이상반응 보고
| VAERS ID | 1465031 |
|---|---|
| 성별 | 남성 |
| 나이 | 72세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-04-26 |
| 발병일 | 2021-04-26 |
| 상태 | 회복 |
증상
- 실신(Malaise)
- 심방 세동(Atrial fibrillation)
- 국제 표준화 비율 증가(International normalised ratio increased)
- 국제 표준화 비율(International normalised ratio)
- 태아 와파린 증후군(Foetal warfarin syndrome)
이환 중 질병
지병
Medical History/Concurrent Conditions: Flu vaccination
기타 의료
VERAPAMIL; WARFARIN
이전 예방접종
알레르기
임상 검사
Test Name: INR; Result Unstructured Data: Test Result:2.
4; Test Name: INR; Result Unstructured Data: Test Result:2.
2; Test Name: INR; Result Unstructured Data: Test Result:2.
0; Test Name: INR; Result Unstructured Data: Test Result:2.
0; Test Name: INR; Result Unstructured Data: Test Result:2.
1; Test Date: 20210426; Test Name: INR; Result Unstructured Data: Test Result:5.
0
증상 상세
my last five reading with my inr readings read; af reaction; I felt really ill; Foetal warfarin syndrome; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency.
The regulatory authority report number is GB-MHRA-WEBCOVID-202106252249274540-XVSJX, Safety Report Unique Identifier GB-MHRA-ADR 25547970.
A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 (at the age of 72-years-old) (Lot number was not reported) as dose 2, single for COVID-19 immunisation.
Medical history included influenza immunisation from an unknown date and unknown if ongoing, Concomitant medications included verapamil (VERAPAMIL) taken for influenza immunisation from Sep2020 to an unspecified stop date; warfarin (WARFARIN) taken for an unspecified indication from 2011 to an unspecified stop date.
Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test.
Patient was not enrolled in clinical trial.
Patient has not tested positive for COVID-19 since having the vaccine.
On an unspecified date, the patient experienced his last five reading with INR readings read increased (medically significant), AF reaction (medically significant), and he felt really ill (medically significant).
On 26Apr2021, patient experienced foetal warfarin syndrome (medically significant).
After his second jab, he felt his existing atrial fibrillation went crazy.
His heart was going in and out of AF to normal rhythm.
His last five reading with his INR readings read, 2.
4, 2.
2, 2.
0, 2.
0, 2.
1.
After the second jab, on the 26th of April he felt really ill until his INR got checked reading 5.
0.
His warfarin intake was either 4 or 4.
5 daily before the 5.
0 reading.
since the 5.
0 reading his warfarin intake has dropped to 3.
5.
He had no doubt the second jab influenced both his AF reaction and his body needed less warfarin, he had been on a similar dose since 2011.
The 2nd jab on the 26th April 2021 had changed his dose, his concern was long term and possibly any future boosters that may be needed.
The patient underwent lab tests and procedures which included international normalised ratio: 2.
4 on an unspecified date, international normalised ratio: 2.
2 on an unspecified date, international normalised ratio: 2.
0 on an unspecified date, international normalised ratio: 2.
0 on an unspecified date, international normalised ratio: 2.
1 on an unspecified date, international normalised ratio: 5.
0 on 26Apr2021.
Outcome of foetal warfarin syndrome was recovered on 30Apr2021, INR readings increased, and AF reaction was recovered on unspecified date in 2021, felt really ill was unknown.
No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained.
No further information is expected.