Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Electromyogram, Emotional distress, Fall, Muscular weakness
Clinical narrative: ALS; arm extremely painful/unusual pain; left arm weakness/right arm weakness as well/weakness in hands; fallen a couple of times; increased secretions; becoming emotional which is uncontrollable at times; itching; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 12:00 as dose 4 (booster), single (Lot number: GL0446) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE,, Lot: EL8982), administration date: 12Jan2021, for COVID-19 immunization, reaction(s): "Had no issues at all"; BNT162b2 (DOSE 2, SINGLE,, Lot: EL9269), administration date: 03Feb2021, for COVID-19 immunization, reaction(s): "Had no issues at all"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE,, Lot: PF12, something E, 182, not sure all scribbled on vaccination card), administration date: 01Oct2021, for COVID-19 immunization, reaction(s): "Had no issues at all". The following information was reported: PAIN IN EXTREMITY (disability) with onset 15Jan2023, outcome "not recovered", described as "arm extremely painful/unusual pain"; AMYOTROPHIC LATERAL SCLEROSIS (medically significant) with onset 15May2023, outcome "unknown", described as "ALS"; EMOTIONAL DISTRESS (non-serious) with onset 2023, outcome "unknown", described as "becoming emotional which is uncontrollable at times"; FALL (non-serious) with onset 2023, outcome "unknown", described as "fallen a couple of times"; SECRETION DISCHARGE (non-serious) with onset 2023, outcome "unknown", described as "increased secretions"; PRURITUS (non-serious) with onset 2023, outcome "unknown", described as "itching"; MUSCULAR WEAKNESS (disability) with onset 2023, outcome "not recovered", described as "left arm weakness/right arm weakness as well/weakness in hands". The events "arm extremely painful/unusual pain", "als", "left arm weakness/right arm weakness as well/weakness in hands", "fallen a couple of times", "increased secretions", "becoming emotional which is uncontrollable at times" and "itching" required physician office visit. The patient underwent the following laboratory tests and procedures: Electromyogram: (Apr2023) nerve damage in body, notes: a nerve conductor test. Unit: Not Provided. Clinical course: The patients arm started getting extremely painful, after the booster, had unusual pain. A couple of weeks later saw an orthopaedic doctor and mentioned patient started having left arm weakness on same arm patient received the vaccine. Also having weakness in hands. Scheduled an EMG in April, a nerve conductor test, and by the time EMG was scheduled, was generalized, clarified was not feeling well, was feeling weak. EMG showed nerve damage in body. The patient had no issues at all prior to vaccine. The doctor recommended patient to see a neurologist, the patient went to neurologist and was referred to neuromuscular doctor and went there in May, all of this happened so quickly. The patient could hardly perform any function in left arm and atrophy to muscles in arm. The pateint had fallen a couple of times. Started having increased secretions, difficulty speaking, speaking at lower tone, becoming emotional which was uncontrollable at times, his back was hurting and itching. The diagnosis from neuromuscular doctor was ALS, had gone to neurologist a week or 2 before then and suspected it, but then went to neuromuscular doctor and wants to do another EMG on 15Jun2023, waiting for the call back. This all happened after receiving the vaccine.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Pain in extremity , Amyotrophic lateral sclerosis, Muscular weakness and the use of suspect product comirnaty cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.