Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.     On 04-Aug-2022 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Aug-2022 at 4:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided. The vaccination anatomical site was also reported as deltoid. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   The Nurse reported a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.  Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. On 08Sep2022, both product vials were moved from freezer to refrigerator.  It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Same reporter US-MODERNATX, INC.-MOD-2022-654537:Same reporter