Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue, Wrong product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), PRODUCT STORAGE ERROR (Temperature excursion in the freezer and they had an inspection and saw that their DDL was not recording), WRONG PRODUCT ADMINISTERED (received the 611-year-old vaccine instead of the 12+ vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), PRODUCT STORAGE ERROR (Temperature excursion in the freezer and they had an inspection and saw that their DDL was not recording), WRONG PRODUCT ADMINISTERED (received the 611-year-old vaccine instead of the 12+ vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), PRODUCT STORAGE ERROR (Temperature excursion in the freezer and they had an inspection and saw that their DDL was not recording), WRONG PRODUCT ADMINISTERED (received the 611-year-old vaccine instead of the 12+ vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), PRODUCT STORAGE ERROR (Temperature excursion in the freezer and they had an inspection and saw that their DDL was not recording) and WRONG PRODUCT ADMINISTERED (received the 611-year-old vaccine instead of the 12+ vaccine./received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine).    Concomitant medications were not reported.  The facility had a temperature excursion in the freezer.  was not recording the temperatures and they need a viability letter from Moderna stating what they should do. Storage condition at the time of the excursion was frozen storage. Individual vials or unbroken cartons: Unbroken Cartons. Vial size? 2.5 mL or 5.5 mL: Both. Maximum or minimum temperatures reached, as applicable (specify temp is in C or F) *: Unknown, only have manual twice a day recording. Excursion duration was unknown. Date vial(s) moved from freezer to refrigerator, if applicable: N/A. Where are they stored now? Returned to the freezer. Visual inspection noting any vaccine state change: Still frozen. Proposed desired Use by Date: Already administered to patients. Did the vial undergo any temperature excursions? First time. Patients involved. If yes, obtain previous excursion information or case number of previous assessment.  Treatment information was not provided.