio (OR) and 95% confidence intervals were calculated to assess risk factors. 340 individuals (61.5% females; median age 49 years) participated. Adverse events were reported by 279 (82%) and 281 (82.6%) individuals as induced by the first and second dose, respectively. Mild reactions were mainly reported (80.9% and 80.3%), followed by moderate (11.8% and 37.1%) and severe (3.8% and 4.7%). Adverse events were identical to those already described as very common (81.8% and 80.6%), although vaccine-coincidental events not cited in the literature were reported by 6% and 15.6% following each dose. Age ≤ 55 years was a risk factor for any adverse event after each injection (ORs: 2.942 and 2.818), as well as female sex for those mild (ORs: 1.856 and 2.818) and common (ORs: 3.452 and 2.145). Findings were consistent with national reports as most of the adverse events were mild and associated with female sex and young age, while investigations are needed for reactions not described elsewhere. Data are useful to support the vaccine safety profile, also because largely targeted healthcare personnel more skilled than general population in self-diagnosis of health-related issues.

A SARS-CoV-2 Outbreak Among Nursing Home Residents Vaccinated with a Booster Dose of mRNA COVID-19 Vaccine.

This study describes a SARS-CoV-2 outbreak caused by the Delta (B.1.617.2) variant in a nursing home in Central Italy during October-November 2021. Trained interviewers collected data from residents, staff, and administration officers with an agreed informed consent procedure. Thirty-two (44.5%) out of 72 residents (median age 89 years) and six (26.1%) of 23 healthcare workers were found to be infected with SARS-CoV-2. Infections occurred more often among residents with a higher index of independence in daily living activities, suggesting an increased risk for those with more interactions. Twenty-five infected residents (78.1%) received the booster dose of mRNA anti-COVID-19 vaccine > 7 days before SARS-CoV-2 onset. Half of the infected residents had mild symptoms, and only three required hospitalisation, one of whom died from COVID-19 complications. The study underlines the effectiveness of a booster dose in providing a high protection against severe disease and hospitalisation even among vulnerable individuals infected with the Delta variant of concern.

Airway distensibility by HRCT in asthmatics and COPD with comparable airway obstruction.

INTRODUCTION: Decreased airway distensibility (AD) in response to deep inspirations, as assessed by HRCT, has been associated with the severity of asthma and COPD. AIMS: The current study was designed to compare the magnitude of AD by HRCT in individuals with asthma and COPD with comparable degrees of bronchial obstruction, and to explore factors that may influence it. RESULTS: We enrolled a total of 12 asthmatics (M/F:7/5) and 8 COPD (7/1) with comparable degree of bronchial obstruction (FEV1% predicted mean ± SEM: 69.1 ± 5.2% and 61.2 ± 5.0%, respectively; p = 0.31). Each subject underwent chest HRCT at FRC and at TLC. A total of 701 airways (range 20 to 38 airway per subject; 2.0 to 23.1 mm in diameter) were analyzed. AD did not differ between asthmatics and COPD (mean ± SEM: 14 ± 3.5% and 17 ± 4.3%, respectively; p = 0.58). In asthmatics, AD was significantly associated with FEV1% predicted (r(2) = 0.45, p = 0.018). We found a significant correlation between the change in lung volume and the change in AD by HRCT (r(2) = 0.64, p = 0.002). In COPD, we found significant correlations between AD and the RV% predicted (r(2) = 0.51, p = 0.046) and the RV/TLC (r(2) = 0.68, p = 0.01). CONCLUSIONS: AD was primarily affected by the dynamic ability to change lung volumes in asthmatics, and by static lung volumes in COPD.

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy.

This survey investigated on adverse events after vaccination with mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine in children aged 5-11 years in central Italy through active surveillance reporting. During December 2021-January 2022, parents of children who undergone vaccination were interviewed using a structured questionnaire. 197 out of 208 contacted parents participated (94.7% response rate), of whom 166 (84.3%) had one child. Of the 229 children, the mean age was 8.9 years, 50.7% were female. 193 (84.3%) had at least one adverse event after the first dose (mean age 9.1 years; 54.4% female), and 146 (73.4%) of 199 after the second (mean age 8.9 years; 54.8% female), which was not administered to 30 children due to previous COVID-19 history. Local symptoms after the first and second dose occurred in 183 (94.8%) and 141 (96.6%) recipients (p = .435), respectively, while systemic reactions in 62 (32.1%) and 34 (23.3%) (p = .074). Mild events were reported by 81.7% and 69.8% children after the first and second dose, followed by moderate (3.9% and 10.6%) and severe (1.3% and 0.5%). After each dose, injection site reactions (79.5% and 68.8%) were the most frequent, followed by headache (13.1%) and lymphadenopathy (8.5%) after the first and second dose, respectively. The adverse events were reported to pediatricians only for 5.7% and 3.9% of children and treated for 17.6% and 15.8%. This is the first report about safety profile through active surveillance of mRNA BNT162b2 among children in Italy, revealing temporary and mild-to-moderate symptoms with no serious events after each vaccine dose.

A Coronavirus Outbreak Linked to a Funeral Among a Romani Community in Central Italy.

