Age: 79.0
Sex: F
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 79-year-old female 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 27-Feb-2021 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:31 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion 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.   The age of patient was provided as 79.28 on 27-Feb-2021 and 79.36 on 27-Mar-2021.  No concomitant medications were reported.  On 27-Feb-2021 with batch number 014M20A, excursion time was 9 AM temperature was 33, 11 AM, temperature was 35, 12 PM, temperature was 35, 1 PM, temperature was 35, 2 PM temperature was 35, 3 PM temperature was 34, 4 PM temperature was 34 and 5PM temperature was 35. Total doses given for the day was 199, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. 20 vials were sent to clinic on 27-Feb-2021.  On 27-Mar-2021 with batch number 019B21A, at excursion time 9 AM and 10 AM, temperature was 35. Total doses given for the day was 195, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. 20 vials were sent to clinic on 27-Mar-2021.  Vial which was stored on cooler 1 on 27-Feb-2021 with excursion duration at 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 PM: 35, 1PM: 35, 2 PM : 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  Vial which was stored on cooler 1 on 27-Mar-2021 with excursion duration at 8 AM: 48, 9 AM: 35, 10 AM: 35, 11 AM: 38, 12 PM: 43, 1 PM: 41, 2 PM: 41, 3 PM: 41 and 4 PM: 40.   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.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 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.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).