Adverse Event Reporting
|Number of vaccinations||1|
- Pain in extremity
- SARS-CoV-2 test negative
- Neurological symptom
- Musculoskeletal disorder
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Test Date: 202012; Test Name: COVID; Test Result: Negative
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself).
A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization.
Medical history was none.
There were no concomitant medications.
There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine.
On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability.
On 21Dec2020, the patient had itchiness in her head.
The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability.
The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL).
No further details provided.
The patient was sent home for 10 days and she was sent back to work.
The patient underwent lab tests and procedures which included COVID: negative in Dec2020.
The outcome of the events was not recovered.
The reported assessed the events related to the suspect product, BNT162B2.
; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship.
However, stroke was not diagnosed.
The case will be reassessed should additional information become available.
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.