Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in fridge on 14-Dec-2022 and administered on 13-Jan-2023; No adverse event; Patient received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in fridge on 14-Dec-2022 and administered on 13-Jan-2023) 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in fridge on 14-Dec-2022 and administered on 13-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in fridge on 14-Dec-2022 and administered on 13-Jan-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in fridge on 14-Dec-2022 and administered on 13-Jan-2023).    This case pertained the information of patient 1st out of 9 reported patients.  No concomitant product reported by reporter.  Total 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date with lot number AS7168B. Vial size was 2.5mL. Date vial was initially stored in the fridge Dec 14 2022.  Vaccine was administered on different dates. One dose was given on the 13-Jan-2023, 4 doses were given on 14-Jan-2023 one dose was given on 16-Jan-2023, one dose was given on 17-Jan-2023 and two doses were given on 19-Jan-2023. Vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-705057, US-MODERNATX, INC.-MOD-2023-705066, US-MODERNATX, INC.-MOD-2023-705087, US-MODERNATX, INC.-MOD-2023-705092, US-MODERNATX, INC.-MOD-2023-705093, US-MODERNATX, INC.-MOD-2023-705097, US-MODERNATX, INC.-MOD-2023-705106, US-MODERNATX, INC.-MOD-2023-705109 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705092:5th adult patient (vaccine start date: 14-Jan-2023) US-MODERNATX, INC.-MOD-2023-705066:3rd adult patient (vaccine start date: 14-Jan-2023) US-MODERNATX, INC.-MOD-2023-705057:2nd adult patient (vaccine start date: 14-Jan-2023) US-MODERNATX, INC.-MOD-2023-705087:4th adult patient (vaccine start date: 14-Jan-2023) US-MODERNATX, INC.-MOD-2023-705093:6th adult patient (vaccine start date: 16-Jan-2023) US-MODERNATX, INC.-MOD-2023-705097:7th adult patient (vaccine start date: 17-Jan-2023) US-MODERNATX, INC.-MOD-2023-705106:8th adult patient (vaccine start date: 19-Jan-2023) US-MODERNATX, INC.-MOD-2023-705109:9th adult patient (vaccine start date: 19-Jan-2023)