Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Sleep disorder, Tinnitus, Tremor
Clinical narrative: Caller says she is below weight; She got sick; Precursor to seizures; Facial tremor; Severe migraine; Fever; Didn't sleep for five nights; Soaked in sweat; In her head she had unusual noises for example sometimes like an airhorn; Was seeing flashings lights and colors; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 1, single (Lot number: FP4554) at the age of 62 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: It was diagnosed about 10 years ago. She takes the Prednisone normally for her rheumatoid arthritis.; "Neuropathy" (ongoing), notes: She started taking both medications, Prednisone and Gabapentin, about 10 years ago.; "Lyme disease", start date: Sep1986 (unspecified if ongoing); "Mononucleosis", start date: 1975 (unspecified if ongoing), notes: She has been sick ever since.; "COVID" (unspecified if ongoing), notes: She kept getting COVID and getting sick and having to wait to get the vaccine; "Sick" (unspecified if ongoing), notes: She kept getting COVID and getting sick and having to wait to get the vaccine.; "Flu symptoms" (unspecified if ongoing), notes: She had flu symptoms every month and was horribly ill; "Horribly ill" (unspecified if ongoing), notes: She had flu symptoms every month and was horribly ill; "Depressed immune with underlying disease" (unspecified if ongoing), notes: Depressed immune with underlying disease; "Facial tremors" (unspecified if ongoing), notes: She had facial tremors in the past whenever she was undergoing viral infections; "Viral infections" (unspecified if ongoing), notes: She had facial tremors in the past whenever she was undergoing viral infections; "Facial paralysis" (unspecified if ongoing), notes: Has a history of Lyme disease that progressed to facial paralysis 30 years ago. Concomitant medication(s) included: PREDNISONE oral taken for rheumatoid arthritis; GABAPENTIN oral taken for neuropathy peripheral. She started taking both medications, Prednisone and Gabapentin, about 10 years ago. The following information was reported: SLEEP DISORDER (non-serious) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Didn't sleep for five nights"; TREMOR (non-serious) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Facial tremor"; PYREXIA (non-serious) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Fever"; TINNITUS (non-serious) with onset 26Apr2022, outcome "not recovered", described as "In her head she had unusual noises for example sometimes like an airhorn"; SEIZURE (medically significant) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Precursor to seizures"; MIGRAINE (non-serious) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Severe migraine"; HYPERHIDROSIS (non-serious) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Soaked in sweat"; PHOTOPSIA (non-serious) with onset 26Apr2022, outcome "recovered" (02May2022), described as "Was seeing flashings lights and colors"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Caller says she is below weight"; ILLNESS (non-serious), outcome "unknown", described as "She got sick". The patient underwent the following laboratory tests and procedures: Body temperature: Results unknown, notes: Temperature for her fever is unknown; Weight: Below weight, notes: Caller says she is below weight. Therapeutic measures were taken as a result of pyrexia which included Tramadol and Acetaminophen. The Tramadol was 50mg one daily, though she was doing it every 6-8 hours, which she clarified that the Tramadol was ordered as needed. The Acetaminophen was low dose, mixed, and probably around 325mg taken once daily by mouth. The patient received Pfizer COVID-19 vaccine on Sunday and then on Tuesday evening she had facial tremors, severe migraines, was seeing flashings lights and colors like the precursor to seizures, in her head she had unusual and weird noises for example sometimes like an airhorn and a fever every day and she was in bed for five days. She said seeing flashing lights and colors was scary. She didn't sleep for five nights, she was so soaked in sweat. This was not really serious, it began on 26Apr2022 and stopped about the same time as the others. The patient said that she believes her reaction was due to her medical history. She just had the reaction after the vaccine a week ago that day. The patient got the vaccine because she kept getting COVID and getting sick and had to wait to get the vaccine. She had flu symptoms every month and was horribly ill though her lungs were not affected and she was just as confused about this. She has a depressed immune with underlying disease, which she assumes was why she reacted to the vaccine. She got the vaccine because she was trying to prevent getting COVID. She did not provide the dates she had COVID prior to getting the vaccine. She had felt the best she had felt in two months, which was why she went and got the vaccine. She had facial tremors in the past whenever she was undergoing viral infections. She said at the moment it had resolved and that day which was Monday was the first day she felt ok. She had a history of lyme disease that progressed to facial paralysis 30 years ago. She took Prednisone and Gabapentin. Prednisone was 5mg and she takes one daily by mouth. She was so sick in bed she couldn't take her regular medications. She takes the Prednisone normally for her rheumatoid arthritis. She takes Gabapentin 300mg twice daily by mouth, which she clarified is taken normally for neuropathy. She started taking both medications, Prednisone and Gabapentin, about 10 years ago. She said for the Prednisone, she was out of it, she just went back on it on Monday. The patient got the shot 24Apr2022 and the tremors started on the 26Apr2022, they started then just went away on 02May2022. The migraines and seeing flashing lights gradually tapered off and Sunday she had to lay down. That day was the first day everything disappeared. She still had some whooshing noises, but she hadn't had those that day, knock on wood. The temperature for her fever was unknown, it was gone by that day, her fever kind of went away on Saturday. There was bloodwork ordered by her rheumatologist but then she got sick so she hasn't had those drawn yet. The case was assessed as non-serious.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 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.