Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Renal failure, Urticaria
Clinical narrative: PASSED AWAY (DEATH); KIDNEYS STARTED TO FAIL / KIDNEY FAILURE; COGNITIVE ABILITY WAS BARELY FUNCTIONING COULD NOT TALK; DIZZINESS; COULD NOT WALK; SORENESS IN ARM / ARM PAIN; BRONCHITIS / BRONCHIAL INFECTION; HIVES ON STOMACH; HUGE BLISTERS (QUARTER SIZE) ACROSS FOREHEAD; BACK PAIN; NECK PAIN; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled blood pressure (Was taking amlodipine/valsartan, Blood pressure normally controlled), and other pre-existing medical conditions included: The patient had no underlying conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 and expiry: Unknown) dose was not reported, 1 total, dose 1 (initial dose) administered in right arm on 27-JUN-2022 for covid-19 prophylaxis. Age at time of vaccination 52 years old. Concomitant medications included amlodipine for controlled blood pressure, and valsartan for controlled blood pressure. On an unspecified date in JUL-2022 (2 weeks after vaccination), the patient started feeling not right, experienced cold and had soreness in arm. The patient went to the doctor/clinic on 27-JUL-2022 and 01-AUG-2022. On 03-AUG-2022, in the evening the patient went to the emergency room. On an unspecified date in AUG-2022, the patient had cold symptoms and then really bad cough, shortness of breath, dizziness. cognitive ability was barely functioning that he could not talk, could not walk and emergency room thought he was drunk and even performed blood alcohol test and patient to be not drunk, the patient also experienced lactic acidosis, kidneys started to fail / kidney failure, and blood work was completely off results shown clearly abnormal / clearly seen lactic acidosis and kidney failure. The patient was diagnosed twice with bronchitis / bronchial infection at doctor/emergency room (ER) visits. The patient was given medications by doctor at clinic to treat bronchial infection / bronchitis included: albuterol sulfate inhaler, benzonatate 100mg, doxycycline 100mg (on an unspecified date and month in 2022), also received prednisone in emergency room (on an unspecified date in AUG-2022), and had an steroid  injection at one of the medical facilities. On an unspecified date and month in 2022, the patient experienced chest pain, hives on stomach that faded, huge blisters (quarter size) across forehead, back pain, neck pain and arm pain. On 04-AUG-2022 (6 week after vaccination), the patient passed away (Death) from unknown cause of death. It was unknown if an autopsy was performed. The patient visited Physician office and emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away (death) on 04-AUG-2022 from unknown cause of death, recovered from hives on stomach, and the outcome of bronchitis / bronchial infection, soreness in arm / arm pain, cognitive ability was barely functioning could not talk, kidneys started to fail / kidney failure, huge blisters (quarter size) across forehead, back pain, neck pain, dizziness and could not walk was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20230107294- Passed away(death). Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20230107294-kidneys started to fail / kidney failure, bronchitis / bronchial infection. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH