Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Localised infection, SARS-CoV-2 antibody test, Stomatitis
Clinical narrative: Caller reported that he loses his voice a two to three minutes after talking; mouth sores and a foot infection; was diagnosed with voice fatigue; mouth sores and a foot infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EL8982, Expiration Date: 31May2021) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic  Lymphocytic Leukemia" (unspecified if ongoing), notes: For 6 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EK9231, Arm), administration date: 13Jan2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "Voice disturbance", "Sore throat", "Feeling miserable", "Foot infection", "Sores mouth", "Loss of voice", "Sensitive skin", "Feeling unwell", "Pain in arm", "Chills".  The following information was reported: APHONIA (non-serious) with onset 2021, outcome "unknown", described as "Caller reported that he loses his voice a two to three minutes after talking"; LOCALISED INFECTION (non-serious), STOMATITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "mouth sores and a foot infection"; DYSPHONIA (non-serious) with onset 2021, outcome "unknown", described as "was diagnosed with voice fatigue". The events "caller reported that he loses his voice a two to three minutes after talking", "mouth sores and a foot infection", "was diagnosed with voice fatigue" and "mouth sores and a foot infection" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of aphonia, dysphonia.  Additional Information: The second dose was on 4Feb2021. The reporter stated he has been miserable for 4.5 months. The reporter stated he has a history of Chronic Lymphocytic Leukaemia for six years and has been in touch with his oncologist. The reporter stated he has had issues since the both doses. The reporter reported that he loses his voice a two to three minutes after talking. The reporter reported mouth sores and a foot infection. The reporter has seen an ENT, a speech pathologist and a speech therapist. The reporter stated the ENT did not see anything wrong and he has been doing speech exercises. The reporter was diagnosed with voice fatigue by speech pathologist. The reporter asked if anyone else reported losing their voice after being vaccinated. Reported he had CLL for 6 years, and was starting to get bulky lymph nodes and spleen. He said he was being close to beginning treatment. No further details provided. Reported he was in a quandary. He said he had been to ENTs, and had pictures taken of his vocal cords. He said he had been to a speech pathologist, and speech therapist, and was given exercises to do. He said according to everyone he had gone to, there was nothing wrong with his vocal cords. He said he was told everything looked good. He said the doctor diagnosed him with voice fatigue. Reported he also developed sores in his mouth, and had an infection in his foot. He said he knows he can't blame everything on the COVID-19 Vaccine, but his voice issues, the sores in his mouth, and his foot infection all happened right after he took the COVID-19 Vaccine shots. He said he wanted to know if his voice issue was a reported effect of the COVID-19 Vaccine, as well as certain kinds of skin infections. He said he had been miserable for the past 4-1/2 months. Reported he had asked his oncologist a month ago for a COVID-19 antibody test for the COVID-19 Vaccine. He said his oncologist told him the COVID-19 antibody test was not a good test but gave him a prescription to have the COVID-19 antibody test performed. He said his COVID-19 antibody test showed negative. He said he had a second COVID-19 antibody test offered through a Lymphoma clinical trial, and that COVID-19 antibody test was negative also. The reporter asked how Pfizer regards the COVID-19 antibody test, and if the COVID-19 antibody test was considered reliable. He clarified his wife told him the testing he had performed was to check for the COVID-19 Virus spike protein. The reporter wanted to know if voice loss was a reported side effect of the COVID-19 Vaccine. The reporter wanted to know what Pfizer's opinion was on the reliability of the COVID-19 antibody test.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021041330 same patient/different dose/event