Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: vomiting blood; vision deterioration; diarrhoea; fever; weakness; fatigability; pain of skin; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-290021. A 69-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW4815; Expiration Date: Jul2021), intramuscular, administered in Arm Left on 16Apr2021 09:10 (at unknown age) as 0.3 ml single for COVID-19 immunisation. Medical history included Ovarian cancer from 2006, ongoing Papular rash, ongoing IHD (Myocardial ischaemia), ongoing Hepatic cirrhosis, Esophageal varices from 2014 and ongoing. Concomitant medications included hydrocortisone, oxytetracycline hydrochloride (OXYCORT); colecalciferol (VITAMIN D3 FRESENIUS); diclofenac; spironolactone (VEROSPIRON); famotidine (QUAMATEL); furosemide; chlordiazepoxide (ELENIUM); potassium chloride (KALDYUM); etacrynic acid (UREGYT); metamizole sodium (ALGOPYRIN). A physician describes the occurrence of adverse events resulting in death after vaccination with COMIRNATY (tozinameran). On 21Apr2021, the patient experienced diarrhoea, fever, weakness, fatigability and pain of skin. From 24Apr2021, she experienced vision deterioration (low visual acuity). On 26Apr2021, the patient had vomiting blood and died after when submitted to hospital. The patient was hospitalized on unknown date. COVID-19 test was negative on 26Apr2021. Autopsy has been done, the results are not available. Based on the patient physician, the patient symptoms and death are not related with the vaccination. The patient died on 26Apr2021. Sender comments: Diarrhoea, fever, weakness, fatigability and skin pain are expected adverse events of COMIRNATY. Vision decreased and haematemesis are not expected adverse events. They might be resulted by the patient chronic diseases. TTO was 5 days for diarrhoea, fever, weakness, fatigability and skin pain; 8 days for low visual acuity and 10 days for haematemesis. Based on the above, relationship between the events and COMIRNATY is unlikely. The case is serious because the patient died. Comirnaty/Weakness, Fever, Pain of skin, Fatigability, Diarrhoea/Time Interval between Beginning of Drug Administration and Start of Reaction 5 days, Comirnaty/ Vision decreased/Time Interval between Beginning of Drug Administration and Start of Reaction 8 days, Comirnaty/Haematemesis/Time Interval between Beginning of Drug Administration and Start of Reaction 10 days. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information available the events are attributed to intercurrent medical conditions and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: diarrhoea; fever; weakness; fatigability; pain of skin; vision deterioration; vomiting blood
Copyright © 2022 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166