Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 Unpunctured Bivalent Blue Cap vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 10-Jul-2023 through 15-Jul-2023. 4 Adult patients received doses from 3 affected vials.; No adverse event; Patient received doses from 3 affected vials.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 Unpunctured Bivalent Blue Cap vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 10-Jul-2023 through 15-Jul-2023. 4 Adult patients received doses from 3 affected vials.), POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from 3 affected vials.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In July 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from 3 affected vials.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 Unpunctured Bivalent Blue Cap vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 10-Jul-2023 through 15-Jul-2023. 4 Adult patients received doses from 3 affected vials.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 Unpunctured Bivalent Blue Cap vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 10-Jul-2023 through 15-Jul-2023. 4 Adult patients received doses from 3 affected vials.), POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from 3 affected vials.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 Unpunctured Bivalent Blue Cap vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 10-Jul-2023 through 15-Jul-2023. 4 Adult patients received doses from 3 affected vials.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received doses from 3 affected vials.).    Concomitant product use was not provided by the reporter.  It was reported that Data logger was not working and have no data. Checked temperature twice a day and according to manual temperature log twice daily the temperature was within range (36 degree to 46 degree Fahrenheit). The manual reading was being done. 5 days vials moved from freezer to refrigerator. Refrigerated storage in intact Carton and vial size was 2.5 ml. As of 23-Jun-2023, it was reported that vials were stored in room Temperature and would be discarded today because before use date (BUD) Visual inspection noting any vaccine state change. Suspect vaccine dosage text was reported as unknown. Suspect vaccine expiry date was reported as 14-Oct-2023.  Treatment information was not provided.  This case contains information about patient 2nd out of 4 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734501 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734501:Master case