Received Jan 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
45% ejection fraction; Palpitation; Total wall motion score is 2:00/ Global ventricular hypokinesia; Severe tricuspid valve stenosis/Trivial tricuspid regurgitation with an RVSP of 13 mmHg; Heart attack; Mildly depressed left ventricular systolic ejection fraction; Can be sue; No longer fly I can no longer go snowboarding; The patient was frustrated and angry; Case reference number US-BN-2025-001754 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: unknown) on 01-Nov-2025 and concerns a male 33-years-old patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date in Oct-2023, the patient received a dose of *Jynneos vaccine* (batch number: unknown), at unknown dose, site or route for an unknown indication. On unspecified date in Oct-2023, one day after the vaccination shot, the patient experienced heart attack and patient is currently receiving heart failure medication. On an unspecified date, the patient experienced persistent cardiac symptoms which he attributed to a vaccination he stated to have received approximately two years earlier. The patient stated that he now has a 45% ejection fraction and reported that he had been in and out of hospital over the past two years. He further reported functional limitations, including inability to fly or participate in snowboarding, and expressed concern regarding his health, as well as emotional distress, anger and frustration. An echocardiographic assessment (transthoracic complete echocardiogram) was provided. The report described normal left ventricular size with mildly depressed left ventricular systolic function. Global left ventricular hypokinesis was noted, with a total wall motion score of 2.00, while diastolic function was reported as normal. The right ventricular size and systolic function were normal, and the left and right atria were normal in size. The mitral and aortic valves were reported as having normal appearance and function. The pericardium appeared normal, with no evidence of pericardial effusion. The indication for the echocardiogram included palpitations. Additional echocardiographic findings included severe tricuspid valve stenosis and trivial tricuspid regurgitation with a right ventricular systolic pressure (RVSP) of 13 mmHg. Reported measurements included left ventricular internal diameter in diastole (LVIDd) 4.84 cm (reference range 4.205.80 cm), left ventricular internal diameter in systole (LVIDs) 3.18 cm (reference range 2.504.00 cm), left ventricular fractional shortening (LV FS) 34.28% (reference range 25.0043.00%), and interventricular septal thickness in diastole (IVSd) 0.85 cm (reference range 0.601.00 cm). At the time of reporting, the patient stated that his symptoms had persisted for approximately two years. Outcomes were considered as not recovered for the cardiac events left ventricular systolic dysfunction, palpitation, ejection fraction decreased, global ventricular hypokinesia, severe tricuspid valve stenosis, and heart attack, while outcome for general physical health deterioration, feeling of despair and emotional distress was unknown. The reported considered the events left ventricular systolic dysfunction, palpitation, ejection fraction decreased, global ventricular hypokinesia, severe tricuspid valve stenosis, heart attack as serious due to hospitalization and additionally the events global ventricular hypokinesia, severe tricuspid valve stenosis, and heart attack considered as serious due to medically significant. The reporter did not provide the seriousness for the event's general physical health deterioration, feeling of despair and emotional distress. Additional information received from the consumer on 09-Jan-2026: New information included information about heart attack, and patient expressing emotional distress. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow-up information received from the consumer on 15-Jan-2026 included name of the vaccine as Jynneos.; Reporter's Comments: A 33-year-old male reported persistent cardiac symptoms following Jynneos vaccine, for an unknown indication administered in Oct-2023. One day later, he suffered a serious (hospitalisation and medically significant) event of myocardial infarction and has since required heart failure medication. Over the subsequent two years, he experienced serious (hospitalisation and medically significant) events of ejection fraction decreased, ventricular hypokinesia; serious (hospitalisation) events of left ventricular dysfunction, palpitations, and tricuspid valve stenosis, with outcomes for these cardiac events considered not recovered. He also reported feeling of despair, general physical health deterioration, emotional distress, with outcomes for general health deterioration and