이상반응 보고
| VAERS ID | 2298530 |
|---|---|
| 성별 | 여성 |
| 나이 | 65세 |
| 주 코드 | CO |
| 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
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
014M20A) for COVID-19 vaccination.
No Medical History information was reported.
On 02-Mar-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 02-Mar-2021 at 9:12 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion).
On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion).
At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) 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.
40 for dose administered on 02-Mar-2021.
No concomitant medications were reported.
Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27,29,32,33,35,36 Fahrenheit from 09:00 AM to 03:00 PM.
This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-MAR-2021.
Product moved to clinic on 02-MAR-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).