Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was stored in refrigerator on 07-Jun-2022 and was administered on 08-Jun-2022; No adverse event; Patient received vaccine that was expired and past the Manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 07-Jun-2022 and was administered on 08-Jun-2022), EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was expired and past the Manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received third 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 received vaccine that was expired and past the Manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 07-Jun-2022 and was administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 07-Jun-2022 and was administered on 08-Jun-2022), EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was expired and past the Manufacturers expiration date) 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 PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 07-Jun-2022 and was administered on 08-Jun-2022) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was expired and past the Manufacturers expiration date).    No concomitant medications were reported.  Vaccine was initially stored in refrigerator on 07-Jun-2022.  The vial did not undergone any temperature excursion issue.  The reporter thought that previously, the reporter saw that the expiration date of the vial was 20-Jun-2022 when the reporter looked up to it but however, the reporter had nothing in writing or printed to confirm the expiration date of 20-Jun-2022 for the vial.  On 08-Jun-2022, the patient received booster dose of Moderna COVID-19 vaccine.  No adverse events were reported by the reporter.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow up received contains updated suspect product dose details (added dose regimens) and an updated narrative On 02-Sep-2022: Follow up received included no new information.