Adverse Event Reporting
|Number of vaccinations||1|
|Condition||Hospitalized Permanent Disability|
- Influenza like illness
- SARS-CoV-2 test negative
- Muscular weakness
- Neurological symptom
- Peroneal nerve palsy
Medical History/Concurrent Conditions: Diabetes; Eosinophilic granulomatosis with polyangiitis; Hypertension; Migraine
Test Date: 20201219; Test Name: Nasal Swab; Test Result: Negative
Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; Flu like symptoms first 3 days; This is a spontaneous report from a contactable physician (patient).
A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ek5730) at left arm, via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation.
Medical history included hypertension, diabetes, migraines, Eosinophilic granulomatosis with polyangiitis (EGPA) remission.
Prior to vaccination, the patient was not diagnosed with COVID-19.
The patient did not have any allergies to medications, food, or other products.
The patient's concomitant medications were not reported.
On 21Dec2020, the patient experienced flu like symptoms first 3 days.
Followed by neurological symptoms staring day 4, parasthesias of both upper extremity with progression to muscle weakness of all four extremities.
Leading to 2 ER visits and hospital admission.
Evaluation by internal medicine, neurology and rheumatology.
Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop.
The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage.
The treatment for events included High dose steroid.
Covid test included Nasal Swab: negative on 19Dec2020.
The outcome of events was not recovered.
; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events influenza like illness, neurological symptom, paraesthesia, muscular weakness and peroneal nerve palsy cannot be excluded.
The information available in this report is limited.
This case will be reassessed once additional information becomes 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.