Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Doses 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 (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021 at 10:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 10:36 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 27-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses 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 (Doses 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 (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses 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 73.63 during 27-Mar-2021 administration and 74.21 during 27-Oct-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 vials were 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), 29-Sep-2021 or 05-Oct-2021 (Lot: 035C21A) and moved to clinic on 27-Mar-2021 (Lot: 019B21A), 27-Oct-2021 (Lot: 035C21A). Vials were punctured right before administration. Vials best before use date were 22-Apr-2021 (Lot: 019B21A) and 29-Oct-2021 or 04-Nov-2021(Lot: 035C21A). Vials were undergone temperature excursion at 09:00 AM and 10:00 AM with 35 degree Fahrenheit both times (Lot: 019B21A) and 09:00 AM and 10:00AM with 29 and 32 degree Fahrenheit (Lot: 035C21A) respectively. After administration, the vials were returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).