Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (inadvertently administer the vaccine 11 days after expiration date, vial was initially stored in the refrigerator on 27May2022 and administered on 31May2022) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis. No allergies (medications, food and other products), Unknown if patient ever had COVID positive test or diagnosis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Vaccines given within 1 month prior to Moderna COVID-19 vaccine: Flu Lot No : UJ745AA.) on 18-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (inadvertently administer the vaccine 11 days after expiration date, vial was initially stored in the refrigerator on 27May2022 and administered on 31May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (inadvertently administer the vaccine 11 days after expiration date, vial was initially stored in the refrigerator on 27May2022 and administered on 31May2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 01-Nov-2021, patient received first booster dose of Moderna vaccine. On 31-May-2022, patient received second booster dose of Moderna vaccine (batch no. 033K21-2A) after expiration date. It was reported that the vial was initially stored in the refrigerator on 27May2022 and vial  did not undergo any temperature excursions. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Unknown if patient experienced a similar event in the past. No treatment medications were reported.