Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.; No adverse event; Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.), PRODUCT STORAGE ERROR (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055A22A, 012L20A and 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.), PRODUCT STORAGE ERROR (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.) 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 (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.) and PRODUCT STORAGE ERROR (Vial was initially thawed on 11-Aug-2022 and administered to the patient on 16-Sep-2022, beyond 30-use by date.).    No concomitant drug was reported.  The vial size was reported as 5.5 ml.  The vial initially moved from the freezer to the refrigerator on 11-Aug-2022.  It was reported that, the vial did not undergo any temperature excursions.  Patient did not experience any symptoms after receiving the dose.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654159, US-MODERNATX, INC.-MOD-2022-654164, US-MODERNATX, INC.-MOD-2022-654166, US-MODERNATX, INC.-MOD-2022-654157, US-MODERNATX, INC.-MOD-2022-654171 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654159:Patient 2 (same reporter) US-MODERNATX, INC.-MOD-2022-654164:Patient 3 (same reporter) US-MODERNATX, INC.-MOD-2022-654166:Patient 4 (same reporter) US-MODERNATX, INC.-MOD-2022-654157:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-654171:Patient 6 (same reporter)