Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna temp excursion - administered 3 doses past beyond use date; No adverse event; Moderna temp excursion - administered 3 doses past beyond use date; Moderna temp excursion - administered 3 doses past beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date), POOR QUALITY PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna temp excursion - administered 3 doses past beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date) and POOR QUALITY PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna temp excursion - administered 3 doses past beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date), POOR QUALITY PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna temp excursion - administered 3 doses past beyond use date) 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 (Moderna temp excursion - administered 3 doses past beyond use date), POOR QUALITY PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna temp excursion - administered 3 doses past beyond use date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine expiry date was reported as 26-Sep-2023. Beyond use date was reported as 02-Jul-2023. No other temp excursions experienced by this product. No particulates or discoloration noted. Moderna product was transported and maintained between 36 to 46 Fahrenheit. Administered a 0.5mL vaccine dose to two patients on 06-Jul-2023 and another 0.5ml dose to a different patient on 07-Jul-2023. Dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 1st out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733332, US-MODERNATX, INC.-MOD-2023-733336 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733336:Patient 2 US-MODERNATX, INC.-MOD-2023-733332:Patient 3