Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022. Initially stored in the refrigerator on 21-Jan-2022. The used vial was stored in refrigerator on 26-May-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. Initially stored in the refrigerator on 21-Jan-2022. The used vial was stored in refrigerator on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 011J20A, 004M20A and 058F21A) 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. The chronic or long standing health condition reported included HPB.  Concurrent medical conditions included Drug allergy (Septra allergy), Hypothyroidism and Diabetes. Concomitant products included SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL and METFORMIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 1:39 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-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. Initially stored in the refrigerator on 21-Jan-2022. The used vial was stored in refrigerator on 26-May-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. Initially stored in the refrigerator on 21-Jan-2022. The used vial was stored in refrigerator 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 (Administered an expired vaccine to patient) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022. Initially stored in the refrigerator on 21-Jan-2022. The used vial was stored in refrigerator on 26-May-2022) to have an unknown relationship.    The event does not cause the patient to seek medical care. It was unknown whether there are any other potential causes for the event to occur and was unknown that patient experienced any similar event in the past.   Date of the vial was initially stored in the refrigerator was reported as 21-Jan-2022. The used vial was stored in refrigerator on 26-May-2022. The vial did not undergo any temperature excursions.  It was reported that they thought the vial would expire on the 13 Jul 2022 but it was expired on the 13 May 2022, and they realize this on the 08 Jun 2022.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-586783 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-586783:Master case (26 May 2022)