ABSTRACT
Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective(s): Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Method(s): We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Result(s): We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p<0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p<0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion(s): Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
ABSTRACT
Introduction: Recently, capillary leak syndrome (CLS) emerged as new suspected adverse event after immunization (AEFI) associated to COVID-19 vaccination. This condition is rare, but serious and potentially fatal [1]. Objective(s): Our pharmacovigilance study aims to evaluate the onset of CLS as AEFI with COVID-19 mRNA vaccines (Spikevax and Comirnaty) compared to viral vector vaccines (Janssen and Vaxzevria). Method(s): We carried out descriptive and disproportionality analyses of all Individual Case Safety Reports (ICSRs) reporting a vaccine COVID-19 as suspected drug and the CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. For the disproportionality analysis we applied the Reporting Odds Ratio (ROR) 95% CI. Result(s): During study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19, Vaxzevria-, (N = 36) and Janssen-, (N = 9), while the ICSR reported to vaccines COVID-19 mRNA were 39 (Comirnaty-, N = 33;Spikevax-, N = 6). Majority of ICSRs were reported by healthcare professionals (N = 60;71.4%). The nonhealthcare professional represented the primary source in the 41.7% of Vaxzevria related ICSRs. Majority of the patients were adult (N = 49;58.3%). The female gender accounted in more than 65% of ICSRs referred both to mRNA and viral vector vaccines. The CLS outcome was more frequently favorable in mRNA ICSRs (N = 13;33,3%). On the other hand, among the ICSRs reporting CLS with unfavorable outcome (N = 25;29.8%) we found 9 ICSRs describing fatal CLS (Comirnaty N = 1;Vaxzevria N = 4;Janssen N = 4). From disproportionality analysis emerged a lower CLS reporting probability after COVID-19 vaccination with mRNA vaccines compared to viral vector-based ones. Conclusion(s): According to our results, few ICSRs describing CLS have been collected in EV in front of billion administered doses. This could underline the rarity of this AEFI or the limit of underreporting of spontaneous reporting and therefore also our study. Since the significant clinical relevance of CLS, this AEFI requires a careful monitoring. Healthcare professionals as well as patients should be aware of the signs and symptoms of CLS. Patients with a history of CLS require particular attention because of a possible risk of flare-up of disease. Since a precise mechanism is still not identified, further studies are necessary to confirm the causal relationship between CLS and COVID-19 vaccination.
ABSTRACT
Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective: Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Methods: We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Results: We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p < 0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p < 0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion: Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
ABSTRACT
Introduction: Recently, capillary leak syndrome (CLS) emerged as new suspected adverse event after immunization (AEFI) associated to COVID-19 vaccination. This condition is rare, but serious and potentially fatal [1]. Objective: Our pharmacovigilance study aims to evaluate the onset of CLS as AEFI with COVID-19 mRNA vaccines (Spikevax and Comirnaty) compared to viral vector vaccines (Janssen and Vaxzevria). Methods: We carried out descriptive and disproportionality analyses of all Individual Case Safety Reports (ICSRs) reporting a vaccine COVID-19 as suspected drug and the CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. For the disproportionality analysis we applied the Reporting Odds Ratio (ROR) 95% CI. Results: During study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19, Vaxzevria®, (N = 36) and Janssen®, (N = 9), while the ICSR reported to vaccines COVID-19 mRNA were 39 (Comirnaty®, N = 33;Spikevax®, N = 6). Majority of ICSRs were reported by healthcare professionals (N = 60;71.4%). The non-healthcare professional represented the primary source in the 41.7% of Vaxzevria® related ICSRs. Majority of the patients were adult (N = 49;58.3%). The female gender accounted in more than 65% of ICSRs referred both to mRNA and viral vector vaccines. The CLS outcome was more frequently favorable in mRNA ICSRs (N = 13;33,3%). On the other hand, among the ICSRs reporting CLS with unfavorable outcome (N = 25;29.8%) we found 9 ICSRs describing fatal CLS (Comirnaty® N = 1;Vaxzevria® N = 4;Janssen® N = 4). From disproportionality analysis emerged a lower CLS reporting probability after COVID-19 vaccination with mRNA vaccines compared to viral vector-based ones. Conclusion: According to our results, few ICSRs describing CLS have been collected in EV in front of billion administered doses. This could underline the rarity of this AEFI or the limit of underreporting of spontaneous reporting and therefore also our study. Since the significant clinical relevance of CLS, this AEFI requires a careful monitoring. Healthcare professionals as well as patients should be aware of the signs and symptoms of CLS. Patients with a history of CLS require particular attention because of a possible risk of flare-up of disease. Since a precise mechanism is still not identified, further studies are necessary to confirm the causal relationship between CLS and COVID-19 vaccination.
