Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial expired on 20-May-2022 was stored in refrigerator on 07-Jun-2022; No adverse event; Patient was provided vaccine after 19 days of the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after 19 days of the published expiry date), PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after 19 days of the published expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after 19 days of the published expiry date), PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was stored in refrigerator on 07-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 (Patient was provided vaccine after 19 days of the published expiry date) and PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was stored in refrigerator on 07-Jun-2022).    No concomitant medications were reported.   It was unknown if the adverse event caused patient to seek medical care (office visit, Urgent care, ER, hospitalized), or the patient experienced a similar event in the past and the symptoms improved or worsened.  It was reported that, the medical assistant thought that the expiration date was 20-Jun-2022 when looked this up before however there was nothing in writing or printed to confirm the same. The vial did not undergo temperature excursion. The patient did not experience any adverse events.  No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow-up received reporter city was updated. On 02-Sep-2022: Live follow-up received reporter city was updated, dosing details were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642501:Dose 2 (Inappropriate schedule of vaccine administered, No adverse event)