Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).; No adverse event; patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023), PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 057A22A and 074B22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 12-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023), PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).) 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 (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023) and PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 10FEB2023 2:47PM Pharmacist was called to report that patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023). Case was related to Excursion Case MI-0001322. First Primary monovalent dose on 12JAN2023 (Lot number 074B22A& Exp. Date:11MAR2023) and FLU shot.  Second Primary monovalent dose on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).   Dose administered after manufacturer date of expiry Product(s) Monovalent Lot number(s) Lot number 057A22A & Exp. Date: 06FEB2023  intact cartons were used. Vial size was reported as 5.5 ml. On 10-Feb-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported.