Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebrovascular accident, Death, Inappropriate schedule of product administration, Pneumonia aspiration
Clinical narrative: stroke; UTI; sepsis; aspiration pneumonia; first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), CEREBROVASCULAR ACCIDENT (stroke), URINARY TRACT INFECTION (UTI), SEPSIS (sepsis), PNEUMONIA ASPIRATION (aspiration pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criteria hospitalization and medically significant), SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant), PNEUMONIA ASPIRATION (aspiration pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) (seriousness criterion medically significant). The patient died on 10-Sep-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, URINARY TRACT INFECTION (UTI), SEPSIS (sepsis), PNEUMONIA ASPIRATION (aspiration pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: elevated blood pressure (High) elevated blood pressure.         No concomitant medications information was reported. No treatment medications were provided.  This is a case of Inappropriate schedule of vaccine administered concerning an 88-year-old female patient with no reported medical history who experienced the fatal unexpected events of cerebrovascular accident, urinary tract infection, sepsis and aspiration pneumonia. The events of urinary tract infection, sepsis and aspiration pneumonia occurred on an unspecified date after  CVA occurred 3 day after the second dose and the subject expired 1 month 4 days after the second dose of mRNA-1273 The rechallenge was not applicable as events occurred after second dose with a fatal outcome. Causality assessment for the event was not provided by the reporter. However, the subject is of an advanced age and UTI is of an infective origin which can lead to sepsis and thus assessment with product used is determined as unlikely. The benefit-risk relationship of mRNA-1273is not affected by this report; Sender's Comments: This is a case of Inappropriate schedule of vaccine administered concerning an 88-year-old female patient with no reported medical history who experienced the fatal unexpected events of cerebrovascular accident, urinary tract infection, sepsis and aspiration pneumonia. The events of urinary tract infection, sepsis and aspiration pneumonia occurred on an unspecified date after  CVA occurred 3 day after the second dose and the subject expired 1 month 4 days after the second dose of mRNA-1273 The rechallenge was not applicable as events occurred after second dose with a fatal outcome. Causality assessment for the event was not provided by the reporter. However, the subject is of an advanced age and UTI is of an infective origin which can lead to sepsis and thus assessment with product used is determined as unlikely. The benefit-risk relationship of mRNA-1273is not affected by this report; Reported Cause(s) of Death: stroke