Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Death, Dyspnoea, Hallucination
Clinical narrative: RESPIRATORY FAILURE FROM PROSTATE CANCER  AND METASTASIS; HALLUCINATING, TALKING TO HIS DEAD MOTHER AND BROTHER AND CHASING SQUIRRELS; STOPPED EATING; LOSS OF VOICE; TROUBLE SLEEPING; HEALTH STARTED TO DETERIORATE; DID NOT FEEL GOOD; LOW ENERGY; MIGHT BE GETTING A COLD; AGITATION; This spontaneous report received from a consumer concerned a 77 year old male. Initial information was processed with additional information received on 19-MAY-2021, 21-MAY-2021 and 22-MAY-2021. The patient's weight was 140 pounds, and height was 68 inches. The patient's past medical history included prostate issue and kidney shut down in 2014 because he could not urinate. Patient was hospitalized and doctor ruled out prostate cancer; he did have a serious infection, sepsis, surgery to open his prostate for urination and Foley catheter for 6 months. On 21-JUL-2014, daughter took patient home. Doctor wanted to place him in nursing home, he needed 24-hour care, but daughter refused. He went home with a feeding tube, had metabolic issues described as low pressure but high heart rate, "insulin dependent/diabetes/sugar issues" due to the feeding tube; within 3 weeks, he was up functioning, no more feeding tube, gained 25 pounds he was doing good with home care OT/PT, and blood sugar issues were corrected. The pulmonologist or cardiologist told daughter that he did not have damage to his heart. An echocardiogram was completed during this time, any other results are unknown. On 16-APR-2020, patient had trouble breathing, thought he was getting a cold. Ambulance was called and he was responding to supplemental O2, but was taken to the hospital. He was calm and fine but waiting for antibiotics during a 6-hours visit to the emergency room. X-ray showed he had a slight infection in his lower lobe. Apparently, the patient was told he had COVID-19 disease and had an anxiety attack. A couple hours later the reporter was notified that her father was intubated and placed in a drug-induced coma for COVID-19 disease. The reporter stated that this was not true and the hospital had no evidence because a rapid COVID-19 test was not available at that time and they had no evidence of COVID-19 infection. Five days later, the COVID-19 test result was positive. He was hospitalized for 95 days. While in coma, he had 2 heart attacks, his right lung collapsed due to hydropneumothorax with 85% of chest filled with loculated effusions; 900 mL of pleural fluid was removed from the lung. He received plasma antibodies during coma; he had hematomas all over both arms and hands. Daughter refused DNR (do-not-resuscitate). Daughter took her father home on 21-JUL-2020.  Patient had a long history of hospital stays and health problems, was in coma from 16-APR-2020 to 24-JUL-2020. Patient was on ventilator. He was discharged and was still on feeding tube, He regained most of his abilities, but still was not able to retain information, and did not have a memory of what happened to him. He was not mentally capable. He was still recovering from his coma. On 05-SEP-2020,he had a bone marrow biopsy which ruled out cancer. Anemia treated with iron supplement. On an unspecified date in 2021, patient broke his hip and stayed in the hospital for another 11 days. Patient had chronic cough and was diagnosed with prostate cancer metastatic. The patient experienced rash when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  Reporter reported that her father received the Janssen COVID-19 Vaccine on 05-MAY-2021. He sat for the 15 minutes monitoring period at the vaccine facility. He did not intend to get vaccinated, but rather, was exchanging his glasses at the facility and proceeded to get vaccinated. The reporter stated that her father was escorted by the optical department associate to the pharmacy and that her father did not have the mental capacity to provide consent for vaccination. He was not capable of making medical decisions for himself. She was his contact person for informed consent. He went to pharmacy for eyeglasses and saw all the advertisement for JJ vaccine and went to get the shot. Even though He did not have the mental capacity to make decisions, the JJ vaccine was administered by pharmacy staff without any notifications to his family. There were no other risk factors or anything different that he did in those days. After 4 days of receiving the vaccine (on 10-MAY-2021) his health started to deteriorate and died within 24 hours after symptoms. On 07-MAY-2021 and 09-MAY-2021, the reporter was in contact with her father and he was fine. On 10May2021, her father did not feel good and thought he might be getting a cold, however, it was nothing alarming. He had fatigue, trouble sleeping, agitation, and low energy. On 11-MAY-2021, he was not eating, lost his voice, had trouble breathing, and told his wife he was going to lay down. On an unspecified date in MAY-2021, patient's breathing changed. On 11-MAY-2021, he was hallucinating, talking to his dead mother and brother and chasing squirrels (coded as visual hallucinations), then died. He was feeling tired and wanted to rest, he lied down and he dropped dead in short time. Patient died on 11-MAY-2021. Family did not have time to take him to the hospital. Daughter believed JJ vaccine is a killer and it was a death sentence for her father. The cause of death was reported as respiratory failure from prostate cancer and metastasis, which the reporter disagrees. She denied the cause of death. Reporter was angry and disappointed, blaming the death of her father on JJ vaccine. She stated so many times that the vaccine was a death sentence and how was it still continued, it was killing people. Reporter mentioned after her dad's passing his doctor called asking why was he given the vaccine and that patient was not a candidate for it considering his past medical history. Doctor did not want him to get the vaccine. Reporter also looked at her dad's journal, according to it he thought vaccine was created to help with side effects instead of actually preventing it. She already called pharmacy and spoke to the pharmacist/district manager, it was a completely new pharmacy for him and he had only gone for eye glasses only. District manager said they made a judgement call about vaccinating him. Daughter was angry with them for not checking with her or his doctor first.  On JUL-2014, Laboratory data included: Blood pressure (NR: not provided) low pressure, Echocardiogram (NR: not provided) No damage to his heart., and Heart rate (NR: not provided) high heart rate. On APR-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 16-APR-2020, Laboratory data included: X-ray (NR: not provided) a slight infection in lower lobe. On 05-SEP-2020, Laboratory data included: Bone marrow biopsy (NR: not provided) ruled out cancer.  An autopsy was performed on 11-MAY-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from respiratory failure from prostate cancer and metastasis. The patient had not recovered from hallucinating, talking to dead mother and brother and chasing squirrels, stopped eating, loss of voice, did not feel good, trouble sleeping, low energy, health started to deteriorate, and might be getting a cold, and the outcome of agitation was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint :90000179909. The suspected product quality complaint has been confirmed to be voided based on the PQC evaluation/investigation performed. Confirmed no PQC was identified within the reported complaint reported. Complaint is approved for void. This case, from the same reporter is linked to 20210534689 and 20210544901.; Sender's Comments: V0: 2021054583 -covid-19 vaccine ad26.cov2.s Respiratory Failure From Prostate Cancer And Metastasis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 2021054583 -covid-19 vaccine ad26.cov2.s - Hallucinating, talking to his dead mother and brother and chasing squirrels. 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: RESPIRATORY FAILURE FROM PROSTATE CANCER  AND METASTASIS