Effusive–constrictive pericarditis after the second dose of BNT162b2 vaccine (comirnaty): a case report

Background Whereas effusive-constrictive pericarditis can rarely occur in COVID-19, to date no cases of effusive-constrictive pericarditis related to SARS-CoV2 vaccine have been documented. Case summary A 59-year-old caucasian man presented to our emergency department with effusive-constrictive pericarditis. Symptoms occurred shortly after the second dose of BNT162b2 (Comirnaty) vaccine. No other etiological causes were identified. Guidelines directed therapy for acute pericarditis was implemented, with clinical benefit. Discussion Systemic inflammatory response to COVID-19 can rarely trigger pericarditis. In our case a strong temporal relation between the second dose of BNT162b2 vaccine and symptoms occurrence was documented, indicating a possible rare adverse reaction to the vaccine, similarly to natural infection. Further research is needed to confirm a causal relationship.

A report of two cases of myocarditis following mRNA COVID-19 vaccination

Background Vaccination is the most important measure to control the coronavirus disease 2019 (COVID-19) pandemic. Myocarditis has been reported as a rare adverse reaction to COVID-19 vaccines. The clinical presentation of myocarditis in such cases can range from mild general symptoms to acute heart failure. Case summary We report the cases of two young men who presented with chest pain and dyspnoea following the administration of the mRNA COVID-19 vaccine. Cardiac investigations revealed findings typical of acute myocarditis. Discussion Myocarditis is a rare complication following mRNA COVID-19 vaccination. In this case series, the temporal proximity of the development of acute myocarditis and the administration of the mRNA COVID-19 vaccine was acknowledged. In the absence of other causative factors, myocarditis in these patients potentially occurred due to an adverse reaction to the mRNA COVID-19 vaccine. However, a causal relationship remains speculative. Clinical suspicion of myocarditis should be high if patients present with chest pain or dyspnoea after receiving COVID-19 vaccination.

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs’ safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

Case Report: Infusion-Related Reactions to Intravenous Infliximab and Subcutaneous Ustekinumab in Pediatric Crohn's Disease

Background: Although the biological agent ustekinumab (UST) is reported to be effective for Crohn's disease (CD) in pediatric as well as adult patients, data on the efficacy and safety of UST in pediatric patients with CD are limited. Here, we describe the case of a pediatric patient who showed an allergic reaction to UST after subcutaneous (SC) maintenance injections but not immediately after initial intravenous (IV) injection.Case Presentation: A 9-year-old boy presented to our hospital with diarrhea lasting 2 years and weight loss, leading to the diagnosis of CD. After prednisolone (PSL) was tapered and discontinued, he promptly relapsed. According to our institution's protocol, we introduced the biological agent infliximab (IFX) with premedication. Coughing and vomiting was observed after the second dose of IFX and it was changed to adalimumab (ADA). However, the effect of ADA gradually disappeared after 18 months; therefore, it was discontinued and he was treated using UST. The first IV UST dose was given after administering hydrocortisone (HDC), an antiallergic and antipyretic analgesic, as premedication, and no obvious adverse reaction was observed. After 8 weeks, UST was subcutaneously injected without premedication. The patient then complained of nausea, dizziness, and headache within 15 min of UST administration. Therefore, for the third dose of UST, HDC was administered again as premedication. However, nausea, dizziness, and headache presented 10 min after UST administration, resulting in discontinuation of further UST treatment.Conclusion: Careful distinction between “true” infusion-related reactions (IRRs) and anaphylaxis or allergic reactions is necessary to determine whether biological agents can be continued after the development of “so-called” IRRs. For true IRRs, it may be possible to continue using the biological agent with appropriate premedication; however, in cases of anaphylaxis, the biological agent itself should be changed.

Drug-induced parkinsonism

Drug-induced parkinsonism (DIP) is the most common drug-induced movement disorder and is most commonly associated with antipsychotic drugs, monoamine reuptake inhibitors, and calcium channel blockers. DIP manifests as a typical movement disorder, which makes it practically indistinguishable from idiopathic Parkinson's disease (PD) and requires differential diagnosis. DIP symptoms develop fairly quickly (hours to weeks) after the antipsychotic is started or after the dose is increased. Therefore, DIP is predominantly a clinical diagnosis that must be kept in mind when a patient develops typical symptoms during treatment onset or increasing the dose of drugs that most often lead to such an adverse reaction (ADR). DIP evaluation includes using the Naranjo algorithm, which helps assess a causal relationship between drug intake and the development of parkinsonism symptoms. The primary DIP treatment is the reduction of the dose of the inducer drug, or its cancellation, or replacement with another drug. In patients with schizophrenia and antipsychotic-induced DIP, dose reduction, replacement with another medication, or prescription of a drug with anticholinergic activity may be possible. The awareness of the doctor and the patient about the possibility of developing this ADR is crucial in the prevention of DIP. Therefore, choosing a drug with the lowest risk of developing DIP is necessary for pharmacotherapy.