Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Monoclonal gammopathy, Oral discomfort, Paraesthesia, Red blood cell count decreased, Serum ferritin
Clinical narrative: severe burning, tingling and numbness in her lower limbs; severe burning, tingling and numbness in her lower limbs; severe burning, tingling and numbness in her lower limbs; excruciatingly painful lesions in her mouth, mostly tongue / nearly 10 months and the lesions persist and are incredibly painful; excruciatingly painful lesions in her mouth, mostly tongue / nearly 10 months and the lesions persist and are incredibly painful; excruciatingly painful lesions in her mouth, mostly tongue / nearly 10 months and the lesions persist and are incredibly painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: nuts" (unspecified if ongoing), notes: known allergies: nuts; "known allergies: mushrooms" (unspecified if ongoing), notes: known allergies: mushrooms; "known allergies: oranges" (unspecified if ongoing), notes: known allergies: oranges; "known allergies: grapefruit" (unspecified if ongoing), notes: known allergies: grapefruit; "known allergies: dust" (unspecified if ongoing), notes: known allergies: dust; "known allergies: mold" (unspecified if ongoing), notes: known allergies: mold; "other medical history:  kidney donor" (unspecified if ongoing), notes: other medical history: kidney donor; "known allergies: Oxycodone" (unspecified if ongoing). No COVID prior the vaccination. No other vaccine in four weeks. Concomitant medication(s) included: ESTROGEN PATCH. Vaccination history included: Bnt162b2 (DOSE:1, lot number: EL9264,, administration date: 27Jan2021, time: 03:45 PM, prev dose vaccine location: Right arm), administration date: 27Jan2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "severe headache".  The following information was reported: BURNING SENSATION (disability), PARAESTHESIA (disability), HYPOAESTHESIA (disability), outcome "unknown" and all described as "severe burning, tingling and numbness in her lower limbs"; ORAL DISORDER (medically significant), TONGUE DISORDER (medically significant), ORAL PAIN (medically significant), outcome "not recovered" and all described as "excruciatingly painful lesions in her mouth, mostly tongue / nearly 10 months and the lesions persist and are incredibly painful". The event "excruciatingly painful lesions in her mouth, mostly tongue / nearly 10 months and the lesions persist and are incredibly painful" and "excruciatingly painful lesions in her mouth, mostly tongue / nearly 10 months and the lesions persist and are incredibly painful" was evaluated at the physician office visit. Therapeutic measures were taken as a result of burning sensation, paraesthesia, hypoaesthesia, oral disorder, tongue disorder, oral pain. Clinical course: Patient had a severe headache almost immediately following the first dose of the vaccine. It persisted for 5 days and the patient could not work the first 2 days. Almost immediately following the second dose of the vaccine, patient developed severe burning, tingling and numbness in her lower limbs. In both vaccinations, patient was monitored by a paramedic for 30 minutes (previous anaphylaxis) but to the patient's knowledge, the paramedics did not document this in her medical record. She was assured that it was of no concern. Three to four days later, patient developed excruciatingly painful lesions in her mouth, mostly tongue. Patient trusted it would resolve and finally went in to see her Primary Care Physician a few weeks later. It has now been nearly 10 months and the lesions persist and are incredibly painful. No medications prescribed have helped. Patient has been advised not to get a booster.