Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Muscle spasms, Muscle twitching, Muscular weakness, Off label use
Clinical narrative: Began to experience vertigo within hours of vaccine. 12 hours from vaccine woke up with left leg numb. Visited ER after 2 days of numbness and tingling in left leg. Symptoms continued and a week to da; Began to experience vertigo within hours of vaccine. 12 hours from vaccine woke up with left leg numb. Visited ER after 2 days of numbness and tingling in left leg. Symptoms continued and a week to da; told possible GBS from vaccine; Began to experience vertigo within hours of vaccine. 12 hours from vaccine woke up with left leg numb. Visited ER after 2 days of numbness and tingling in left leg. Symptoms continued and a week to da; numbness and tingling in left leg; numbness and tingling in left leg; hard to walk; extreme fatigue; heaviness in legs; burning; weakness in arms; severe muscle cramping, knots, twitching in legs; severe muscle cramping, knots, twitching in legs; This is a spontaneous report from a contactable other healthcare professional. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 13:30 (at the age of 36-years-old) as a single dose for covid-19 immunization. Medical history included none. Concomitant medication(s) included ascorbic acid, beta carotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETA CAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]); medications in two weeks included prenatal vitamins (breastfeeding), vitamin D & C. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced began to experience vertigo within hours of vaccine. 12 hours from vaccine woke up with left leg numb. Visited ER after 2 days of numbness and tingling in left leg. Symptoms continued and a week to date of vaccine numbness and tingling began in right foot and up right leg by end of day, then began in hands and arms. Next day, hard to walk - extreme fatigue and heaviness in legs. Visited ER again and told possible GBS from vaccine and to watch for worsening symptoms. Has been 3.5 months - tingling continues in all four limbs as well as burning and weakness in arms, and severe muscle cramping, knots, twitching in legs. Arms burn from simple tasks such as wiping off my counter or whisking an egg. Before vaccine, I was walking miles per day and now my legs are cramping and fatigued from walking down my block. Adverse event resulted in patient to visit doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment with several supplements, massage therapy for legs. The seriousness of the event was considered as disability or permanent damage. Outcome of the event was not recovered, at the time of this report.; Sender's Comments: Based on current information available events was considered related to suspect drug based on  temporal association.   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 RAs, Ethics Committees, and Investigators, as appropriate.