Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees; patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 017B21A and 030A21A) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees) to be not related.  It was unknown if the patient had concomitant medications taken at time of vaccination and or at the time of the adverse event. The vial was stored in the refrigerator since 07-Mar-2022 in temperatures between 2 to 8 degrees Celsius The vial did not undergo any temperature excursion. The event did not cause patient to seek medical care. The reporter did not report any other potential causes. It was unknown if the patient experienced a similar event in the past. No information on treatment medications was reported.   This case was linked to MOD-2022-539513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Significant follow-up information received: Case was upgraded to valid. Additional reporter, patient demographics, suspect details (1st, 2nd and 3rd vaccination details) were added. Event onset date, reporter causality for the events and i-narrative were updated.