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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EP9598 / 1||- / -|
Administered by: Other Purchased by: ??
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Other Medications: CLOPIDOGREL; SIMVASTATIN; VIBEDEN; LOSARTAN; FURIX [CEFUROXIME]; METFORMIN; LANSOPRAZOLE
Current Illness: Anaemia pernicious; Diabetes; Gastroesophageal reflux; Hypercholesterolaemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Myocardial infarct; Unspecified vitamin B deficiency
Diagnostic Lab Data:
CDC 'Split Type': DKPFIZER INC2021370067
Write-up: Died 10 days after vaccination; This is a spontaneous report downloaded from the Regulatory Authority (regulatory authority number: DK-DKMA-ADR 25005752) received from a lawyer and a physician from the Association via the Agency. An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection lot number: EP9598, expiration date: 30Jun2021), via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, anaemia pernicious, hypercholesterolaemia, gastroesophageal reflux, all were from an unspecified date and ongoing; b-vitamin deficiency; myocardial infarct and apoplexy from 2017 to an unspecified date. Concomitant medication(s) included clopidogrel (CLOPIDOGREL) taken for thrombosis prophylaxis from 2016 to an unspecified stop date; simvastatin (SIMVASTATIN) taken for hypercholesterolaemia from 2016 to an unspecified stop date; hydroxocobalamin (VIBEDEN) taken for pernicious anaemia from 2016 to an unspecified stop date; losartan (LOSARTAN) taken for hypertension from Feb2019 to an unspecified stop date; cefuroxime (FURIX [CEFUROXIME]) taken for diuretic therapy from 20May2020 to an unspecified stop date; metformin (METFORMIN) taken for diabetes mellitus from Mar2019 to an unspecified stop date; lansoprazole (LANSOPRAZOLE) taken for gastrooesophageal reflux disease from 2019 to an unspecified stop date. The patient died 10 days after vaccination on 04Mar2021. An autopsy was performed and results were not provided. Causality: The physician does not suspect that the death is due to the vaccine, as the patient is co-morbid. Therefore, he has not reported it as an ADR of the vaccine. The patient is known to have hypertension, Hypercholesterolaemia, diabetes and B-vitamin deficiency. The patient has previously had Myocardial infarct and Apoplexy in 2017. The physician is not aware that the patient should have reacted to vaccines in the past. The physician states that he has been in contact with the Police at the beginning of March, and that he therefore is aware that an inquest and autopsy of the patient should be performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information it is unlikely that the patient''s death was related to bnt162b2 (COMIRNATY). The patient''s hypertension, diabetes, anaemia pernicious, hypercholesterolaemia may have all contributed to the patient''s death: however, based on current convention, the case of death is assessed as related to bnt162b2 (COMIRNATY). until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed if additional information is received. 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: Died 10 days after vaccination
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