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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||EM0477 / 2||LA / OT|
Administered by: Other Purchased by: ??
Symptoms: C-reactive protein, C-reactive protein increased, General physical health deterioration
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
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment; Living in nursing home
Diagnostic Lab Data: Test Date: 20210131; Test Name: C-reactive protein; Result Unstructured Data: Test Result:About 90-94
CDC 'Split Type': NOPFIZER INC2021158458
Write-up: CRP was about 90-94; GENERAL PHYSICAL CONDITION DECREASED; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uq7ng, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014862. A 103-years-old female patient received the second dose of bnt162b2 (COMIRNATY, lot# EM0477), intramuscular at left arm on 28Jan2021 11:35 at single dose for covid-19 immunization. Medical history included living in nursing home and cognitive failure. The patient''s concomitant medications were not reported. The patient experienced general physical condition decreased on 29Jan2021 with outcome of fatal. The clinical course was reported as follow: patient was reduced on 29Jan2021, denied food and drink, on 31Jan2021 she was no longer contactable and was put on palliative care, died 01Feb2021 at 22:35. The nurse was asked by the doctor to report the event due to strong time relation to the vaccine. After vaccine the patient had no nausea or fever. No infection sign before 31Jan2021, then CRP was about 90-94 with outcome of unknown. The patient underwent lab tests included c-reactive protein: about 90-94 on 31Jan2021. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Sender''s Comment: When vaccinating patients with frailty who are ill with underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else incidental, at the same time a cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is also classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: GENERAL PHYSICAL CONDITION DECREASED
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