Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 17Jan2023 at 4:35PM and patient administered vaccine on 18Jan2023 at 9:32AM; No Adverse Event; patient received Expired Bivalent booster dose of Moderna COVID-19 vaccine on 18JAN2023 17 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Expired Bivalent booster dose of Moderna COVID-19 vaccine on 18JAN2023 17 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 17Jan2023 at 4:35PM and patient administered vaccine on 18Jan2023 at 9:32AM) and NO ADVERSE EVENT (No Adverse Event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023 at 9:32 AM, 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 18-Jan-2023 at 9:32 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Expired Bivalent booster dose of Moderna COVID-19 vaccine on 18JAN2023 17 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 17Jan2023 at 4:35PM and patient administered vaccine on 18Jan2023 at 9:32AM) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Expired Bivalent booster dose of Moderna COVID-19 vaccine on 18JAN2023 17 hours post puncture) had not resolved and PRODUCT STORAGE ERROR (The vial was first punctured on 17Jan2023 at 4:35PM and patient administered vaccine on 18Jan2023 at 9:32AM) 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 (patient received Expired Bivalent booster dose of Moderna COVID-19 vaccine on 18JAN2023 17 hours post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 17Jan2023 at 4:35PM and patient administered vaccine on 18Jan2023 at 9:32AM).    No concomitant medications was provided. Dosage text was reported as Additional booster for moderna covid-19 vaccine, bivalent. Patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 18Jan2023 17 hours post puncture. guidelines received on dose administered was greater than 12 US hours post puncture.  Patient received intact cartons. The vial size was 2.5 ml. the vial was initially stored in the refrigerator on 27Dec2022  vial was first punctured on 17Jan2023 at 4:35PM and administration of vaccine was on 18JAN2023 at 9:32AM. the vial was stored in the refrigerator post puncture. the vial did not undergo temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was unknown It was  unknown, the vial exposed to room temperature for greater than 24 hours. The vial was stored in the refrigerator for 17 hours post puncture, then administered to the patient.  No treatment medications was provided.