Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022; Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-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 (vaccine expired on 13-may-2022 were administered on 08-june-2022)) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 034F21A, 031B21A and 036A21A) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food or other products. It was unknown if patient was diagnosed with/ tested positive for COVID-19.  It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before and if patient had chronic or long-standing health conditions.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 11-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 8:48 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 8:48 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date (vaccine expired on 13-may-2022 were administered on 08-june-2022)) and PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-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 (vaccine expired on 13-may-2022 were administered on 08-june-2022)) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial expired on 13-May-2022 and placed in refrigerator on 17-May-2022 and vaccine was administered on 8-Jun-2022).    No concomitant medication was reported by reporter. Event did not cause the patient to seek medical care. There was no other potential cause for the event.  No treatment medication was reported by reporter.