Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Confusional state, Electroencephalogram
Clinical narrative: Stroke; Tonsillitis; Confusion; This is a solicited report from the marketing program 'Facilitated Collect' received from a contactable consumer (patient) based on information received by Pfizer from via (Manufacturer Control Number: 21K-163-3999881-00).  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via intramuscular, on 17Mar2021 at single dose for COVID-19 immunisation. Co-suspect drug includes adalimumab (HUMIRA), via subcutaneous, at dose of 40 mg cyclic (1 in 2 weeks) from 2016 to an unspecified date on Feb2021 and then restarted in Feb2021 at same dose and regimen for moderate to severe rheumatoid arthritis. The patient is a non-smoker and abstains from alcohol. Relevant medical history included back problems, rheumatoid arthritis, high blood pressure, depression, anxiety, acid reflux, patent foramen ovale, weight loss, fluid retention, allergies, chronic pain in back and legs, insomnia and anti-inflammatory therapy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Past drug history included allergy manifested by hives to acetylsalicylic acid (ASPIRIN), naproxen sodium (ALEVE), ibuprofen, benzylpenicillin potassium (PENICILLIN), and naproxen. Relevant concomitant medications included paracetamol (TYLENOL), cefixime (FLEXERIL) for back problems, gabapentin (NEURONTIN) as anti-inflammatory therapy, prednisone for rheumatoid arthritis, methotrexate for rheumatoid arthritis, folic acid for rheumatoid arthritis, amlodipine besilate (NORVASC) for high blood pressure, escitalopram oxalate (LEXAPRO) for depression, buspirone hydrochloride (BUSPAR) for anxiety, alprazolam (XANAX) for anxiety, aluminum hydroxide gel, dried, magnesium carbonate (PEPCID) for acid reflux, clopidogrel bisulfate (PLAVIX) for patent foramen ovale, phentermine for weight loss, furosemide sodium (LASIX) for fluid retention, colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), cetirizine for allergies, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) for chronic pain in back and legs, trazodone for insomnia, losartan potassium (COZAAR) for high blood pressure, and multivitamin.  In Dec2020 the patient had tonsillitis. In Feb2021, physical examination of throat revealed tonsils infected and on 04Feb2021, the patient underwent removal of her tonsils because it was infected and was hospitalized overnight. She was prescribed antibiotics (unspecified) for two weeks. She stopped taking HUMIRA when she was taking her antibiotics as advised by her physician. On 18Mar2021, the patient had stroke for which she was hospitalized for 3 days. The event stroke was also considered medically significant. She was given tissue plasminogen activator to stop her stroke. She believed that she had her stroke when she received her COVID 19 Vaccine because it was her vaccinations a day before she had her stoke. She was kicked by her student which was autistic in the head. On unknown date, the patient presented confusional state. On 18Mar2021, blood test, computerized tomogram and electroencephalogram were normal. The patient had recovered from stroke in 2021; she was recovering from confusion; and she had recovered from tonsillitis in 2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via intramuscular, on 05Apr2021 to complete COVID-19 immunisation.   Pfizer's statement: The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the events of stroke, tonsillitis and confusion with adalimumab (HUMIRA) was no reasonable possibility.   Manufacturer opinion is that there is no reasonable possibility that the events of stroke, and confusion are related to adalimumab (HUMIRA). Manufacturer opinion is that there is a reasonable possibility that the event of tonsillitis (infected tonsils) is related to adalimumab (HUMIRA).  No follow-up attempts are possible;  information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: The events are considered intercurrent conditions and unrelated to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown).