Adverse Event Reporting
| VAERS ID | 944270 |
|---|---|
| Gender | Male |
| Age | 58 |
| StateCode | MA |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2020-12-16 |
| Onset | 2020-12-16 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- Fatigue
- Pyrexia
- Blood pressure increased
- Impaired work ability
- Myalgia
- Syncope
- Muscular weakness
- Platelet count decreased
- Computerised tomogram head abnormal
- Hemiparesis
- Basal ganglia haemorrhage
- Cerebrovascular accident
- Brain oedema
- Culture negative
- Coagulation test normal
- Intracranial mass
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Hypertension; Stress
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201218; Test Name: BP; Result Unstructured Data: Test Result:high as 200s/100; Test Date: 20201218; Test Name: BP; Result Unstructured Data: Test Result:179/101; Test Date: 20201218; Test Name: head CT; Result Unstructured Data: Test Result:Rt basal ganglia hemorrhage w/ edema and mass effe; Comments: Rt basal ganglia hemorrhage w/ edema and mass effect; Test Name: platelets; Result Unstructured Data: Test Result:normal coags; Test Date: 20201218; Test Name: platelets; Result Unstructured Data: Test Result:114 (unknown baseline); Test Date: 20201218; Test Name: platelets; Result Unstructured Data: Test Result:Low; Test Date: 20201218; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative
Write-up
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.
; Rt basal ganglia hemorrhage w/ edema and mass effect.
; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician.
A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization.
Medical history included hypertension with reported med noncompliance in the last few months due to stress.
Concomitant medication included hypertension medications in two weeks.
The patient was presumed neg covid status prior to vaccine.
He worked as a Pulm/critical care physician.
He reported fever, myalgia, fatigue on 16Dec2020.
Next day (17Dec2020), he took off from work due to his symptoms.
The following day (18Dec2020), he came to work.
He c/o ongoing severe fatigue & hand weakness in am.
Staff noted him to be evaluating his hands during clinic.
At 12:15, he collapsed with left sided hemiparesis.
The reporter had suspicion for stroke.
He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect.
Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date.
BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100.
He had a history of hypertension with reported med noncompliance in the last few months due to stress.
Patient was transferred for further care.
Full course was unknown but had rebleed there with low plts.
Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage.
Treatment was received for adverse events.
Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative.
The outcome of events was not recovered.
Unknown if any other vaccines within 4 weeks prior to the COVID vaccine.
Prior to vaccination, the patient was not diagnosed with COVID-19.
Since the vaccination, the patient was not tested for COVID-19.
Information on the lot/batch number has been requested.
; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension.
Low platelet also contributes to brain hemorrhage.
All these serious events are unrelated to the vaccine use.
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.