Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysuria, Haemorrhage urinary tract, Impaired work ability, Renal haemorrhage, Ultrasound pelvis
Clinical narrative: Heavy clotting issues in my left kidney through my bladder which is causing urinary issues; Urinating large blood clots; Hemorrhaging blood clots/ bleeding; This is spontaneous report from a contactable consumer, the patient. A 52-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 21May2021 10:10 (reported as 10:10 EST) (at the age of 52-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22May2021, the patient called to report an adverse reaction to 1st dose of vaccine, and currently in the emergency room (ER) at the hospital, in a bed with heavy clotting issues in his left kidney through his bladder which was causing urinary issues, literally urinating large blood clots. He currently had a catheter in, they have done blood work and CT scan, but no results provided. The patient had no issues with anything with prostate or kidney but hemorrhaging blood clots. The patient was not yet admitted to the hospital, just in the ER somewhere around 10:00 in the morning. The patient had a follow up and still at home had a catheter and still he was bleeding and follow up tomorrow with Urology department at 10:00; had full blood work follow up tomorrow and had a CT scan. Everything came back as normal as far as his organs go. The patient added, "I would appreciate it if someone would call me with some professional advice what I should do about this whether I need to take the second dose. I need some clarification on what is going on with this and then I need to have a discussion on whether I should take the second dose or not." The outcome of the event was not recovered, at the time of this report. The seriousness of the events was unspecified by the reporter.  There is a medical information request included Caller (male, age 52 years)- his question was the first and 2nd dose the same. Tomorrow he should have the full make up back and causes of this from the doctor. It has been a rather traumatic event which he thought was going to be nothing." Due date of second dose. Response included: As noted in the Fact Sheet for Recipients, the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They refer him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knows your health situation and has access to information that can better help inform this decision. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine." and from VR-As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with doctor/healthcare provider about what he had experienced/were experiencing.  Information on Lot/Batch number has been requested.