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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||- / 2||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Abdominal discomfort, Apnoea, Blood creatinine, Body temperature, C-reactive protein, C-reactive protein increased, Loss of consciousness, Physical examination, Pyrexia, Urine analysis, General physical health deterioration, Feeding disorder, Auscultation
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? Yes
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (date of diagnosis not known); Chronic obstructive airways disease (date of diagnosis not known); Chronic renal insufficiency (creatinine on 17Mar2021 181 mcmol/L); COVID-19; Decubitus ulcer (sacral deep but clean ulcer); Deep vein thrombosis (Suspicion of DVT right leg); Dementia (moderate grade); Heart failure NYHA class IV (date of diagnosis not known); Hospitalization (for surgery to clean a sacral decubitus); Ileostomy
Diagnostic Lab Data: Test Date: 20210322; Test Name: heart auscultation; Result Unstructured Data: Test Result:No abnormal heart and lung auscultation; Test Date: 202103; Test Name: Lung auscultation; Result Unstructured Data: Test Result:normal; Test Date: 20210322; Test Name: Lung auscultation; Result Unstructured Data: Test Result:No abnormal heart and lung auscultation; Test Date: 20210317; Test Name: Blood creatinine; Result Unstructured Data: Test Result:181 umol/l; Test Date: 20210317; Test Name: creatinine; Result Unstructured Data: Test Result:181; Comments: mcmol/L; Test Date: 20210318; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210317; Test Name: C-reactive protein; Result Unstructured Data: Test Result:37.4 mg/l; Test Date: 20210319; Test Name: C-reactive protein; Result Unstructured Data: Test Result:21.6 mg/l; Test Date: 20210322; Test Name: abdomen; Result Unstructured Data: Test Result:was hard in the lower abdomen, no sounds were dete; Comments: was hard in the lower abdomen, no sounds were detectable/no oedema/no stool or air in the stoma bag; Test Date: 202103; Test Name: urine; Result Unstructured Data: Test Result:normal
CDC 'Split Type': CHPFIZER INC2021381353
Write-up: Apnoea; unconscious; temperature of 38 degrees C; elevation of CRP (37.4mg/L on 17Mar2021 and 21.6mg/L on 19Mar2021); poor general condition; abdomen was indolent; difficulty feeding himself/hardly ate and drank; This is a spontaneous report received from a contactable physician via Swissmedic, the regulatory authority. Regulatory authority report number CH-SM-2021-13577. An 86-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot and expiry were not reported), intramuscular on 06Mar2021 (at the age of 86-years-old) as single dose for covid-19 immunisation. The patient''s first dose of bnt162b2 (lot not reported) was in Feb2021 (at the age of 86-years-old) IM, given during hospital stay as single dose for COVID-19 immunisation. Medical history included Heart failure NYHA class IV (date of diagnosis not known), chronic obstructive airways disease (date of diagnosis not known), deep vein thrombosis (DVT) from Aug2020 (Suspicion of DVT right leg), alcohol abuse (date of diagnosis not known), dementia (moderate grade), hospitalized on 08Feb2021 to 05Mar2021 (for surgery to clean a sacral decubitus), decubitus ulcer from Feb2021 (sacral deep but clean ulcer), chronic renal insufficiency (creatinine on 17Mar2021 181 mcmol/L), Covid-19 in Oct2020 and ileostomy wearer. Following hospitalization, he was discharged to a home for the elderly. Usual pharmacotherapy not known and not known if the patient had any allergies. Concomitant medications included unspecified peroral medications (unknown) were discontinued. On 15Mar2021, the doctor was called because of poor general condition and Biox under oxygen therapy with apneas fluctuating to below 60%. Lung auscultation was normal in Mar2021. The abdomen was indolent, he had difficulty feeding himself from Mar2021 and from 18Mar2021 a temperature of 38 degrees C and slightly above was noted. The laboratory showed an elevation of CRP (37.4mg/L on 17Mar2021 and 21.6mg/L on 19Mar2021) and normal urine in Mar2021. He was given ciprofloxacin 250mg 2x daily starting 18Mar2021 for the fever of unclear etiology. His condition did not improve and the family refused hospitalization and ventilation, including CPAP. From 21Mar2021, he hardly ate and drank and was unconscious on 22Mar2021 when he visited the doctor, his abdomen was hard in the lower abdomen, no sounds were detectable. No abnormal heart and lung auscultation, no oedema. There was no stool or air in the stoma bag. Peroral medications (unknown) were discontinued and the patient died of apnea the same evening on 22Mar2021. Swissmedic assessed this case as serious, results in death. The outcome of the events was unknown except for apnea which was fatal. The patient died due to apnea on 22Mar2021. It was unknown if an autopsy was performed. A causal relationship between Comirnaty and death (apnea) was assessed as being unlikely. Sender''s comment (Swissmedic): Death occurred 15 days after administration of the second dose of Comirnaty of very elderly and frail patient. Sudden deaths are not known according to the Swiss monograph of Comirnaty among possible adverse events. Foreign monographs also do not list sudden deaths among the ADEs of mRNA-based Covid-19 vaccines, even in the frail elderly population subgroup. The patient presented very frail in the presence of severe comorbidities, particularly NYHA IV heart failure, COPD, and renal failure. The decline in general condition, already very impaired on entry into the home for the elderly, worsened with fever 12 days after the second dose of the vaccine. Uptodate reports a time of onset of fever in correlation with Covid-19 mRNA vaccine of 1-3 days, which is therefore not compatible with the case of this patient. In conclusion, in view of the advanced age and the already very compromised state of health of the patient, further proven by a recent hospitalization for sacral decubitus cleaning, we hypothesize a progressive decline until death due to apnea on COPD, a hypothesis supported by the reporting physician. At the current state of knowledge, therefore, despite the temporal correlation of 15 days, not being able to exclude other possible pathophysiological causes in this severely compromised patient, we judge the causal correlation between the vaccine and death unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Death due to apnea in COPD in the setting of a recent Covid vaccination.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the apnea and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. 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: Apnoea
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