Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Renal failure, Renal-limited thrombotic microangiopathy, Skin hyperpigmentation
Clinical narrative: PERICARDITIS; SKIN HYPERPIGMENTATION; RASH; FATIGUE; HAEMODIALYSIS; ASPIRATION PLEURAL CAVITY; LABORATORY TEST NORMAL; BIOPSY; THROMBOCYTOPENIA; RENAL FAILURE; RENAL-LIMITED THROMBOTIC MICROANGIOPATHY; DYSPNOEA EXERTIONAL; NORMOCYTIC ANAEMIA; ORTHOPNOEA; PLEURAL EFFUSION; MULTISYSTEMIC INFLAMMATORY SYNDROME; LEUKOCYTOSIS; VARIABLE THROMBOCYTOSIS; CATHETER-RELATED DEEP VEIN THROMBOSIS; ITCHY SCALY RASH; PROGRESSIVE SHORTNESS OF BREATH FROM PERICARDIAL EFFUSION REQUIRING 3 PERICARDIOCENTESES.; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID:) concerned a 56-year-old African American female. This spontaneous report was received from literature. This report concerned a 56 year old female. The objective of this study was to describe case of renal TMA without thrombocytopenia in the setting of a hyperinflammatory state arising weeks after receiving Ad26.COV2.S COVID vaccine. The patient's height, and weight were not reported. The patient's past medical history included: eczema, and concurrent conditions included: hypertension, chronic right knee pain, and 2cm pancreatic head mass, and other pre-existing medical conditions included: The patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 at right arm for an unspecified indication. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, and metoprolol tartrate.On 08-APR-2021, the patient developed orthopnea (orthopnoea), dyspnea on exertion (dyspnoea exertional), fatigue (fatigue) after receiving the vaccine.  On 09-APR-2021, patient developed generalized itchy scaly rash 2 days after receiving J&J vaccine. On 14-APR-2021, 1 week after the vaccine, she developed a profuse disseminated non-pruritic hyperpigmented rash (rash) that started on the hands and spread to the body (skin hyperpigmentation), self-resolved. Patient had developed bilateral transudative pleural effusions (pleural effusion) necessitating therapeutic thoracentesis (aspiration pleural cavity), she also had thrombocytopenia (thrombocytopenia) and normocytic anemia (normocytic anaemia) that was not present prior to vaccine. Patient had been now diagnosed with renal thrombotic microangiopathy (renal-limited thrombotic microangiopathy) confirmed on biopsy (biopsy) now in renal failure (renal failure) required hemodialysis (haemodialysis). All laboratory reports related to thrombotic microangiopathy worked-up for causes such as SLE (systemic lupus erythematosus) TTP (thrombotic thrombocytopenic purpura) had been negative. The thrombotic microangiopathy seems to be related to the vaccine or a potential malignancy as an incidental 2 cm pancreatic head mass had been found that may be malignant. Laboratory data included: Aspiration pleural cavity (NR: not provided) Unknown, Biopsy (NR: not provided) renal thrombotic microangiopathy, and Laboratory test (NR: not provided) normal. The patient had 2 episodes of pericarditis (pericarditis) within 3-4 months of vaccine administration once in July 2021 and once in August 2021. On an unspecified date, the patient was hospitalized for 12 days other details was not provided. On APR-2021, (2 weeks later), patient developed progressive shortness of breath from pericardial effusion requiring three pericardiocenteses. On AUG-2021, (4 months later), patient experienced acute kidney injury requiring hemodialysis. A renal biopsy revealed extensive active TMA(Thrombotic microangiopathy)with arterial/arteriolar thrombi, glomerular ischemia, and ischemic acute tubular necrosis. There was no evidence of immune complex deposition. Patient's course was complicated by catheter-related deep vein thrombosis. Anticoagulant was started. Patient received two plasmaphereses and 1gm solumedrol while waiting for ADAMTS 13 test result. Throughout patient's course, patient's laboratory results showed leukocytosis; normocytic anemia; variable thrombocytosis; mild hemolysis with occasional schistocytes. Inflammatory markers were elevated. Blood, urine, sputum, pericardial and pleural fluid culture were negative. interleukin-2 receptor (IL2R) was elevated but bone marrow biopsy did not reveal hemophagocytosis or malignant cell. COVID RT-PCR(COVID reverse transcription polymerase chain reaction) and HIT-PF4 Ab (heparin induced thrombocytopenia) were also negative. Definitive diagnosis remains unclear. Patient remained dialysis dependent. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin hyperpigmentation, rash, and itchy scaly rash, had not recovered from aspiration pleural cavity, dyspnoea exertional, fatigue, normocytic anaemia, orthopnoea, pericarditis, pleural effusion, renal failure, renal-limited thrombotic microangiopathy, thrombocytopenia, biopsy, haemodialysis, and laboratory test normal, and the outcome of catheter-related deep vein thrombosis, multisystemic inflammatory syndrome, leukocytosis, variable thrombocytosis and progressive shortness of breath from pericardial effusion requiring 3 pericardiocenteses. was not reported. The authors emphasized on the knowledge that this was the only case reported with extensive, isolated kidney arterial/arteriolar thrombosis after vaccination. This case appears to represent multisystemic inflammatory syndrome in an adult occurring after Ad26.COV2.S vaccination. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).  Additional information was received from other health care professional via literature article on 21-MAR-2022. The following information was updated and incorporated into the case narrative: reporters and reporter details, patient's race, events (itchy scaly rash, catheter-related deep vein thrombosis, multisystemic inflammatory syndrome, leukocytosis, variable thrombocytosis and progressive shortness of breath from pericardial effusion requiring 3 pericardiocentesis), lab data, literature details, treatment medication (solumedrol and pericardiocenteses) were added. The eczema updated to past condition.; Sender's Comments: V1:This follow up version updates new events added. 20211061607-COVID-19 VACCINE AD26.COV2.S-pericardial effusion, catheter-related DVT, multisystemic inflammatory syndrome.The events have compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility.There is no information on any other factors potentially associated with the events. Therefore, this events are considered unassessable.  This spontaneous report received from a health care professional via(VAERS ID: 1794223) concerned a 56-year-old female who was hospitalized for renal-limited thrombotic microangiopathy(TMA) and renal failure that required hemodialysis unspecified time after vaccination.The patient's concurrent conditions included: hypertension, eczema, chronic right knee pain, 2 cm pancreatic head mass that had not been biopsied.Concomitant medications included amlodipine, and metoprolol.The patient developed orthopnea, exertional dyspnea ,fatigue 1 day after receiving the vaccine.One week after vaccination she developed a self-resolving profuse disseminated non-pruritic hyperpigmented rash.Patient had developed bilateral transudative pleural effusions necessitating therapeutic thoracentesis.She also had thrombocytopenia and normocytic anemia that was not present prior to vaccine.The patient had 2 episodes of pericarditis within 3-4 months of vaccination.On an unspecified date, the patient was hospitalized for 12 days. All laboratory reports such as SLE,TTP had been negative.Biopsy -renal thrombotic microangiopathy, Laboratory test normal. Patient had recovered from skin hyperpigmentation,rash and had not recovered from other events.Information regarding other potential etiologies was insufficient, and the occurrence of renal TMA and renal failure could represent background incidence of such events in the general population.Considering the temporal relationship,the event is assessed to have an indeterminate relationship with vaccination.