Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Oral discomfort, Smear buccal
Clinical narrative: she cannot "eat things"; burning of the mouth/terrible burning; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: pfizer COVID-19 vaccine (DOSE 1, Left arm, Lot number: Either G or E for first letter, so either GN6201 or EN6201), administration date: 05Feb2021, when the patient was 61-year-old, for covid-19 immunisation, reaction(s): "never had a reaction"; pfizer COVID-19 vaccine (DOSE 2, Left arm. Lot number: Must be EN6198), administration date: 26Feb2021, when the patient was 61-year-old, for covid-19 immunisation, reaction(s): "never had a reaction"; pfizer COVID-19 vaccine (DOSE 3, Left arm. Lot number: EW0176), administration date: 27Sep2021, when the patient was 61-year-old, for covid-19 immunisation, reaction(s): "never had a reaction"; pfizer COVID-19 vaccine (DOSE 4, Left arm. Lot number: EW0176), administration date: 28Apr2022, when the patient was 62-year-old, for covid-19 immunisation, reaction(s): "never had a reaction"; pfizer COVID-19 vaccine (DOSE 5, Left arm. Lot number: GH9694), administration date: 23Sep2022, when the patient was 62-year-old, for covid-19 immunisation, reaction(s): "never had a reaction"; pfizer COVID-19 vaccine (DOSE 6, Left arm. Lot number: Thinks HD9786, could be a 1 on the end, kind of sloppy), administration date: 22Sep2023, when the patient was 63-year-old, for covid-19 immunisation, reaction(s): "never had a reaction". The following information was reported: ORAL DISCOMFORT (non-serious) with onset Sep2024, 1 week after the suspect product(s) administration, outcome "not recovered", described as "burning of the mouth/terrible burning"; EATING DISORDER (non-serious), outcome "not recovered", described as "she cannot "eat things"". The events "burning of the mouth/terrible burning" and "she cannot "eat things"" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oral discomfort, eating disorder.  Additional information included: The patient has experienced burning sensation in mouth, it was a terrible burning, that sensation. And that she cannot "eat things", such as sugar. The patient thinks burning sensation in mouth started a week later. She did undergo testing, in which results with regard to viral or fungal infection came back negative. Also, caller added that she has experienced side effect for 3 months now. Also added caller has had every Pfizer COVID-19 vaccine ever since the first one was released and caller has never had a reaction, but suspects that this last vaccination of the Pfizer COVID-19 vaccine may be responsible for this reaction caller has had. Concomitant products included the regular medicines patient takes, nothing new. The events were ongoing, has improved slowly. Treatment or medical interventions: Was on oral rinse for fungal infection, like oral thrush, was on a steroid rinse which was dexamethasone, was on big doses of Diflucan, tried everything. Finally at the end HCP did swab, found out at that point after this many months, still has symptoms, but swabbed and all came back negative.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.