Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Swollen tongue
Clinical narrative: her first dose, she has had multiple incidents of "tongue swelling", with two of those incidents; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558; 202101758385). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6202) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Factor V Leiden Blood Clotting Mutations" (ongoing), notes: she takes Aspirin for that every day. She was diagnosed with this about 15 years ago; "Acid Reflux" (ongoing); "Shatzky Ring on her esophagus" (ongoing), notes: She was diagnosed with these a long time ago, probably like 15 years ago or 10 years ago. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for factor v leiden mutation (ongoing). The following information was reported: SWOLLEN TONGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "her first dose, she has had multiple incidents of "tongue swelling", with two of those incidents". The event "her first dose, she has had multiple incidents of "tongue swelling", with two of those incidents" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Ever since she had she 1st dose, she has had the 2 vaccines and the booster, she had episodes of her tongue swelling. The first time it happened it was after her 1st dose of the vaccine on 26Feb2021, and she did not equate this with the vaccine because her tongue did not swell until 11Mar2021, so it was a couple weeks afterwards. 11Mar2021 was the first time that it happened. The allergist did bloodwork and did not thought that the caller had the symptoms and enzymes that show that it was an allergy. It was a weird thing that was happened and no one can figure it out. She also saw an oral pathologist because the allergist thought that she might had needed a tongue biopsy. At that point the swelling had subsided and there were no lumps in her mouth or on her tongue so there was nothing to biopsy. The oral pathologist also thought that it was an allergy and that something had triggered it. The oral pathologist thought that the caller should be patch tested for allergies which was the same thing that both rheumatologists had said to her. Additional Vaccines Administered on Same Date of the Pfizer Suspect: 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): None. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): No, not at all. No one had any kind of reactions to vaccines or anything like that that was similar to what she had. Her mother had an allergic reaction to the IVP dye like when you get an x ray that she was highly allergic to and went anaphylactic but the caller did not know if that had anything to do with what she had. Relevant Tests: None. Investigation Assessment: No.   No follow-up attempts are possible. No further information is expected.