Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered post the expiration or beyond use date; The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 031H21A, 044A21A and 011A21A) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food and other products.  It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before.  It was unknown if the patient had chronic or long-standing health conditions.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 08-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 8:50 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022). On 19-May-2022 at 8:50 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022).    No concomitant medications were reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies had been taken by the patient at the time of vaccination and/or at the time of the adverse event.  It was reported that the vaccines expired on 13-May-2022 were administered on 19-May-2022. the vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022.  It was also unknown if the patient had experienced a similar event in the past. Reportedly, the event didn't cause the patient to seek medical care. There were no other potential causes reported.  No treatment information was provided by the reporter.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:Manufacturer Control Numbers (MCN)