Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022error; The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022error) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 011F21A, 011M20A and 026L20A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Influenza (Dose no.1) in November 2021, Zoster (Dose no.1, Manufacturer: GSK, Lot number: D4CZ3, Route: IM, Body site: L Deltoid) on 20-Dec-2021, Zoster (Dose no.2, Manufacturer: GSK, Lot number: D4CZ3, Route: IM and Body site: L Deltoid) on 07-Mar-2022. Past adverse reactions to the above products included No adverse event with Influenza, Zoster and Zoster. Concurrent medical conditions included Iodine allergy (Povidone Iodine), Drug allergy (sulfamethoxazole/trimethoprim), Drug allergy (Terazosin), Drug allergy (Cimetidine), Drug allergy (Testosterone), Type 2 diabetes mellitus (No recent changes in condition status) since 26-Feb-2017, Hyperlipidemia (No recent changes in condition status) since 26-Feb-2017, B-cell lymphoma (No recent changes in condition status) since 24-May-2017, Klinefelter's syndrome (No recent changes in condition status) since 02-Apr-2019 and Hypogonadism (No recent changes in condition status) since 20-Jul-2016. Concomitant products included LORATADINE for Allergy, TESTOSTERONE for Hormone replacement therapy.   On 13-Jan-2021 at 11:51 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021 at 12:12 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Sep-2021 at 9:59 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022 at 11:57 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022 at 11:57 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-May-2022 and was administered on 21-Jun-2022error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 19-May-2022 and expiry was 18-Jun-2022 and was administered on 21-Jun-2022. The vial did not undergo any temperature excursions.  No adverse events have occurred.  It was unknown if the patient ever been diagnosed with or tested positive for COVID-19.  No acute illnesses at the time of vaccination and up to one month before.  No treatment information was provided.