Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023; Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Breast cancer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023) 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 (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Her office administered vaccines that were reported being out of temperature on 24-Feb-2023. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. Up to 14 vaccinations were administered within this time line.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter (Master case)