Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was unknown if the vial was undergone a previous temperature excursion. The storage condition at the time of the excursion was frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was partially thawed/liquid. The maximum temperature reached was 8°C. the total duration of the excursion refrigerated temps for max of 4 hours. The temperature fluctuations occurred as frozen-refrigerated and refrozen.  It was also reported that on 01-Dec-2021, the vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2°C to 8°C.  No treatment information was provided.   This case was linked to MOD-2022-496015 (Patient Link).