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 POOR QUALITY PRODUCT ADMINISTERED (Patient administered dose of the Moderna COVID-19 vaccine after a potential temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered dose of the 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 vaccination. No Medical History information was reported. In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered dose of the Moderna COVID-19 vaccine after a potential temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered dose of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered dose of the Moderna COVID-19 vaccine after a potential temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered dose of the 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 POOR QUALITY PRODUCT ADMINISTERED (Patient administered dose of the Moderna COVID-19 vaccine after a potential temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered dose of the Moderna COVID-19 vaccine after a potential temperature excursion). No concomitant medications were reported. It was reported that there were 2 incidents of potential temperature excursions. On 26-Jul-2022 the vaccine reached a maximum temperature of 9.3 degrees Fahrenheit before returning to the recommended freezer temperatures within a few minutes. On 29-Jul-2022 the same vials reached a maximum temperature of 33.2 degrees Fahrenheit and were moved into the refrigerator at that time. The vaccines were stored in a frozen condition at the time of the excursion. On 26-Jul-2022 for a few minutes, temperature dropped while other things were being (Unknown duration on 29-Jul-2022). Maximum or minimum temperatures reached, as applicable was reported as 9.3 degrees Fahrenheit, 33.2 degrees Fahrenheit. The vials were stored into refrigerator with some administrations. There were no visual changes, appeared frozen for both. Proposed desired use by date was reported as that afternoon. Total 8 vials were impacted and 3 vials were administered unknown number of patients. In November 2021, patient received first booster and on 05-Aug-2022, patient received second booster. No symptoms reported. Patient did not received any additional doses, medications or treatments.