Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
COVID-19 infection was confirmed by PCR testing; COVID-19 infection was confirmed by PCR testing; This is a literature report for the following literature source(s). A 77-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in 2021 as dose unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (ongoing); "paroxysmal atrial fibrillation" (ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (death, medically significant), DRUG INEFFECTIVE (death, medically significant), outcome "fatal" and all described as "COVID-19 infection was confirmed by PCR testing". Clinical course: We present a case of COVID-19 induced myocarditis leading to hemodynamic instability and end-organ dysfunction. A 77-year-old male with a history of CKD, paroxysmal atrial fibrillation, and COPD was transferred to our hospital for a higher level of care due to worsening cardiogenic shock. He was cold and wet (Forrester class IV) with a High Sensitivity troponin of 331 and a BNP level of 21,503. EKG showed atrial fibrillation with RVR but no evidence of acute ischemic changes. A TTE was done which revealed an EF of 30-35% and diffuse hypokinesis with regional variation, a significant reduction from an EF of 50-55% just 4 weeks prior. The patient exhibited end-organ dysfunction, as evidenced by deranged liver function tests and a rise in creatinine from a baseline of 2 to 4.6, indicating congestive hepatopathy and cardiorenal syndrome respectively. The patient's hemodynamics necessitated milrinone and norepinephrine infusions and efforts to wean them off were unsuccessful due to repeated failed fluid bolus challenges. Considering the patient's clinical picture, there was a strong suspicion of viral-induced cardiomyopathy, and a COVID-19 infection was confirmed by PCR testing; his last COVID-19 booster dose was in 2021. The patient was promptly started on remdesivir and IV steroids. Unfortunately, the patient's condition continued to deteriorate, and he succumbed to his illness. Discussion: A myriad of cardiovascular manifestations have been implicated with COVID-19, including ACS, myocarditis, and heart failure. Although the exact underlying mechanisms for each of these conditions are unclear, a complex interplay between direct viral injury, systemic inflammation, and cytokine storm has been hypothesized. Our case illustrates the quick progression of heart failure into cardiogenic shock requiring pressor support, with subsequent rapid decompensation rendering CMR, cardiac catheterization, and biopsy timely impractical. It serves as a reminder to explore COVID-19 as a potential cause of biventricular failure in individuals with no evident reason and rapid clinical deterioration, particularly as early initiation of antiviral therapy could improve prognoses. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COVID-19 Vaccine - Manufacturer Unknown 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.; Reported Cause(s) of Death: COVID-19 infection; Myocarditis leading to cardiogenic shock; Myocarditis leading to cardiogenic shock
Chronic kidney disease; Paroxysmal atrial fibrillation
Medical History/Concurrent Conditions: COPD
Test Name: creatinine; Result Unstructured Data: Test Result:2; Test Name: creatinine; Result Unstructured Data: Test Result:4.6; Test Name: BNP level; Result Unstructured Data: Test Result:21503; Test Name: TTE; Result Unstructured Data: Test Result:EF of 30-35% and diffuse hypokinesis with regional; Comments: a significant reduction from an EF of 50-55% just 4 weeks prior.; Test Name: EF; Result Unstructured Data: Test Result:50-55 %; Comments: reduction just 4 weeks prior; Test Name: EKG; Result Unstructured Data: Test Result:atrial fibrillation with RVR but no evidence of; Comments: acute ischemic changes; Test Name: liver function; Result Unstructured Data: Test Result:deranged; Test Name: PCR; Result Unstructured Data: Test Result:COVID-19 infection was confirmed; Test Name: troponin; Result Unstructured Data: Test Result:331; Comments: High Sensitivity