Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: had a temperature excursion; no adverse event; administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion) and NO ADVERSE EVENT (no adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient was never had COVID positive test or diagnosis. The patient did not receive any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-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 POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion).    No concomitant medications were reported.   It was reported that, there was 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. There were no changes in visual inspection noting any vaccine state change. It was also reported that one vial was punctured and discarded.  Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).   No treatment details were reported.