Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pneumonia, Renal failure, Sepsis, Thrombosis
Clinical narrative: Renal failure; Sepsis; Blood clot in groin; Double pneumonia; Unconsciousness; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Renal failure), SEPSIS (Sepsis), THROMBOSIS (Blood clot in groin), PNEUMONIA (Double pneumonia) and LOSS OF CONSCIOUSNESS (Unconsciousness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) for Type 2 diabetes mellitus.    Concurrent medical conditions included Diabetes mellitus.   In 2016, the patient started INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) (Subcutaneous) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria hospitalization and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Blood clot in groin) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Double pneumonia) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 07-Jun-2022 due to LOSS OF CONSCIOUSNESS, PNEUMONIA, RENAL FAILURE, SEPSIS and THROMBOSIS. At the time of the report, RENAL FAILURE (Renal failure), SEPSIS (Sepsis), THROMBOSIS (Blood clot in groin), PNEUMONIA (Double pneumonia) and LOSS OF CONSCIOUSNESS (Unconsciousness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported. All the events were assessed as unlisted for co-suspect Tresiba flex-touch. Company comment-This spontaneous case concerns an elderly female  patient of unspecified age with relevant medical history of Diabetes mellitus on TRESIBA FLEXTOUCH reported, who experienced the unexpected serious (Medically significant/Hospitalization) events of Renal failure(AESI), Sepsis , Thrombosis(AESI) (reported as Blood clot in groin), Pneumonia and Loss of consciousness unspecified days after unspecified dose of mRNA-1273 vaccination in covid -19 vaccination series. Patient experienced unconsciousness after moderna vaccine, was hospitalized, found to have Pneumonia, sepsis and renal failure. She was found to have a blood clot in groin. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history could be confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female  patient of unspecified age with relevant medical history of Diabetes mellitus on TRESIBA FLEXTOUCH reported, who experienced the unexpected serious (Medically significant/Hospitalization) events of Renal failure(AESI), Sepsis , Thrombosis(AESI) (reported as Blood clot in groin), Pneumonia and Loss of consciousness unspecified days after unspecified dose of mRNA-1273 vaccination in covid -19 vaccination series. Patient experienced unconsciousness after moderna vaccine, was hospitalized, found to have Pneumonia, sepsis and renal failure. She was found to have a blood clot in groin. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history could be confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.