Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Arthralgia, Condition aggravated, Investigation, Magnetic resonance imaging
Clinical narrative: Speech issues started and were significant by May2021; Speech issues started and were significant by May2021/Speech issues worsened; Joint pain; Apathy; Personality changes; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 10:00 as dose 2, single (Lot number: EL9264) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LISINOPRIL; LEVOTHYROXINE; SINGULAIR. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EM6200, Route of administration: Intramuscular, Time of administration: 09:00 AM, Location: Left arm), administration date: 18Feb2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Speech issues", "Joint pain", "Apathy", "Personality changes". The following information was reported: SPEECH DISORDER (disability) with onset May2021, outcome "not recovered", described as "Speech issues started and were significant by May2021"; CONDITION AGGRAVATED (disability) with onset May2021, outcome "not recovered", described as "Speech issues started and were significant by May2021/Speech issues worsened"; APATHY (disability) with onset 2021, outcome "not recovered"; ARTHRALGIA (disability) with onset 2021, outcome "not recovered", described as "Joint pain"; PERSONALITY CHANGE (disability) with onset 2021, outcome "not recovered", described as "Personality changes". The events "speech issues started and were significant by may2021", "speech issues started and were significant by may2021/speech issues worsened", "joint pain", "apathy" and "personality changes" required physician office visit. The patient underwent the following laboratory tests and procedures: ALS clinic eval: Negative, notes: ALS (amyotrophic lateral sclerosis) clinic eval (negative); Negative, notes: Neurologist eval, Neuro Surgeon eval, etc. All negative; Negative; Magnetic resonance imaging: Negative, notes: Speech issues worsened which  lead to 2 MRI (negative). Therapeutic measures were taken as a result of speech disorder, condition aggravated, arthralgia, apathy, personality change. The patient received treatment as Ivermectin, Naltrexone and Synapsin.   Clinical course: It was reported that no other vaccines administered in four weeks, no covid prior vaccination and not tested for covid post vaccination. Allergies were reported as none. Speech issues started and were significant by May2021. Speech issues worsened which lead to 2 MRI (negative), ALS clinic eval (negative), Neurologist eval, Neuro Surgeon eval, etc. All negative. Speech issues, joint pain, apathy, personality changes are some of the issues that lead after the vaccine.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events speech disorder, condition aggravated, arthralgia, personality change, apathy and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate