Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Hypersensitivity, Immunisation, Investigation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (202101758385). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 14:45 (Lot number: FJ8757) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Factor V Leiden Blood Clotting Mutations" (ongoing), notes: Blood Clotting Mutations, She was diagnosed with this about 15 years ago; "acid reflux" (ongoing), notes: 15 years ago or 10 years ago she doesn't remember; "Shatzky Ring on her esophagus" (ongoing). Family history included: "allergic reaction to the IVP dye" (unspecified if ongoing), notes: Mother (get an x ray that she is highly allergic to and goes anapalyactic ). Concomitant medication(s) included: ASPIRINE taken for factor v leiden mutation (ongoing). Vaccination history included: Bnt162b2 (First dose; Lot Number: EN6202 (She says that the lot number is either ENG202 or EN6202, but she thinks that it is EN6202), Location: Left arm), administration date: 26Feb2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "tongue swelling"; Bnt162b2 (Second dose, Lot Number: EN6204, Location: Left arm, (patient has had multiple incidents of "tongue swelling", with two of those incidents occurring after surgeries on 11Mar2021, 17Jun2021, 19Jul2021, 28Oct2021.)), administration date: 19Mar2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "tongue swelling", "A robotic hernia surgery", "breast surgery". The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 14:45, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "The next day after her booster dose she had a fever in the evening, 101 degrees Fahrenheit."; SWOLLEN TONGUE (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "She had woken up with a swollen tongue."; HYPERSENSITIVITY (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "It was an allergy"; MOUTH SWELLING (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "the swelling of her tongue and the floor of the mouth"; TONGUE DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "tongue feeling uncomfortable". The events "she had woken up with a swollen tongue.", "it was an allergy" and "the swelling of her tongue and the floor of the mouth" 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 pyrexia.  Additional information: Patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient and her husband had one of the doses on the same day but for some reason she doesn't have the time. Patient took ibuprofen and went to bed then she woke up without the fever, so it resolved during the night at some time. The tongue swelling subsided after a few hours and it left a lump under her tongue, which the oral pathologist said that is all part of the swelling. The oral pathologist said that with tongue swelling it is not uncommon to also have swelling on the floor of the month, that had lasted another couple of hours so by 2:00 it had all resolved, the swelling of her tongue and the floor of the mouth had subsided. It feels like when patient had hot pizza and it burns mouth and leaves that feeling for half of the day in mouth or for the rest of the day. All of her doctors seem to think it was an allergic thing but the allergist doesn't think that. It was a weird thing that was happening and no one can figure it out. Patient also saw an oral pathologist because the allergist thought that patient may have needed a tongue biopsy. At that point the swelling had subsided and there were no lumps in patient mouth or on tongue so there was nothing to biopsy. She had 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.  Follow-up attempts are completed. No further information is expected.