Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Dose have been administered to patient after this excursion occurred.; Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023), POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1, Lot 025L20A) on 05-Jan-2021, Moderna COVID-19 vaccine (Dose 2  and lot 032L20A) on 29-Jan-2021; for Product used for unknown indication: Pfizer Bivalent vaccine (Dose 3) on 25-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Pfizer Bivalent vaccine.    On 10-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jul-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023). On 10-Aug-2023,  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 (Dose have been administered to patient after this excursion occurred.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023), POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.) 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)) (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 (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023) and POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.).    No concomitant medication was reported. It was reported that HCP stated that there were vials of the Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31-JUL-2023 and potentially 3 doses have been administered to patients after this excursion occurred. No adverse reactions were reported by patient. No treatment medication was reported. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736987, US-MODERNATX, INC.-MOD-2023-736988 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736987:Patient 2 US-MODERNATX, INC.-MOD-2023-736988:Patient 3