Received Jan 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
could not move her legs and her toes were completely numb.; she had difficulty walking and resolved to using a wheelchair.; Guillain-Barre syndrome; weakness and pain in both her legs; chest pain; abdominal bloating; Anxiety; tingling; headaches; fatigue; severe pain in bilateral legs from the knees down.; could not move her legs and her toes were completely numb.; This is a spontaneous report received from a Physician and Lawyers. A 17-year-old female patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 13Aug2021, for Covid-19 immunization, reaction(s): "mild fatigue", "arm pain". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "unknown", described as "severe pain in bilateral legs from the knees down."; HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", DIPLEGIA (medically significant), outcome "unknown" and all described as "could not move her legs and her toes were completely numb."; GAIT DISTURBANCE (disability), outcome "unknown", described as "she had difficulty walking and resolved to using a wheelchair."; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "weakness and pain in both her legs"; CHEST PAIN (non-serious), outcome "unknown"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "abdominal bloating"; ANXIETY (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; FATIGUE (non-serious), outcome "unknown". The event "guillain-barre syndrome" required physician office visit. The events "could not move her legs and her toes were completely numb.", "she had difficulty walking and resolved to using a wheelchair." and "severe pain in bilateral legs from the knees down." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: normal. Therapeutic measures were taken as a result of gait disturbance. Clinical course: It was reported that a healthy 17-year-old teenager. She was a good student who enjoyed school, socialized with her friends, had a passion for agriculture, and started to become active with the local (withheld) group. (name) wanted a "normal school year" and did not want to be forced to quarantine with Covid-19 outbreaks at school. Thus, (name) and her mother decided she would receive the Pfizer Covid-19 vaccination. They both felt the vaccination would be safe and effective given the information provided from the (withheld) regulatory agencies. (name) received her first Pfizer vaccination on 13Aug2021 at a local hospital. She experienced some mild fatigue and arm pain after the first vaccination. On 09Sep2021(name) received the second Pfizer vaccination at her school Covid-19 clinic. By the next morning, she was unable to attend school because of severe pain in bilateral legs from the knees down. She presented to the local emergency room and was told these were normal aches and pains from the vaccination. Within the same day, she re-presented to the emergency room still in pain. (name) could not move her legs and her toes were completely numb. Again, she was told this was a normal reaction to the vaccine. Two days later, she was taken to her primary care physician by her mother. The physician could not offer any help because the vaccine was "too new" and not enough information was known about the vaccination. Physical therapy was recommended. (name) was seen by a different family physician who thought she may have Guillain-Barre syndrome. Subsequently, she was referred to neurology. MRI of the spine was completed and demonstrated normal results. Neurology told (name) her symptoms were related to anxiety. (name) continued to decline with neurologic symptoms including weakness and pain in both her legs, she had difficulty walking and resolved to using a wheelchair. 09Sep2021 was the last day (name) remembers a "normal life" and a "normal school year." Instead of returning to a normal life after vaccination, she now has the exact opposite. (name) suffers on a daily basis with numerous symptoms including pain, weakness, fatigue, headaches, chest pain, tingling, and abdominal bloating. She no longer attends school and is considered homebound. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on plausible temporal relationships and current known available information, a possible contributory role of BNT162b2 cannot be excluded for the reported events diplegia, gait disturbance, Guillain-Barre syndrome. 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.
Test Name: MRI of the spine; Result Unstructured Data: Test Result:normal