Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Biopsy, Brain oedema, Cerebral haemorrhage, Cerebral venous thrombosis
Clinical narrative: Cerebral venous thrombosis; bilateral intracerebral hemorrhage in the left, greater than the right; tonic-clonic seizure; brain swelling/cerebral edema; headaches; overall imbalance/having balance problems; he had a decline; kind of getting worse/ had the worst symptoms; His prostate is enlarged; patient's mental status is altered; This is a spontaneous report from a contactable physician. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EN6203) as 0.3 ml single for COVID-19 immunisation. Patient age at vaccination was 65 years old. Medical history included hyperlipidemia and high cholesterol. Historical vaccine included 1st dose of BNT162B2 (LOT: EL3247) on 03Feb2021 for COVID-19 immunisation. Concomitant medication included pravastatin (strength: 10 mg) taken for an unspecified indication from an unspecified start date and ongoing. Reporter did not know all of the symptoms that the patient had and cannot get the history, because the patient's mental status was altered (from unknown date in 2021). It was reported that he was having symptoms for at least 2 weeks with some increasing over the last 2 weeks. Knew that he had an overall imbalance and was having headaches, both from unknown date in May2021. He had been having symptoms for weeks and went to his doctor as an outpatient. He had initial imaging that was concerning and he went to the hospital because he had a decline (from unknown date in 2021). He had declined and had a hemorrhagic hemorrhage with cerebral venous thrombosis, both from 04Jun2021. He was admitted to the hospital 04Jun2021, and 05Jun2021 he was transferred to the ICU. He had declined since his initial presentation and had been kind of getting worse over the last couple of weeks. Stated the patient was stoic and does not have a lot of medical problems, but everyone knew he was having symptoms over the last 2 weeks. 02Jun2021 he had the worst symptoms and was basically having balance problems. He was getting concerned and had called to get an appointment with his primary care physician. They had done an outpatient CT scan which found the cerebral venous thrombosis and he went to the hospital and was placed on Heparin. While in the hospital, he had a generalized tonic-clonic seizure and had further decline on 04Jun2021. Repeat imaging showed that he had bilateral intracerebral hemorrhaging, the left greater than the right, and they had expanded a bit. He was still on heparin and now (Jun2021) had some cerebral edema due to it but was not on a ventilator. He was still in the time period where he was continuing to have small declines. He was therapeutic on heparin. He had a central line and was getting hypertonic saline for the brain swelling and cerebral edema. Patient previous health condition was reported as he did not have a real significant past medical history. He maybe carried a diagnosis of hyperlipidemia and high cholesterol. He was pretty healthy; regularly went to the doctor and was otherwise pretty stable. Reporter did not even think his LDL was that high. He had never been on any blood thinners or anything like that. They did a full scan to look for cancer and had no history of blood clots. They did a scan that was negative for any types of masses or any concerns for cancer. His prostate was enlarged (from unknown date in 2021) and they had spoken to the family about it and they said he had been worked up with a biopsy which had been negative. Physician Office? Yes, He was directly admitted to the hospital from primary care. He presented to the clinic because he had these symptoms and headaches. The imaging was done and then he was admitted. He never went through the emergency room. Cerebral venous thrombosis, bilateral intracerebral hemorrhage, overall imbalance/having balance problems, he had a decline, headaches resulted in Physician Office Visit. Outcome of cerebral venous thrombosis, bilateral intracerebral hemorrhage was not resolved; outcome of tonic-clonic seizure, brain swelling/cerebral edema, headache, overall imbalance/having balance problems, he had a decline, kind of getting worse/ had the worst symptoms, enlarged prostate and mental status was altered was unknown. Causality: Cerebral venous thrombosis: Can't say for sure because reporter does not know the timeline but can't find any other reason, he would have cerebral venous thrombosis.; Sender's Comments: Based on the temporal relationship, the association between the events cerebral venous thrombosis, intracerebral hemorrhage, tonic-clonic seizure, and brain swelling with BNT162b2 can not be fully 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.