Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted; time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted), PRODUCT TEMPERATURE EXCURSION ISSUE (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted) 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)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    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 STORAGE ERROR (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted), PRODUCT TEMPERATURE EXCURSION ISSUE (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted), PRODUCT TEMPERATURE EXCURSION ISSUE (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted) 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 STORAGE ERROR (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted) and PRODUCT TEMPERATURE EXCURSION ISSUE (time frame at 36F to 46F varies but post the 30 day date/this is not the number of patients immunized but rather doses potentially impacted).    No concomitant medication information was reported. It was unknown the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that, the Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature -Lot number: 050C21A, 076C21A, AS7164B, 057F22A -Maximum or minimum temperatures reached, as applicable (specify whether temp is in C or F): they do not have these specifics -Excursion duration out of recommended storage range (Frozen -25°C to -15°C (-13°F to 5°F) or Liquid 2°C to 8°C (36°F to 46°F): time frame at 36F to 46F varies but post the 30 day date -Excursion from refrigerated state, date vials were initially stored in refrigeration (moved from freezer to refrigerator, or date of delivery receipt if vials were stored under refrigeration from date of delivery): varies 050C21A  5/20/21, 076C21A  9/15/21 and 9/29/21, AS7164B  9/21/22, 057F22A - 09/28/2022 -Interim disposition of vials: returned to the freezer/refrigerator, or maintained at room temperature: maintained at fridge temp -Visual inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): no changed noted -Proposed Use by Date (date of vaccination clinic, patient appointments, etc) varies 050C21A  Use by date 06/19/2021, 076C21A  use by date 10/15/21 and 10/29/21, AS7164B  use by date 10/21/22, 057F22A - use by date 10/28/2022 -Number of vials/doses impacted: 050C21A  700 doses, 076C21A  400 doses, AS7164B  200 doses, 057F22A  200 doses (Please note  this is not the number of patients immunized but rather doses potentially impacted) -Pertinent details: whether the vial(s) were punctured, any previous excursions with the impacted vial(s) No known previous excursion and not punctured. No treatment medication information was reported.