Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator and administered; No adverse event; They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on), PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator and administered) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, 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 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator and administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on), PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator and administered) 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 (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on) and PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator and administered).    No concomitant medications were reported.  It was reported that the vial size was 2.5 ml. On 12-Jun-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The reporter asked to escalate the case to Tier-2 for a lot analysis.  No treatment medications were reported.  This case contains information for the 02 of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live significant follow-up received: Reporter, patient gender, suspect product details, event verbatim and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Master case