이상반응 보고
| VAERS ID | 923193 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | |
| 접종일 | 2020-12-16 |
| 발병일 | 2020-12-17 |
| 상태 | 후유증 |
증상
- 구토(Vomiting)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 트림(Eructation)
이환 중 질병
지병
Medical History/Concurrent Conditions: Clinical trial participant (Siren); Gastroesophageal varices; Hypercholesterolaemia; Liver cirrhosis; Liver resection; Non-alcoholic fatty liver; Radical neck dissection; Squamous cell carcinoma; Suspected COVID-19; Type 2 diabetes mellitus
기타 의료
; ; ; ; LANTUS; NOVORAPID
이전 예방접종
알레르기
임상 검사
Test Date: 20201027; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
증상 상세
Vomiting; Malodorous burping; This is a spontaneous report received from the Medicines Agency (EMA) EudraVigilance-WEB from a contactable other health professional.
The Regulatory authority report number is GB-MHRA-WEBCOVID-20201218113148, the Safety Report Unique Identifier is GB-MHRA-ADR 24544819.
A 60-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot # unknown), via an unspecified route of administration on 16Dec2020 21:00 at single dose for Covid-19 vaccination.
Medical history included non-alcoholic fatty liver, liver resection, squamous cell carcinoma, radical neck dissection, liver cirrhosis, clinical trial participant (Siren), type 2 diabetes mellitus, hypercholesterolaemia, gastroesophageal varices all from an unknown date and unknown if ongoing, suspected Covid-19 from 26Oct2020 to 07Nov2020.
Concomitant medication included empagliflozin from unknown date for Insulin-requiring type 2 diabetes mellitus, ezetimibe from unknown date for Hypercholesterolaemia, omeprazole from unknown date for Gastroesophageal varices, carvedilol from unknown date for BP (Blood pressure), insulin glargine (LANTUS) from unknown date for Insulin-requiring type 2 diabetes mellitus, insulin aspart (NOVORAPID) from unknown date for Insulin-requiring type 2 diabetes mellitus.
The patient experienced vomiting on 17Dec2020 07:00, malodorous burping on 17Dec2020 05:30.
The events were reported as serious per disability.
On 17Dec2020 at 05:30 woke up and started sulphurous burping.
At 07:00 started vomiting.
Unable to keep food or water down.
Last vomiting 19:00.
On 18Dec2020, the patient was able to keep food down.
Patient had not tested positive for COVID-19 since having the vaccine.
The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 27Oct2020.
The outcome of events for vomiting was resolving, for malodorous burping was unknown.
No follow-up attempts are possible.
No further information is expected.
Lot/batch number was not provided and unable to obtain.