Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood test, Myocarditis
Clinical narrative: acute renal failure; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 72-year-old male patient received bnt162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "had a bunch of problems after the third dose"; Prevnar 13, when the patient was 65 years old, for Immunization; Pneumovax 23, when the patient was 66 years old, for Immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "acute renal failure"; MYOCARDITIS (medically significant), 5 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy kidney: acute interstitial nephritis and acute tubular nec, notes: His renal biopsy indicated acute interstitial nephritis and acute tubular necrosis; Blood test: Stable, notes: A week or two prior the patient's blood work was stable.  Clinical course: AE filed for myocarditis and acute kidney injury, caller (physician) believes AE was already filed with VAERS Additional AE Details: Gastroenterologist, calling on behalf of patient, male, (ethnicity-withheld), aged 72, who is on the cusp of needing a renal transplant, is asking about Prevnar 20. The patient had a previous reaction to the original Pfizer BioNTech Covid 19 vaccine (BNT162B2, not the bivalent formulation) last spring. It was after his fourth dose of the Pfizer Covid vaccine. A week or two prior the patient's bloodwork was stable. However, 5 days after receiving his fourth dose of the Pfizer BioNTech Covid 19 vaccine original BNT162B2, he developed renal failure. He also developed myocarditis. His renal biopsy indicated acute interstitial nephritis and acute tubular necrosis. He probably had a bunch of problems after the third dose of the Pfizer Covid vaccine but got the acute renal failure and myocarditis after dose 4. The myocarditis has since resolved but the kidney damage has not. There was nothing else that changed in that time frame, there isn't another explanation other than the Pfizer Covid vaccine. It is unknown what component of the vaccine could have caused the renal damage. Patient had Prevnar 13 at age 65 and received Pneumovax 23 the following year at age 66 with no problems. Because its been longer than 5 years, he is being recommended a dose of Prevnar 20. The physician sees that someone shouldn't get Prevnar 20 if they've had a severe reaction to any component of Prevnar 20. He doesn't want the patient's kidneys to get even worse. Caller (Physician) would like to know a safety information for Prevnar 20, patient has allergic reaction and the patient is very worried to get the vaccine, and this is for the preparation for the surgery of the patient and also mention that the patient already got the Covid vaccine. Caller stated that Are there any common components of Prevnar 20 and the original Pfizer BioNTech Covid 19 vaccines 12+? Is there a known compound in the Pfizer Covid vaccine that is known to cause kidney failure, and if so, is it in the Prevnar 20 vaccine?.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the given information and temporal association ,the possible contributory role of the suspect for the event acute kidney injury and myocarditis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.