Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; Dose administered past manufactures expiration date/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/Dose administered after 30-day use by date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-May-2022 at 2:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/Dose administered after 30-day use by date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/Dose administered after 30-day use by date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/Dose administered after 30-day use by date or after manufacturer date of expiry) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    No concomitant drug was reported.  The vial was pulled from freezer at 3-May-2022 10:00 and was put in refrigerator until approximately 13:45. All 12 doses were administered between 2-3 PM on 3-May-2022. The vial did not undergo temperature excursion.  No treatment drug was reported.  Adverse event did not cause the patient to seek medical care. It was reported that there was no other potential cause of the event expired vaccine administration.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Case validity, patient demographics, race and ethnicity, suspect dose details and previous dose detail added. causality updated