Age: 62.0
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 29-SEP- 2022 and administered on 30-Oct-2022; No adverse event; bivalent vaccine were administered to patient after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccine were administered to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-SEP- 2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 62-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 Drug use for unknown indication: DTaP (Patient age group: Adult 55 years 1 month, Dose number: 1) on 01-Jun-2015, Influenza 11V3 (Influenza 11V3(Inject) 57 years 9 months,Dose number: 1) on 17-Jan-2018, influenza cciiv4 (influenza cciiv4 (Flucelvax Quad P-Free Inj) 58 years 8 months, Dose number: 2) on 06-Jan-2019, Shingrix (Zoster RZV) on 12-Jul-2019, influenza (INFLUENZAIIV4 (P- Free Inject), 59 years 5 months, Dose number: 3) on 20-Sep-2019, Shingrix (Zoster RZV) on 20-Sep-2019, INFLUENZA (INFLUENZAIIV4 (P- Free Inject), 60 years 4 months,Dose number: 4) on 29-Aug-2020, Pfizer (COVID-19 (PFR 30 mcg), 60years 10 months,Dose number: 1) on 01-Mar-2021, Pfizer (COVID-19 (PFR 30 mcg), 60years 11months,Dose number: 2) on 22-Mar-2021, Pfizer (COVID-19 (PFR 30 mcg), 61years 6 months,Dose number: 3) on 10-Oct-2021, Pfizer (COVID-19 (PFR-BNT 30 mcg/0.3 ml ), 62 years 4 months andDose number: 4) on 09-Aug-2022. Past adverse reactions to the above products included No adverse event with DTaP, INFLUENZA, Influenza 11V3, Pfizer, Pfizer, Pfizer, Pfizer, Shingrix, Shingrix, influenza and influenza cciiv4. Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 30-Oct-2022, the patient received fifth 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 (bivalent vaccine were administered to patient 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 29-SEP- 2022 and administered on 30-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccine were administered to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-SEP- 2022 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 (bivalent vaccine were administered to patient after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 29-SEP- 2022 and administered on 30-Oct-2022).    Patient age reported as 62 years 6 months at the time of Moderna bivalent vaccination.  It was reported patient age reported as 62 years 6 months at INFLUENZAIIV4 (P- Free Inject) Dose 5 vaccination.   No concomitant medications were reported.  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. Hepatitis B vaccine due date was 01-Apr-2022. The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown. The patient had any acute illness at the time of vaccination and up to 1 month before was unknown. The chronic or long-standing health conditions was unknown. It was reported prescription, over the counter medication, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event was unknown. It was reported 10(ten) Moderna Bivalent vaccines were administered to 10 patients the by use date. Reporter contacted Moderna to report the error. Moderna the did an analysis of the LOT. The vaccine maintained the activity necessary to protect against the virus at the time of administration. Since the vaccine was evaluated as valid, no adverse event occurred.  No treatment medications were reported.