Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (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 (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes).    This case was created for the 6th patient of the 6 patients involved.  Concomitant medication was not provided. HCP stated that they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion on previous day morning for 15 minutes. She stated that some of the vials were used to administer the vaccine to patients on that day, 25SEP2023. There were potentially 6 patients impacted by that. None of the patients have reported any adverse reactions at that time.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Patient 6 out of 6