Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: neurological side effects; She has a sensation of pressure built up, like her arm was going to explode. It got to the point where she wanted to cut her arm off.; numbness/ left side of the body and skin feels numb; muscle spasms on her leg; twitching of different body parts including my eye/ legs twitch; her finger tips there is painful pressure and it is on and off.; tingling sensation/ tingling on my whole left side of my body; itchiness/ left arm is super itchy up; demyelination; This is a spontaneous report from a contactable nurse (patient herself) via a Pfizer-sponsored program, . A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9261) via an unspecified route of administration, administered in left arm, on 19Jan2021 (at the age of 35 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included an oral contraceptive birth control which she has been on it for years and ongoing. On 19Jan2021, it was reported that the patient experienced neurological side effects and (medically significant), and demyelination (medically significant) on unspecified date in 2021. The neurological side effects started the same day she got the first COVID vaccine and it was getting worse. She got it on 19Jan2021, and the neurological side effects started within a minute or less. The reporter queried if it's possible that the COVID vaccine triggered an autoimmune reaction to cause demyelination and if there's any information about neuro effects. The patient stated that she experienced a tingling sensation within a minute of receiving the vaccine and then it went away. 2 weeks later, the patient had tingling on her whole left side of the body.  She continued to have tingling, itchiness, twitching of different body parts including the eye. Her legs twitch, the numbness never went away, and the tingling comes and goes since January when she received the 1st dose. The patient stated that the twitching got worse every time she experiences it. She stated that she has seen a neurologist and had a video assessment and has an in-person appointment tomorrow to be evaluated. She has a primary one and a neurologist since experiencing these side effects. Neurological side effects: When she got the shot the first symptom, it was a tingling sensation like her arm was falling asleep. It was her arm and hand on the side she got the injection. She got the shot on left arm and it was her left arm and hand that had the tingling sensation and it went away in 15 minutes the first day. A couple of weeks later the tingling sensation came back except it was on the whole left side. It was her arm, brain, and whole left side of body that had the tingling sensation. She knew it was normal for eyes to have a twitch at times. After the second time the tingling sensation came back, her left eye has been twitching on and off. It was not constant, but it was on and off. Her left arm was super itchy up until this date, which was months after. She has a sensation of pressure built up, like her arm was going to explode. It got to the point where she wanted to cut her arm off. Thankfully she didn't because she talked herself out of it. Her left side of the body and skin felt numb like when her arm falls asleep, not tingling. The numbness as always there, but the tingling comes and goes on the left side only. Her main ones ere tingling sensation, numbness, itching, and pressure built up that felt like it was going to explode. She has muscle spasms on her leg. Everything was only occurring on left side, the injection side. She can't cross her legs anymore because it feels like pressure builds up on her left side. Now, on her fingertips there was painful pressure and it is on and off. The patient was afraid to get a 2nd dose and have neuro symptoms become worse and queried how she would know if she had an allergy. She clarified that she only got the first dose and refused second dose because she got scared. The events did not require visit to emergency room. Physician's office was required for the events. There were no events prior the vaccination. The outcome of the events demyelination and muscle spasms was unknown, while for the other events was not recovered. The reporter assessed the event neurological side effect as related with the suspect product.; Sender's Comments: Based on the Limited information in the case, a possible contributory role of the vaccine BNT162B2 to the reported events. 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.