Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was unknown, it this lot number undergone a previous temperature excursion; storage condition at the time of the excursion was frozen storage/refrigerated storage/ambient room temperature frozen storage/refrigerated storage; state of the vaccine at the time of the excursion was partially thawed/liquid, interim disposition of vials (returned to the freezer/refrigerator, or maintained at room temperature): frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): re-frozen and pertinent detail related to the impacted vial(s) (punctured/unpunctured or temperature fluctuations, etc.): temperature fluctuations, Frozen - refrigerated - re-frozen. Move to fridge date for the vaccine was 06-Oct-2021.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-496015 (Patient Link).