Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fall, Muscle twitching, Muscular weakness, Nerve conduction studies
Clinical narrative: new acute denervation bilateral spinal muscles as well as right L5/S1 acute denervation; I started falling by getting jolts down my right leg and the leg goes weak and I fall; I started falling by getting jolts down my right leg and the leg goes weak and I fall; worsening of the chronicity of the radiculopathy; jolts down my right leg; This is a spontaneous report from a contactable physician (Patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: En6199) via intramuscular route of administration (age at vaccination 55-year) in Left Arm on 04Mar2021 at 02:30 as dose 1, single for COVID-19 immunization. Medical history included diabetes, hypertension, low testosterone, high triglycerides, Flu, latex, tetanus, chronic back issues, chronic L5/S1 radiculopathy, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Cymbalta and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination, but none new. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Mar2021 at 08:00 the patient experienced new acute denervation bilateral spinal muscles as well as right l5/s1 acute denervation, he started falling by getting jolts down his right leg and the leg goes weak and he fall, worsening of the chronicity of the radiculopathy. It was reported by the patient that "I have chronic back issues already with chronic L5/S1 radiculopathy. Mid-March I started falling by getting jolts down my right leg and the leg goes weak and I fall. It has progressively gotten worse to where I need a cane to walk. Had repeat myelogram in June because of this and no change from prior. Had NCS/EMG end of July showing worsening of the chronicity of the radiculopathy but also new acute denervation bilateral spinal muscles as well as right L5/S1 acute denervation. I continue to worsen". The patient underwent lab tests and procedures which included nerve conduction studies: worsening of the chronicity of the radiculopathy, nerve conduction studies: acute denervation bilateral spinal muscles as well, nerve conduction studies: right l5/s1 acute denervation, all in Jul2021; spinal myelogram: no change from prior in Jun2021. Therapeutic measures were taken as a result of the adverse events, PT. Neurology consult treatment was pending. The seriousness of the events was reported as serious (Disabling/Incapacitating). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was not recovered.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.