Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Temperature excursion; No adverse event; Today (21Sep2022), 2 doses of this Moderna Covid-19 vaccine (Monovalent) were administered to patients/removed from the refrigerator & stored at room temperature for 2 months; removed from the refrigerator & stored at room temperature for 2 months; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today (21Sep2022), 2 doses of this Moderna Covid-19 vaccine (Monovalent) were administered to patients/removed from the refrigerator & stored at room temperature for 2 months), PRODUCT STORAGE ERROR (removed from the refrigerator & stored at room temperature for 2 months), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Today (21Sep2022), 2 doses of this Moderna Covid-19 vaccine (Monovalent) were administered to patients/removed from the refrigerator & stored at room temperature for 2 months) and PRODUCT STORAGE ERROR (removed from the refrigerator & stored at room temperature for 2 months). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Today (21Sep2022), 2 doses of this Moderna Covid-19 vaccine (Monovalent) were administered to patients/removed from the refrigerator & stored at room temperature for 2 months), PRODUCT STORAGE ERROR (removed from the refrigerator & stored at room temperature for 2 months), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Today (21Sep2022), 2 doses of this Moderna Covid-19 vaccine (Monovalent) were administered to patients/removed from the refrigerator & stored at room temperature for 2 months), PRODUCT STORAGE ERROR (removed from the refrigerator & stored at room temperature for 2 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported.  On 01-Aug-2022, the facility lost power & 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 2 vials were administered. 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. The vial is stored back to the refrigerator. The vials were thawed and no changes were noted in visual inspection.  No treatment  medications were reported.