Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered  4 doses out of a 100 doses past the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (frozen storage / vials stored in freezer) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  4 doses out of a 100 doses past the 30 day use by date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (frozen storage / vials stored in freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered  4 doses out of a 100 doses past the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (frozen storage / vials stored in freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered  4 doses out of a 100 doses past the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and PRODUCT STORAGE ERROR (frozen storage / vials stored in freezer). No concomitant medication was reported. Patient did not have any allergies (medications, food and other products). The patient was never tested and diagnosed as COVID Positive. Patient did not have any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Reportedly, reporter had a temperature excursion from the day they received the vaccine on the 24-Jun-2022 until 24-Aug-2022, because their freezer was not acceptable according to the DOH, they did not know a what temperature the vials were because they did not have DDT. They had administer 4 doses out of a 100 doses. The vial was never stored in the refrigerator. Storage condition at the time of the excursion was frozen storage. One vial was punctured and discarded. No treatment information was provided.