Age: 72.0
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 26-May-2022; No adverse event; Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     The patient had never been diagnosed with or tested positive for COVID-19.  It was unknown if the patient had any acute illness at the time of vaccination or chronic or long-standing health conditions.  Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose: 1, time: 11:43 AM, lot number: EL9266, route: intramuscular, body site: left arm, volume: 0.3 ML) on 02-Mar-2021, COVID-19 Vaccine (Dose: 2, time: 10:06 AM, lot number: EP7534, route: intramuscular, body site: left arm, volume: 0.3 ML) on 23-Mar-2021, COVID-19 Vaccine (Dose: 3, lot number: FH8020, route: intramuscular, body site: left arm and volume: 0.3 ML) on 14-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 26-May-2022 at 8:44 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-May-2022 at 8:44 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-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 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-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 (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) 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 26-May-2022).    It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination or at the time of the adverse event.  The vaccines were administered on 26-May-2022 after their expiration date set for 13-May-2022. The used vials were placed in the refrigerator on 26-May-2022, the same day of administration.  The vial was initially stored in the refrigerator on 21-Jan-2022. Total 5 vials were affected. Reportedly, the vial did not undergo any temperature excursions.  The event did not cause the patient to seek medical care. It was unknown whether the patient had experienced a similar event in the past. It was unknown if any other potential causes were there.  No treatment information was provided by the reporter.