Age: 41.0
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 07-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 059M21A and 069H21A) for COVID-19 prophylaxis.     The patient's past medical history included Erectile dysfunction (No recent changes in condition status) on 10-Sep-2021. Concurrent medical conditions included Multiple sclerosis (No recent changes in condition status) since 22-Dec-2020, Chronic pain (Chronic pain/opioid dependence,No recent changes in condition status) since 07-Sep-2017, GERD (No recent changes in condition status) since 16-Apr-2016 and Hyperlipidemia (No recent changes in condition status) since 07-Dec-2015. Concomitant products included BUPRENORPHINE from 17-May-2022 to an unknown date for Chronic pain, FAMOTIDINE from 10-Feb-2021 to an unknown date for GERD, ATORVASTATIN from 07-Jan-2022 to an unknown date and GEMFIBROZIL from 10-Sep-2021 to an unknown date for Hyperlipidemia, GLATIRAMER ACETATE from 10-Sep-2021 to an unknown date for Multiple sclerosis.   On 04-Jan-2022 at 9:34 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 07-Jul-2022 at 9:11 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 07-Jul-2022 at 9:11 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on 04-Jan-2022 and booster dose on 07-Jul-2022), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Acute illness at the time of vaccination and up to one month before was reported as none.  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.