Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator; No adverse event; Patients received vaccine after 30 day beyond use date. Vaccines were moved to their fridge on 06Dec2022. Agent let HCP know the vaccines were expired / expired doses were given to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date. Vaccines were moved to their fridge on 06Dec2022. Agent let HCP know the vaccines were expired / expired doses were given to 7 patients), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in 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. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, 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 16-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date. Vaccines were moved to their fridge on 06Dec2022. Agent let HCP know the vaccines were expired / expired doses were given to 7 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date. Vaccines were moved to their fridge on 06Dec2022. Agent let HCP know the vaccines were expired / expired doses were given to 7 patients), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date. Vaccines were moved to their fridge on 06Dec2022. Agent let HCP know the vaccines were expired / expired doses were given to 7 patients) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator).    This case included information of 4th patient out of 7 patients. No concomitant product reported by reporter.  It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial initially stored in the refrigerator on 06-Dec-2022. Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator. Vial size was 2.5ml.  Dates of administration of vaccine were 12-Jan-2023 for 2 patients, 16-Jan-2023 for 2 patients, 20-Jan-2023 for 1 patient, 24-Jan-2023 for 1 patient and 01-Feb-2023 for 1 patient. Vial did not undergone any temperature excursion issue.  No concomitant product reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708306 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708306:Master case