Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: HCP is calling for an excursion that happen on 22May2022 in the freezer.; No adverse event; HCP is calling for an excursion that happen on 22May2022 in the freezer.; Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     HCP stated she was unaware if any patient had any medical history or condition. The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In June 2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In June 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first 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 POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose).    Concomitant product use was not provided by the reporter.  The vials did not have a previous excursion. The maximum temperature reach was 12.84 Fahrenheit. The 1st lot number was AS7642B, which was administered to 6 patients in June. The 2nd lot number was 201L22A and had not been administered. The patients were 4 female and 2 male.  Treatment information was not provided.  This case contains information about patient 5th out of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732263 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732263:same report, male patient 1