Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; Patient had expired vaccine that was administered on March 15,2023/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 (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) 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 EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023/Dose administered after 30-day use by date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication use information was not provided by reporter.  HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 people on 15MAR2023.   There was potentially a second lot number that was expired and was administered to patients on 3MAR2023, but HCP did not have any details on this event at this time.  Dose administered after 30-day use by date or after manufacturer date of expiry.  Individual vials or intact cartons was unknown.  Vial size was reported as 10 dose vial.   Date the vial was initially stored in the refrigerator was reported as 14 March 2023.  The vial did not undergo any temperature excursions.  It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case