Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Burning sensation, Electromyogram normal, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second  single dose for covid-19 immunization.  Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits).  The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations.  The patient previously received BNT162B2  (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at  08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No  COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting.  Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus,  burning sensation, condition aggravated 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.