Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; dose was administered to a patient on 27FEB2023 after the 17FEB2023 excursion; a dose from lot number AS7167B (Expiration date: 7JUN2023) was administered to a patient on 27FEB2023 after the 17FEB2023 excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (a dose from lot number AS7167B (Expiration date: 7JUN2023) was administered to a patient on 27FEB2023 after the 17FEB2023 excursion), POOR QUALITY PRODUCT ADMINISTERED (dose was administered to a patient on 27FEB2023 after the 17FEB2023 excursion) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, 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 17-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (a dose from lot number AS7167B (Expiration date: 7JUN2023) was administered to a patient on 27FEB2023 after the 17FEB2023 excursion). On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose was administered to a patient on 27FEB2023 after the 17FEB2023 excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (a dose from lot number AS7167B (Expiration date: 7JUN2023) was administered to a patient on 27FEB2023 after the 17FEB2023 excursion), POOR QUALITY PRODUCT ADMINISTERED (dose was administered to a patient on 27FEB2023 after the 17FEB2023 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)) (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 (a dose from lot number AS7167B (Expiration date: 7JUN2023) was administered to a patient on 27FEB2023 after the 17FEB2023 excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose was administered to a patient on 27FEB2023 after the 17FEB2023 excursion).    No concomitant medication were reported. Dosage text was reported as unknown. HCP stated that Moderna COVID-19 bivalent lot numbers AS7167B and 021H22A experienced 3 excursions, on 15-FEB-2023, 17-FEB-2023, and 28-FEB-2023. For the first excursion on 15-FEB-2023, the excursion tool was used by HCP and the recommendation was to place the vaccine back in the freezer and use until expiry. The 17-FEB-2023 excursion was missed and HCP tried to use the online excursion tool after the 28-FEB-2023 and was told to call Moderna Medical Information. He stated that a dose from lot number AS7167B was administered to a patient after the 17-FEB-2023 excursion. The patient has not reported any adverse reactions at this time. No treatment information was provided by the reporter.