Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 100's of patients potentially impacted by the dose administered after the 30 day beyond use date; Using incorrect storage unit for storing the vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100's of patients potentially impacted by the dose administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (Using incorrect storage unit for storing the vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (100's of patients potentially impacted by the dose administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (Using incorrect storage unit for storing the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100's of patients potentially impacted by the dose administered after the 30 day beyond use date), PRODUCT STORAGE ERROR (Using incorrect storage unit for storing the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100's of patients potentially impacted by the dose administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Using incorrect storage unit for storing the vaccine).    Concomitant medication was not provided. It was reported that 100's of patients were potentially impacted by the dose administered after the 30 day beyond use date at this facility. He says that there were both Moderna COVID-19 monovalent and bivalent vaccine that were administered past the beyond use date and there are dates of administration going back all the way to 2021. It was explained to HCP that Moderna conducts lot analysis for these scenarios and each result was lot based. Reporter stated that the date of refrigeration can only be assumed as the date that the facility had received the vaccine at the facility and was not keeping any logs for thaw dates or beyond use dates. Additionally, he stated that they were also using incorrect storage unit for storing the vaccine. He did state that the temperature logs they had in their records seemed to have been stable and within recommended ranges.  The Monovalent Lot number(s) involved include: 061B22A, 014B22A, 056M21A, 033K21-2A, 084J21A, 001C21A, 020B21A, and 022M20A  Date the vial was initially stored in the refrigerator: 061B22A - 1AUG2022, 014B22A - 7JUN2022, 056M21A - 14APR2022, 033K21-2A - 27FEB2022, 084J21A - 7JAN2022, 001C21A - 1SEP2021, 020B21A -15MAY2021, 022M20A - 12FEB2021. Date(s) of administration of vaccine: 061B22A - 8SEP2022, 014B22A - 7JUL2022, 13JUL2022, 14JUL2022 056M21A - 17MAY2022, 033K21-2A - 30MAR2022 - 11MAY2022, 084J21A - 7FEB2022 - 9FEB2022, 001C21A - 3OCT2021 - 5NOV2021, 020B21A - 18OCT2021 - 29OCT2021, 022M20A - 23APR2021. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728900 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2023: Live follow-up received and had no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728900:Bivalent case