Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 28-MAY-2022 and dose was administered in 29-MAY-2022 beyond MFG expiry date.; no adverse event; 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 28-MAY-2022 and dose was administered in 29-MAY-2022 beyond MFG expiry date.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 28-MAY-2022 and dose was administered in 29-MAY-2022 beyond MFG expiry date.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 28-MAY-2022 and dose was administered in 29-MAY-2022 beyond MFG expiry date.) 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 (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 28-MAY-2022 and dose was administered in 29-MAY-2022 beyond MFG expiry date.).    No concomitant medications were reported. 8 adult patients received monovalent vaccine Beyond manufacture Expiration Date. It was reported that expiry date of vaccine had not been extended. It was unbroken cartons. Vial size was reported as 5.5 mL. Vial was initially stored in the refrigerator 20-MAY-2022 and 28-MAY-2022. 4 adult patients received vaccine on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022. Vial did not undergo any temperature excursions. No treatment information was provided.  This case contains information for the 5 out of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679408, US-MODERNATX, INC.-MOD-2022-679413, US-MODERNATX, INC.-MOD-2022-679142, US-MODERNATX, INC.-MOD-2022-679409, US-MODERNATX, INC.-MOD-2022-679410, US-MODERNATX, INC.-MOD-2022-679414, US-MODERNATX, INC.-MOD-2022-679415 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679413:same reporter US-MODERNATX, INC.-MOD-2022-679408:same reporter US-MODERNATX, INC.-MOD-2022-679142:same reporter US-MODERNATX, INC.-MOD-2022-679409:same reporter US-MODERNATX, INC.-MOD-2022-679410:same reporter US-MODERNATX, INC.-MOD-2022-679414:same reporter US-MODERNATX, INC.-MOD-2022-679415:same reporter