Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion; No adverse event; administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 77-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the 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 (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (administered doses 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 PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion).    Concomitant medications details were not reported by the reporter.  There were 2 incidents of potential temperature excursions. The vaccines were stored in a frozen condition. On 26-Jul-2022 for a few minutes, temperature dropped while other things were being (Unknown duration on 29-Jul-2022). The Vials were returned into refrigerators with some administrations. There was no visual changes, appeared frozen for both. Proposed desired date for administration was this afternoon. Total 8 vials were impacted and 3 vials were administered unknown number of patients.  No symptoms were reported.   Patient did not received any additional doses medications or treatments.   This case was linked to MOD-2022-631187 (Patient Link).