Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: We had a temperature excursion today 6/6/2022.; The patient was administered booster after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had a temperature excursion today 6/6/2022.) and POOR QUALITY PRODUCT ADMINISTERED (The patient was administered booster after excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 039A21A and 045A21A) for COVID-19 prophylaxis.     The patient had no known allergy and had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies had been taken by the patient at the time of vaccination and/or at the time of the adverse event.  The patient's past medical history included COVID-19.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022 at 10:49 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jun-2022 at 10:49 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient was administered booster after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had a temperature excursion today 6/6/2022.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had a temperature excursion today 6/6/2022.) and POOR QUALITY PRODUCT ADMINISTERED (The patient was administered booster after excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter mentioned that they had a temperature excursion today on 06-Jun-2022. The vaccine was thawed at the time of excursion. The Lowest reading was 35.6 for a total time of 30 minutes. The vaccines remained in travel cooler. No visible changes to vial were noted. At 11:18am vaccines were placed in refrigerator.  It was reported that there was no adverse reaction with the administration of this vaccine. On 06-Jun-2022 the reporter noticed that the datalogger from the travel cooler was out of range, and they tool the necessary actions to bring the cooler back within range. It took approximately 6 mins for the temperature to be regulated. The datalogger failed to alert the reporter of the excursion of approximately 36 minutes.   The patient was administered booster after excursion. The manufacturer was advised of the excursion and of the administration of the booster, The response from the manufacture was that the vaccine was not affected, therefore being a viable booster dose.  No Treatment medication was reported.