Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysarthria, Eating disorder, Fatigue, Somnolence
Clinical narrative: an ulcer or sore on the tongue; an ulcer or sore on the tongue; did not eat for about four or five days; slurring a little; lost about five pounds; groggy from taking the vaccine; felt weak and fatigue the last 4 or 5 days; felt weak and fatigue the last 4 or 5 days; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 31Aug2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcer" (unspecified if ongoing); "stress" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: TONGUE ULCERATION (non-serious) with onset 01Sep2024 at 18:00, outcome "recovering", TONGUE DISORDER (non-serious) with onset Sep2024, outcome "recovering" and all described as "an ulcer or sore on the tongue"; EATING DISORDER (non-serious) with onset Sep2024, outcome "recovered" (Sep2024), described as "did not eat for about four or five days"; ASTHENIA (non-serious) with onset Sep2024, outcome "unknown", FATIGUE (non-serious) with onset Sep2024, outcome "not recovered" and all described as "felt weak and fatigue the last 4 or 5 days"; SOMNOLENCE (non-serious) with onset Sep2024, outcome "unknown", described as "groggy from taking the vaccine"; WEIGHT DECREASED (non-serious) with onset Sep2024, outcome "unknown", described as "lost about five pounds"; DYSARTHRIA (non-serious) with onset Sep2024, outcome "unknown", described as "slurring a little". Therapeutic measures were taken as a result of tongue ulceration.  Additional information: Patient wanted to know if an ulcer or sore on the tongue was a normal side effect from this vaccine. He also mentioned that he felt weak and fatigue the last 4 or 5 days. He said he read online that some people experienced sores on the mouth after a dose of this vaccine. A review of the Prescribing Information for Comirnaty did not find information regarding ulcers on the mouth. Calling about Pfizer Comirnaty, COVID-19, said LIN221G or LIM221G, patient was not sure, patient cannot read the technician's handwriting. Patient got the vaccine a week ago on Saturday 31Aug2024, and in about a day and a half had ulcer on tongue, which as gone down quite a bit, but patient was slurring a little, ulcer was still there, but better. Patient was also really fatigued, did not eat for about four or five days, mostly because of tongue but still a little bit fatigued. Wanted to make sure not overreacting mentally, patient was weak but was okay. Patient ate a lot of food last night, but not over the four or five days, Patient lost about five pounds, didn't eat, was chewing on left side of mouth. Patient wanted advice on what to do. Ulcer on tongue was about closed up, but asking was that a normal adverse reaction to have an ulcer? Patient read it was, but wanted to be sure correct. Ulcer was better but wanted to make sure. Stated Pfizer was a good company, patient had all Pfizer doses for all of patient's five COVID vaccines. Patient was also groggy from taking the vaccine, but stated patient was a big boy. Ulcer started around 6PM Sunday night, 01Sep2024. was minor, but annoying. Patient has been putting hydrogen peroxide on it with a Q-tip, and doing mouthwash with hydrogen peroxide. Hopefully ulcer will be gone tomorrow since has had for a week. Patient has had ulcers before, just normal from stress, confirmed not from the vaccines, but those ulcers only lasted two or three days, and this has gone on for a week. Patient got the vaccine from grocery store. Patient's wife and patient went together, Patient's wife had no reaction. Patient's wife got the flu shot at the same time. Patient was pretty decent. Patient had the other doses with no reaction until now.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.