Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Chest discomfort, Computerised tomogram, Dehydration
Clinical narrative: Pain in her upper back; Doctor diagnosis regarding her urine and the 8 cups of blood, was cancer; Product caused internal bleeding; White blood cells in urine; Urinated 8 cupful of blood bright red gushing in her urine sample; Lightheaded; Heaviness in chest; Heaviness in shoulder; Sore arm; Pain while urinating was so horrific; Logy feeling; Still was not feeling well; She's probably lost more weight; She lost so much fluid; She does feel weak.; Psychological issues; Tired; Feeling short of breath; This is a spontaneous report from a contactable physician (patient).   A 67-year-old female (patient) reported for herself who received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FE3592 ), via an unspecified route of administration in right arm on 16Sep2021 (on Thursday) at 09:00 (at the age of 67-year-old) as dose 1, single for covid-19 immunization at pharmacy/drug store facility. Vaccine administered at military facility was no. Medical history included graves disease from 1990 or1991 and came back in 1995, reflex sympathetic dystrophy in her left foot in 1982 and had to be hospitalized for 3 weeks to receive high doses of Prednisone, shingles with severe chest pain in 2018 and she was treated with an antiviral medication, heart problems like heart valve replacement, pericarditis since two years, thyroid therapy and history of allergies to antibiotics. She has no history of urinary problems or infection. Concomitant medication included Aspirin (acetylsalicylic acid) 81 mg daily since having her heart valve replacement, Synthroid (levothyroxine sodium) 100 mcg daily and she had the radioactive iodine to obliterate her thyroid. The patient received tetanus booster in Jan2020 and experienced sore arm, prior to the vaccination. No other vaccines administered on the same day of vaccination. Next day of vaccination on 17Sep2021 (about 24hrs later), she was lightheaded, sore arm and started to feel a heaviness in both shoulders, chest and a logy feeling. She then urinated with excruciating pain and 8 cupsful of blood. The pain while urinating was so horrific. She took photos of her undergarments and the toilet bowl. She went to physician office at 15:30 on Friday and suggested to go to emergency room. She went to emergency room at 15:30 on 17Sep2021, the first doctor she saw and the emergency room doctor both saw the bright red blood in her urine sample. It was many samples of urine over a period of 13:00 to 21:00 on Friday, 17Sep2021, the day after she received the vaccine. Doctor checked for urine infection, and it was negative, and she was fine until she received the Covid 19 vaccine. She states two doctors and her pharmacist believe the Pfizer Covid 19 vaccine caused internal bleeding. She doesn't have any blood that she can see in her urine like the bright red gushing blood she had. She has to follow up with her doctor and have some more blood work like her platelets. She knows this reaction can go on for 2 months and of course she was not going to get the second vaccine. She thought she would get the two vaccine doses and be protected but what happened to her was a catastrophe and she was scared to death for getting Covid 19 vaccine if something would happen, and it did. She was not admitted to the hospital, she was discharged from the emergency room because the bleeding had stopped on its own at about 21:00 Friday night. She doesn't know if she's out of the woods yet. Based on the number of WBC in urine she was prescribed an antibiotic. She has many allergies to antibiotics, and she was told this antibiotic should be ok for her to take. She has started taking it and the next day on 18Sep2021, she thinks she was getting side effects from the antibiotic like pain in her upper back. She doesn't know if it's from the antibiotic or the Covid 19 vaccine. Since the urine test was negative for infection she doesn't know if she should keep taking it. The last time she had an antibiotic was when she had her heart surgery. She had IV antibiotics at that time about 2 years ago. The antibiotic that was prescribed was Cefdinir 300mg twice daily for 7 days. She was on day 3. It was in a pharmacy bottle; she does not have the NDC/lot/Expiry. She hasn't taken her pill yet this morning but she's leaning towards continuing taking it. On an unspecified date in 2021, when probing weight, she weighed 135 lbs, with clothes on at the doctor's office, now she weighs 133 lbs. She lost so much fluid and blood she was probably lost more weight. She would like to add that she hasn't had any heart tests yet. She will be following up with her cardiologist to have an EKG. She does feel weak. She had no other urinary symptoms, and doctor told the reporter and her daughter she had cancer. That was all the doctors could say was cancer. One doctor she saw doesn't think she has an infection, that doctor thinks she has cancer and now she has psychological issues because this doctor mentioned the word cancer. This doctor recommended the caller be tested for 3 types of cancer. She states she was tired and not feeling well. She does blame the Covid 19 vaccine and if she had a million dollars, she would bet that her side effects are from the vaccine. She doesn't know if it was the Covid 19 vaccine or her heart issues, but she was also feeling short of breath. The patient underwent lab tests and procedures which included urinary infection was negative in both facilities. There was no evidence of infection on CT scan in emergency room. Blood work done, CBC, white blood cells in her urine. She reports the test showed 50 and she should only have about 5. The outcome of the events urinated 8 cupful of blood look like bright red gushing blood in her urine sample and product caused internal bleeding was recovered as bleeding stopped on 17Sep2021 and remaining all events were reported as unknown.   No follow up attempts were needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Cancer, Internal bleeding 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.