Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine after a potential temperature excursion). Patient received 2nd booster dose. No concomitant medications were reported. Vaccine undergo two temperature excursion incidents. The vaccines were stored in a frozen condition. On 26-JUL-2022, the vaccine reached a maximum  temperature of 9.3 Fahrenheit before returning to the recommended freezer temperatures within a few minutes and on 29-JUL-2022 the same vial reached a maximum temperature of 33.2 Fahrenheit and were moved into the refrigerator. Excursion duration was few minutes on 26-Jul-2022 and unknown duration for 29-Jul-2022. Vial was moved to refrigerator on 29-Jul-2022. No visual changes on visual inspection appeared frozen for both. Proposed desired date for administration was afternoon (19-Jul-2022). Total 8 vials were impacted and 3 vials were administered unknown number of patients. Patient had no symptoms. No treatment information was provided. This case was linked to MOD-2022-630755 (Patient Link).