Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 19-May-2022, expired on 18-Jun-2022 and administered on 21-Jun-2022; Vaccines were given to patients from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were given to patients from a vial that was expired) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 19-May-2022, expired on 18-Jun-2022 and administered on 21-Jun-2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 011F21A, 011M20A and 026L21A) for COVID-19 vaccination.     Patient have no known allergy.  Previously administered products included for Drug use for unknown indication: Influenza vaccine (Dose number in series-1  Route of administration-Intramuscular.) since October 2021. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Coronary artery disease since 21-Jan-2020, Atrial fibrillation since 21-Jan-2020, Chronic lymphoid leukemia since 26-Jan-2021, Hyperlipidemia since 21-Jan-2020, Hypertension since 21-Jan-2020 and Depression. Concomitant products included DIGOXIN from 21-Jan-2020 to an unknown date for Atrial fibrillation, ASPIRIN [ACETYLSALICYLIC ACID] from 21-Jan-2020 to an unknown date for Coronary artery disease, METOPROLOL TARTRATE from 21-Jan-2020 to an unknown date for Coronary artery disease and Atrial fibrillation, FLUOXETINE from 21-Jan-2020 to an unknown date for Depression, SIMVASTATIN from 21-Jan-2020 to an unknown date for Hyperlipidemia.   On 13-Jan-2021 at 2:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021 at 2:32 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Jun-2022 at 1:26 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were given to patients from a vial that was expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 19-May-2022, expired on 18-Jun-2022 and administered on 21-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were given to patients from a vial that was expired) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 19-May-2022, expired on 18-Jun-2022 and administered on 21-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received a booster dose on 21-Jun-2022, and vaccine had reached working expiration on 18-Jun-2022. Vial was initially stored in refrigerator on 19-May-2022, 30 day use by date was on 18-Jun-2022 and the vial hadn't undergone any temperature excursion issue.  No treatment medications were provided.   This case was linked to MOD-2022-595453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2022: Follow up received include patient demographics, medical history, dose details and concomitant medication were updated.