Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product storage error
Clinical narrative: They moved them from freezer to the refrigerator on and off since AUG2022 and administered to their patients; data logger did not record any temperature but they have been manually monitoring the refrigerator; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (They moved them from freezer to the refrigerator on and off since AUG2022 and administered to their patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (data logger did not record any temperature but they have been manually monitoring the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They moved them from freezer to the refrigerator on and off since AUG2022 and administered to their patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (data logger did not record any temperature but they have been manually monitoring the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (They moved them from freezer to the refrigerator on and off since AUG2022 and administered to their patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (data logger did not record any temperature but they have been manually monitoring the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (They moved them from freezer to the refrigerator on and off since AUG2022 and administered to their patients) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (data logger did not record any temperature but they have been manually monitoring the refrigerator).    No concomitant medications were reported.  Reporter reported that several doses of Bivalent Moderna COVID-19 vaccine were in the refrigerator. As they moved them from freezer to the refrigerator on and off since Aug2022 and administered to their patients, now they realized that the refrigerator Internal sensor has been offline since Aug2022. There was a digital sensor on refrigerator which shows that temperatures were within recommended range 36-46F. Basically, the data logger did not record any temperature, but they had been manually monitoring the refrigerator and the temperature never went outside the recommended 36-46F. Currently there are 10 unpunctured Bivalent vials of Moderna COVID-19 in the refrigerator. Moved from Freezer to the refrigerator on 14Feb2023. Since Aug2022 some vaccines that were stored in the refrigerator have been injected to patients and she does not have the lot numbers nor patient's names. Frozen vials were thawed, thawed vials were re-frozen.  No treatment medications were reported.