Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Muscle twitching, Pain, Pain in extremity
Clinical narrative: twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; stinging in her legs and it went up to her waist and felt like a band around her waist; stinging in her legs and it went up to her waist and felt like a band around her waist; Unexpected weight loss; no appetite; Unexpected weight loss; no appetite; This is a spontaneous report received a contactable nurse, the patient. A 50-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EW0158 and expiry information not provided) as a single dose via unspecified route in the right arm on 08Apr2021 at 19:30 (at 50-years-old) for COVID-19 immunisation. Relevant medical history included COVID with insomnia (Nov2020). There were no concomitant medications or past drug history reported. The patient reported as soon as she got the shot, she did not feel sick or nauseated, maybe she had no appetite, but she has lost ten pounds three weeks. States before the vaccine she was 138 pounds. The patient reported that on 18Apr2021, reported as eight to ten days later she developed stinging in her legs and it went up to her waist and felt like a band around her waist. The patient reported that on 20Apr2021 she experienced twitches in her legs and then pain after, her face periodically twitches; eye twitches periodically especially after sneezing or coughing. The patient reported that she had COVID back in Nov2020 and she had some problems after and then recovered. States she just got the Pfizer COVID vaccine three weeks ago and she did really well with the first one; however eight to ten days later, she noticed stinging in her legs and it went up to her waist and felt like a band around her waist. Then she started having twitches in her legs, and then pain, states the twitches have remained, she cannot see them, but she can feel them. Caller states her face periodically twitches as well. Her eye will twitch periodically when she sneezes or coughs. The patient, a retired nurse, assessed the events as medically significant, because she needs to know if it is something more serious. The patient denied any visits to the emergency room or to any doctor's office for the events reported. The patient reported that she called a few neurologists to see if she could have gotten in but they are so booked up that she could not get an appointment until August. The patient stated that the neurology place said they are seeing some very strange things, so the patient believes she is not the only one. The reporter stated that maybe because she had COVID, she does not know if it is because of that, but maybe the first one acting is acting like the second dose for her. The patient inquired if it was okay to get the second dose. The outcome of the event stinging in her legs and it went up to her waist and felt like a band around her waist was recovered on 20Apr2021. The outcome of the event weight loss; no appetite, twitches in her legs and then pain after, and Face periodically twitches; eye twitches periodically especially after sneezing or coughing was not recovered.; Sender's Comments: Based on a compatible temporal association a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. 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.