Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema peripheral, Paraesthesia
Clinical narrative: difficulty controling internal temperature; unable to sweat except feet and hands; chills that start at neck and go down nerve endings of back; hot spot on the back of her neck; felt pressure in her neck and head; felt pressure in her neck and head; face was now numb, ears were numb; decreased sensation in all extremities; started with burning flushing from elbow down to hand; started with burning flushing from elbow down to hand; burning tingling progressed from feet up to her abdomen; This is a spontaneous report from a contactable nurse (the patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ek9231), via an unspecified route of administration in the right arm on 03Jan2021 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: seizure disorder and osteoarthritis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: levetiracetam (KEPPRA), levetiracetam (KEPPRA XR), pyridoxine hydrochloride (B6), folic acid, vitamin D NOS, and acetylsalicylic acid (BABY ASPIRIN). The patient previously took and had allergies to: H1N1 vaccine, oxcarbazepine (TRILEPTAL), carbamazepine (TEGRETOL), and lacosamide (VIMPAT). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that about 30 hours after receiving the vaccine, on 04Jan2021 23:00, she started to experience burning flushing from elbow down to hand. She took paracetamol (TYLENOL), went to bed, then the burning tingling progressed from feet up to her abdomen. She stated it felt like she had shingles from below the breast down. The symptoms have continued to evolve, moving up her back. The patient had difficulty controlling internal temperature; she was unable to sweat except feet and hands (unspecified dates). She had chills that start at neck and go down nerve endings of back (unspecified date). She was on gabapentin (NEURONTIN) to control tingling and burning. The patient had a hot spot on the back of her neck. She felt pressure in her neck and head. Her face was now numb, ears were numb, and she had decreased sensation in all extremities. She was currently unable to work. The events were serious due to disability. They involved doctor or other healthcare professional office/clinic visit and emergency room visit. Treatment was received for the events. The patient had a negative saliva COVID test in Jan2021, post vaccination, and a negative nasal swab COVID test in Feb2021. The clinical outcome of the events was not recovered.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE0 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.