Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Joint instability, Muscular weakness, Paraesthesia
Clinical narrative: numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbness to her left arm; My left knee was buckling, making walking very difficult; My left knee was buckling, making walking very difficult; my right side also became slightly numb, and was also tingling; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO140, expiration date unknown), via an unspecified route of administration in the left arm on 10Jan2021 at 11:45 AM at a single dose for COVID-19 immunization.  Medical history included neuropathy and migraine.  The patient did not have COVID prior to vaccination. Patient is not pregnant. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) on unspecified dates for unspecified indications. The patient has not had other vaccines in four weeks. On 10Jan2021, three hours after being vaccinated (at approximately 3:00 PM), the patient experienced complete numbness to her left leg (from her ankle to her hip/waist). Hours later, the patient noted numbness to her left arm. Her left knee was buckling, making walking very difficult. The patient reported to the ER, and after several hours of waiting to be seen by a doctor, her right side also became slightly numb, and was also tingling. 18 hours after symptom onset (at approximately 9:30am, the day following injection), the numbness on her right side resolved. It was also reported that the numbness on her left side did not completely resolve for more than 24 hours.  The patient underwent lab tests and procedures which included nasal swab test which was negative on 13Jan2021 . Therapeutic measures were taken as a result of the events which included anti-anxiety medication for calming. The outcome of the events left knee was buckling, making walking very difficult and tingling was recovered on unspecified date, while the rest of the events was recovering at the time of report.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported complete numbness to her left leg (from her ankle to her hip/waist)/numbness to her left arm,  left knee was buckling,  walking very difficult, right side also became slightly numb and tingling, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.