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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 70-year-old woman developed constrictive pericarditis following treatment with Coronavirus-vaccine-Stemirna-Therapeutics/Tongji-University for SARS-CoV-2.
The woman presented with peripheral oedema, dyspnoea and body weight gain. Anamnesis revealed that received the first dose of Coronavirus-vaccine-Stemirna-Therapeutics/Tongji-University vaccine [dosage and route not stated] against SARS-CoV-2. Later, she received second dose of Coronavirus-vaccine-Stemirna-Therapeutics/Tongji-University and developed dyspnoea and weight gain within one week. She was initiated on unspecified oral diuretics. Two weeks later, her body weight and dyspnoea decreased, however her pro-brain natriuretic peptide (BNP) level elevated. Her medical history included hypertension, dyslipidemia, pulmonary fibrosis and type 2 diabetes. She was receiving many co-medications. She also had a history of smoking (28 pack per year). Her medical history included her father with myocardial infarction and diabetes. On examination, her vital signs included BP 129/60mm Hg, pulse rate 88 beats per minute, body temperature 36.3°C, respiratory rate was 18 breaths per minute and oxygen saturation was 98% while breathing ambient air. The jugular venous pressure was high with a prominent y descent (Friedreich's sign) and paradoxical increase on inspiration (Kussmaul's sign). Eventually, there was mild pitting oedema in the legs. The chest radiography revealed a cardiothoracic ratio of 38% with reduced opacity in both lung fields. She resulted positive for IgG specific to SARS-CoV-2 spike protein and negative for IgM against SARS-CoV-2 and IgG specific to SARSCoV-2, which confirmed the presence of vaccine-induced antibody and no COVID-19 infection. The echocardiography showed pericardial thickening and septal bounce. The CT scan of chest showed pericardial thickening. The right heart catheterization showed an increase in end-diastolic filling pressures with a steep y descent on right ventricular pressure tracing and a prominent x and y descent on right atrial pressure tracing. Based on all these clinical findings, a diagnosis of right-sided heart failure due to constrictive pericarditis attributed to Coronavirus-vaccine-Stemirna-Therapeutics/Tongji-University was made.
The woman received unspecified oral diuretics and underwent pericardiectomy. Further, her condition remained well, however her mild dyspnoea persisted.
Reference
- Nakanishi Y, et al. Constrictive pericarditis after SARS-CoV-2 vaccination: A case report. International Journal of Infectious Diseases 116: 238-240, Mar 2022. Available from: URL: 10.1016/j.ijid.2022.01.027 [DOI] [PMC free article] [PubMed]
