Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022; No adverse event; Vaccine expired on 13-Aug-2022 and administered on 13-Sep-2022/Patient administered expired Moderna COVID-19 vaccine (Monovalent); Patient received second booster dose as 0.5 milliliter; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-Aug-2022 and administered on 13-Sep-2022/Patient administered expired Moderna COVID-19 vaccine (Monovalent)), EXTRA DOSE ADMINISTERED (Patient received second booster dose as 0.5 milliliter), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 1), COVID-19 vaccine (Unspecified COVID-19 vaccine, first booster dose), COVID-19 VACCINE (Unspecified COVID-19 vaccine Dose 3) and COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 13-Sep-2022 at 2:33 PM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Aug-2022 at 2:33 PM, the patient experienced EXTRA DOSE ADMINISTERED (Patient received second booster dose as 0.5 milliliter). On 13-Sep-2022 at 2:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-Aug-2022 and administered on 13-Sep-2022/Patient administered expired Moderna COVID-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-Aug-2022 and administered on 13-Sep-2022/Patient administered expired Moderna COVID-19 vaccine (Monovalent)), EXTRA DOSE ADMINISTERED (Patient received second booster dose as 0.5 milliliter), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022) 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 (Vaccine expired on 13-Aug-2022 and administered on 13-Sep-2022/Patient administered expired Moderna COVID-19 vaccine (Monovalent)), EXTRA DOSE ADMINISTERED (Patient received second booster dose as 0.5 milliliter) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022).    No concomitant medications were reported.  Vial size was reported as 5.5 ml. The vaccine was delivered and placed into the freezer on 18-Apr-2022 and the vial did not undergo any temperature excursion.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022 vial was placed into refrigerator on 12-Sep-2022.  No treatment information was reported.