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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||FA4597 / 1||LA / OT|
Administered by: Other Purchased by: ??
Symptoms: Blood pressure increased, Body temperature, Cerebral haemorrhage, Depressed level of consciousness, Dysarthria, Paresis, Sensory disturbance, Computerised tomogram head, Thalamus haemorrhage, Blood pressure measurement
Life Threatening? No
Birth Defect? No
Permanent Disability? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? Yes, days:
Write-up: When the emergency team arrived home (9:00 pm), blood pressure was 140/90, when they came to the hospital (9:26 pm) blood pressure was 146/110; Left thalamus haemorrhage; Intra-cerebral haemorrhage; Dysarthria; Right paresis; consciousness level JCSII-10; Sensory disturbance; This is a spontaneous report from a contactable physician received via regulatory authority and from another contactable physician received from the agency. Regulatory authority report number is v21111591. The patient was a 68-year and 0-month-old male. Body temperature before vaccination was 35.3 degrees Centigrade on 01Jun2021. The patient had no family history. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antihypertensive drugs within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 01Jun2021 at 11:00 (the day of vaccination, at the age of 68-year-old), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the Arm Left as a single dose for COVID-19 immunisation. On 01Jun2021 at 18:00 (7 hours after the vaccination), the patient experienced Intra-cerebral haemorrhage. On 01Jun2021 (the day of vaccination), the patient was admitted to the hospital. On 03Jun2021 (2 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: On 01Jun2021 at around 18:00 (7 hours after the vaccination), the patient experienced sudden dysarthria and right paresis, then the patient was transported to hospital by emergency. At the time of admission, the consciousness level JCSII-10, right paresis and sensory disturbance appeared, and computed tomography (CT) showed left thalamus haemorrhage, the patient was hospitalized. When the emergency team arrived home (9:00 pm), blood pressure was 140/90, when they came to the hospital (9:26 pm) blood pressure was 146/110. The reporting physician classified the event as serious (hospitalization, Disability) and stated the events result in emergency room/department or urgent care, Hospitalization and Disability or permanent damage. The outcome of the events was not recovered with treatment including blood pressure control, drug treatment. The causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was Hypertension. The reporting physician commented as follows: The relationship with vaccination was unknown. Since the vaccination, the patient has not been tested for COVID-19.
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