Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 31 MAY 2023 and Date of administration of vaccine was 31MAY2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 31 MAY 2023 and Date of administration of vaccine was 31MAY2023) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-May-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 31-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 31 MAY 2023 and Date of administration of vaccine was 31MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 31 MAY 2023 and Date of administration of vaccine was 31MAY2023) 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 (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 31 MAY 2023 and Date of administration of vaccine was 31MAY2023).    Pharmacist was calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine, located in the freezer thawed and injected, on 31-May-2023.  Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry Products. Bivalent BA.4-5 Adult Lot number(s) : AS7147B and manufacturer expiry Date: 19-May-2023.  Intact carton, Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 31-May-2023.  Confirmed that the vial expired on 19-May-2023.  Moderna Bivalent Booster Lot AS7147B was given to approx. 20 patients.  Moderna did lot check and stated it was still effective. There has been no adverse reaction for patients. All booster doses. All patients qualified age greater-than 65 or immune compromised.  Concomitant medication not reported.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-729793, US-MODERNATX, INC.-MOD-2023-729795, US-MODERNATX, INC.-MOD-2023-729791, US-MODERNATX, INC.-MOD-2023-729794, US-MODERNATX, INC.-MOD-2023-729796, US-MODERNATX, INC.-MOD-2023-729797, US-MODERNATX, INC.-MOD-2023-729799, US-MODERNATX, INC.-MOD-2023-729800, US-MODERNATX, INC.-MOD-2023-729801, US-MODERNATX, INC.-MOD-2023-729810, US-MODERNATX, INC.-MOD-2023-729812, US-MODERNATX, INC.-MOD-2023-729815, US-MODERNATX, INC.-MOD-2023-729817, US-MODERNATX, INC.-MOD-2023-729818, US-MODERNATX, INC.-MOD-2023-729819, US-MODERNATX, INC.-MOD-2023-729820 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2023: Follow-up information received included updated dose description and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729795:Patient 18 Out of 20 US-MODERNATX, INC.-MOD-2023-729793:Patient 15 Out of 20 US-MODERNATX, INC.-MOD-2023-729799:(patient 13 out of 20) US-MODERNATX, INC.-MOD-2023-729818:Patient 14 out of 20 US-MODERNATX, INC.-MOD-2023-729796:(patient 7 out of 20) US-MODERNATX, INC.-MOD-2023-729820:Patient 20 out of 20 US-MODERNATX, INC.-MOD-2023-729800:(patient 16 out of 20) US-MODERNATX, INC.-MOD-2023-729817:Patient 11 out of 20 US-MODERNATX, INC.-MOD-2023-729791:OCCC (patient 1 out of 20) US-MODERNATX, INC.-MOD-2023-729812:Patient 5 out of 20 US-MODERNATX, INC.-MOD-2023-729794:(patient 4 out of 20) US-MODERNATX, INC.-MOD-2023-729810:Patient 2 out of 20 US-MODERNATX, INC.-MOD-2023-729815:Patient 8 out of 20 US-MODERNATX, INC.-MOD-2023-729801:(patient 19 out of 20) US-MODERNATX, INC.-MOD-2023-729797:(patient 10 out of 20) US-MODERNATX, INC.-MOD-2023-729819:Patient 17 out of 20