Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022; No adverse event; 10 doses of the bivalent vaccine were administered to patients after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 doses of the bivalent vaccine were administered to patients after the 30 day beyond use date), PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: TDAP (adol/adult 58 yrs 5 months, Dose 1) on 26-Oct-2007, Prevnar 13 (PCV 13, 65 yrs 9 months, Dose 1) on 02-Mar-2015, PREVNAR 13 (PCV 13, 66 yrs 9 months, Dose 2) on 07-Mar-2016, TDAP (adol/adult 67 yrs, Dose 2) on 11-Jun-2016, INFLUENZA (IIV3, High dose, 68 yrs 4 months, Dose 1) on 03-Oct-2017, INFLUENZA (IIV3, High dose, 69 years 4 months, Dose 2) on 01-Oct-2018, PPSV23 (PPSV23, 66 yrs 11 months) on 02-May-2019, INFLUENZA (IIV3, High dose, 70 yrs 4 months, Dose 3) on 07-Oct-2019, FluZone HD Quad (IIV4, High dose, 71 yrs 3 months, Dose 4) on 10-Sep-2020, FLUZONE HIGH DOSE QUADRIVALENT (IIV4, High dose, 72 yrs 4 months, Dose 5) on 05-Oct-2021, FLUZONE HIGH DOSE QUADRIVALENT (IIV4, High dose, 73 yrs 3 months and Dose 6) on 14-Sep-2022. Past adverse reactions to the above products included No adverse event with FLUZONE HIGH DOSE QUADRIVALENT, FLUZONE HIGH DOSE QUADRIVALENT, FluZone HD Quad, INFLUENZA, INFLUENZA, INFLUENZA, PPSV23, PREVNAR 13, Prevnar 13, TDAP and TDAP.   On 30-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 30-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 doses of the bivalent vaccine were administered to patients after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 doses of the bivalent vaccine were administered to patients after the 30 day beyond use date), PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (10 doses of the bivalent vaccine were administered to patients after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29SEP2022 and administered on 30-Oct-2022).    The patient had received three doses of the Moderna vaccine: the first on 16-Jan-2021, second on 13-Feb-2021, third on 10-Nov-2021, all of which were 100 mcg.  The patient had received a Moderna Bivalent booster when she was 73 years and 5 months old.   The size of the vial was 2.5ml.  The vial was initially stored in refrigerator on 29-Sep-2022.  The vial did not undergo any temperature excursions.  It was reported that patients had no reported symptoms, no additional doses, medications, or treatments.  On 30-Oct-2022, 10 (ten) Moderna Bivalent vaccines were administered to 10 patients. The by-use-date on the product was 29-Oct-2022. Lot 027E22A The error was discovered on 31-Oct-2022.  It was unknown if patient had been diagnosed with or tested positive for COVID-19.  No treatment medications were reported.