Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Administered vaccine after being open for more than 24 hours; Patient has not reported any reactions; Administered vaccine after being open for more than 24 hours / The nurse has a question of the stability of the bivalent vial if it was opened for over 12 hours and a dose was given. The HCP confirmed it was an actual situation; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after being open for more than 24 hours / The nurse has a question of the stability of the bivalent vial if it was opened for over 12 hours and a dose was given. The HCP confirmed it was an actual situation), PRODUCT STORAGE ERROR (Administered vaccine after being open for more than 24 hours) and NO ADVERSE EVENT (Patient has not reported any reactions) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Tetanus vaccine in other arm 25Apr2023 (Tetanus vaccine in other arm) on 25-Apr-2023. Past adverse reactions to the above products included No adverse event with Tetanus vaccine in other arm 25Apr2023.    On 25-Apr-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 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after being open for more than 24 hours / The nurse has a question of the stability of the bivalent vial if it was opened for over 12 hours and a dose was given. The HCP confirmed it was an actual situation). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine after being open for more than 24 hours) and NO ADVERSE EVENT (Patient has not reported any reactions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after being open for more than 24 hours / The nurse has a question of the stability of the bivalent vial if it was opened for over 12 hours and a dose was given. The HCP confirmed it was an actual situation), PRODUCT STORAGE ERROR (Administered vaccine after being open for more than 24 hours) and NO ADVERSE EVENT (Patient has not reported any reactions) 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 (Patient has not reported any reactions) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered vaccine after being open for more than 24 hours / The nurse has a question of the stability of the bivalent vial if it was opened for over 12 hours and a dose was given. The HCP confirmed it was an actual situation) and PRODUCT STORAGE ERROR (Administered vaccine after being open for more than 24 hours).    Concomitant medications were not reported.  It was reported that bivalent vaccine was left open in fridge for more than 24 hours Dose was given 04/25/2023 and wasn't emptied completely and then administered next day 04/26/23 Administered vaccine after being open for more than 24 hours Dose was administered > 12 hours post puncture.  Lot number(s) was reported as 069H22A blue cap.  It was 1 individual vial. HCP was unsure about vial size but knows it was a multi dose vial.  Date the vial was initially stored in the refrigerator was 20Apr2023.  Date(s) and time(s) vial was first punctured was 24apr2023 at 2pm.  Date(s) and time(s) of administration of vaccine was 24Apr2023 2pm (same time it was opened), the following day on 25Apr2023 at 4pm.  The vial was stored post puncture in Fridge.  The vial had not undergone any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): vaccines were only out at room temperature to draw up dose and then put back into fridge. The vial was not exposed to room temperature for >24 hours. The nurse had a question of the stability of the bivalent vial if it was opened for over 12 hours and a dose was given. The HCP confirmed it was an actual situation.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2023: Live follow up received. Narrative was updated.