Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Acute kidney injury, Blood creatinine increased, Colitis, Haematochezia, Hepatic enzyme increased
Clinical narrative: spike in his liver enzymes; Creatinine level of 9.61; Acute kidney injury; pretty bad colitis symptoms; Decrease of kidney function/his kidney function is down; Bloody water in stool; he also has Norovirus.; This serious case was reported by a pharmacist via call center representative and described the occurrence of elevated liver enzymes in a 30-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13-APR-2024, the patient received Boostrix. In APR-2024, an unknown time after receiving Boostrix, the patient experienced elevated liver enzymes (Verbatim: spike in his liver enzymes) (serious criteria hospitalization), creatinine increased (Verbatim: Creatinine level of 9.61) (serious criteria hospitalization), acute kidney injury (Verbatim: Acute kidney injury) (serious criteria GSK medically significant), colitis (Verbatim: pretty bad colitis symptoms) (serious criteria GSK medically significant), function kidney decreased (Verbatim: Decrease of kidney function/his kidney function is down) (serious criteria GSK medically significant), blood in stool (Verbatim: Bloody water in stool) (serious criteria GSK medically significant) and norovirus infection (Verbatim: he also has Norovirus.). In APR-2024, the outcome of the elevated liver enzymes was resolved. The outcome of the creatinine increased was resolving and the outcome of the acute kidney injury, colitis, blood in stool and norovirus infection were unknown and the outcome of the function kidney decreased was not resolved.   It was unknown if the reporter considered the elevated liver enzymes, creatinine increased, acute kidney injury, colitis, function kidney decreased, blood in stool and norovirus infection to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the elevated liver enzymes, creatinine increased, acute kidney injury, colitis, function kidney decreased, blood in stool and norovirus infection to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 18-APR-2024 A pharmacist reported that a patient received Boostrix, and then was admitted to the hospital with like a spike in his liver enzymes, and now he had an acute kidney injury, his kidney function is down to, like, his creatinine was now 9.06, and he had pretty bad colitis symptoms. The liver enzymes had resolved, but the kidney function continues to decline, and he also had norovirus. The reporter mentioned that the patient was admitted to the hospital on 14th April 2024 and also reporter mentioned that when the patient was admitted to the hospital, the creatinine levels of the patient were 1.61.  The reporter also mentioned that the patient had bloody water in stool. The reporter was not able to provide details on vaccine lot number since it was administered on another facility, but agreed to follow up by safety team.