Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022; No adverse event; Expired dose was given after the 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022), EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     It was unknown if the patient ever had been diagnosed with or tested positive for COVID-19. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.    On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022), EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days) 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 EXPIRED PRODUCT ADMINISTERED (Expired dose was given after the 30 days) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Oct-2022 and was administered on 07-Nov-2022).    Prescriptions, over-the-counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event was reported as unknown.  On 26-Feb-2021, patient received dose 1 (0.5mL), batch no.- 010A21A.  On 26-Mar-2021, patient received dose 2 (0.5mL), batch no.- 016B21A.  On 18-Nov-2021, patient received dose 3 (0.25mL), batch no.- 076C21A on left arm.  On 09-May-2022, patient received dose 4 (0.25mL), batch no.- 056M21A on left arm.  On 07-Nov-2022, patient was administered a Bivalent Moderna vaccine from a vial of size 2.5mL with a fridge BUD of 05-Nov-2022 (removed from freezer and put in fridge on 06-Oct-2022). The vaccine was punctured and used.  The vial was in fridge for 32 days.  Patient had reported no issues and was just waiting to hear back about re-vaccinating.  The vial was individual vial and had not undergone any temperature excursions.