Sex: F
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 was calling for an excursion that happen on 22-May-2022 in the freezer. administered to 6 patients in June.; MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) vaccine received as first dose to an adult patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer), POOR QUALITY PRODUCT ADMINISTERED (HCP was calling for an excursion that happen on 22-May-2022 in the freezer. administered to 6 patients in June.), WRONG PRODUCT ADMINISTERED (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) vaccine received as first dose to an adult patient.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age 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 was calling for an excursion that happen on 22-May-2022 in the freezer. administered to 6 patients in June.) and WRONG PRODUCT ADMINISTERED (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) vaccine received as first dose to an adult patient.). 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, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer), POOR QUALITY PRODUCT ADMINISTERED (HCP was calling for an excursion that happen on 22-May-2022 in the freezer. administered to 6 patients in June.), WRONG PRODUCT ADMINISTERED (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) vaccine received as first dose to an adult 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)) (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 (HCP is calling for an excursion that happen on 22May2022 in the freezer), POOR QUALITY PRODUCT ADMINISTERED (HCP was calling for an excursion that happen on 22-May-2022 in the freezer. administered to 6 patients in June.) and WRONG PRODUCT ADMINISTERED (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) vaccine received as first dose to an adult patient.).    Patient was not breastfeeding or pregnant.  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 3rd out of 6 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732263:same report, female patient