Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine were given after the beyond use date BUD 17Nov2022, administration of vaccine on 18Nov2022; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (vaccine were given after the beyond use date BUD 17Nov2022, administration of vaccine on 18Nov2022) 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. 051d22a) for COVID-19 prophylaxis. No Medical History information was reported. On 18-Nov-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. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine were given after the beyond use date BUD 17Nov2022, administration of vaccine on 18Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (vaccine were given after the beyond use date BUD 17Nov2022, administration of vaccine on 18Nov2022) 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 (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (vaccine were given after the beyond use date BUD 17Nov2022, administration of vaccine on 18Nov2022). No concomitant medication were reported. 14 doses of the bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022.  Bivalent vaccine. Individual vials with Vial size of 2.5 mL. The vial was initially stored in the refrigerator on 18-Oct-2022. Vaccine was administered on 18-Nov-2022. No treatment information was provided by the reporter. This case was for 13th patient of 14 patients. This case was linked to MODERNATX, INC.-MOD-2022-675260, MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675238, US-MODERNATX, INC.-MOD-2022-675258, US-MODERNATX, INC.-MOD-2022-675261, US-MODERNATX, INC.-MOD-2022-675262, US-MODERNATX, INC.-MOD-2022-675263, US-MODERNATX, INC.-MOD-2022-675265, US-MODERNATX, INC.-MOD-2022-675266, US-MODERNATX, INC.-MOD-2022-675271 (E2B Linked Report); Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:patient 4; US-MODERNATX, INC.-MOD-2022-675264:patient 8; US-MODERNATX, INC.-MOD-2022-675268:Patient 11; US-MODERNATX, INC.-MOD-2022-675269:patient 12; US-MODERNATX, INC.-MOD-2022-675259:patient 3; US-MODERNATX, INC.-MOD-2022-675238:patient 1 US-MODERNATX, INC.-MOD-2022-675258:patient 2; US-MODERNATX, INC.-MOD-2022-675261:patient 5 US-MODERNATX, INC.-MOD-2022-675262:patient 6; US-MODERNATX, INC.-MOD-2022-675263:patient 7 US-MODERNATX, INC.-MOD-2022-675265:patient 9; US-MODERNATX, INC.-MOD-2022-675266:patient 10 US-MODERNATX, INC.-MOD-2022-675271:patient 14