Sex: M
Vaccine: COVID19
Symptoms: Bacterial test, Cardiac tamponade, Cytology, Cytomegalovirus test, Echocardiogram
Clinical narrative: Cardiac tamponade following COVID-19 vaccination; Post-vaccine inflammatory pericarditis; Pericardial effusion; This is a literature report for the following literature source:  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Non-Hodgkin's lymphoma" (unspecified if ongoing), notes: in remission. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: CARDIAC TAMPONADE (hospitalization, medically significant, life threatening), 1 week after the suspect product(s) administration, outcome "not recovered", described as "Cardiac tamponade following COVID-19 vaccination"; PERICARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "Post-vaccine inflammatory pericarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Bacterial test: Negative; Negative; Cytology: didn't show malignancy; Cytomegalovirus test: represented past infection; Echocardiogram: showed cardiac tamponade; only showed small pericardial effusion, which did, notes: not require drainage; Epstein-Barr virus test: represented past infection; Fungal test: Negative; Parvovirus B19 test: represented past infection; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of cardiac tamponade, pericarditis, pericardial effusion. Background: The author present two cases of life-threatening cardiac tamponade following COVID-19 vaccination. Methods: Two cases of cardiac tamponade in temporal association with COVID-19 vaccination were reviewed. Case 2: 66-year-old male with non-Hodgkin's lymphoma in remission. He developed chest pain a day after his 2nd dose of Pfizer-BioNTech COVID-19 vaccine. Admitted 4 days later with pericardial effusion and managed medically. Readmitted a week later with fever and chest pain. Echocardiogram now showed cardiac tamponade. Pericardiocentesis removed 400 ml of exudative fluid with 1,191 nucleated cells/mL. Cultures for bacteria, fungi, and mycobacteria were negative. Cytology didn't show malignancy. Serologies for CMV, EBV and parvovirus represented past infection. He was discharged with a pericardial drain, colchicine, and NSAIDs. He was later readmitted with fevers. Echocardiogram only showed small pericardial effusion, which did not require drainage. Conclusion: Given the proximity to COVID-19 vaccination and lack of alternative explanations, the author believe that tamponade was a direct result of post-vaccine inflammatory pericarditis. Neither patient had a prior history of pericardial effusion. Both tested negative for SARS-CoV-2 by nasopharyngeal swab excluding active infection. Healthcare providers should consider the possibility of pericardial effusion and tamponade in patients with chest pain, shortness of breath, or hypotension following COVID-19 vaccination.; Sender's Comments: There is a reasonable possibility that the event pericarditis was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events cardiac tamponade and pericardial effusion with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300012321 same article and drug; different patient and event;US-PFIZER INC-202300029168 same article and drug; different patient and event;