Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23; No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line) and NO ADVERSE EVENT (No adverse event) in a 72-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 Hyperlipidemia.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line) 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 advised that her office administered vaccines that were reported being out of temperature on 2-24-23) and POOR QUALITY PRODUCT ADMINISTERED (No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Dosage text for suspect product was reported as unknown. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter