이상반응 보고
| VAERS ID | 2298448 |
|---|---|
| 성별 | 남성 |
| 나이 | 65세 |
| 주 코드 | |
| 제약회사 | MODERNA |
| 로트 번호 | 014M20A |
| 예방접종 횟수 | |
| 접종일 | 2021-03-02 |
| 발병일 | 2021-03-02 |
| 상태 |
증상
- 품질이 좋지 않은 제품이 관리됨(Poor quality product administered)
- 제품 온도 편차 문제(Product temperature excursion issue)
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증상 상세
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 65-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 02-Mar-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 30-Mar-2021 at 9:38 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .
5 milliliter.
On 02-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, 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.
Age of patient was reported as 65.
89 for dose administered on 02-Mar-2021 and 65.
97 for dose administered on 30-Mar-2021.
No concomitant medications were reported.
Vial was moved to fridge on 24-Feb-2021.
Product moved to clinic on 02-Mar-2021.
Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit from 09:00 AM to 10:00 AM.
Beyond use date for the vial was reported as 26-Mar-2021.
Vial was moved to fridge on 23-Mar-2021.
Product moved to clinic on 30-Mar-2021.
Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit from 09:00 AM to 10:00 AM.
Beyond use date for the vial was reported as 22-Apr-2021.
Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.
Vials were only punctured right before administration.
Vaccines were not frozen at time of administration.
It was reported that each time a vial was put into a cooler, sometimes there was a period 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.
No treatment medications were reported.
This case was linked to MOD-2022-566976 (Patient Link).