Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: No adverse event; Dose have been administered to patient after this excursion occurred.; Patient received Modena Bivalent vaccine in the primary series as second dose; 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.), WRONG PRODUCT ADMINISTERED (Patient received Modena Bivalent vaccine in the primary series as second dose) and NO ADVERSE EVENT (No adverse event) in a 70-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 (Lot: 027H21B First Dose) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 08-Aug-2023, the patient received second 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 08-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.) and WRONG PRODUCT ADMINISTERED (Patient received Modena Bivalent vaccine in the primary series as second dose). 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.), WRONG PRODUCT ADMINISTERED (Patient received Modena Bivalent vaccine in the primary series as second dose) 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), POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.) and WRONG PRODUCT ADMINISTERED (Patient received Modena Bivalent vaccine in the primary series as second dose).    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 2 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-736986, US-MODERNATX, INC.-MOD-2023-736988 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736986:Master, Patient 1 US-MODERNATX, INC.-MOD-2023-736988:Patient 3