Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months; Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months; No adverse event; Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months. This vaccine was administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months. This vaccine was administered to patient), PRODUCT STORAGE ERROR (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months) and NO ADVERSE EVENT (No adverse event) in a 29-year-old patient of an unknown gender who received mRNA-1273 (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months. This vaccine was administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccines (Monovalent) was removed from the refrigerator and stored at room temperature for 2 months) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months. This vaccine was administered to patient), PRODUCT STORAGE ERROR (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccines (Monovalent) was removed from the refrigerator and stored at room temperature for 2 months) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months. This vaccine was administered to patient), PRODUCT STORAGE ERROR (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator and stored at room temperature for 2 months).    No concomitant medications were reported.  On 01-Aug-2022, the facility lost power and Moderna COVID-19 vaccines (Monovalent) were removed from the refrigerator & stored at room temperature for 2 months, while repairs were being made, related to power.  Total number of vials was 2 and the size of the vial was 5.5 mL. The date the vial was initially stored in the refrigerator was unknown. The vial did undergo temperature excursions. The total amount of time the vial was exposed to room temperature was for 2 months. At some unknown point, the vaccines were returned to the refrigerator. The vials were thawed, and no changes were noted in visual inspection.  No treatment medications were reported.