Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Cerebral disorder, Confusional state, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: her mind doesn't work well anymore, she has a thought she cant get it out, she can't process it; multiple sclerosis flare, MS symptoms were elevated; forgetting the name of a medicine she used to take because her brain just went dead; her mind doesn't work well anymore, she has a thought she cant get it out, she can't process it/could not think straight; could not walk properly with her left leg; head spinning; brain disorder NOS; forgetting the name of a medicine she used to take because her brain just went dead; losing her voice; sore throat; the palm of her hand doesn't feel right; confused because of some issues with insurance; stress; vision changes; doesn't move very fast; fatigue; fever; body aches/achy; heart racing; Sick; legs are really weak; pain in her legs; Muscle ache; losing her hair; Headache; loose stool; bilirubin was out of range by 2.0; tingling in her arm in both arms; bowel problems; This is solicited report from a contactable consumer (patient) based on the information received by Pfizer from a Facilitating Company. (Report No: 2019SA004708).    A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization at the age of 76 years old; and teriflunomide, oral from 15Jun2018 (Lot Number: 1582645; Expiration Date: 31Dec2020) to 2018, at 14 mg, daily, oral from 22Nov2018 (Lot Number: 1582642; Expiration Date: 31Dec2020) to Feb2019, at 14 mg, daily and oral from 2019 (Lot number was not reported) and ongoing, at 14 mg, daily for multiple sclerosis. Medical history included ongoing multiple sclerosis from Oct1991 and ongoing, seizure, ongoing gait problems, drug hypersensitivity, did not tolerate sulfa, blood pressure, reflux and headache, from an unknown date. Concomitant medication(s) included simvastatin taken for blood pressure from an unspecified start date and ongoing; ranitidine taken for gastrooesophageal reflux disease from an unspecified start date to 2019; lisinopril taken for diuretic therapy from an unspecified start date and ongoing; and famotidine taken for diuretic therapy from 08Sep2020 and ongoing.  The patient previously took gabapentin and experienced drug intolerance, metoprolol succinate and experienced drug intolerance, gabapentin and experienced hypersensitivity, metoprolol succinate and experienced hypersensitivity. The patient experienced her mind doesn't work well anymore, she has a thought she can't get it out, she cant process it, MS symptoms just were bonkers for 3 days/ her ms symptoms were elevated, forgetting the name of a medicine she used  to take because her brain just went dead, losing her voice, sore throat, bowel problems, condition  worsened, the palm of her hand doesn't feel right, confused because of some issues with her insurance, for the past 15 months. The patient has been under tremendous stress, experienced vision changes, doesn't move very fast, fatigue, she had fever until the next day. 7hrs after receiving BNT162B2, the patient developed headache, muscle aches, fatigue, fever for over 24 hrs (hours), and heart racing for 3 days/ fever, body aches/achy, legs are really weak, pain in her legs, heart started racing/ heart rate race, hair is coming out/ losing her hair and there's something going on with her hair  again (recurrent), recurrent low grade headache that is aggravating/consistent headaches/ in the last week or two, consumer was more prone to having headaches/ bad headache/ the headaches sometimes goes away but she has it all the time, diarrhea, bilirubin was out of range by 2.0, had tingling in her arm in both arms, it got worst in the right arm and the palm of her hand does not feel right, headaches/horrible headache, off aubagio for 18 days, sick and heart racing giving her issues. The patient prior to teriflunomide, of going a year and a half between magnetic resonance imaging (MRI) with having no changes and that her last MRI was early last year in 2018; being on a popular medicine that was an injection (unspecified, unknown dosage and unknown frequency) for a couple of weeks which she discontinued  because one evening she had a horrible problem (unspecified) that threw her into seizures (unspecified); being on Rebif (interferon beta-1a) (unknown dosage and unknown frequency) which she showed signs of reacting (unspecified) after a few weeks and then discontinued with the interferon beta-1a because she was well over two weeks off of the interferon beta-1a since her neurologist screwed up with the prescription, and by the time they sent her the interferon beta-1a in the middle of February (patient did not specify the date), it was sitting out in freezing temperatures from probably 5 pm the day before so the patient did not use that interferon beta-1a; and in 2018 the patient began experiencing more gait problems and was much worse (unspecified)(gait disturbance) and noticeably different (unspecified), which was why she decided to go on teriflunomide therapy. The patient's family history was not provided. At the time of the event, the patient had ongoing multiple sclerosis (MS) diagnosed since Oct1991, did not tolerate sulfa, gabapentin, metoprolol succinate and another medication (unspecified medication) (hypersensitivity). The patient's muscles started going crazy (muscle disorder) (since last