Development of Dermatomyositis after Pfizer BioNTeh COVID-19 Vaccine: A Case Report.

INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) pandemic led to the fast development of vaccines, which is considered a medical advance in healthcare. With the extensive vaccination campaign performed worldwide, many adverse events following immunization (AEFI) were reported. Most of them were flu-like symptoms, mild and self-limiting. However, serious adverse events, such as dermatomyositis (DM), an idiopathic autoimmune connective tissue disease, have also been reported. CASE PRESENTATION: In this report, we describe a case of skin erythema, edema, and diffuse myalgia attributed at first to Pfizer BioNTeh, COVID-19 vaccination, given the temporal relationship and the absence of significant medical history. The causality assessment score was I1B2. However, after completing the etiological assessment, an invasive breast carcinoma was identified, and we retained the diagnosis of paraneoplastic DM. CONCLUSION: This study underlines the importance of completing the etiological assessment before attributing any adverse reaction to vaccination to maintain optimal patient care.

Cutaneous adverse effects of antiepileptic drugs.

Antiepileptic drugs (AED) are widely used in therapy. They are mainly indicated in the treatment of epilepsy and some psychiatric pathologies as well as for their analgesic action. Their cutaneous adverse effects (CAE) are common, often mild but sometimes serious. The aim of this work was to study the epidemiological and clinical features of CAE occurring in adults and elderly patients (aged over 20 years-old) and to identify the most implicated AED. We conducted a descriptive retrospective study over a period of five years from January 2017 to December 2022 about CAE of AED in adults and elderly patients notified to The National Center Chalbi Belkahia of Pharmacovigilance (Tunis,Tunisia). All cases were analyzed according to the updates French methods of imputability. We collected 71 cases of patients aged over 20 years old who presented CAE to AED. The age ranged from 20 to 79 years (mean age=44.8 years). The sex ratio F/M was 0.7. AED were indicated for neurological pathology in 70.5% of cases, for psychiatric pathology in 15.9% of cases and for their analgesic action in 12.9% of cases. Epilepsy was the first indication (51.1% of cases). The most notified CAE in our study were drug reaction with eosinophilia and systemic symptoms (DRESS syndrome; 34% of cases), maculopapular exanthema (MPE; 26% of cases), erythematous rash (8% of cases) and photosensitivity in 5% of cases. Severe cutaneous adverse reactions were accounted for 37% of all CAE. The most implicated AED were carbamazepine (52%), phenobarbital (24%) and lamotrigine (18%). However, further study with a larger number of patients and in collaboration with prescribing physicians are needed to better clarify features of CAE associated with AED intake and specify the risk factors, specific to our Tunisian population.

DRESS Syndrome Associated with Liposomal Amphotericin-B in a Kidney Transplant Patient: A Case Report.

INTRODUCTION: Liposomal amphotericin B is a widely used broad-spectrum antifungal drug. It was developed to reduce nephrotoxicity and maximize the therapeutic utility of amphotericin B in the treatment of invasive fungal infections. Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a severe drug-induced hypersensitivity syndrome commonly associated with aromatic antiepileptic drugs. Liposomal amphotericin-B was associated with DRESS syndrome in only one case. CASE REPORT: We report an exceptional case of possible DRESS syndrome associated with liposomal amphotericin B in a 31-year-old male renal transplant recipient. Seventeen days after starting liposomal amphotericin B for visceral leishmaniosis, he developed a skin rash with elevated liver tests. Liposomal amphotericin B was then discontinued. A favourable outcome was slowly observed in one month. RESULTS AND CONCLUSION: This case scored two (possible case) based on the criteria adopted by the European group RegiSCAR. The Naranjo score for liposomal amphotericin B was four (possible).

Myocarditis following Coronavirus vaccination.

Introduction: Myocarditis is an adverse reaction discovered after the marketing of SARS-CoV-2 mRNA vaccines. Nevertheless, this effect is not mentioned as an adverse reaction in the summary of product characteristics of other types of vaccines against this disease. Objective: In this work, we aim to present the cases of myocarditis after vaccination against COVID-19 reported to the national Tunisian centre of pharmacovigilance. Method: We present the cases of myocarditis reported after the COVID-19 vaccination. All cases are diagnosed according to Brighton's case definition of myocarditis. The vaccines causality assessment was estimated by the French imputability updated method of Bégaud et al. Results: We included five patients. The sex ratio (M/F) was 4. The mean age was 30 years. All patients had no notable cardiovascular history and did not report any significant past medical history. The onset of symptoms was two days post-vaccination in three patients. The predominant reported symptoms are chest pain and dyspnea in the five cases. Cardiac magnetic resonance imaging (MRI) confirmed the myocarditis diagnosis in four patients (not performed for one patient).All cases were classified as definitive cases according to the Brighton case definition of myocarditis. No patient required hospitalization in a cardiac intensive care unit. All the patients recovered from acute myocarditis within a few days. Conclusion: Reported cases of myocarditis post-COVID-19 vaccination in our population are rare, not severe, and have a quick favorable outcome.

Drug reaction with eosinophilia and systemic symptoms in pediatric patients: A clinicopathological study of 16 cases in the National Center of Pharmacovigilance of Tunisia.

INTRODUCTION: Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe cutaneous adverse drug reaction (SCAR) that can affect the pediatric population. However, data on its characteristics in this age group are limited. This study aims to evaluate clinical and pathological features of cases of DRESS in children reported to the national center of pharmacovigilance of Tunisia. METHODS: We conducted a descriptive retrospective study on the cases of children with DRESS reported to the National Center of Pharmacovigilance of Tunisia between January 2011 and December 2017. We used for the diagnostic the criteria suggested by the European Registry of Severe Cutaneous Adverse Reactions (RegiSCAR). RESULTS: There were 16 patients with a diagnosis of DRESS. Mean age was six years. The most common offending drugs were anticonvulsants (68.75%). The mean latency period from using the culprit drug to the onset of drug reaction was 21 days. Skin lesions and internal organ involvement were present in all patients. Hepatitis was the most common visceral involvement. Eosinophilia (>1500 cells/µL) was present in 10 patients (62.5%). The outcome was favorable for all patients after drug withdrawal and symptomatic treatment. CONCLUSION: Clinical features of DRESS in Tunisian children provide clinical information that could be useful for the early detection and the outcome improvement of this severe adverse reaction.

Meprobamate-induced fixed drug eruption.

Meprobamate is usually a safe drug prescribed for anxiety disorders. Fixed drug eruption (FDE) is an exceptional cutaneous adverse effect of this drug. We report a case of FDE induced by meprobamate with positive patch test. A 22-year-old woman was prescribed for depression meprobamate, aceprometazine, valpromide and lorazepam. On the second day of treatment, the patient presented red erythematous and pruriginous plaques in the limbs and the face. After stopping the previous treatment, the patient's lesions resolved completely within 3 weeks with residual pigmentation. One month later, patch tests were performed and were positive to meprobamate. Exceptional cases of FDE were reported in literature with meprobamate. None has reported the use of patch test to confirm the diagnosis.