Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; Second dose 10-Feb-2022 and booster dose 06-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 10-Feb-2022 and booster dose 06-Jul-2022) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 068H21A and 066H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Methadone), Chronic pain since 13-Nov-2017, Hyperlipidemia since 05-Oct-2020, Hypertension since 17-Jan-2017, Anxiety disorder since 18-Oct-2021, Goiter since 21-Dec-2018 and Erectile dysfunction. Concomitant products included HYDROCODONE from 03-Mar-2022 to an unknown date and SULINDAC from 21-Sep-2020 to an unknown date for Chronic pain, SILDENAFIL from 19-Apr-2022 to an unknown date for Erectile dysfunction, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL SANDOZ) from 02-Jul-2018 to an unknown date for Hypertension, VITAMINS NOS (MULTIVITAMINUM) from 18-Nov-2005 to an unknown date for Supplementation therapy.   On 13-Jan-2022 at 8:16 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Feb-2022 at 9:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jul-2022 at 8:01 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 10-Feb-2022 and booster dose 06-Jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 10-Feb-2022 and booster dose 06-Jul-2022) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had never been diagnosed with/ tested positive for COVID 19.  Acute illness at the time of vaccination and up to one month before was reported as none. Patient received a booster dose of vaccine from a vial that had exceeded its 30 day working expiration. No adverse events noted at the time of reporting. Number of doses and vials were reported as 15 doses and 3 red cap vials.  Vial was initially stored in the refrigerator on 02-JUN-2022  The vial did not undergo any temperature excursions. Treatment details were not reported by the reporter.