Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Taste disorder, Tongue discomfort, Tongue pruritus
Clinical narrative: Roof of her mouth feels like when you've eaten something that is too hot/roof of her mouth feels burned; her tongue was itching and burning; her tongue was itching and burning; Her ears did same thing, itching and burning; She had itching and burning down the side of her neck like when you get sinus drainage itching and burning; She had itching and burning down the side of her neck like when you get sinus drainage itching and burning; itching on the roof of her mouth; slight tongue swelling; bad taste in her mouth /She could taste the vaccine, it was really nasty; This is a spontaneous case received from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6202, expiration date: 30Jun2021) via an unspecified route of administration in arm left on 25Feb2021 14:37 (age at vaccination 69-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing diabetic (She does not require medication at this point for this condition. Onset date several years ago, probably 4-5 years ago. She was able to control it) and allergy to statins (she cannot take more than 20 mg/day or she hurts so. Additional statin product names/Lots/NDCs/Expiries: Unknown, she does not have products with her at time of call which are dispensed in white manufacturer bottles by pharmacy company- includes Atorvastatin). The patient had previously taken water pill. Concomitant medications include propranolol hydrochloride (INDERAL), ATORVASTATIN, HYDROCHLOROTHIAZIDE, acetylsalicylic acid (BABY ASPIRIN), VITAMIN D NOS. Historical vaccine include flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. Family Medical History Relevant to AE(s) was reported as none. Relevant tests were reported as none. On 25Feb2021 15:07, the patient experienced a bad taste in her mouth and at 15:37 itching on the roof of her mouth, her tongue was itching and burning and had slight tongue swelling. Her tongue started itching and burning; and it was like her ears did same thing, itching and burning. She had itching and burning down the side of her neck like when you get sinus drainage itching and burning. On 26Feb2021, the patient stated roof of her mouth feels like when you have eaten something that is too hot. The patient called her family physician's office regarding these events and talked to the nurse. The nurse said to call Pfizer because she did not know what to do. The nurse said she had not heard of that reaction before. Consumer reported she researched last night and has not seen that either. Emergency room and Physician office visit was reported as none. The outcome of the event (bad taste in her mouth) was unknown, event (itching on the roof of her mouth, her tongue was itching and burning, slight tongue swelling) was recovered on 25Feb2021 19:30 and event, event (roof of her mouth feels like when you've eaten something that is too hot) was recovered with sequel.  No follow-up attempts are possible. No further information was expected.