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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||EM6950 / UNK||- / -|
Administered by: Other Purchased by: ??
Symptoms: Sudden death, Vaccination site pain
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: Basal cell carcinoma (In 2020 ulcerative lesion but malignancy was ruled out); Herpes labialis; Hypertension arterial; Ulceration (but malignancy was ruled out); Comments: HISTORY OF ARTERIAL HYPERTENSION, herpes labialis and basal cell carcinoma in 2015 (in 2020 ulcerative lesion but malignancy is ruled out)
Diagnostic Lab Data:
CDC 'Split Type': ESPFIZER INC2021256310
Write-up: outcome: death, not vaccine-related; Vaccination site pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB (Regulatory Authority number ES-AEMPS-764232). A 96-year-old male patient received BNT162B2 (COMIRNATY; lot EM6950, expiry date 31May2021) on 18Feb2021 (at 96 years of age), at single dose, for COVID-19 immunisation. Medical history included basal cell carcinoma from 2015 to 2015 (in 2020 ulcerative lesion but malignancy was ruled out), herpes labialis from 2018 and hypertension arterial. The patient''s concomitant medications were not reported. The patient experienced vaccination site pain on 18Feb2021 with unknown outcome and death, not vaccine-related (sudden death) on 22Feb2021. The patient died at home on 22Feb2021. It was unknown if an autopsy was done. Event was reported given the time elapsed between administration and the episode, although it was not correlated apparently with the vaccination. The reporter did not consider the death of the patient related to the vaccine. He only had "a little pain in the vaccination area" and no other symptoms, he was fine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The Company concurs with the reporter that there is not a reasonable possibility of an association between BNT162B2 and sudden death in this 96 year old elderly patient. 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: outcome: death, not vaccine-related
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