Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022; No adverse Event; Vaccine was expired on 20-May-2022 and was administered to patient on 08-Jun-2022, 19 days afetr expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 20-May-2022 and was administered to patient on 08-Jun-2022, 19 days afetr expiration) and NO ADVERSE EVENT (No adverse Event) in a 67-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 patient was diagnosed or tested positive for COVID-19.  It was unknown if patient was  diagnosed acute illness at the time of vaccination and or up to one month before.  It was unknown if patient was having chronic or long standing health condition.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-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 (Vaccine was expired on 20-May-2022 and was administered to patient on 08-Jun-2022, 19 days afetr expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 20-May-2022 and was administered to patient on 08-Jun-2022, 19 days afetr expiration) 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 (Vaccine was expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 20-May-2022 and was administered to patient on 08-Jun-2022, 19 days afetr expiration).    No concomitant medications were reported.  Vaccine was initially stored in refrigerator on 07-Jun-2022.  The vial did not undergo any temperature excursion issue.  The reporter thought that previously 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. It was unknown if the event cause patient to seek medical care. It was unknown if the patient had experienced a similar event in the past.  No treatment medication was reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow up received contains suspect product dose details added and I narrative was updated. On 02-Sep-2022: Follow up received included no new information.