Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after more than 1 temperature excursion; Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 72.67 No concomitant medications were reported. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 36 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. Temperature excurtion time was reported as 9A, Temperature as 34. Vial was stored on cooler 1 , on 27-FEB-2021, Excursion duration At 8AM: 38 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5PM: 41  No treatment information was provided.