Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP stated 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 POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male 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.     No Medical History information was reported.    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 (HCP stated 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, POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes) 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 POOR QUALITY PRODUCT ADMINISTERED (Dose were administered after the excursion happened.) and PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Suspect product dosage text was reported as unknown.  It was reported that some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-AUG-2023 for 2 hours and 50 minutes. Maximum temperature reached was 21.4-degree Fahrenheit. This was the first and only excursion. It was reported that patient did not experience any adverse events according to health care professional.  No treatment medication was reported.  This case is reported for patient 9 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736913 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736913:Master case (Patient 1)