Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug Ineffective; Covid-19 Infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 80 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cerebral infarction", start date: 03May2021 (unspecified if ongoing); "Cerebral hemorrhage", start date: 31Jul2021 (unspecified if ongoing), notes: Right ACA infarct with right parietal IPH; "Vascular dementia" (unspecified if ongoing); "Prostate cancer metastatic" (ongoing), notes: receiving Lupron injections Q3 monthly; "Bladder incontinence" (unspecified if ongoing); "Hemoptysis" (unspecified if ongoing); "Fever" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN taken for cerebrovascular accident prophylaxis, stop date: 29Dec2021; ASPIRIN [ACETYLSALICYLIC ACID], stop date: 29Dec2021; PLACEBO, stop date: 29Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Jan2022, outcome "recovered" (04Jan2022), described as "Drug Ineffective"; COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (04Jan2022), described as "Covid-19 Infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Nasopharangeal specimen for Covid-19 collected at 01:27 hours, resulted positive for Covid.  Clinical course: Patient has had 3 doses of Pfizer Vaccine. Patient was enrolled in a phase III study titled "Atrial Cardiopathy and Antithrombotic Drugs in prevention after cryptogenic stroke". On an unknown date, the subject started apixaban; aspirin; placebo (unknown route). On 01Jan2022, an unknown time after starting apixaban; aspirin; placebo, the subject experienced COVID-19 (Covid-19 Infection). On 04Jan2022, COVID-19 resolved. On 01Jan2022, patient admitted to hospital for syncope workup. Found to be incidentally positive for Covid. While in the ER (emergency room) complained of cough productive of white phlegm and streaks of blood. Intermittently febrile. During 4 days of hospitalization patient in isolation with Covid precautions as per hospital policy. According to daughter last dose of study drug was on 29Dec2021 in morning. He stopped taking it because his throat was hurting. On 01Jan2022, order written for Aspirin 81 mg once a day while in hospital and to resume study drug on DC at home. Discharged home on 04Jan2022 at 22:00. Spoke to daughter who said he would resume study drug 05Jan2022. For apixaban; aspirin; placebo (unknown), the reporter considered COVID-19 to be not related.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.