two years). On 15Dec2018, (latency: 6 months), patient experienced recurrent low grade headache that was aggravating with intensity mild (headache) and dragged her out and characterized by having a constant ache even before she woke up that was more in her forehead that any place else but did not get worse during the day and was just there. On an unknown date, unknown latency, the patient forgot the name of a medicine she used to take because her brain just went dead. Patient's bilirubin was out of rage by 2.0 (blood bilirubin abnormal), had hair loss/losing her hair (alopecia)  and there was something going on with her hair again (recurrent) and she was off teriflunomide. The patient did not know if her bilirubin was normal now, because her doctor moved and she had an appointment with him on 21-May-2019. She mentioned that she went to toilet bunch of time and stool was loose too, she took Imodium once in a while, recently her diarrhea was not that violent (diarrhoea). On unknown date in 2019, patient stopped ranitidine because she said it was causing cancer. Since an unknown date and latency, the patient  experienced mild bowel problem now (abdominal discomfort) and then for low grade headache that was aggravating. Patient used to take because her brain just went dead. In the past, patient reported she had tingling in her arm in both arms. Since, the last 2 months (date: unknown), it got worst in the right arm, the palm of her right hand did not feel right (paraesthesia). Upon follow up, it was reported that, on an unknown date (latency unknown) patient reported her mind did not work well anymore (mental impairment) seriousness criteria medically significant) as she had thought she could not get it out and could not process it. On an unknown date, (latency: unknown}, patient had vision changes after start of teriflunomide, heart started racing, pain in her legs and issues with her gait where she was not to able to walk as well. Patient had three MRls before COVID came about and were no changes with it but she was disappointed in the read out because they did not compare the MRls to the previous MRls. Patient previously used teriflunomide also. The patient was going to the emergency room and she stopped atenolol on 08Jul2020 and started verapamil on same day for her heart started racing. On an unknown date in Aug2020, patient had hand surgery for carpal tunnel. Nurse mentioned a couple of medications (unspecified) the doctor gave patient to set her multiple sclerosis off. On 08Sep2020, the patient started taking famotidine as she stopped taking ranitidine. On unknown date, the patient could not think straight, her brain was fried. All multiple sclerosis symptoms just were bonkers for 3 days. It made her heart rate race. The patient had a bad headache. It was reported that, patient had trouble with the stairs, her muscles in her leg and arms are not acting right ,  she could not walk properly with her left leg, it was starting to get to her knee. Further, patient had fever until the next day (pyrexia). The headaches sometimes goes away but she had it all the time, she was not a hundred percent. Patient heart medications (unspecified) changed so many times   due to the multiple sclerosis (MS) and her head was spinning. Treatment for headaches included paracetamol (Tylenol). There was no reported treatment for all other events. On Saturday (unspecified date), patient was a little better but she doesn't feel comfortable driving. At the time of the report, the patient feels a little better. At the time of report, teriflunomide was continued. The patient had a stress test on 20Apr2021. Corrective action/ treatment: throat lozenges (unspecified) for aphonia/ oropharyngeal pain; paracetamol (Tylenol) and Ibuprofen (Advil) for recurrent low grade headache that is  aggravating/ consistent headaches// In  the last week or two, consumer was more prone to having headaches/ bad headache, the headaches sometimes goes away but she has it al the time, imodium for diarrhea, the patient also reported the throat lozenge did soothe the throat  being sore but did not  stop it, no treatment for hair loss, confusion, stress; wearing reading glasses for visual impairment, using cane for gait disturbance, atenolol and verapamil for palpitations, hand surgery for carpal tunnel syndrome, not reported for rest f the events. Reporter causality: not reported for all events teriflunomide: related for headache, myalgia, fatigue , fever, palpitations and MS flare, nor reported for the rest of events w.r.t. COVID-19 vaccine. Company causality: not reportable for all events for both suspects. The action taken in response to the events for teriflunomide was dose not changed. The outcome of MS, brain dead, forgetting, losing voice, sore throat, fatigue, fever, muscle ache, bowel problems was recovered on unspecified date. The outcome of bilirubin was out of range, doesn't move very fast, palm of he hand doesn't feel right, brain disorder and tingling was unknown. The outcome of loose stool was recovering; and the outcome of the rest of events was not recovered.  No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.; Sender's Comments: Underlying medical condition multiple sclerosis, elderly age, concomitant medications and long-latency of onset of events the causal role of vaccine is unlikely.   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