Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Atrial fibrillation, Blood creatine phosphokinase increased, Death
Clinical narrative: DEATH; RHABDOMYOLYSIS; ACUTE KIDNEY INJURY; SEPSIS; PNEUMONIA; INTENSIVE CARE; CHEST X-RAY ABNORMAL; METABOLIC FUNCTION TEST; MICROBIOLOGY TEST; SARS COV-2 TEST; SPUTUM CULTURE; This spontaneous report was received from literature via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1391630), concerned an 86 year old male. The objective of the study was to better understand the underlying pathomechanism and to investigate whether subcutaneous injection of vaccines may be able to prevent rhabdomyolysis. The patient's height, and weight were not reported. The patient's past medical history included: atrial fibrillation (AFib), hyperlipidemia and tumor in lungs, and concurrent conditions included: penicillin allergy, sulfa drug allergy, severe sepsis, bilateral pneumonia, acute kidney injury, and rhabdomyolysis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included azithromycin, cetirizine hydrochloride, and meclozine.  On 23-MAY-2021 (3 days after vaccination), the patient was found down in his home and admitted to Intensive care unit (ICU) from the emergency room (ER) with severe sepsis, bilateral pneumonia, acute kidney injury and rhabdomyolysis. On 23-MAY-2021 and 24-MAY-2021 Laboratory data included: chest X-ray abnormal, comprehensive metabolic panel, microbiology test, SARS-CoV-2 test, and sputum culture. The patient was hospitalized for two days. Laboratory data (dates unspecified) included: Creatine kinase (NR: not provided) Unknown. On 24-MAY-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. Author stated that it remained unclear whether the development of acute kidney failure in patient was due to the vaccine or was multicausal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 24-MAY-2021, the outcome of rhabdomyolysis, acute kidney injury, sepsis, pneumonia, intensive care, chest x-ray abnormal, metabolic function test, microbiology test, SARS-CoV-2 test and sputum culture was fatal. The author emphasized that physicians should be aware of the possibility of vaccine-induced rhabdomyolysis as a potentially serious side-effect in patients complaining of myalgia following vaccination, particularly in times of mass vaccinations. Patients may be advised to monitor the color of their urine for the early detection of rhabdomyolysis. Finally, the article report suggests the need for aggressive fluid resuscitation and close monitoring for the prevention of acute kidney failure in patients with rhabdomyolysis. This report was serious (Death, Life Threatening, and Hospitalization Caused / Prolonged). This case, from same Literature article is linked to 20210528518, 20210922810, 20210922823, 20210543394, 20210924285, 20210914711, 20210924327, 20210705289, 20210721677, 20210757800, 20210762171, 20210905291, 20210923028, 20210923039, 20210528129, 20210702722 and 20210705289.; Sender's Comments: V0:20210927103-JANSSEN COVID-19 VACCINE Ad26.COV2.S -  Death, rhabdomyolysis, acute kidney injury, sepsis, pneumonia, intensive care, chest x-ray abnormal, metabolic function test, microbiology test, sars cov-2 test ,sputum culture - 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