Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Slow speech, Temperature intolerance, Urinary tract disorder, Vertigo
Clinical narrative: covid test result=Positive; covid test result=Positive; Severe muscle cramps/Severe muscle spasms; difficulty walking; difficulty with balancing; muscle weakness; coordination issues; stiff muscles and legs; Severe fatigue; memory loss; slow speech; difficulty finding words; voice changes; vertigo; dizziness; sporadic shocks; sleep issues; burning; tingling; heat intolerance; urinary issues; foot issues; Severe widespread pain; falls; This is a spontaneous report received from an Other HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 1, single (Lot number: FJ5683) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies"; Morphine, reaction(s): "Known allergies". The following information was reported: FATIGUE (disability) with onset 24Jan2022, outcome "not recovered", described as "Severe fatigue"; MUSCLE SPASMS (disability) with onset 24Jan2022, outcome "not recovered", described as "Severe muscle cramps/Severe muscle spasms"; PAIN (disability) with onset 24Jan2022, outcome "not recovered", described as "Severe widespread pain"; BURNING SENSATION (disability) with onset 24Jan2022, outcome "not recovered", described as "burning"; COORDINATION ABNORMAL (disability) with onset 24Jan2022, outcome "not recovered", described as "coordination issues"; APHASIA (disability) with onset 24Jan2022, outcome "not recovered", described as "difficulty finding words"; GAIT DISTURBANCE (disability) with onset 24Jan2022, outcome "not recovered", described as "difficulty walking"; BALANCE DISORDER (disability) with onset 24Jan2022, outcome "not recovered", described as "difficulty with balancing"; DIZZINESS (disability) with onset 24Jan2022, outcome "not recovered"; FALL (disability) with onset 24Jan2022, outcome "not recovered", described as "falls"; LIMB DISCOMFORT (disability) with onset 24Jan2022, outcome "not recovered", described as "foot issues"; TEMPERATURE INTOLERANCE (disability) with onset 24Jan2022, outcome "not recovered", described as "heat intolerance"; AMNESIA (disability) with onset 24Jan2022, outcome "not recovered", described as "memory loss"; MUSCULAR WEAKNESS (disability) with onset 24Jan2022, outcome "not recovered", described as "muscle weakness"; SLEEP DISORDER (disability) with onset 24Jan2022, outcome "not recovered", described as "sleep issues"; SLOW SPEECH (disability) with onset 24Jan2022, outcome "not recovered"; SHOCK (disability) with onset 24Jan2022, outcome "not recovered", described as "sporadic shocks"; MUSCULOSKELETAL STIFFNESS (disability) with onset 24Jan2022, outcome "not recovered", described as "stiff muscles and legs"; PARAESTHESIA (disability) with onset 24Jan2022, outcome "not recovered", described as "tingling"; URINARY TRACT DISORDER (disability) with onset 24Jan2022, outcome "not recovered", described as "urinary issues"; VERTIGO (disability) with onset 24Jan2022, outcome "not recovered"; DYSPHONIA (disability) with onset 24Jan2022, outcome "not recovered", described as "voice changes"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result=Positive". The events "severe muscle cramps/severe muscle spasms", "difficulty walking", "difficulty with balancing", "muscle weakness", "coordination issues", "stiff muscles and legs", "severe fatigue", "memory loss", "slow speech", "difficulty finding words", "voice changes", "vertigo", "dizziness", "sporadic shocks", "sleep issues", "burning", "tingling", "heat intolerance", "urinary issues", "foot issues", "severe widespread pain" and "falls" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures (meds) were taken as a result of muscle spasms, gait disturbance, balance disorder, muscular weakness, coordination abnormal, musculoskeletal stiffness, fatigue, amnesia, slow speech, aphasia, dysphonia, vertigo, dizziness, shock, sleep disorder, burning sensation, paraesthesia, temperature intolerance, urinary tract disorder, limb discomfort, pain, fall.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded. There is a reasonable possibility that the events fatigue, tingling, and dizziness were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events muscle cramps, gait disturbance, difficulty with balancing, muscle weakness, coordination issues, stiff muscles and legs, amnesia, slow speech, difficulty finding words, dysphonia, vertigo, sporadic shocks, sleep issues, burning, temperature intolerance, urinary issues, foot issues, widespread pain, and fall with BNT162b2 can not 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.