Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Loss of personal independence in daily activities, Magnetic resonance imaging, Neck pain, Thrombosis
Clinical narrative: stroke; He had a TIA and visual changes with a headache on 10Oct2021; He had a TIA and visual changes with a headache on 10Oct2021; Neck pain on the right side of his neck; He said that the Dissection clotted and then embolized on 12Oct2021; He said that the Dissection clotted and then embolized on 12Oct2021; Vertebral artery dissection; He had a TIA and visual changes with a headache on 10Oct2021; He cannot longer work or drive/ difficulty reading emails; he is legally blind from the stroke; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 2, Single, Expiry: Unknown , Site: Left arm, 30mcg/0.3ml), administration date: 20Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 1, Single, Expiry: Unknown, Site: Left arm injection, 30mcg/0.3ml), administration date: 30Dec2020, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 10Oct2021, outcome "unknown", TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 10Oct2021 at 15:00, outcome "unknown", HEADACHE (non-serious), outcome "unknown" and all described as "He had a TIA and visual changes with a headache on 10Oct2021"; VERTEBRAL ARTERY DISSECTION (prolonged hospitalization, disability, medically significant, life threatening) with onset 10Oct2021, outcome "recovered with sequelae"; THROMBOSIS (medically significant), EMBOLISM (medically significant) all with onset 12Oct2021, outcome "unknown" and all described as "He said that the Dissection clotted and then embolized on 12Oct2021"; CEREBROVASCULAR ACCIDENT (prolonged hospitalization, disability, medically significant, life threatening) with onset 12Oct2021 at 18:00, outcome "unknown", described as "stroke"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "He cannot longer work or drive/ difficulty reading emails"; BLINDNESS (medically significant) with onset Oct2021, outcome "unknown", described as "he is legally blind from the stroke"; NECK PAIN (non-serious), outcome "unknown", described as "Neck pain on the right side of his neck". The patient prolonged hospitalization for cerebrovascular accident (start date: 12Oct2021, discharge date: 21Oct2021, hospitalization duration: 9 day(s)); for vertebral artery dissection (start date: 10Oct2021); the patient was hospitalized for transient ischaemic attack (start date: 10Oct2021, discharge date: 11Oct2021, hospitalization duration: 1 day(s)). The events "stroke", "vertebral artery dissection" and "he had a tia and visual changes with a headache on 10oct2021" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: showed a a Stroke, notes: MRA and CTA showed a a Stroke on both. He had dopplers of legs which were negative; showed a a Stroke, notes: MRA and CTA showed a a Stroke on both. He had dopplers of legs which were negative. Right vertebral artery V3 segment; all the labs were fine: all the labs were fine; Magnetic resonance imaging: Normal, notes: MRI of heart was normal Event monitor showed no evidence of AFib; Ultrasound Doppler: Negative, notes: He had dopplers of legs which were negative.  Clinical information: Patient was a 60 year old MD who was asking for information for the bivalent presentation of Comirnaty.  He had a booster dose on 20Sep2021. After that, he had stroke on 12Oct2021. He would like another booster, but was hesitant because of that stroke. It was not an embolism to begin with, but had a clot due to a vertebral artery dissection. Caller was a physician that believed he had an adverse event after receiving the Pfizer Covid-19 vaccine Booster dose. He received the booster on 20Sep2021 and had a vertebral artery dissection 3 weeks later and a stroke. He knows the spike protein is cytotoxic to endothelial cells. It can induce endothelial cell damage. He had the stroke on 12Oct2021. He was hoping to get a new booster and is hesitant to do it at this point. He has been left legally blind from the stroke and has could not fill anything out online. Patient was in the intensive care unit for 9 days and was now disabled. He could not longer work or drive. Caller was unsure of the Vaccine cap color. The patient was hospitalized, first time from 10Oct2021 to 11Oct2021, when he had the stroke he was in the hospital from 12Oct2021 thru 21Oct2021. Patient might have gotten a flu shot, but he was unsure. He did not remember the time frame. On 10Oct2021 no stroke, but evidence of dissection on the CTA and the MRA. On 12Oct2021 that is when he had the stroke and emboli was evident on CTA and MRA. Had a large stroke on the right and a stroke on the Left.  No follow-up attempts are possible. No further information is expected.; 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.