Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, No adverse event, Product storage error
Clinical narrative: Vial expired on 24-Apr-2022 was administered on 19-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry; patient received 2nd booster dose of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), EXTRA DOSE ADMINISTERED (patient received 2nd booster dose of expired vaccine), PRODUCT STORAGE ERROR (Vial expired on 24-Apr-2022 was administered on 19-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and EXTRA DOSE ADMINISTERED (patient received 2nd booster dose of expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 24-Apr-2022 was administered on 19-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), EXTRA DOSE ADMINISTERED (patient received 2nd booster dose of expired vaccine), PRODUCT STORAGE ERROR (Vial expired on 24-Apr-2022 was administered on 19-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator) 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 (Dose administered after manufacturer date of expiry), EXTRA DOSE ADMINISTERED (patient received 2nd booster dose of expired vaccine) and PRODUCT STORAGE ERROR (Vial expired on 24-Apr-2022 was administered on 19-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator).    No concomitant medications were reported.  Number of doses/vials were reported as 200 doses 20 vials. The vials were initially stored in the refrigerator on 05-May-2022, 06-May-2022,19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-Jun-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. The vial did not undergo any temperature excursions. Reporter found out because a couple were going on a cruise, and needed to verify their vaccine information and upon entering the lot, it showed the vaccine expired 24-Apr-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547: