Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Moderna bivalent vaccine was administered after a temperture excursion; No adverse event; Moderna bivalent vaccine was administered as dose 1; Moderna bivalent vaccine was administered after a temperture excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion), WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1), POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Patient didn't had any known allergies.  Concurrent medical conditions included Hypertension.    On 04-Oct-2022 at 3:56 PM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Oct-2022 at 3:56 PM, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1) and POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion), WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1), POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture 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 (Moderna bivalent vaccine was administered after a temperture excursion), WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1) and POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion).    It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown. No concomitant medication was reported.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   No treatment information was provided.   This case was linked to PR-MODERNATX, INC.-MOD-2022-680467 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-680467:same reporter