Background: The epidemic dynamics of COVID-19 in the Molise region, central Italy, has dramatically changed from the beginning of May 2020, which was when infections were reported amongst Romani people. The aims of this study were to describe the characteristics of an outbreak that occurred in the Romani community and the interventions implemented for control. Methods: A retrospective analysis of outbreak data was performed to describe the SARS-CoV-2 transmission dynamics. Results: A young Romani woman was the first case reported and epidemiological investigation established a possible link with the funeral of a deceased member of this community. In total, 150 close contacts within 34 family groups in two cities were traced, and 109 (72.7%) Romani individuals were found to be infected by COVID-19. The patient's median age was 31 years, 58% were female, and the highest (20.2%) incidence occurred in the 0-9 years age group. A total of 26 (23.8%) patients developed typical SARS-CoV-2 symptoms, 15 (57.8%) were hospitalized, and 21 (22.1%) had comorbidities [most commonly hypertension (28.6%) and/or coronary heart diseases (23.8%)]. The outbreak was effectively controlled through compulsory quarantine and enhanced active surveillance. Conclusions: This is the first study providing insight into COVID-19 transmission dynamics among a Romani population living in Italy. These findings support general conclusions about the role of crowded social gatherings in SARS-CoV-2 spread, the high communicability among close contacts and household settings, and the impact of asymptomatic carriers. These features are of relevance to certain Romani customs where family gatherings are a fundamental pillar of their lives. Although difficulties emerged in interacting with Romani people related to cultural drivers, beliefs, and lifestyle, the outbreak management was effective and should be considered as a valuable model applicable to similar incidents occurring in minority populations.

Fitz-Hugh-Curtis Syndrome Secondary to Postpartum Endometritis: Case Report and Literature Review.

We report a case of Fitz-Hugh-Curtis syndrome (FHCS) 1 week after an urgent cesarean section. Although its onset in the postpartum period is poorly reported in the literature, we suggest that FHCS can complicate puerperal endometritis; therefore, it should be consider in differential diagnosis in puerpera with right upper quadrant pain. Again, it can be useful to perform a contrast computed tomography that allows early diagnosis and conservative treatment.

Physical capacity in performing daily activities is reduced in scleroderma patients with early lung involvement.

BACKGROUND AND AIMS: Patients with systemic sclerosis (SSc) often complain reduced capacity at submaximal exercise; conversely, physical capacity in performing daily duties has never been measured in SSc. The aim of this study is to evaluate this performance and its correlates, in patients with SSc compared with healthy controls, in a free-living setting. METHODS: Twenty-seven outpatients with stable SSc and 11 controls were recruited. Physical activity was assessed by portable multiple sensor device (SenseWear Armband) worn for at least 6 days. Physical activity duration (PAD; in minutes) for non-sedentary activities and physical activity level (PAL = total daily energy/resting energy expenditure) per day were calculated. Nutritional status was estimated by bioelectrical impedance analysis and pulmonary arterial hypertension excluded by echocardiography. RESULTS: Daily physical activities (243 ± 145 min per day vs 397 ± 142 min, respectively; P = 0.005) and PAL were significantly reduced in SSc compared with controls (1.5 ± 0.4 vs 2 ± 0.7, respectively; P = 0.019). Seventy-four per cent of SSc patients showed PAL < 1.70, whereas only 27% of controls were below this threshold for sedentary life style. Both PAD and PAL positively correlated with DLco. Patients and controls did not differ for spirometric parameters, body mass index, phase angle at bioelectrical impedance analysis, fat mass or fat-free mass indexes. In SSc, exercise capacity during daily activity was reduced compared with controls, and was associated with early evidence of functional decay (decreasing DLco) but not with malnutrition (undernutrition). CONCLUSIONS: A reduction of daily physical activity is already present even in early stages of lung involvement in SSc, characterized by unaltered spirometry and well-preserved nutritional status.

Giant hepatic hydatid cyst as a cause of small bowel obstruction.

Today, giant hydatid cysts are fairly rare even in endemic areas. We describe a case of an extremely large hydatid cyst of the liver that was causing massive compression of the neighboring organs, giving rise to a subocclusive syndrome of the intestine. After considering the various approaches available for the treatment of this disease, it was decided that radical surgery was still the best therapeutic choice, especially when extremely large cysts are involved. In particular, in clinical situations where it is difficult to perform radical surgical procedures, less aggressive surgery followed by drug treatment should be the treatment of choice.

Asymptomatic bone cement pulmonary embolism after vertebroplasty: case report and literature review.

Introduction. Acrylic cement pulmonary embolism is a potentially serious complication following vertebroplasty. Case Report. A 70-year-old male patient was treated with percutaneous vertebroplasty for osteoporotic nontraumatic vertebral collapse of L5-S1. Asymptomatic pulmonary cement embolism was detected on routine postoperative chest radiogram and the patient was treated with enoxaparin, amoxicillin, and dexamethasone. At the followup CT scan no further migration of any cement material was reported; and the course was uneventful. Discussion. The frequency of local leakage of bone cement is relatively high (about 80-90%), moreover, the rate of cement leakage into the perivertebral veins (seen in up to 24% of vertebral bodies treated) with consequent pulmonary cement embolism varies from 4.6 to 6.8% (up to 26% in radiologic studies); the risk of embolism is increased with the liquid consistency of the cement and with the treatment of some malignant lesions. Patients may remain asymptomatic and develop no known long-term sequelae. Conclusions. Our ancedotal case illustrates the need for close monitoring of patients undergoing percutaneous vertebroplasty and emphasizes the importance of prompt and correct diagnosis and treatment, even if actually there is no agreement regarding the therapeutic strategy.

Giant hepatocellular adenoma as cause of severe abdominal pain: a case report.

The authors describe the case of a large hepatocellular adenoma diagnosed in a 30-year old woman who came to us complaining of acute pain in the upper abdominal quadrants. The patient had been taking an oral contraceptive pill for the last ten years. We present the clinical features, the diagnostic work-up and the treatment prescribed.