Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Impaired gastric emptying, Influenza like illness, Neuropathy peripheral
Clinical narrative: felt very ill (flu like symptoms); Blood Sugars have ranged from 40-440 for no reason, with no change in diet or exercise; Neuropathy in her feet/legs; Severe fatigue and weakness in my legs, have intensified to the point of not being able to walk, or put my feet to the ground.; Severe fatigue and weakness in my legs, have intensified to the point of not being able to walk, or put my feet to the ground.; Memory loss; confusion; stomach had become paralyzed (Gastroparesis); Severe fatigue and weakness in my legs, have intensified to the point of not being able to walk, or put my feet to the ground.; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN5318, on 17Feb2021 15:30 at single dose in left arm for COVID-19 immunization. Medical history included depression, Anxiety, Fibromyalgia, Neuropathy, Type II Diabetic. The patient was not diagnosed with COVID-19 Prior to vaccination. Concomitant medication was not reported. The patient did not have other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, Lot/Batch: EL1283 on 27Jan2021 15:15 on left arm. The patient previously received droperidol (INAPSINE) and had allergy. On 19Feb2021, the patient felt very ill (flu like symptoms) for 10 days. Her Blood Sugars have ranged from 40-440 for no reason, with no change in diet or exercise. She was not on insulin prior to the vaccine. The Neuropathy in her feet/legs and severe fatigue and weakness in her legs, have intensified to the point of not being able to walk, or put her feet to the ground. She had also had memory loss and confusion. Also, her stomach had become paralyzed (Gastroparesis). Her employer stated, that they will place her on inactive status until her Doctors and her figure out what was going on. Lab data included Nasal swab (Rapid test) negative on 06Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for all events. The outcome of all events was not resolved. All events are serious with disability.; Sender's Comments: Based on the available information, the company considers that a causal relationship between felt very ill (flu like symptoms), severe fatigue and weakness in her legs, have intensified to the point of not being able to walk, or put her feet to the ground and BNT162B2 vaccination cannot be excluded due to plausible temporal association. The Company considers the reported events Blood Sugars have ranged from 40-440, Neuropathy in her feet/legs, memory loss and confusion, stomach had become paralyzed (Gastroparesis) are unrelated to BNT162B2 vaccination, but more likely due to underlying or inter-current medical conditions. 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.