Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer; Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer), EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration ) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 939906) for COVID-19 vaccination.     It was reported unknown the patient ever been diagnosed with or tested positive for COVID-19. Not known acute illness at the time of vaccination and up to one month before. Not known any prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of adverse event.  Concurrent medical conditions included Allergy to molds, Adhesive tape allergy, Depression since 17-Mar-2016 and GERD since 22-Mar-2016.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Sep-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 unaware that vial was not shipped frozen, staff put vial back into freezer) and PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration ). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of moderna vial lot 032B21A at refrigerator temperature, Office was unaware that vial was not shipped frozen, staff put vial back into freezer), EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration ) 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 unaware that vial was not shipped frozen, staff put vial back into freezer) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration ).    No concomitant medication information was provided. Per Moderna CMC Lot analysis, regarding doses administered, Moderna could not guarantee patients received full protection against the COVID-19 Virus. 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 02-Sep-2021 to thaw for one hour to room temperature. Dose of 0.5 ml then given to patient on 02-Sep-2021. Per Moderna one re-freeze was fine, but could not be given beyond 30 days. The 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.