Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was removed from the refrigerator and administered on 07-May-2022 at 11:30 AM, expired on 25-Mar-2022; No adverse event; Vaccine was Expired at the time of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was Expired at the time of administration), PRODUCT STORAGE ERROR (The vial was removed from the refrigerator and administered on 07-May-2022 at 11:30 AM, expired on 25-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022 at 2:25 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was Expired at the time of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was removed from the refrigerator and administered on 07-May-2022 at 11:30 AM, expired on 25-Mar-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was Expired at the time of administration), PRODUCT STORAGE ERROR (The vial was removed from the refrigerator and administered on 07-May-2022 at 11:30 AM, expired on 25-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was Expired at the time of administration) and PRODUCT STORAGE ERROR (The vial was removed from the refrigerator and administered on 07-May-2022 at 11:30 AM, expired on 25-Mar-2022).    No concomitant products were reported. Patient race information reported.  Patient was vaccinated at a Large vaccine Clinic. No known allergies were reported. It was unknown whether the patient had ever been diagnosed with/ tested positive for COVID-19. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. There was no information about 3rd dose of COVID-19 vaccination and it was reported as not received. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses were administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters. The patient did not had any adverse effects with the vaccine. The vial was removed from the refrigerator on 07-May-2022 at 11:30 AM. There were no temperature excursion events for this vaccine. No treatment products were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714990 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714990:Master Doc