Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022; No adverse event; monovalent series 2nd dose was given 4 days past the products expiration date /Dose administered after 30-day Use By Date and Dose administered after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (monovalent series 2nd dose was given 4 days past the products expiration date /Dose administered after 30-day Use By Date and Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (monovalent series 2nd dose was given 4 days past the products expiration date /Dose administered after 30-day Use By Date and Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (monovalent series 2nd dose was given 4 days past the products expiration date /Dose administered after 30-day Use By Date and Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (monovalent series 2nd dose was given 4 days past the products expiration date /Dose administered after 30-day Use By Date and Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022).    No concomitant medications were reported.  It was reported Individual vials or unbroken cartons was 2 vials. It was reported Vial size 5.5 mL with 10-dose vials. The vial did not undergo any temperature excursions.  The pharmacist realized that the Moderna was stored in the fridge on 17-Aug-2022 and beyond use date was on 17-Sep-2022. The product was expired on 24-NOV-2022 and patient received vaccine on 28-Nov-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-694374 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Upon internal review on 05-Jan-2023, significant correction performed to update report type from  invalid case to spontaneous and details were updated as per valid case. On 01-Dec-2022: Follow-up received and Updated iNarrative supplement.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-694374:Case for patient who received dose on 14Nov2022