Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Death, Expired product administered
Clinical narrative: Passed away; 34 patients were administered from an expired vaccine\16 staff members were administered from the expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2022 and was forwarded to Moderna on 03-Mar-2022.    This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Passed away) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation and Acute kidney failure.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (Passed away) (seriousness criteria death and medically significant) and EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine\16 staff members were administered from the expired vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine\16 staff members were administered from the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. 50 expired vaccine doses were administered to patients and staff. Date the vial was initially stored in the refrigerator: 04-Nov-2021. Date(s) of administration of vaccine was reported as some 05-Nov-2021 and the other doses on 12-Nov-2021. Vial did not undergo any temperature excursions. No any adverse event as a result of this misadministration, patients were monitored. Company Comment: This spontaneous case concerns a 87 year old patient with unknown gender with relevant medical history of atrial fibrillation  and Acute kidney injury  , who experienced Serious ( fatal ) unexpected event of Death which occurred on an unknown date  after vaccination with an unknown dose number of mRNA-1273.  Non-serious , unexpected event of expired product administered was reported for this case.  I t was reported that 50 expired vaccine doses were administered to patients and staff. The vial was initially stored in the refrigerator and the next day it was administered and other doses 7 days after. The vial did not undergo any temperature excursions. No  adverse event as a result of this misadministration was reported and the patients were monitored. This patient being reported was included  in the list of the patients who received the expired product. The date and the cause of death of this patient was not reported and it is unknown if an autopsy was done. The details surrounding the event of death were  not reported. The medical history of atrial fibrillation , age  and acute kidney failure are considered confounders for the event of death ( ageing and  these medical conditions can lead to this death  ) .  The administration of expired vaccine may also be considered a confounder however as mentioned above the patients were closely monitored and no report of adverse events noted after the incident. The benefit -risk relationship of mRNA -1273  is not affected by report.   This case was linked to MOD-2022-501867, MOD-2022-502703.; Sender's Comments: This spontaneous case concerns a 87 year old patient with unknown gender with relevant medical history of atrial fibrillation  and Acute kidney injury  , who experienced Serious ( fatal ) unexpected event of Death which occurred on an unknown date  after vaccination with an unknown dose number of mRNA-1273.  Non-serious , unexpected event of expired product administered was reported for this case.  I t was reported that 50 expired vaccine doses were administered to patients and staff. The vial was initially stored in the refrigerator and the next day it was administered and other doses 7 days after. The vial did not undergo any temperature excursions. No  adverse event as a result of this misadministration was reported and the patients were monitored. This patient being reported was included  in the list of the patients who received the expired product. The date and the cause of death of this patient was not reported and it is unknown if an autopsy was done. The details surrounding the event of death were  not reported. The medical history of atrial fibrillation , age  and acute kidney failure are considered confounders for the event of death ( ageing and  these medical conditions can lead to this death  ) .  The administration of expired vaccine may also be considered a confounder however as mentioned above the patients were closely monitored and no report of adverse events noted after the incident. The benefit -risk relationship of mRNA -1273  is not affected by report; Reported Cause(s) of Death: unknown cause of death