Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Wrong technique in product usage process
Clinical narrative: The bivalent product (lot number AS7173B) was received by the vaccination facility and placed in the refrigerator on 8FEB2023/BUD 10MAR2023; Some of the vials were initially punctured on 9FEB2023 and administered up until 21FEB2023; They had also been using a 30 day use by date after the initial puncture for their vaccine storage prior to disposing of those vaccines; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The bivalent product (lot number AS7173B) was received by the vaccination facility and placed in the refrigerator on 8FEB2023/BUD 10MAR2023), POOR QUALITY PRODUCT ADMINISTERED (Some of the vials were initially punctured on 9FEB2023 and administered up until 21FEB2023), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (They had also been using a 30 day use by date after the initial puncture for their vaccine storage prior to disposing of those vaccines) 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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The bivalent product (lot number AS7173B) was received by the vaccination facility and placed in the refrigerator on 8FEB2023/BUD 10MAR2023), POOR QUALITY PRODUCT ADMINISTERED (Some of the vials were initially punctured on 9FEB2023 and administered up until 21FEB2023), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (They had also been using a 30 day use by date after the initial puncture for their vaccine storage prior to disposing of those vaccines) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The bivalent product (lot number AS7173B) was received by the vaccination facility and placed in the refrigerator on 8FEB2023/BUD 10MAR2023), POOR QUALITY PRODUCT ADMINISTERED (Some of the vials were initially punctured on 9FEB2023 and administered up until 21FEB2023), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (They had also been using a 30 day use by date after the initial puncture for their vaccine storage prior to disposing of those vaccines) 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 (The bivalent product (lot number AS7173B) was received by the vaccination facility and placed in the refrigerator on 8FEB2023/BUD 10MAR2023), POOR QUALITY PRODUCT ADMINISTERED (Some of the vials were initially punctured on 9FEB2023 and administered up until 21FEB2023) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (They had also been using a 30 day use by date after the initial puncture for their vaccine storage prior to disposing of those vaccines).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712827 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712827:Monovalent Dose