Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023; Product storage error; No adverse event; initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion) 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. 022h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Refrigerator was out of range for 13-15 min multiple times. Product affected was the bivalent Moderna COVID-19 vaccine. No treatment information was reported. This case belongs to 2 of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-705052 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705052:Master