Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: It was reported that, the vials were expired on 13-May-2022 and were placed in refrigerator on 17-May-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 (It was reported that, the vials were expired on 13-May-2022 and were placed in refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 011F21A, 040B21A and 038A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high (No recent changes in condition status), Asthma (No recent changes in condition status) and Seafood allergy (crustaceans).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 12-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 2:19 PM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 2:19 PM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), 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 (It was reported that, the vials were expired on 13-May-2022 and were placed in refrigerator on 17-May-2022). At the time of the report, PRODUCT STORAGE ERROR (It was reported that, the vials were expired on 13-May-2022 and were placed in refrigerator on 17-May-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 (It was reported that, the vials were expired on 13-May-2022 and were placed in refrigerator on 17-May-2022).    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 was reported as unknown.  It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before was reported as unknown. The event did not cause the patient to seek medical care. There were no any other potential causes. It was unknown if the patient experienced a similar event in the past. It was reported that, the vials were expired on 13-May-2022 and were placed in refrigerator on 17-May-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided.   This case was linked to MOD-2022-586794 (Patient Link).