Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Somnolence, Tooth fracture, Tremor, Vision blurred
Clinical narrative: Chipped tooth; eye sight has gotten blurry; Her arms were going all over the place. Her arms are tingling.  Her muscles and stuff are sore because of the blood, she was shaking so hard.; Her arms were going all over the place. Her arms are tingling.  Her muscles and stuff are sore because of the blood, she was shaking so hard.; Her body got into chills, she thought she was having a seizure; shaking so hard she thought she would fall on the floor; Her body got into chills, she thought she was having a seizure; shivering so hard she almost broke her teeth; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; heart went funny and felt like she was going into the floor; Felt like she couldn't walk, dizzy, felt like she was floating; Felt like she couldn't walk, dizzy, felt like she was floating; Chest hurt; This is a spontaneous report from a contactable consumer. This is report 1 of 3. This consumer reported for self that the 46-year-old female patient received bnt162b2 (BNT162B2) at the age of 46-year-old, dose 1 via an unspecified route of administration, administered in Arm Right on 07Jun2021 09:40 AM (Batch/Lot Number: EVV0181) as dose 1, single for covid-19 immunisation. Medical history included seizure (she was diagnosed when she was 18 years old. Her sister had them too.), scleroderma (She was diagnosed 10 years ago.), epilepsy and all from an unknown date and unknown if ongoing. Family Medical History was none. Concomitant medications included prednisone (PREDNISONE) at 2.5mg, 1 tablet daily for scleroderma for 6 years; leflunomide (LEFLUNOMIDE) at 10mg tablet once daily for scleroderma 2 years ago; levetiracetam (LEVETIRACETAM) at 750 mg 4 tablets daily for epilepsy 20 years ago; phenobarbital (PHENOBARBITAL) at 64.8 take 4 of them, tablet for epilepsy (Started taking it 30 years ago. You'd think she'd be knocked out, but she's so used to this stuff); lamotrigine (LAMOTRIGINE) at 100 mg, 6 a day for epilepsy (Started taking it at least 20 years ago, its been a while, before she had her boy.). The patient experienced her body got into chills, she thought she was having a seizure on 25Jun2021 with outcome of recovered with sequelae, shivering so hard she almost broke her teeth on 25Jun2021 with outcome of recovered with sequelae, typical mild fever, stomach ache, drowsy. she felt like she had the flu on 07Jun2021 09:45 with outcome of recovered with sequelae, heart went funny and felt like she was going into the floor on 07Jun2021 with outcome of recovered, felt like she couldn't walk, dizzy, felt like she was floating on 07Jun2021 with outcome of recovered, shaking so hard she thought she would fall on the floor on 25Jun2021 with outcome of recovered with sequelae, eye sight has gotten blurry on 26Jun2021 with outcome of not recovered, her arms were going all over the place, her arms are tingling, her muscles and stuff are sore because of the blood, she was shaking so hard on 25Jun2021 with outcome of recovered with sequelae, chest hurt on 07Jun2021 with outcome of recovered, chipped tooth on an unspecified date with outcome of unknown.    The clinical course was reported as follows: Consumer states she is calling about the COVID shot, later verified as being Pfizer manufactured COVID shot. She received it on 7Jun2021. When she first got the shot she experienced typical mild fever, she expected it to happen but was out for about a week. Her sister told her she had an odd reaction to it, she said get ready. Friday, she had the same reaction her sister did. Her body got into chills, she thought she was having a seizure but she knew it wasn't seizure because she has epilepsy and this was different. She wasn't cold, but she was shivering so hard she almost broke her teeth. Her twin sister had same thing. She was shaking like cold extreme, she was in a ball. She had to keep from cracking her teeth. She tried to get out of bed but she couldn't stop. She was shaking so hard she would fall on the floor. She thought she was in shock or had a sugar thing. The following day she had a mild fever, her legs hurt, her hands hurts, she still has a mild headache. She also had stomach ache, drowsy, felt like she had the flu. Consumer states her sister and her sisters husband experienced the same thing. 3 people that had the same thing. Consumer states she was really cold but if she could've she would have shrunken into a tiny ball and disappeared she would have. Her sister and her sister's husband also experienced this so she doesn't know if it's the batch or what. She is calling her doctor to see if she should take a second one or what. Her boy is taking the second one today. Consumer states when she first had the shot she had a heart population-documented as verbally provided by caller; described by caller as her heart went funny and she felt like she was going into floor. She has epilepsy. She had to go home, she had a kid with her. After that her chest hurt for a little bit, for a full week. She thinks it was a nerve thing. She has never experienced anything like this before. She has had seizures before, this was not seizures. She states there is something wrong. She was shaking and chipped her tooth. She was trying to keep from biting her cheeks. Her arms were going all over the place. Her hands and feet, arms were tingling. Her muscles and stuff are sore because of the blood she guessed, she was shakng so hard. Consumer states she didn't feel cold. Her legs were contracting in, more like she was going into shock or having a sugar thing. She was wondering if she should ask her husband to get bananas. She doesn't have diabetes. Consumer states she has a twin sister she had this too. Consumer states she is still recovering from the muscle pulls and stuff. Her hands and legs hurt muscles from her rib cages from pulling. Caller mentioned she was going to get her glasses and reported another thing is her eye sight has gotten blurry. Her eyesight was bad as it is, but is worse now. It is very blurry. Consumer states this started a day after the shivering, on 26Jun2021. Consumer states she is still running a low grade fever. She thinks it is a second response, she was reading it could be a delayed reaction, she states it is weird. Consumer states her eye sight is so bad. Her calves hurt really bad. Vaccination Facility Type was Pharmacy. No AE required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Relevant Tests was none after Vaccination.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Chipped tooth cannot be totally excluded. It is noted that the patient has the medical history of seizure.   The case will be reassessed if additional information becomes available.  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.