Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Endotracheal intubation, Haemodialysis, Hyperkalaemia, Hypotonia
Clinical narrative: RESPIRATORY FAILURE; HYPERKALAEMIA; RENAL FAILURE; DIPLEGIA; ANURIA; RHABDOMYOLYSIS; ENDOTRACHEAL INTUBATION; TRACHEOSTOMY; MECHANICAL VENTILATION; MEDICAL INDUCTION OF COMA; HAEMODIALYSIS; MUSCLE INJURY; MUSCULAR WEAKNESS; HYPOTONIA; DYSPHAGIA; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; INTENSIVE CARE; BLOOD CREATINE PHOSPHOKINASE INCREASED; BLOOD POTASSIUM INCREASED; MYOGLOBIN BLOOD INCREASED; COMPUTERISED TOMOGRAM; MAGNETIC RESONANCE IMAGING; X-RAY; LABORATORY TEST; This spontaneous report received from a health care professional via the Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1430442), in addition to information received via literature: Jilma B, Firbas C, Gelbenegger G, Cacioppo F, Rhabdomyolysis Following Ad26.COV2.S COVID-19 Vaccination. Vaccines 2021, 27-AUG-2021, 9, 956, pages 1-7, and concerned a patient of unspecified age, sex, race, and ethnicity. The patient's height, and weight were not reported. No medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient developed severe rhabdomyolysis with blood creatine phosphokinase peak increased approximately up to 750,000, blood myoglobin increased and was more than 5000 and he was admitted to the emergency room in hospital. The patient had severe life-threatening hyperkalemia with blood potassium (K) which was approximately 7.5. The patient had renal failure (also reported as acute kidney failure) included anuria for approximately more than two weeks and was on hemodialysis for five weeks post onset with uncertain prognosis. The patient developed respiratory (muscle) failure (respiratory failure), was on ventilator (mechanical ventilation) for around 18 days with endotracheal tube (endotracheal intubation), followed by tracheostomy for nearly one week. The patient had loss of swallowing function (dysphagia) and required to be retrained. The patient also experienced profound diffuse muscle damage (muscle injury) and weakness (muscular weakness), with loss of muscle mass nearly 20 lbs and hypotonia. The patient was unable to move arms, legs or support head (loss of personal independence in daily activities). The patient required extensive physical therapy to achieve ability to care for self and function independently (diplegia). The patient underwent extensive imaging including multiple magnetic resonance imaging (MRI), computerised tomogram (CT), and numerous X-rays which results were not reported along with extensive laboratory tests during hospitalization. The patient was hospitalized for 26 days including 19 days in intensive care unit along with eleven days in medically induced coma (medical induction of coma). The patient also visited the emergency room and physician's office. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from rhabdomyolysis (recovered with permanent disability), and had not recovered from anuria, blood creatine phosphokinase increased, blood potassium increased, computerised tomogram, diplegia, dysphagia, endotracheal intubation, haemodialysis, hyperkalaemia, hypotonia, intensive care, laboratory test, loss of personal independence in daily activities, magnetic resonance imaging, mechanical ventilation, medical induction of coma, muscle injury, muscular weakness, myoglobin blood increased, renal failure, respiratory failure, tracheostomy, and x-ray. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage). This case, from Same Literature article is linked to 20210923039, 20210757800, 20210702722, 20210762171, 20210905291, 20210543394, 20210923028, 20210705289, 20210639871, 20210922810, 20210528129 and 20210528518.  Additional information was received via literature on 07-SEP-2021. The following information was updated and incorporated into the case narrative: literature citation, as the patient involved was quoted in a table of similar events contained within the article, event term acute kidney failure (renal failure), and the outcome for rhabdomyolysis reported as recovered with permanent disability.; Sender's Comments: V1-The additional information information in this version updates literature citation, as the patient involved was quoted in a table of similar events contained within the article, event term acute kidney failure (renal failure), and the outcome for rhabdomyolysis reported as recovered with permanent disability. This updated information does not alter prior causality assessment of reported event. :20210721677-JANSSEN COVID-19 VACCINE Ad26.COV2.S- respiratory failure, hyperkalaemia, renal failure, diplegia, anuria, rhabdomyolysis, endotracheal intubation, tracheostomy, mechanical ventilation, medical induction of coma, haemodialysis ,muscle injury, muscular weakness, hypotonia, dysphagia, loss of personal independence in daily activities, intensive care, blood creatine phosphokinase increased, blood potassium increased, , myoglobin blood increased, computerised tomogram, magnetic resonance imaging, x-ray, laboratory test.- 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).