Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial had expired on 20-May-2022 and was initially stored in the refrigerator on 07-Jun-2022 that was administered on 08-Jun-2022; No adverse event; The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date), PRODUCT STORAGE ERROR (The vial had expired on 20-May-2022 and was initially stored in the refrigerator on 07-Jun-2022 that was administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown. Allergies to medication, food and other products were not applicable. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown. It was unknown if the patient had chronic or long-standing health conditions.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial had expired on 20-May-2022 and was initially stored in the refrigerator on 07-Jun-2022 that was administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date), PRODUCT STORAGE ERROR (The vial had expired on 20-May-2022 and was initially stored in the refrigerator on 07-Jun-2022 that was administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date) and PRODUCT STORAGE ERROR (The vial had expired on 20-May-2022 and was initially stored in the refrigerator on 07-Jun-2022 that was administered on 08-Jun-2022).    It was unknown if the patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event. No concomitant medication was reported. Moderna booster doses were given to 27 patients 19 days after expiration date of 20-May-2022. On 07-Jun-2022, the vial was initially stored in the refrigerator. The vial had not undergone any temperature excursions. It was unknown if an adverse event had caused the patient to seek medical care office visit, Urgent care, emergency room, hospitalized and unknown if the symptoms were improved or worsened. The patient had not experienced any adverse events.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-630785 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Follow up received contains significant information: Suspect vaccine details were added, and narrative updated. On 02-Sep-2022: Follow up received contains non-significant information: Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-630785:Same reporter