Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 939906) for COVID-19 vaccination.     It was unknown if patient ever have tested/diagnosed positive for Covid-19. The acute illnesses at time of vaccination or 1 month before vaccination were unknown. Patient did not have chronic or long standing health conditions.  Concurrent medical conditions included Drug allergy.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days).    No concomitant medication information was provided. On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature.  The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021. Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature. Dose of 0.5 ml then given to patient on 27-Aug-2021. Per moderna one re-freeze was ok, but can not be given beyond 30 days. This dose was beyond that time.  Patient had no signs or symptoms of any adverse reactions to the injection given. No treatment medication were provided. Patient did not seek medical care. Reporter stated that Moderna can not guarantee that patient received full protection against the covid-19 virus.   This case was linked to MOD-2022-539750 (Patient Link).