Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine transported on 07Apr2022, Previously frozen at the previous facility and dose administered after 30-day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial temperature maintained 2-8 degrees Celsius for 10-15 minutes before thawing/Dose administered after temperature excursion), PRODUCT STORAGE ERROR (Transport occurred on 07Apr2022 and dose was administered on 09May2022/Returned to the freezer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 15-Oct-2021 and Second dose received on 09 May 2022) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 014F21A) for COVID-19 vaccination. Patient do not have any allergies. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Blood pressure and Diabetes. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 09-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine transported on 07Apr2022, Previously frozen at the previous facility and dose administered after 30-day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 15-Oct-2021 and Second dose received on 09 May 2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial temperature maintained 2-8 degrees Celsius for 10-15 minutes before thawing/Dose administered after temperature excursion) and PRODUCT STORAGE ERROR (Transport occurred on 07Apr2022 and dose was administered on 09May2022/Returned to the freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine transported on 07Apr2022, Previously frozen at the previous facility and dose administered after 30-day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial temperature maintained 2-8 degrees Celsius for 10-15 minutes before thawing/Dose administered after temperature excursion), PRODUCT STORAGE ERROR (Transport occurred on 07Apr2022 and dose was administered on 09May2022/Returned to the freezer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 15-Oct-2021 and Second dose received on 09 May 2022) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant  Blood pressure, Diabetes, Over-the-counter medications were provided. Reporter stated that during the transport the vial temperature maintained 2-8 degrees C for 10-15 minutes. The receiving party stored the vials back into the freezer instead of putting them in the fridge. Storage condition at the time of the excursion: freezer. On 06May2022 vial(s) moved from freezer to refrigerator. On 09May2022, proposed desired Use by Date. On 09May2022 one vial was thawed and a dose was administered to on patient. Transport occurred on 07Apr2022. Previously frozen at the previous facility. Dose administered after temperature excursion. Treatment information was not provided.