Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes; Dose were administered after the excursion happened.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) and NO ADVERSE EVENT (No adverse event) in a 12-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were reported as unknown. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In August 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 04-Aug-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes). In August 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) 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 (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No pqc was reported. HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 during 2 hours and 50 minutes. Maximum temperature reached was 21.4°F. This was the first and only excursion. It was reported that patient did not  experienced any adverse events according to HCP. No treatment medication was reported.  This case was reported for patient 10th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736913 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736913:master case