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This is VAERS ID 1339142

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First Appeared on 7/9/2021

VAERS ID: 1339142
VAERS Form:2
Age:
Sex:Female
Location:Foreign
Vaccinated:2021-04-16
Onset:2021-04-25
Submitted:0000-00-00
Entered:2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other      Purchased by: ??
Symptoms: Oesophageal varices haemorrhage, Laboratory test, SARS-CoV-2 test

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-04-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (treated); Cholelithiasis (treated); Gastrooesophageal varices (treated); Hepatic cirrhosis (treated)
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: Laboratory test; Result Unstructured Data: Test Result:Severe metabolic acidosis, high ammonia levels, si; Comments: Severe metabolic acidosis, high ammonia levels, significant anemia; Test Date: 20210425; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Covid-19 infection was not detected based on tests performed in the Emergency Department.
CDC 'Split Type': HUPFIZER INC2021560201

Write-up: Gastrooesophageal varices haemorrhage; This is a spontaneous report from a contactable physician received from a regulatory authority and downloaded from another regulatory authority-WEB (Regulatory Authority number HU-OGYI-286521). A 45-year-old female patient received the first dose of BNT162B2 (COMIRNATY; lot EW4815) intramuscular, in left arm, on 16Apr2021 at 12:00, at 0.3 ml single, for COVID-19 immunisation. Medical history included hepatic cirrhosis, alcohol abuse, gastrooesophageal varices and cholelithiasis, all from an unknown date to an unknown date and all were treated. Concomitant medications were not reported. No events occurred during the post-vaccination observation period. On 25Apr2021 the patient experienced gastrooesophageal varices haemorrhage. Clinical course included the following details. On 25Apr2021, an ambulance was called as the patient was vomiting fresh blood. Covid-19 infection was not detected based on tests performed in the Emergency Department. Laboratory tests performed on 25Apr2021 showed severe metabolic acidosis, high ammonia levels, significant anemia. The patient received blood transfusion in the intensive care unit; pantoprazole (CONTROLOC), NaHCO3, glucose, and amino acids (GLUTARSIN) were given intravenously. Despite this therapy, the patient died on 26Apr2021 at 6:30 A.M. An autopsy was requested. Results were not yet available. Sender''s comments: The 45-year-old patient died 10 days after Comirnaty vaccination due to gastrooesophageal varices haemorrhage. The causal relationship between the reported event and Comirnaty was considered not related. The case was serious due to fatal outcome. Stop date 26Apr2021 at 06:30 for event: gastrooesophageal varices haemorrhage, provided with outcome fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: The Company considered there was not a reasonable possibility that the reported event Gastrooesophageal varices haemorrhage (with fatal outcome) was related to the suspect product BNT162B2 (COMIRNATY). The event is more consistent with patient''s underlying condition of hepatic cirrhosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Gastrooesophageal varices haemorrhage

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