Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: HCP stated a dose affected by a temperature excursion (46°F for 2 days) was given to a patient Moderna COVID19 vaccine bivalent is involved 1 Patient received a bivalent dose affected by a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated a dose affected by a temperature excursion (46°F for 2 days) was given to a patient Moderna COVID19 vaccine bivalent is involved 1 Patient received a bivalent dose affected by a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received fifth 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 stated a dose affected by a temperature excursion (46°F for 2 days) was given to a patient Moderna COVID19 vaccine bivalent is involved 1 Patient received a bivalent dose affected by a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated a dose affected by a temperature excursion (46°F for 2 days) was given to a patient Moderna COVID19 vaccine bivalent is involved 1 Patient received a bivalent dose affected by a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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 stated a dose affected by a temperature excursion (46°F for 2 days) was given to a patient Moderna COVID19 vaccine bivalent is involved 1 Patient received a bivalent dose affected by a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medications were not reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated a dose affected by a temperature excursion (46?F for 2 days) was given to a patient Moderna COVID19 vaccine bivalent was involved 1 Patient received a bivalent dose affected by a temperature excursion lot #042h22a as a fifth dose.   On 23-Dec-2022, the vials was initially stored in the fridge. Storage condition at the time of the excursion was refrigerated storage.  The vial was reported as Individual vials and size was reported as 5.5ml.   Maximum or minimum temperatures reached was reported as  max 52?F // min 48.4?F. Excursion duration was reported as above of 46?F for 2 days and 20 hours.   The vial(s) moved from freezer to refrigerator was reported as 23Dec2022. The vaccine was discarded now.  There were no visual inspection noting in any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all).   Treatment information was not provided.