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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||FC3558 / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Body temperature, Death, Heart rate, Hypertension, Respiratory rate, Blood pressure measurement
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: METFORMIN; GLIMEPIRIDE; ENALAPRIL; AMLODIPINE; ASPIRIN (E.C.); HALOPERIDOL; HYDROCHLOROTHIAZIDE
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Diagnostic Lab Data: Test Date: 20210603; Test Name: temperature; Result Unstructured Data: Test Result:32.4 Centigrade; Test Date: 20210604; Test Name: temperature; Result Unstructured Data: Test Result:34 Centigrade; Test Date: 20210603; Test Name: pulse; Result Unstructured Data: Test Result:70 bpm; Test Date: 20210604; Test Name: pulse; Result Unstructured Data: Test Result:89 bpm; Test Date: 20210603; Test Name: respiration rate; Result Unstructured Data: Test Result:20/min; Test Date: 20210604; Test Name: respiration rate; Result Unstructured Data: Test Result:22/min; Test Date: 20210603; Test Name: BP; Result Unstructured Data: Test Result:150/78 mmHg; Test Date: 20210604; Test Name: BP; Result Unstructured Data: Test Result:181/110 mmHg
CDC 'Split Type': ZAPFIZER INC2021676429
Write-up: Death; Elevated blood pressure; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 03Jun2021 11:15 (Batch/Lot Number: FC3558; Expiration Date: Sep2021) dose 1, single for covid-19 immunization. The diluent batch# L1945; exp date May2023. The vaccine was reconstituted on 03Jun2021. Medical history included hypertension and diabetes mellitus. Concomitant medications included metformin, glimepiride, enalapril, amlodipine, acetylsalicylic acid (ASPIRIN), haloperidol and hydrochlorothiazide. The patient was reported to have died on 04Jun2021, prior to that, the patient had an elevated blood pressure (hypertension) on 04Jun2021, post vaccination vital sign - temperature 34 degrees celsius (body temperature decreased). The patient died on 04Jun2021. It was not reported if an autopsy was performed; the death was reported to have been classified as natural death by the paramedics. The outcome of the event elevated blood pressure was unknown. Department report dated 05 Jun2021: The case was assessed/screened pre vaccination for COVID-19 Symptoms on 3Jun2021 and reported not to be having any signs. Pre-vaccination her vital signs were BP 150/78, temperature 32.4d egrees, pulse 70 beats per minute and respiration rate 20 per minute. Post vaccination ON 04Jun2021 the late reported to be feeling well but her post vaccination vital signs were BP 181/110, Temperature 34 degrees Celsius, pulse 89 beats per minutes and respiration rate 22 per minute. The case was advised to stay for the vital signs to be repeated and transferred if BP was not subsiding, but she requested to be released. On interview with the family, it was alleged that she did not report any pains before going to bed. The family discovered that she was no longer breathing in the morning on 4Jun2021 at 11:00 am and was certified dead by the paramedics at 14:00. The family then notified the Agency supervisor of her demise on 4 June 2021. The body was collected by the funeral undertaker, and no COVID-19 sample was collected at home for this case to rule out the COVID-19 disease. During the investigation packs of tablets that she collected at the clinic in March were still sealed to show that she was not taking her treatment as prescribed. The case is a known hypertensive and diabetic who defaulted her treatment as there were packs of sealed treatment and did not return to the clinic for her follow-up treatment in May 2021. Therefore, the death is not classified as vaccine related adverse event following immunization death. The death was classified under natural causes of death.; Sender''s Comments: Based on the current available information, the events Death from natural causes and Blood pressure high are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes 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: died
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