Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral discomfort, Oral pain, Stomatitis, Temperature intolerance
Clinical narrative: my lips started to feel rubbery, numb; my lips started to feel rubbery, numb; extremely sensitive to heat and spicy food; extremely sensitive to heat and spicy food; inside of my mouth broke out into numerous sores; came back looks viral; awful, constant discomfort and pain; awful, constant discomfort and pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20May2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 16Jun2021, outcome "not recovered" and all described as "my lips started to feel rubbery, numb"; TEMPERATURE INTOLERANCE (non-serious), FOOD ALLERGY (non-serious) all with onset 16Jun2021, outcome "not recovered" and all described as "extremely sensitive to heat and spicy food"; STOMATITIS (non-serious) with onset 16Jun2021, outcome "not recovered", described as "inside of my mouth broke out into numerous sores"; VIRAL INFECTION (non-serious) with onset 16Jun2021, outcome "not recovered", described as "came back looks viral"; ORAL DISCOMFORT (non-serious), ORAL PAIN (non-serious) all with onset 16Jun2021, outcome "not recovered" and all described as "constant discomfort and pain". The events "my lips started to feel rubbery, numb", "my lips started to feel rubbery, numb", "extremely sensitive to heat and spicy food", "extremely sensitive to heat and spicy food", "inside of my mouth broke out into numerous sores", "came back looks viral", "constant discomfort and pain" and "constant discomfort and pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, hypoaesthesia oral, temperature intolerance, food allergy, stomatitis, viral infection, oral discomfort, oral pain.  Additional information: Facility where the most recent covid-19 vaccine was administered noted as public health clinic/veterans administration facility. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Approximately 1 month after getting the 2nd dose, patient's lips started to feel rubbery, numb, and extremely sensitive to heat and spicy food. Also, the inside of the mouth broke out into numerous sores. Patient went to the PCP (primary care provider) who gave patient magic mouthwash, it did nothing. Patient went to urgent care who put patient on anti-viral medication (unspecified), nothing happened. Patient went to ENT (ears, nose and throat specialist) who biopsied and cultured the inside of the cheek, came back "looks viral". He put patient on more anti-viral medications (unspecified), did not help. Patient went to the department of health where they tested patient for Herpes, came back negative. Patient went to the dentist, he thought it was from the vaccine. At the time of this report )reported as now), patient was waiting to get in to a dermatologist. That had been awful, constant discomfort and pain for 6 months. Very disturbing and patient did not know if it will ever go away, or if one day patient would lose the my lips. It was relentless. Patient was desperate to find a way to make this go away, but no doctor had any answers for patient. Treatment received for the adverse event noted as 2 rounds of antiviral medications, metronidazole (FLAGYL) and magic mouthwash. Device date noted as 21Nov2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.