Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:26 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 73.19 during 28-Mar-2021 administration and 73.11 during 28-Feb-2021 administration.  No concomitant medication was reported by reporter.  Vials were in cooler storage and were not in frozen storage during high-pace COVID-19 vaccination at around 2021.  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. Temperature recordings were taken using a  traceable temperature monitor at every hour. Vials were moved to fridge on 23-Mar-2021 (Lot: 019B21A), 24-Feb-2021 (Lot: 014M20A) and moved to clinic on 27-Mar-2021 (Lot: 019B21A), 27-Feb-2021 (Lot: 014M20A). Vials were punctured right before administration. Vials best before use date were 22-Apr-2021 (Lot: 019B21A) and 26-Mar-2021 (Lot: 014M20A). Vials were undergone temperature excursion on 10:00 AM with 35 degree Fahrenheit (Lot: 019B21A) and 09:00 AM & 13:00 PM with 27 and 26 degree Fahrenheit (Lot: 014M20A). After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.