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; initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023; No adverse event; 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 Dates of administration 05Jan2023) 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 an unknown date, 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 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), POOR QUALITY PRODUCT ADMINISTERED (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023) 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 Dates of administration 05Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 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 Dates of administration 05Jan2023).    No concomitant and treatment were provided   This case was linked to US-MODERNATX, INC.-MOD-2023-705052 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705052:Master