Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022; Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 048F21A, 031M20A and 032220A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medications, food and other products. It was unknown if patient had ever been diagnosed with COVID-19.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 28-Oct-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 9:36 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 9:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022). At the time of the report, PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022).    It was unknown whether prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. Date the vial was initially stored in the refrigerator was reported as 21-Jan-2022. Number of doses/vials was reported as 5 vails. The vial did not undergo any temperature excursions. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown whether the patient had chronic or long-standing health conditions. The event did not cause the patient to seek medical care. There were no any other potential causes. It was unknown whether the patient experienced a similar event in the past. Treatment information was not reported.   This case was linked to MOD-2022-586794 (Patient Link).