Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Disorientation, Fall, Muscular weakness, Renal failure
Clinical narrative: KIDNEY STOPPED WORKING; DISORIENTED; FELL DOWN; NO STRENGTH IN LEGS; WORSENING CELLULITIS; This spontaneous report received from a patient concerned a 71 year old white, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cellulitis, non-alcohol user, non-smoker, glaucoma (patient was blind), and congestive heart failure. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 06-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included furosemide and a statin for congestive heart failure. On 10-MAR-2021, 4 days after vaccination, patient was disoriented and slept on the floor. The paramedic rushed to his home, where he had fallen down and had no strength in legs and he was out of it. In the hospital, they mentioned that they were not surprised that he had ended up there because his cellulitis had flared up. Patient did not blame the vaccine at any point about worsening of his cellulitis. The patient was given antibiotics in the hospital but they did not give him any after being discharged. He received nursing staff at home to change his dressing. However, they stopped coming as the insurance did not pay further.  In the first week of OCT-2021, the paramedic rushed to his home because he was out of it and they thought he was dead. They took him to the same hospital. His cellulitis had worsened, he was in intensive care for 30 days and was put on respirator and his kidneys had stopped working. He could not remember anything about the first 20 days. In the hospital he was seen by an older specialist and he mentioned that he had to be on antibiotics on a long term basis. The patient was also in the rehab (rehabilitation). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worsening cellulitis, disoriented, fell down, no strength in legs and kidney stopped working was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0. 20220330900-covid-19 vaccine ad26.cov2.s -worsening cellulitis. 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. Therefore, this event(s) is considered not related.  20220330900-covid-19 vaccine ad26.cov2.s -kidney stopped working. 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 (worsening of cellulitis, congestive heart failure and being on ventilator). Therefore, this event(s) is considered not related.  20220330900-covid-19 vaccine ad26.cov2.s -disoriented, fell down. 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). Therefore, this event(s) is considered unassessable.  20220330900-covid-19 vaccine ad26.cov2.s - No strength in legs . This event(s) is labeled per RA and is therefore considered potentially related.