Adverse Event Reporting
| VAERS ID | 940791 |
|---|---|
| Gender | Male |
| Age | 39 |
| StateCode | TX |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EL0140 |
| Number of vaccinations | 1 |
| Vaccinated | 2020-12-20 |
| Onset | 2020-12-22 |
| Condition | Permanent Disability |
Symptoms
- Pain in extremity
- Hypoaesthesia
- Paraesthesia
- Pain
- Back pain
- SARS-CoV-2 test negative
- Muscular weakness
- Balance disorder
- Coordination abnormal
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Hypertension
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201230; Test Name: nasal swab for covid test; Test Result: Negative ; Comments: Antigen Test
Write-up
severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient).
A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization.
Medical history included hypertension from an unknown date and unknown if ongoing.
The patient's concomitant medications in two weeks included multivitamins.
Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.
The patient was not diagnosed with COVID-19 prior to vaccination.
No known allergies to medications, food, or other products.
On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs.
Pricking, pins and needles sensations in the hands and feet.
Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg.
The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test).
Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage.
Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment.
Outcome of all events was not recovered.
; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset of the events cannot be excluded.
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.