Age: 66.0
Sex: M
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 66-year-old male 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: Influenza (IIV 4, (Inject), 62 years 10 months) on 15-Oct-2018, Prevnar 13 (63 years 10 months) on 03-Oct-2019, Influenza (IIV 4, (P- Free Inject), 63 years 10 months) on 03-Oct-2019, DTaP on 15-Oct-2020, Influenza (IIV 4, (P- Free Inject), 64 years 10 months) on 15-Oct-2020, PFIZER BIONTECH COVID-19 VACCINE (65 years 3 months) on 02-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (65 years 3 months) on 24-Mar-2021, Fluad Quad (all V 4, (P- Free Inject), 65 years 10 months) on 29-Sep-2021 and PFIZER BIONTECH COVID-19 VACCINE (65 years 10 months) on 29-Sep-2021. Past adverse reactions to the above products included No adverse effect with DTaP, Fluad Quad, Influenza, Influenza, Influenza, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Prevnar 13. Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for an unknown indication.    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.        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 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, the patient received Moderna bivalent vaccine. The by-use-date on the product was 29Oct2022. LOT 027E22A The error was discovered on 31Oct2022.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2022: Follow up received included report type, dose details, patient information, other relevant history, concomitant medications and narrative was updated.