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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||ER9480 / 1||LA / OT|
Administered by: Other Purchased by: ??
Symptoms: Death, Peripheral swelling
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: Alcohol addiction; Arterial hypertension; Cerebral infarction; Chronic ischaemic heart disease, unspecified (Chronic ischaemic heart disease); Encephalopathy (multiorgan encephalopathy); Epilepsy; Myocardial infarction; Type 2 diabetes mellitus
Diagnostic Lab Data:
CDC 'Split Type': PLPFIZER INC2021380218
Write-up: death during sleep; Swelling of the limb; This is a spontaneous report received from a contactable physician reporting for a patient downloaded from the Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-471-2021. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 13:08 (Batch/Lot Number: ER9480; Expiration Date: 28Mar2021) as 0.3 mL, single for covid-19 immunisation, at 60 years old. Medical history included epilepsy, Alcohol addiction, Arterial hypertension, cerebral infarction, Chronic ischaemic heart disease, unspecified, encephalopathy (multiorgan encephalopathy), type 2 diabetes mellitus, and myocardial infarction from an unknown date. The patient''s concomitant medications were not reported. The patient experienced swelling of the limb on 25Mar2021 and death during sleep on 26Mar2021 03:20. The patient died on 26Mar2021. Case narrative was reported as follows: The PL-URPL-3-471-2021 notification was sent to the Regulatory Authority on 26Mar2021. Patient: male; was administered on 25Mar2021 at 1308, Comirnaty vaccine, 0.3ml, first dose, left arm, i.m., lot ER9480, exp.28Mar2021, Pfizer. Date of occurrence of the reaction 26Mar2021 at 03.20. In the submitted report of an adverse reaction after vaccination, the following symptoms were listed: swelling of the left limb. Description of the reaction: death. Additional data: condition after cerebral infarction, heart attack, type II diabetes, alcohol addiction, epilepsy, multiple cause encephalopathy, arterial hypertension, chronic ischemic heart disease. He was vaccinated at around 1:15 pm (also reported as 13:08), left limb edema was observed during the evening toilet, elevations were applied (treatment), and at 03:20 death during sleep was confirmed. Health result: death. The data contained in the electronic report are all available to the Regulatory Authority - in the case of obtaining additional information, another version will be sent. Outcome of the events was fatal. It was not reported if an autopsy was performed. Sender comment: Name of the vaccine Comirnaty- COVID-19 vaccine (mRNA). The report mentioned the side effect of limb edema without specifying the exact location of the reaction. It is not known whether the edema was related to the grafted limb or the lower limb. There is a time relationship between the administration of the vaccine and the occurrence of a side effect. The immediate cause of death is unknown, and based on the patient''s medical history, it cannot be determined whether the vaccine contributed to the patient''s death. The person reporting Adverse Events Following Immunization qualified it as severe. The Regulatory Authority assessed the AEFI as severe. Swelling of limb: Source of assessment, Method of assessment WHO scale, Result of Assessment Possible No follow-up attempts possible. No further information expected. Lot number has been obtained.; Reported Cause(s) of Death: death during sleep; Swelling of the limb
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