Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius; no adverse event; Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, 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. In October 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) 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 (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius).    No concomitant medications were reported.  It was reported that the excursion occurred in the refrigerator on 03-Oct-2022 involved 1 unpunctured Red cap vial and 3 unpunctured Bivalent booster vials. Temperature was reported as Min 1.76 Celsius and Max 1.97 Celsius. They no longer had stored the vials, some were used and some were discarded. Excursion duration was reported as 1 Hour & 40 Minutes. It was the first time those vials experienced excursion. Since the excursion date total 11 Adult patients received booster doses from the Bivalent vials on 03-Oct-2022 and 05-Oct-2022 and 3 patients had received Monovalent primary doses from the red cap vial on 19-Oct-2022.  No treatment details were reported.