Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: Vaccine expiry date on 24-Apr-2022, vial was initially stored in the refrigerator on 25-Apr-2022 and administration of vaccine date was 25-Apr-2022; Vaccine expiry date was on 24-Apr-2022 and administration of vaccine date was on 25-Apr-2022; 0.5mL of booster dose was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was on 24-Apr-2022 and administration of vaccine date was on 25-Apr-2022), ACCIDENTAL OVERDOSE (0.5mL of booster dose was administered) and PRODUCT STORAGE ERROR (Vaccine expiry date on 24-Apr-2022, vial was initially stored in the refrigerator on 25-Apr-2022 and administration of vaccine date was 25-Apr-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was on 24-Apr-2022 and administration of vaccine date was on 25-Apr-2022) and ACCIDENTAL OVERDOSE (0.5mL of booster dose was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expiry date on 24-Apr-2022, vial was initially stored in the refrigerator on 25-Apr-2022 and administration of vaccine date was 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was on 24-Apr-2022 and administration of vaccine date was on 25-Apr-2022), ACCIDENTAL OVERDOSE (0.5mL of booster dose was administered) and PRODUCT STORAGE ERROR (Vaccine expiry date on 24-Apr-2022, vial was initially stored in the refrigerator on 25-Apr-2022 and administration of vaccine date was 25-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was on 24-Apr-2022 and administration of vaccine date was on 25-Apr-2022) and ACCIDENTAL OVERDOSE (0.5mL of booster dose was administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine expiry date on 24-Apr-2022, vial was initially stored in the refrigerator on 25-Apr-2022 and administration of vaccine date was 25-Apr-2022).    Concomitant medication information was not provided by the reporter.  It was reported that the patient did not have any acute illness at the time of vaccination and up to one month before.  The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 25-Apr-2022. The event did not cause patient to seek medical care. The reporter did not report any other potential causes.   Treatment information was not provided by the reporter.