emotional distress considered unknown. Events ejection fraction decreased, ventricular hypokinesia, left ventricular dysfunction, tricuspid valve stenosis, feeling of despair, general physical health deterioration, emotional distress are unlisted per CCDS v8 and unexpected per USPI, whilst palpitations are listed and expected. The case is constrained by limited medical information. No co-suspect medications were reported. The patient's relevant medical history, concurrent diseases, and concomitant or past medications were not provided. Tricuspid valve stenosis is most often caused by rheumatic hear disease, where past infections such as strep throat trigger inflammation that gradually scars and narrows the valve. Because the damage develops slowly, the stenosis usually takes many years to cause noticeable symptoms. Any heart attack occurring one day after vaccination should be promptly evaluated by a doctor. Current evidence in the literature does not indicate causal link between the MVA-BN vaccine and heart attack. Ventricular hypokinesia, left ventricular dysfunction, palpitations and decreased ejection fraction are consequences of a heart attack. In this case, the causal relationship between Jynneos administration and the reported events, is assessed as unlikely. The events were considered as serious due to hospitalization and medical significance. For regulatory reporting purposes causality is assessed as related.; Sender's Comments: A 33-year-old male reported persistent cardiac symptoms following Jynneos vaccine, for an unknown indication administered in Oct-2023. One day later, he suffered a serious (hospitalisation and medically significant) event of myocardial infarction and has since required heart failure medication. Over the subsequent two years, he experienced serious (hospitalisation and medically significant) events of ejection fraction decreased, ventricular hypokinesia; serious (hospitalisation) events of left ventricular dysfunction, palpitations, and tricuspid valve stenosis, with outcomes for these cardiac events considered not recovered. He also reported feeling of despair, general physical health deterioration, emotional distress, with outcomes for general health deterioration and emotional distress considered unknown. Events ejection fraction decreased, ventricular hypokinesia, left ventricular dysfunction, tricuspid valve stenosis, feeling of despair, general physical health deterioration, emotional distress are unlisted per CCDS v8 and unexpected per USPI, whilst palpitations are listed and expected. The case is constrained by limited medical information. No co-suspect medications were reported. The patient's relevant medical history, concurrent diseases, and concomitant or past medications were not provided. Tricuspid valve stenosis is most often caused by rheumatic hear disease, where past infections such as strep throat trigger inflammation that gradually scars and narrows the valve. Because the damage develops slowly, the stenosis usually takes many years to cause noticeable symptoms. Any heart attack occurring one day after vaccination should be promptly evaluated by a doctor. Current evidence in the literature does not indicate causal link between the MVA-BN vaccine and heart attack. Ventricular hypokinesia, left ventricular dysfunction, palpitations and decreased ejection fraction are consequences of a heart attack. In this case, the causal relationship between Jynneos administration and the reported events, is assessed as unlikely. The events were considered as serious due to hospitalization and medical significance. For regulatory reporting purposes causality is assessed as related.
Comments: None
Test Date: 20250623; Test Name: IVSd 2D; Test Result: 0.85 cm; Comments: /; Test Date: 20250623; Test Name: LV FS 2D; Test Result: 34.28 %; Comments: /; Test Date: 20250623; Test Name: LVIDd 2D; Test Result: 4.84 cm; Comments: /; Test Date: 20250623; Test Name: LVIDs 2D; Test Result: 3.18 cm; Comments: /; Test Date: 20250623; Test Name: transthoracic complete echocardiogram; Result Unstructured Data: Test Result:/ ;A transthoracic complete echocardiogram showed normal left ventricular size with mildly impaired systolic function and parameters consistent with normal diastolic function (GLS not performed). Global left ventricular hypokinesis was noted. Right ventricular size and systolic function were normal. The left and right atria were normal in size. The mitral valve demonstrated normal appearance and leaflet excursion without evidence of regurgitation, and the aortic valve showed normal appearance and function. Trivial tricuspid regurgitation was observed with a right ventricular systolic pressure of 13 mmHg. The pericardium was normal, with no evidence of pericardial effusion.; Comments: /