Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Temp Excursion - Yes; Date the vial was initially stored in the refrigerator on 3Oct2022and vaccine administered on 11 Nov 2022; No adverse event; Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD; Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD), POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 3Oct2022and vaccine administered on 11 Nov 2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD) and POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 3Oct2022and vaccine administered on 11 Nov 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD), POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 3Oct2022and vaccine administered on 11 Nov 2022) 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 (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD), POOR QUALITY PRODUCT ADMINISTERED (Erroneously vaccinated  clients with expired vaccine/ Vaccine was administred 9 days after BUD), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 3Oct2022and vaccine administered on 11 Nov 2022).    No concomitant medication reported.  Patient was administered vaccine 9 Days the Past Expiry date. The vial size was 2.5.  The vial was initially stored in the refrigerator on 03-Oct-2022. The Beyond use date (BUD) in refrigerator was reported as 02-Nov-2022.   No treatment medication reported.   This case was linked to MOD22-030180 (E2B Linked Report).; Sender's Comments:  MOD22-030180:Master Case