Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses of Moderna  bivalent vaccine  have undergone several temperature excursions and may have been administered to patient; No adverse event; Patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine  have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 11:16 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 22-Sep-2022 at 11:16 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine  have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine  have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine  have undergone several temperature excursions and may have been administered to patient).    Concomitant product use was not provided by the reporter. It has been identified that there were two unbroken cartons out of 20 vials. The vial size was 2.5 ml to 5.5 ml. It was unknown if the patient had ever tested or been diagnosed with COVID-19. The patient received previous three dose of vaccine intramuscular in deltoid. Anatomical location of bivalent vaccine was reported as deltoid. Vilas were moved from moved from freezer to refrigerator on 07-Sep-2022. There were two different lot numbers which went through temperature excursions. It was reported that the vaccines had undergone several temperature excursions in August 2022. Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any patient at the time of report. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Master Case (Monovalent) US-MODERNATX, INC.-MOD-2022-654537:Master Case (Bivalent)