Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Capillary leak syndrome, Condition aggravated, Death, Disseminated intravascular coagulation
Clinical narrative: DEATH; IDIOPATHIC CAPILLARY LEAK SYNDROME; DISSEMINATED INTRAVASCULAR COAGULATION; DISTRIBUTIVE SHOCK; RENAL FAILURE; CONDITION AGGRAVATED; This spontaneous report received from Food and Drug Administration (FDA) via Vaccine Adverse Event Reporting System (VAERS)(VAERS ID:1108312) and concerned a 68 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included idiopathic capillary leak syndrome, further clarified the patient was diagnosed with SCLS (systemic capillary leak syndrome) with monoclonal gammopathy of unknown significance in 2006 after 2 characteristic episodes.  She declined IVIG treatment but had no disease relapses during 15 years of treatment with oral theophylline and terbutaline.  The patient had no allergies to medications, food or other products.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) on 07-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline hydrochloride, lisinopril, simvastatin, and terbutaline and theophylline for SCLS.  On 09-MAR-2021, 48 hours following vaccine administration, the patient presented to the Emergency department. She had hypotension and tachycardia and developed protracted shock and anasarca. The patient was hospitalized. She experienced severe exacerbation of idiopathic capillary leak syndrome leading to profound vasodilatory shock (distributive shock), disseminated intravascular coagulation (DIC), condition aggravated, and renal failure. Results of blood cultures and nasal swab polymerase chain reaction tests for SARS-CoV-2 were negative. After she developed additional SCLS-related complications and continued to deteriorate, care was discontinued on hospital day 7. It was also reported the patient was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of idiopathic capillary leak syndrome, disseminated intravascular coagulation, distributive shock, condition aggravated, and renal failure on 16-MAR-2021. It was not known if an autopsy was performed. This report was serious (Death, and Hospitalization).  The following information was updated and incorporated into the case narrative: patient history, additional adverse event details, and laboratory results.; Sender's Comments: V3: Follow-up received via literature updated patient history, event details and laboratory results.  It does not change the previous assessment. The case concerns a 68- year- old female with idiopathic capillary leak syndrome (ICLS) who was hospitalized for severe exacerbation of ICLS, 48 hours after COVID-19 Vaccine Ad26.COV2.S was administered for prophylactic vaccination. She was diagnosed with SCLS (systemic capillary leak syndrome) with monoclonal gammopathy of unknown significance in 2006 after 2 characteristic episodes.  She declined IVIG treatment but had no disease relapses during 15 years of treatment with oral theophylline and terbutaline. Concomitant medications were not reported.  The patient presented to the Emergency department 48 hours post vaccination with hypotension and tachycardia, she developed protracted shock and anasarca. The patient was hospitalized. She experienced severe exacerbation of idiopathic capillary leak syndrome leading to profound vasodilatory shock (distributive shock), disseminated intravascular coagulation (DIC), condition aggravated, and renal failure. Results of blood cultures and nasal swab PCR tests for SARS-CoV-2 were negative. The patient developed additional SCLS-related complications, continued to deteriorate, and died 7 days after onset due to ICLS, DIC, distributive shock, condition aggravated and renal failure.  It was unknown if an autopsy was performed.  ICLS is a rare condition with acute and severe recurrent attacks associated with a rapid fall in blood pressure, increased hematocrit and hypoalbuminemia. Possible causes are infection and C-1 esterase inhibitor deficiency. Given available information and a lack of known scientific plausibility for the COVID-19 Vaccine Ad26.COV2.S to cause the event, the company causality is considered not related, while additional information has been requested for further assessment.