Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 003K21-2A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE (at 8.08 AM,1st  dose, 0.3 milliliter, IM route on right  arm, lot number EL9266) on 02-Mar-2021, COVID-19 VACCINE (at 10.41 AM,2nd dose, 0.3 milliliter, IM route on right  arm, lot number EP7534) on 23-Mar-2021, COVID-19 VACCINE (at 03.03 PM 3rd dose, 0.3 milliliter, IM route on left arm and lot number 32030BD) on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 07-Jun-2022 at 1:20 PM, the patient received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .25 milliliter. On 07-Jun-2022 at 1:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). 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 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. 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 07-Jun-2022).    No concomitant medications were reported. Patient had never been diagnosed with or  tested positive for COVID-19. It is unknown that patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if patient had any Chronic or long-standing health conditions It was unknown if patient had taken any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and or at the time of the adverse event: The event did not cause the patient to seek medical care. It was unknown that the adverse event most likely caused by mRNA-1273. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The used vials were placed in the refrigerator on the same day of administration 07-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.