Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 4:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 4:13 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.54 for dose administered on 30-MAR-2021 and 68.46 for dose administered on 2-MAR-2021 . Concomitant products were not provided.  Batch number 019B21A underwent temperature excursion on 30-MAR-2021 with temperature 33 degree Fahrenheit  at 9:00 AM, total doses given for the day was 173. This vial was moved to fridge on 23-MAR-2021 and product moved to clinic on 30-MAR-202. Beyond use date for the vial was reported as 22-APR-2021. 1. Number of vials sent was 3.  On 02-MAR-2021 with batch number 014M20A excursion time was reported at 09:00 am, 10 am, 11am, 12 am, 1 pm, 2pm and 3 PM with  temperature as 27, 29,32,33,35 and 36 degrees Fahrenheit, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021 , vial was moved to clinic on 02-MAR-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. Vial was stored on cooler 1, on 02-MAR-2021, Excursion duration At 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM : 35, 3 PM: 36, 4 PM: 37 and 5 PM:37.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion for 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).