Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation factor, Coagulation factor increased, Retinal artery occlusion, Visual impairment
Clinical narrative: retinal artery occlusion; partially blind; elevated COAG; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 94-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration at the end of February or early March in 2021 at 93 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine) in Feb2021 at 93 years old for covid-19 immunization. Caller is a physician calling on behalf of a 94-year-old male patient, who received the second dose of the Pfizer COVID-19 vaccine. Two days post vaccination in 2021, he was diagnosed with retinal artery occlusion, rendering patient partially blind. The patient had elevated COAG. Physician says for treatment the patient went to the ER and they did coags but there was nothing they can do, then literally two days later the patient's coags were normal. He says those doctors felt that some people do have increased coags after the vaccine, so they thought it could be from it but no one could say for sure. According to the hematologist, the condition may be a result of the vaccine. Patient wants to receive the booster dose of the vaccine and is a healthy 94-year-old, but there could be a risk of another occlusion or a stroke of another type if the patient did get a booster dose. The physician is looking for guidance in terms of the eligibility and safety of a booster dose for this patient. He is trying to outweigh the benefits and risks of a booster dose: protection against SARS COVID virus and possible risk of complete blindness considering his age. Patient was hospitalized from Mar2021. Physician said they actually said he wouldn't but the blindness had gotten about 40% better. Physician said the patient was in the hospital for a day while they checked him out, then he was discharged. He said he thought the hospitalization was in March. Physician said that he felt this is medically significant with the patient losing sight in one eye. The outcome of the events retinal artery occlusion and partially blind was recovering, of elevated COAG was recovered in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events Retinal artery occlusion,Visual impairment,Coagulation factor increased  and suspected drug 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