Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Anxiety since 06-Jun-2018, Pure hypercholesterolemia since 01-Aug-2018, Penicillin allergy and Erectile dysfunction since 14-May-2021. Concomitant products included ALPRAZOLAM from 06-Jun-2018 to an unknown date for Anxiety, ROSUVASTATIN from 01-Aug-2018 to an unknown date for Pure hypercholesterolemia.   On 05-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Feb-2021 at 9:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). The patient was treated with TADALAFIL ongoing from 14-May-2021 for Erectile dysfunction, at an unspecified dose and frequency. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) to be not related.    Patient weight was reported as 180.6.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  It was reported that there were no other potential causes for the events and these events did not cause patient to seek medical care and patient had not experienced similar events in the past.   This case was linked to MOD-2022-503763 (Patient Link).