Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebral haemorrhage, Exophthalmos, Gait disturbance, Inappropriate schedule of product administration
Clinical narrative: Severe brain bleed; Has a paralyzed leg that keeps him from walking normally/had a paralyzed arm and leg; Atrial fibrillation; Woken up by his eyeballs popping out of eye sockets; Worst pain; Has a paralyzed leg that keeps him from walking normally; Inappropriate schedule of vaccine administered/Took first vaccine in April and second in August; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Lot number: EW0175, Expiration Date: Aug2021) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Knee replacements" (unspecified if ongoing), notes: The worst medical problem prior to vaccine was from football and he had knee replacements. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: ER2613), administration date: 25Mar2021, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered/Took first vaccine in April and second in August"; CEREBRAL HAEMORRHAGE (hospitalization, disability, medically significant, life threatening) with onset 14Dec2021 at 06:30, outcome "unknown", described as "Severe brain bleed"; MONOPLEGIA (disability, medically significant), outcome "unknown", described as "Has a paralyzed leg that keeps him from walking normally/had a paralyzed arm and leg"; ATRIAL FIBRILLATION (disability, medically significant), outcome "unknown"; EXOPHTHALMOS (disability, medically significant), outcome "unknown", described as "Woken up by his eyeballs popping out of eye sockets"; PAIN (disability), outcome "unknown", described as "Worst pain"; GAIT DISTURBANCE (disability), outcome "unknown", described as "Has a paralyzed leg that keeps him from walking normally". The events "has a paralyzed leg that keeps him from walking normally/had a paralyzed arm and leg", "atrial fibrillation", "woken up by his eyeballs popping out of eye sockets", "worst pain" and "has a paralyzed leg that keeps him from walking normally" required physician office visit. The event "severe brain bleed" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cerebral haemorrhage. Clinical course: Patient had been a lucky person but was unlucky with the vaccine. He was the healthiest 72 year and had been in dental practice for 50 years. He ran 3 miles every 2 to 3 days and exercised regularly. He was the picture of health. He took first vaccine in April and second in August. He didn't have any medical problems. On 14Dec2021 he was woken up by his eyeballs popping out of eye sockets. It was like the movie when they were thrown out of the building into exterior with no air pressure and their eyes were coming out of head. It was worst pain he had. He had a severe brain bleed. It took away his life. He could not practiced dentistry anymore. He could not play with kids. He had to have a craniotomy. He was in rehab for a year. He had a paralyzed leg that kept him from walking normally. He had a paralyzed arm and leg, but the right arm was fine that came back. He could not walk with walker or cane. His left leg was paralyzed. He had to give up life and career. Had good income, but had lots of bills. This took him out. He crashed and burned. Ever since he was born and going through school he played all sports. In college he played tennis. He got into medical school at University. He had learned to do landscaping, but he could not do any landscaping this past June. This was depressing. Caller lost a son aged 7 to brain and that was depressing, but caller never had to take medications. He had lost so much because he could not pay bills. He was making decent money as dentist and wants to pay his bills. He almost lost his life. He had to be resuscitated 3 times. He had brain surgery and then rehab for a year. He felt like a cripple. He could not work and still had bills. His wife's health had been ruined trying to nurse him back. He was not all back. He could not do anything with left leg. He could not tell if he picked up leg because he could not feel it. He could not walk with cane because could not put pressure on it. Patient had a cardiologist and neurologist all in. The surgeon sent 40 pages of notes to neurologist. The brain bleed started at 6:30AM on 14Dec2021. It was life threatening because he died 4 times in surgery and ICU (Intensive care unit). They had to resuscitate him. This had caused him to have atrial fibrillation. He had been on monitors and stuff for the last 9 months.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events Cerebral haemorrhage, Monoplegia, Atrial fibrillation, Exophthalmos, pain, gait disturbance and BNT162B2 is considered possible. 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.