Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date that the vial was initially stored in the fridge 11Oct2022, Date of administration 16Nov2022, 5 patients, 30Nov2022, 3 patients; No adverse event; Received doses after its beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date), PRODUCT STORAGE ERROR (Date that the vial was initially stored in the fridge 11Oct2022, Date of administration 16Nov2022, 5 patients, 30Nov2022, 3 patients) 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. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, 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. In November 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date that the vial was initially stored in the fridge 11Oct2022, Date of administration 16Nov2022, 5 patients, 30Nov2022, 3 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date), PRODUCT STORAGE ERROR (Date that the vial was initially stored in the fridge 11Oct2022, Date of administration 16Nov2022, 5 patients, 30Nov2022, 3 patients) 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 EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date) and PRODUCT STORAGE ERROR (Date that the vial was initially stored in the fridge 11Oct2022, Date of administration 16Nov2022, 5 patients, 30Nov2022, 3 patients).    No concomitant product use was reported.  Via size individual vial 2.5 ml.  On 11-Oct-2022, vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  8 Patients received bivalent doses after its beyond use date on 16-Nov-2022, 5 patients and on 30-Nov-2022, 3 patients.  No treatment information was provided.  This case contains information for the 2nd patient out of 8 patients as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-680808, MODERNATX, INC.-MOD-2022-680811, MODERNATX, INC.-MOD-2022-680812, MODERNATX, INC.-MOD-2022-680813, MODERNATX, INC.-MOD-2022-680814, MODERNATX, INC.-MOD-2022-680815, MODERNATX, INC.-MOD-2022-680816 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-680808:Samer Reporter MODERNATX, INC.-MOD-2022-680811:Samer Reporter MODERNATX, INC.-MOD-2022-680812:Samer Reporter MODERNATX, INC.-MOD-2022-680813:Samer Reporter MODERNATX, INC.-MOD-2022-680814:Samer Reporter MODERNATX, INC.-MOD-2022-680815:Samer Reporter MODERNATX, INC.-MOD-2022-680816:Samer Reporter