Age: 75.0
Sex: M
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; administered an expired vaccine to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient), 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 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     Patient neither diagnosed with COVID-19 nor tested positive.  It was unknown whether patient had any acute illness at the time of vaccination and up to one month before, chronic or long standing health conditions and 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.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (at 7:43 AM,1st  dose, 0.3 milliliter, IM route on left arm, lot number EL9266) on 02-Mar-2021, COVID-19 VACCINE (at 10:34 AM 2nd dose, 0.3 milliliter, IM route on left arm, lot number EP7534) on 23-Mar-2021, COVID-19 VACCINE (at 08 :45 AM 3rd dose, 0.3 milliliter, IM route on left arm and lot number 32030BD) on 01-Nov-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 1:25 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 07-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient). 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 (administered an expired vaccine to patient), 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) to have an unknown relationship.    Concomitant products were not reported.  It was reported that event did not cause the patient to seek medical care. It was unknown whether there are any other potential causes for the event to occur and patient experienced any similar event in the past.  Date of the vial was initially stored in the refrigerator was reported as 21Jan2022. The used vial was stored in refrigerator on 07Jun2022.  The vial did not undergo any temperature excursions.  Treatment information was not reported.