ABSTRACT
TOPIC: Lung Cancer TYPE: Fellow Case Reports INTRODUCTION: Mucosal-associated lymphoid tissue (MALT), is a system of lymphoid tissue found within various organs that plays a role in regulating local immunity. As this tissue contains T, B, and plasma cells, it is the potential site for the development of lymphoma. MALT lymphomas are a form of B-cell extranodal lymphoma that can originate from marginal zone lymphocytes within the lung, referred to as pulmonary marginal zone lymphoma (PMZL). CASE PRESENTATION: We present a 42-year-old female referred to our clinic for evaluation of pulmonary nodules and mediastinal adenopathy. She had a one year history of Sjogren's syndrome. At that time she had no pulmonary or B symptoms. To evaluate her mediastinal adenopathy, she was referred for endobronchial ultrasound where pathologic evaluation revealed only a polymorphous lymphoid population and was negative for malignancy. She had several endobronchial hypervascular and polypoid nodules within the mainstem airways. Pathology from these nodules demonstrated an atypical lymphoid infiltrate, but was unable to be characterized any further.Given ongoing concern for a lymphoproliferative process, she was referred for video-assisted thoracoscopic surgery (VATS). Pathology from her left upper and lower lobar wedge resections demonstrated follicular bronchiolitis. Biopsy of a pleural nodule demonstrated a lymphoproliferative process concerning for a low-grade B-cell neoplasm, thought to be extranodal PMZL. She was referred to oncology where PET/FDG demonstrated hypermetabolic multi-station adenopathy suggesting stage IV disease. Given her asymptomatic nature and anticipated indolent course, it was decided to defer chemotherapy pending resolution of the COVID-19 pandemic. DISCUSSION: MALT lymphoma can develop in response to continuous antigen stimulation, as is seen in Sjogren's syndrome or tobacco use. Radiographic features of MALT lymphoma are numerous, including consolidations, nodules, and masses being the most frequent patterns observed in ~50% of patients. Endobronchial lesions as observed in this patient occur in ~85% of cases. PET/FDG imaging commonly demonstrates mild uptake within identifiable lesions. It has a very favorable prognosis with an overall 5-year survival of 90% due to its indolent nature and excellent response rate to chemoimmunotherapy, typically combination Bendamustine and Rituximab. CONCLUSIONS: MALT lymphoma is an uncommon neoplasm that can occur due to chronic antigen stimulation, especially in patients with Sjogren's syndrome. It has numerous radiographic features, the most common being endobronchial lesions. When given these clinical features, establishing a diagnosis is of utmost importance due to the excellent response rate to therapy and favorable long-term prognosis. REFERENCE #1: Borie R, Wislez M, Thabut G, et al. Clinical characteristics and prognostic factors of pulmonary MALT lymphoma. Eur Respir J. 2009;34(6):1408-1416. REFERENCE #2: Husnain M, Kuker R, Reis IM, et al. Clinical and radiological characteristics of patients with pulmonary marginal zone lymphoma: A single center analysis. Cancer Med. 2020;9(14):5051-5064. REFERENCE #3: Stefanovic A, Morgensztern D, Fong T, Lossos IS. Pulmonary marginal zone lymphoma: a single centre experience and review of the SEER database. Leuk Lymphoma. 2008;49(7):1311-1320. DISCLOSURES: No relevant relationships by Brandon Jakubowski, source=Web Response No relevant relationships by Rosechelle Ruggiero, source=Web Response