Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Visual field defect
Clinical narrative: Stroke; Blood pressure high; Vision peripheral decreased; Joint stiffness; Numbness on left side of body; This is a solicited report from non-Pfizer sponsored marketing program based on the information received by Pfizer from Compay (MFR Control No. # 21K-163-3921608-00).   A contactable consumer reported that a 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at age of 61 years old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 2016 (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe adult crohns disease. Medical history included alcohol use started from 1976, rarely use beer and red wine; tobacco use from 1976 to 2021, a pack of cigarettes a day; and moderate to severe adult crohns disease. Concomitant medications included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (BABY ASPIRIN); both taken for prevent another episode of stroke. The patient previously received the first dose of bnt162b2 intramuscularly in Mar2021 at age of 61 years old for COVID-19 immunisation. The patient experienced stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body on 14May2021. Event stroke was serious per hospitalization, other events were reported as non-serious. Event details: On 14May2021, the patient experienced numbness on left side of body and peripheral vision on left side was affected. On the same day, he had stroke and was hospitalized due to that. He had physical occupational therapy after within two weeks when he returned home from the hospital. His blood pressure was high but could not remember the exact number. His joints got stiff with colder weather. He had unspecified high blood pressure pill as part of his concomitant medications. The action taken in response to the events for adalimumab was dose not changed. The outcome of event stroke was resolving, outcome of event blood pressure high was resolved, outcome of event joint stiffness was not resolved, outcome of other events was unknown.  Causality for adalimumab: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with adalimumab was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with adalimumab was not provided. Company's opinion was that there was no reasonable possibility that the events of stroke, blood pressure high, vision peripheral decreased, joint stiffness were related to adalimumab.  Causality for bnt162b2: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with bnt162b2 was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with bnt162b2 was not provided.   The reporter's assessment of the causal relationship of the events joint stiffness and numbness on left side of body with the suspect product bnt162b2 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.  No follow-up attempts are needed. Information on the lot number cannot be obtained.; Sender's Comments: The events stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body were considered as unrelated tot he use of bnt162b2. Patient received 2nd dose of bnt162b2 in Mar2021 and the events occurred on 14May2021. The temporal relationship between the events and bnt162b2 is weak.