이상반응 보고
| VAERS ID | 2247221 |
|---|---|
| 성별 | 남성 |
| 나이 | 62세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 3004737 |
| 예방접종 횟수 | 3 |
| 접종일 | 2021-12-07 |
| 발병일 | 2021-12-10 |
| 상태 |
증상
- 이명(Tinnitus)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
이환 중 질병
지병
Medical History/Concurrent Conditions: Suspected COVID-19
기타 의료
INFLUENZA VIRUS
이전 예방접종
알레르기
임상 검사
Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
증상 상세
Tinnitus; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 26838805) on 20-Apr-2022 and was forwarded to Moderna on 20-Apr-2022.
This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 62-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
3004737) for COVID-19 vaccination.
The patient's past medical history included Suspected COVID-19 from 17-Mar-2020 to 22-Mar-2020.
Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication.
On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 10-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant).
At the time of the report, TINNITUS (Tinnitus) had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Patient was developed bilateral tinnitus about 3 days post booster vaccine for Covid-19.
Booster was Moderna, previous two doses were Astra-Zeneca vaccines.
Patient had not tested positive for COVID-19 since having the vaccine.
COMPANY COMMENT: This is a regulatory authority case concerning a 62 -years-old male patient with clinical history of Suspected COVID-19 who experienced the unexpected event of TINNITUS3 days after the 3rd dose of mRNA-1273 vaccine.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Terms and onset were captured as provided.
The case was assessed as serious by the Regulatory Authority´s report due to a Regulatory Authority Patient was not enrolled in clinical trial.
Reporter reported patient awaiting hospital appointment but informed this was 2.
5 years.
The report was not related to possible myocarditis or pericarditis.
No treatment medications provided by the reporter.
; Sender's Comments: COMPANY COMMENT: This is a regulatory authority case concerning a 62 -years-old male patient with clinical history of Suspected COVID-19 who experienced the unexpected event of TINNITUS3 days after the 3rd dose of mRNA-1273 vaccine.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Terms and onset were captured as provided.
The case was assessed as serious by the Regulatory Authority´s report due to a Regulatory Authority