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Life Threatening? Yes
Write-up: VACCINE INDUCED MYOCARDITIS (VIRAL MYOCARDITIS); ACUTE HYPOXIC HYPERCAPNIC RESPIRATORY FAILURE; SEPTIC SHOCK; DECLINE IN RENAL FUNCTION; 2+ AORTIC REGURGITATION; PATIENT ADMINISTERED WITH 2 DOSES OF VACCINE; OFF LABEL USE; DEATH; This spontaneous report was received from literature: Case report with literature review. This report concerned a 70 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown), frequency 2 total doses, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after two days post second dose (inappropriate dose of vaccine administered and off label use) the patient experienced developed dyspnea at home and eventually required an ambulance for hospital transfer. The vital signs on arrival included a heart rate of 145 bpm, a 75% oxygen saturation level on room air, a blood pressure of 117/70 mmHg, a respiratory rate of 39, and a BMI of 27.5. The electrocardiogram (ECG) on admission revealed sinus tachycardia with a heart rate of 125bpm and T-wave inversions in leads V4-V6 without any ST-segment change. The patient arrived at the emergency department in severe respiratory distress that warranted immediate intubation. She was admitted to the intensive care unit (ICU) with the provisional diagnoses of acute hypoxic hypercapnic respiratory failure and septic shock. The laboratory screening and blood culture proved negative for all viruses, Mycoplasma pneumonia, and chlamydophila pneumonia. A repeat investigation revealed marked elevations in procalcitonin [185.71(ng/mL)] and troponin [1.260-2.050 ng/mL] levels on the second day of admission. The patient required multiple vasopressors to maintain the mean arterial pressure above 65 mmHg. The transthoracic echocardiogram on admission revealed 2+ aortic regurgitation and diffuse left ventricular hypokinesis with severely decreased left ventricular ejection fraction (10%). A repeat echocardiogram with contrast medium showed diffuse left ventricular hypokinesis with diagnostic monitoring via Swanz-Ganz catheter revealed a pulmonary wedge pressure (PWP) of 14mmHg. The patient continued receiving vasopressors and antibiotic therapy, while her renal function deterioration since admission warranted the prompt administration of renal replacement therapy. Further decline in renal function was marked by oliguria and worsening of creatinine levels. The patient declined cardiac catheterization and remained. On an unspecified date the patient was hospitalized and it was for 8 days. On unspecified date patient died with vaccine induced myocarditis (viral myocarditis) on eighth day of admission to hospital. The exact cause of death was not reported and it was unknown whether autopsy was performed. The other laboratory data includes, Creatinine (NR: 0.05 - 1.20) 1.21 mg/dL, Bicarbonate (NR: 22 - 29) 16 mmol/L, Creatine phosphokinase (NR: 20 - 190) 53 U/L, Procalcitonin (NR: 0.02 - 0.10) 0.07 ng/mL, C-reactive protein (NR: 0 - 3.00) 7.2 mg/L, pH (NR: 7.35 - 7.45) 7.02 (units unspecified), Partial pressure CO2 (NR: 35 - 48) 94 mmHg, Lactate (NR: 0.6 - 1.4) 8.3 mmol/L, PaO2 (NR: 83 - 108) 27 mmHg, The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced myocarditis (viral myocarditis), acute hypoxic hypercapnic respiratory failure, septic shock, decline in renal function, 2+ aortic regurgitation, patient administered with 2 doses of vaccine, off label use was not reported. This report was serious (Death, Life Threatening, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210754113-covid-19 vaccine ad26.cov2.s - Death, vaccine induced myocarditis, acute hypoxic hypercapnic respiratory failure, septic shock, decline in renal function, 2+ aortic regurgitation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
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