Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Breast disorder female, Hernia, Hypersensitivity, Mouth swelling
Clinical narrative: robotic hernia surgery; breast surgery; swelling on the floor of the mouth; tongue feeling uncomfortable; Allergy; tongue swelling/swelled again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6204) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Factor V Leiden Blood Clotting Mutations" (ongoing), notes: she takes Aspirin for that every day; diagnosed with this about 15 years ago; "Acid reflux" (ongoing), notes: diagnosed with these a long time ago, probably like 15 years ago or 10 years ago; "Schatzki's ring on her esophagus" (ongoing), notes: 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). Vaccination history included: Bnt162b2 (Dose 1, single, administered in the left arm, lot Number: EN6202), administration date: 26Feb2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "tongue swelling"; Bnt162b2 (Dose 1, single, administered in the left arm, lot Number: EN6202), administration date: 26Feb2021, when the patient was 56 years old, for COVID-19 immunisation, reaction(s): "swelling on the floor of the mouth", "tongue feeling uncomfortable". The following information was reported: SWOLLEN TONGUE (prolonged hospitalization) with onset 17Jun2021, outcome "unknown", described as "tongue swelling/swelled again"; HERNIA (hospitalization), outcome "unknown", described as "robotic hernia surgery"; BREAST DISORDER FEMALE (hospitalization), outcome "unknown", described as "breast surgery"; HYPERSENSITIVITY (prolonged hospitalization) with onset 17Jun2021, outcome "unknown", described as "Allergy"; MOUTH SWELLING (non-serious), outcome "unknown", described as "swelling on the floor of the mouth"; TONGUE DISCOMFORT (non-serious), outcome "unknown", described as "tongue feeling uncomfortable". The events "tongue swelling/swelled again" and "allergy" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: didn't think that the caller had the symptoms and, notes: enzymes that show that it was an allergy.  Clinical course: Ever since she had she first dose, she has had the 2 vaccines and the booster, she had been having episodes of her tongue swelling. She has been to the emergency room twice because of it and she has been to her primary doctor, an ENT doctor, an allergist and 2 rheumatologists. The first time it happened it was after her first dose of the vaccine on 26Feb2021 and she didn't equate this with the vaccine because her tongue didn't swell until 11Mar2021, so it was a couple weeks afterwards. 11Mar2021 was the first time that it happened. She had her second vaccine on 19Mar2021, and her tongue didn't swell after that time, but it swelled again on 17Jun2021 and then it swelled again on 19Jul2021. She had surgery, a breast surgery on 31Aug2021, and her tongue also swelled that time. She was pretty much done with her recovery and they were going to send her home and then her tongue swelled so they kept her extra few hours because of that. Her tongue swelled again on 28Oct2021. On 04Nov2021, she had another surgery, a robotic hernia surgery and the same thing where she was in her recovery and was pretty much done and doing well and ten her tongue started swelling. She had the booster on 06Dec2021. All of her doctors seemed to think it was an allergic thing, but the allergist didn't think that. The allergist did bloodwork and didn't think that the caller had the symptoms and enzymes that show that it was an allergy. It was a weird thing that was happening, and no one could figure it out. She also saw an oral pathologist because the allergist thought that she may have 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. The oral pathologist said that with tongue swelling it is not uncommon to also have swelling on the floor of the mouth, that had lasted another couple of hours, the swelling of her tongue and the floor of the mouth had subsided. After this, it leaves her tongue feeling uncomfortable, that happened every time. It felt like when you have had hot pizza and it burns your mouth and leaves that feeling for half of the day in her mouth or for the rest of the day. The patient did not have prior vaccinations (within 4 weeks) prior to the first vaccination of BNT162B2. The patient's mother has an allergic reaction to the IVP dye that she is highly allergic and goes to anaphylaxis, but the patient didn't think if that has anything to do with what the patient had.