Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: No adverse event; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    This case contains information for the 1 of 6 patients described by the reporter.  No concomitant medication was reported.  Reporter stated that they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes in the morning on a day before reporting. She stated that some of the vials were used to administer the vaccine to patients on 25-Sep-2023. There were potentially 6 patients impacted by this. None of the patients have reported any adverse reactions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742046, US-MODERNATX, INC.-MOD-2023-742052, US-MODERNATX, INC.-MOD-2023-742061, US-MODERNATX, INC.-MOD-2023-742074, US-MODERNATX, INC.-MOD-2023-742075 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742046:Patient 2 out of 6 US-MODERNATX, INC.-MOD-2023-742052:Patient 3 out of 6 US-MODERNATX, INC.-MOD-2023-742061:Patient 4 out of 6 US-MODERNATX, INC.-MOD-2023-742075:Patient 6 out of 6 US-MODERNATX, INC.-MOD-2023-742074:Patient 5 out of 6